Running head: EVALUATION OF ANTICOAGULATION CLINIC€¦ · Running head: EVALUATION OF...

Running head: EVALUATION OF ANTICOAGULATION CLINIC

Program Evaluation of a Nurse-Managed Anticoagulation Clinic Protocol

Nathan W. Samuels

Doctor of Nursing Practice Capstone

Simmons College

Author Note

Nathan W. Samuels, School of Nursing and Health Sciences, Simmons College.

Correspondence concerning this article should be addressed to Nathan W. Samuels,

Department of Nursing, Simmons College, 300 The Fenway, Boston, MA 02115. E-mail:

[email protected]

© 2011 Nathan W. Samuels

EVALUATION OF ANTICOAGULATION CLINIC ii

The Capstone Manuscript of Nathan W. Samuels entitled

Program Evaluation of a Nurse-Managed Anticoagulation Clinic Protocol

in partial fulfillment of the requirements for the degree of

Doctor of Nursing Practice

in the School of Nursing and Health Sciences at Simmons College

has been read and approved by the Capstone Committee:

_________________________________________

First Chair: Susan Duty, Sc.D., ANP-BC

_________________________________________

Second Chair: Patricia White, Ph.D., ANP-BC

_________________________________________

Third Chair: David E.Schwartz, M.D.

_________________________________________

Program Director: Susan Neary, Ph.D., ANP-BC

Date:____________________

EVALUATION OF ANTICOAGULATION CLINIC iii

Abstract

Nurse-managed anticoagulation programs are employed to provide safe and effective

management of anticoagulant therapy. There is no standardization of dosing protocols for

the nurses who manage this therapy, and various treatment algorithms have been developed,

each with its own benefits and limitations. Despite flexibility within dosing protocols, nurses

encounter situations in which they feel the algorithm directs them inappropriately. The

situations where nurses challenge the validity of protocols are not well understood or defined

in the literature. This program evaluation project studied an existing anticoagulation protocol

and identified clinical issues in the nurses‟ critical thinking processes that lead to clinical

dissonance through a series of focus groups and a comprehensive clinical audit. The process

exposed numerous clinical management issues within the existing anticoagulation protocol,

and then recommended evidence-based solutions from the findings in the literature and from

the outcomes data collected through the audit with the goal of improving the safety and

effectiveness of the clinic.

EVALUATION OF ANTICOAGULATION CLINIC iv

Acknowledgements

I would like to acknowledge the countless hours of work and the incredible support of all the

members of my capstone committee. Without their tireless commitment to the success of

this project, this capstone would not have been possible.

The clinic nurses and medical assistants have my deepest thanks for all of their efforts to

make this project a success, and for their investment in the process of program improvement.

Special thanks are in order to Ilana Steinhauer for her assistance and support in this project.

She went above and beyond her nursing and student responsibilities for this project. Her

dedication to this project is a testament to her professionalism and commitment to the field of

nursing.

Lastly, but very importantly, I would like to thank my family, classmates, and friends for

their encouragement, understanding, and support thought this process. The process of

becoming a DNP would not have been possible without you all.

EVALUATION OF ANTICOAGULATION CLINIC v

Table of Contents

Introduction ............................................................................................................................................ 1

Background Knowledge ...................................................................................................................... 2

Warfarin pharmacology. ................................................................................................................. 2

Anticoagulation clinics. ................................................................................................................... 3

Cost and efficacy............................................................................................................................. 6

Scope of practice. ........................................................................................................................... 7

Variability in practice. ..................................................................................................................... 9

Critical-thinking process. .............................................................................................................. 11

Organizational setting. ................................................................................................................. 14

Problem ............................................................................................................................................ 16

Intended Improvement .................................................................................................................... 17

Study Questions................................................................................................................................ 18

Methods ............................................................................................................................................... 19

Sample .............................................................................................................................................. 19

Setting............................................................................................................................................... 20

Planning ............................................................................................................................................ 20

Focus groups. ................................................................................................................................ 23

Audit tool development. .............................................................................................................. 24

Analysis ............................................................................................................................................. 26

Focus group analysis. .................................................................................................................... 26

Clinic audit analysis. ..................................................................................................................... 27

Second focus group analysis. ........................................................................................................ 28

Ethical Issues .................................................................................................................................... 28

Results .................................................................................................................................................. 29

Outcomes of Focus Group ................................................................................................................ 29

Medication interactions. .............................................................................................................. 30

New to wafarin/suspension of therapy. ....................................................................................... 30

Trending/history. .......................................................................................................................... 31

Dosing calculator ineffective. ....................................................................................................... 32

High-risk/concerning factors. ....................................................................................................... 33

EVALUATION OF ANTICOAGULATION CLINIC vi

Patient factors and extraneous factors. ....................................................................................... 33

Group standard. ........................................................................................................................... 35

Summary of focus group findings. ................................................................................................ 35

Methodological considerations. ................................................................................................... 36

Outcomes of Practice Audit .............................................................................................................. 37

Description of sample. .................................................................................................................. 38


New to warfarin/suspension of therapy. ..................................................................................... 42





Group standard. ........................................................................................................................... 45

Previously unidentified issues. ..................................................................................................... 47

Limitations. ................................................................................................................................... 50

Outcomes of Second Focus Group ................................................................................................... 52

Agreement with findings. ............................................................................................................. 53

Documentation hindrances. ......................................................................................................... 55

EMR deficiencies........................................................................................................................... 56

Routinized patterns of behavior. .................................................................................................. 57

Summary of second focus group findings. ................................................................................... 58

Discussion and Recommendations for Change .................................................................................... 58


New to warfarin/suspension of therapy. ..................................................................................... 62





Group standard. ........................................................................................................................... 67

Previously unidentified issues. ..................................................................................................... 70

Summary and recommendations. ................................................................................................ 71

Process Improvement Recommendations ........................................................................................... 73

EVALUATION OF ANTICOAGULATION CLINIC vii

Tracking and quality assurance. ................................................................................................... 73

Documentation of care. ................................................................................................................ 73

Protocol revisions. ........................................................................................................................ 73

Areas for nursing staff and clinic development. ........................................................................... 73

Proposed Phases of Implementation ................................................................................................... 74

Tables and Graphics ............................................................................................................................. 75

Table 1 .............................................................................................................................................. 75

Table 2 .............................................................................................................................................. 76

Table 3 .............................................................................................................................................. 80

Table 4 .............................................................................................................................................. 81

Table 5 .............................................................................................................................................. 82

Table 6 .............................................................................................................................................. 83

Table 7 .............................................................................................................................................. 84

Table 8 .............................................................................................................................................. 85

Table 9 .............................................................................................................................................. 88

Figure 1 ............................................................................................................................................. 89

Figure 2 ............................................................................................................................................. 90

Appendices ........................................................................................................................................... 91

Appendix A: Timeline of Events ........................................................................................................ 91

Appendix B: Informed Consent ........................................................................................................ 92

Appendix C: Confidentiality Agreement ........................................................................................... 93

Appendix D: Focus Group Guide (Session 1) .................................................................................... 94

Appendix E: Existing Protocol ........................................................................................................... 95

Appendix G: Audit Tools ................................................................................................................. 106

References .......................................................................................................................................... 107

EVALUATION OF ANTICOAGULATION CLINIC 1

Introduction

Successful systemic anticoagulation, specifically with warfarin, requires careful

monitoring, assessment, and adjustment of medication therapy. Anticoagulation Clinics have

been developed in various practice settings to help manage the substantial and growing

volume of patients receiving anticoagulant therapy. Hematology, Oncology, Cardiology,

Orthopedic, and Primary Care practices often utilize Anticoagulation Clinics to monitor and

adjust warfarin dosing for their patients. Treatment protocols and algorithms lack

standardization from institution to institution, and the credentialing of the providers who

manage therapy is also diverse (Ebell, 2005 & Francavilla, 2008). Clinics will often employ

the services of registered nurses (RNs), pharmacists, nurse practitioners, and physician

assistants for delivery of anticoagulant therapy services.

A major safety goal from The Joint Commission (2007) called for the reduction in the

likelihood of patient harm associated with the use of anticoagulant therapy. This program

evaluation project was commissioned the Medical Director of a nurse-managed

anticoagulation clinic to determine the current status and needs of the service. The project

analyzed the utility, reliability, and safety of the existing nurse-managed anticoagulation

protocol; examined the critical thinking processes employed by the nurses using the protocol;

and identified deficiencies in the protocol that required additional attention. Evidence-based

recommendations for change were provided, and ongoing performance-tracking measures

were established.


Background Knowledge

Anticoagulation management is a process by which patients are placed on blood-

thinning agents (anticoagulants) with the goal of preventing thrombotic and embolic events

in patients with various diagnoses and high-risk conditions (Baglin, Keeling, & Watson,

2005). A common method for providing anticoagulation therapy is through the use of

warfarin, an oral prescription medication. Warfarin therapy requires careful monitoring and

dose adjustment to maintain patients within a goal therapeutic range of coagulation measures.

The following review of literature will summarize the state of the science relating to warfarin

therapy care models, and evidence-based means to promote patient safety while providing

this therapy.

Warfarin pharmacology. The anticoagulant effect of warfarin is mediated through

inhibition of vitamin K-dependent coagulation factors, including clotting factors II, VII, IX,

and X (Valentine & Hull, 2009). Warfarin is rapidly absorbed in the GI tract, circulates

bound to plasma proteins, and has a half-life of 36 to 42 hours (Hirsh, Fuster, Ansell, &

Halperin, 2003). Warfarin is a racemic mixture of S and R enantiomers, and the more potent

S form of the drug is metabolized primarily by the hepatic CYP2C9 system. Because this

enzyme system is inducible by many drugs and has a number of genetic variants, warfarin's

activity is highly variable in individual patients (Valentine & Hull, 2009). Variable amounts

of dietary intake of vitamin K will have an effect on warfarin dosing, as will alterations in

vitamin-K producing intestinal flora (Conly & Stein, 1992). Also, because warfarin is

strongly protein-bound and only the non-protein-bound fraction is biologically active, any

substance that binds to albumin may displace warfarin from its albumin binding sites and

increase its biological activity (Valentine & Hull, 2009).


The prothrombin time (PT) responds to reduction of 3 of the 4 vitamin K-dependent

procoagulant clotting factors that are reduced by warfarin (Hirsh, Fuster, Ansell, & Halperin,

2003), and is therefore a surrogate marker of the anticoagulation effect exhibited by the

therapy. The International Normalized Ratio (INR) is the ratio of an individual‟s

prothrombin time to a control sample, raised to the power of the International Sensitivity

Index (Hirsh, Fuster, Ansell, & Halperin, 2003). Thus, the INR is a standardized value for a

patient‟s clotting time. The INR is used to gauge the level of anticoagulation on warfarin

therapy, and is tracked following dosing adjustments.

Anticoagulation clinics. Due to the labor-intensive nature of managing warfarin

therapy, anticoagulation clinic models have been developed in various settings to provide a

centralized service for patients receiving therapy. Rather than having regular monitoring and

dose adjustments performed on a case-by-case basis by a patient‟s medical provider, an

anticoagulation service will assume responsibility for managing therapy. By centralizing

care, the evidence suggests that anticoagulation clinics produce improved patient outcomes

over usual physician-managed care (Nichol, Knight, Dow, Wygant, Borok, Hauch, Hauch,

O‟Connor, 2008).

A meta-analysis of 67 studies involving 50,208 anticoagulated patients found that

study setting (i.e. organizational style for anticoagulation management) had the greatest

effect on anticoagulation control with studies in community practices having significantly

lower control than anticoagulation clinics (van Walraven, Jennings, Oake, Fergusson, &

Forrester, 2006). In this analysis, INR was in therapeutic range an average of 66% of the

time for patients in anticoagulation clinics, and only 57% of the time in patients managed by

community physicians.


Numerous models have been developed for anticoagulation clinics, employing the

services of various medical professionals, including physicians, nurse practitioners, physician

assistants, pharmacists, and registered nurses (RNs). RN-managed anticoagulation programs

have been developed because of the numerous beneficial skill-sets possessed by nurses

(Shimbukuro & Kramer, 2004). RNs are able to collect pertinent patient history, symptoms,

and clinical exam findings; determine clinical relevance of their findings; and formulate a

care plan. Additionally, nurses are able to provide patient education, which is critical to the

success of anticoagulant therapy (Wofford, Wells, & Singh, 2008). Unlicensed technical

support personnel cannot be involved in patient assessment or therapy management (Garcia,

Witt, Hylek, Wittkowsky, Nutescu, Jacobson, et al., 2008). In terms of financing, RNs also

are desirable to practices because of their ability to bill for services, and their relatively lower

salaries as compared to other providers.

The dilemma RN-managed anticoagulation programs face is the scope-of-practice

limitation of RNs related to the adjustment of prescription medications. As RNs (without

advanced practice standing) do not have prescriptive authority, they must operate under

standing-orders or sliding-scales. These orders must be comprehensive enough to allow for

patient-specific dosing without being so loose that they are beyond the nurses‟ scope of

practice regulations. If protocols are overly restrictive, the clinic is less independent and

requires more prescriber involvement.

As warfarin dosing is highly individualized, a carefully tailored plan is necessary for

each patient at each follow-up visit. Specially designed dosing-calculators that recommend

dose adjustments based solely upon an INR value are based on generalizations of predicted

effects of incremental dose changes. These calculators do not have the capacity to take into


account clinically relevant medication interactions or other significant patient-specific

variables (Niiranen & Yli-Hietanen, 2008). As a result, anticoagulation protocols will often

incorporate a dosing calculator into a flexible algorithm that allows for provider discretion.

Protocols for nurse-managed anticoagulation clinics not only need to incorporate

guidelines for dosing adjustments, they must also provide standards for frequency of

monitoring. The algorithms must therefore integrate dosing recommendations with return-to-

clinic instructions. As the complexity of the clinical situation increases, so do the

opportunities for clinical concerns with a dosing protocol. With these dual

recommendations, the nurse may find fault with the dose recommendation, the return-to-

clinic recommendation, or both.

Shimbukuro and Kramer (2004) studied the use of a decision support system utilized

by nurses in an anticoagulation clinic for warfarin dosing determinations. The authors

reported only 86.4% of dose adjustments by nurses were done “correctly” by the nurses

according to the guidelines. Thus, these clinic nurses would legally be required to consult

with a provider for these 13.6% of cases that are dosed outside of protocol. This also

suggests that there may be cases where the nurses sought prescriber consultation that did not

result in a variation from protocol. Previous studies that have demonstrated the safety and

effectiveness of nurse-managed anticoagulation protocols and effectiveness of various dosing

algorithms have not investigated the level of prescriber involvement required to support a

protocol (e.g., Anderson, Wilson, Blundell, Petrie, Leighton, Stanish, et al., 2002;

Shimbukuro & Kramer, 2004)

The decision to vary from protocol is one made from careful clinical assessment skills

and knowledge of warfarin pharmacodynamics. Studies, such as Shimbukuro and Kramer


(2004), which demonstrate nursing deviation from protocol would suggest that there exists a

clinical assessment process that evaluates the appropriateness of a dosing protocol on an

ongoing basis. The situations that prompt this disagreement with a dosing protocol are not

well understood or described in the literature. Better identification of the key issues that

cause a nurse to question a protocol may allow for improvements to the anticoagulation clinic

systems.

Cost and efficacy. The costs associated with anticoagulation care can be measured

in terms of both direct and indirect costs. Operating costs of the clinic, including facilities,

staff, supplies, and other overhead, are included in the direct costs. The costs to the patients

and insurers are related to the charges for provider services, testing services, and medication.

All of these costs incurred by the patients and insurers are affected by the frequency of

testing and need for dosing adjustments. The added costs to the patients are related to time

and money lost by additional appointments with associated travel costs and missed work.

Major indirect costs to the system are related to the adverse outcomes associated with

poorly managed anticoagulation; specifically, adverse outcomes related to sub-therapeutic or

supra-therapeutic INRs. In a meta-analysis by Oake, Fergusson, Forster, and van Walraven

(2007), the data revealed that critically high anticoagulation intensity (defined by an INR

higher than target range) explained 25.6% of all serious events in anticoagulated individuals.

Additionally, critically low anticoagulation intensity (defined as an INR lower than target

range) explained 11.1% of all serious thromboembolic events. The researchers concluded

that improved anticoagulation control could decrease the likelihood of almost half of all

anticoagulant-associated adverse events. The financial implications of improving the

accuracy of a dosing protocol are therefore substantial.


In reviewing the effectiveness of a nurse-managed anticoagulation clinic, Connor,

Wright, and Fegan (2002) found no statistically significant difference in anticoagulation

control between consultant hematologists and anticoagulant nurses, but did find that patients

attended clinics on significantly fewer occasions with nurse-led management. In other

words, these findings suggest that the nurses were able to maintain patients within target-

range equally as well as the hematologists, but were able to do so with fewer visits.

Furthermore, these findings would support the reduced costs to patients and insurers

associated with RN-managed clinics as compared to other models.

Chiquette, Amato, & Bussey (1998) found a savings of $1,621 per patient-year of

therapy in their comparative study of anticoagulation management services versus usual care

due to a significant reduction in hospitalizations and emergency department visits. Wilt,

Gums, Ahmed, & Moore (1995) found a savings of $4,072 per patient-year of therapy with

an anticoagulation service due to reduced utilization of emergency services. Although these

studies have limitations due to design and sample sizes, their findings support the significant

cost-savings that is possible through improved anticoagulation management.

Scope of practice. Shimbukuro and Kramer (2004) studied the use of a decision

support system utilized by nurses in an anticoagulation clinic for warfarin dosing

determinations. The authors reported only 86.4% of dose adjustments by nurses were done

“correctly” by the nurses according to the guidelines. The specifics of the 13.6% of cases

that were not managed according to the guidelines are not provided in this study. The study

did not specify whether or not there was a similar, increased, or decreased rate of adverse

events associated with the cases that were not managed according to the guidelines.

Nevertheless, these findings support the general belief that there are always cases that do not


fall within a dosing algorithm. In Shimbukuro and Kramer‟s study, it would stand to reason

that based upon some unknown factors obtained by the nurses‟ assessments, the nurses

determined that the dosing protocol was not appropriate for these patients. The specifics of

these situations are not fully understood, nor are the decision-making processes by which the

nurses made the determination that the protocol was inappropriate.

Under typical nurse practice acts, RNs do not have the authority to adjust a

medication dosage without specific guidelines from a licensed prescriber, and unique clinic

characteristics and structural elements are influenced by external and internal regulatory

requirements as well as state and federal laws (Garcia, Witt, Hylek, Wittkowsky, Nutescu,

Jacobson, et al., 2008). Operating under a dosing algorithm or protocol, RNs may only

instruct patients to modify dosing based upon the written policy that details the specifics of a

dose change. A “clinical judgment call” by which a provider determines an alternate

medication dose is not within the scope of practice of an RN unless there are specific

protocols that govern this determination. Legal liability issues with variations from protocols

and automated clinical pathways have received increasing amounts of attention as more of

these systems have been developed (e.g. Brugh, 1998). In considering scope of practice

limitations of RNs in Shimbukuro and Kramer‟s study, all 13.6% of the cases where warfarin

doses are adjusted outside of a protocol legally must be approved by another licensed

provider.

Shimbukuro and Kramer did not examine cases where the nurse may have questioned

the appropriateness of a dose adjustment recommended by the protocol, and sought the

advice of another provider. Presumably, there were additional cases that fell within this type

of situation that were not captured by the study because the ultimate dosing recommendation


fell within the protocol‟s range. For instance, a nurse may have questioned the protocol,

sought the advice of a provider, and ultimately dosed a patient as the protocol recommended.

In this example, the study would not have reported that the nurse did not follow the protocol

appropriately, and there would be no record of the nurse having to seek assistance.

Therefore, productivity and clinical-independence are not fully appreciated by the measures

employed in previous studies.

The aspects of clinical decision-making by registered nurses that prompt a nurse to

seek support and possibly stray from an anticoagulation protocol are not well-defined in the

existing literature. The effect of these decisions is presumed to result in improved patient

outcomes; however, the opposite may also be true. Prior evidence has demonstrated that

physician-managed anticoagulation may be inferior to anticoagulation managed by clinics

(Chiquette, Amato & Bussey, 1998; van Walraven, Jennings, Oake, Fergusson & Forster,

2006). It remains unknown as to which aspects of care delivery result in this difference.

Another confounder in the analysis of these data is that anticoagulation clinics have

different collaborative arrangements with physicians depending on the setting. In some

cases, clinics will use an expert hematologist or cardiologist for decision support, and in

others, clinic nurses will rely upon a variety of providers. The effects of having prescriber

consultants of various backgrounds within a single clinic have not been examined in previous

studies (e.g. Connor, Wright, & Fegan, 2002).

Variability in practice. The structure of nurse-managed anticoagulation clinics

varies based on practice setting, and is also affected by the indications for therapy. For

example, some dosing algorithms are specific to orthopedic procedures, and others are

tailored for diagnoses of atrial fibrillation, mechanical heart valves, pulmonary emboli, etc.


Some protocols utilize a graphic nomogram for dosage adjustment (Dalere, Coleman & Lum,

1999), and others utilize a dosage adjustment worksheet (Shimabukuro, Kramer & McGuire,

2004). Also, nomograms have variable dosing recommendations and return-to-clinic

recommendations (Kovacs, Rodger, Anderson, Morrow, Kells, Kovacs, et al., 2003).

At present, there is no standard of care, and there are no standard operating

procedures for all nurse-managed anticoagulation clinics. Clinics are structured differently

and employ various dosing protocols for the nurses to utilize in patient care. The major

safety goal of reduction in the likelihood of patient harm associated with the use of

anticoagulation therapy that was put out by The Joint Commission (2007) has left individual

institutions to devise unique anticoagulation programs that best serve their practice areas and

work with their available resources.

The Anticoagulation Forum (Garcia et al., 2008) published a consensus statement

related to optimized anticoagulant therapy. Within this statement, the authors described

various characteristics of anticoagulation programs that should be considered as “best

practices.” In this statement, the supervisory practice agreement qualities are described. The

authors commented, “Optimized anticoagulation therapy is provided by a dedicated

[Anticoagulation Management Service] in numerous healthcare settings, each with unique

characteristics and structural elements and influenced by internal and external regulatory

requirements as well as state and federal law” (p. 980).

The decision-making process by which nurses make the determination that a protocol

dose recommendation may be inappropriate is not fully understood, and the situations that

prompt these determinations have not been characterized. The effects of a dosing protocol

that only allows for small dosing adjustments within a narrow range of INRs span from


decreased nurse-independence and clinic utility to higher costs on the health care system due

to inefficient management practices. Additionally, a dosing protocol that allows for more

variability in dosing adjustments based upon clinic data places a higher level of responsibility

upon the nurse and relies more heavily upon his or her skill-level, and may be limited based

upon state nursing practice acts.

Critical-thinking process. Benner and Tanner (1987) wrote, “Intuition has seldom

been granted legitimacy as a sound approach to clinical judgment. Instead, it has been

viewed as the basis for irrational acts or guessing, as unfounded knowledge, or even as

supernatural inspiration. In fact, intuition appears to be a legitimate and essential aspect of

clinical judgment” (p. 23). Within this article, the authors explored Dreyfus‟s six key aspects

of intuitive judgment: pattern recognition, similarity recognition, commonsense

understanding, skilled know-how, sense of salience, and deliberative rationality. These six

aspects of intuitive judgment may be recognized in the nurse decision-making process.

Within their discussion, Benner and Tanner asked the question, “Can we teach intuition?” (p.

31).

Benner (1982) explored the Dreyfus Model of Skill Acquisition as a nurse develops

through the five levels of proficiency: novice, advanced beginner, competent, proficient, and

expert. In her assessment of the nurse‟s progression from Novice though the stages to

Expert, Benner concluded the following:

Experience, as it is understood and used in the acquisition of expertise, has a

particular definition that should be clarified. As it is described in this model,

experience is not the mere passage of time or longevity; it is the refinement of

preconceived notions and theory by encountering many actual practical situations that

add nuances or shades of differences to theory (p. 407).


The processes by which nurses make a clinical assessment out of the available data

are not fully described by any single theory. Benner and Tanner (1987) stated, “Neither

information-processing nor statistical-decision theories are particularly useful in describing

how an expert clinician zeros in on the right region for assessment, selects what is relevant

from the vast field of clinical data available, or recognizes changing relevance as the

situation unfolds” (p. 31).

Thompson (1999) provides a comparative analysis of various clinical decision-

making theories. In his review, Thompson describes the Information Processing Model and

its stages of data analysis leading to a diagnosis. He classifies this model as the Systematic-

Positivist Stance on Decision Making, and links it with a structured decision modeling tool,

or decision tree, that helps nurses reach decisions based on calculated probabilities (p. 1224).

In discussing the rational for accepting an intuitive-humanist model for nurse decision-

making, Thompson states, “The basic thrust of all intuitive-humanist models is that intuitive

judgment distinguishes the expert from the novice, with the expert no longer relying on

analytical principles to connect their understanding of the situation to appropriate action” (p.

1224).

The nurse‟s decision-making process therefore results from a blend of scientific

knowledge with an experiential wisdom. That wisdom is not a magical or unfounded notion

without basis in fact. Within the nurse‟s decisions, there is a component of anecdotal

findings blended with evidence-based practice that takes into account numerous clinical

factors.

Kim (1983) wrote, “Nursing practice encompasses both the scientific problem-

solving orientation and the human-practice orientation. Nurses are not only dealing with and


seeking solutions for clients‟ health problems but are also concerned about how to help

clients in their “living with” certain health-related situations” (p. 2). The nurse‟s attention to

both aspects of health concerns may influence how the nurse manages a clinical situation in

ways that may appear unique to the individual patient. Nevertheless, there may be patterns to

some of these decisions that could become apparent when examining these issues from a

broader perspective.

In a study of nurses‟ views of using computerized decision support software to

provide triage advice, O‟Cathain, Sampson, Munro, Thomas, and Nicholl (2004) observed

that nurses found the software to be a “safety net” and “provider of consistency” on which

they relied more upon when they did not have relevant clinical knowledge (p. 280). The

nurses in this study also felt that the software was by no means sufficient, and that there were

circumstances where “the nurse interpreted the software recommendation in the light of

information the software could not process” (p. 283). This would support the theory of a

clinical decision-making process guiding the nurse in an assessment of the applicability of a

decision tree recommendation. Benner‟s expert nurse judgment model would apply in these

circumstances. With the novice nurse, Benner and Tanner raise the following concerns:

Beginners who, because they have no experience with the situations in which they are

expected to perform, must depend on rules to guide their actions. Following rules,

however, has limits. No rule can tell novices which tasks are most relevant in real

situations nor when to make exceptions (Benner & Tanner, 1987, p. 28).

In situations where a decision support tool is being used to assist nurses, especially

when there are varying levels of nurse experience, it is critical that the tool be as fully

developed as possible to prevent advising a nurse to go through with a potentially unsafe

action. In the case of the novice nurse, the inability to recognize an exception to the rules

could result in adverse outcomes. Although a decision support tool may be considered a


back-up or a “safety net” for the expert nurse, the tool has much more significant influence to

the less experienced clinician.

Organizational setting. The practice where this project is conducted is a large,

multi-specialty group that serves the North Shore of Massachusetts. Within the practice are 6

primary care physicians, 7 primary care nurse practitioners, 3 primary care physician

assistants, 3 cardiologists, 1 pulmonologist, 2 nephrologists, 1 hematologist/oncologist, and 2

gastroenterologists.

Patients may be enrolled in the anticoagulation clinic for a variety of medical

conditions. Some of the potential indications for therapy include:

Atrial Fibrillation/Flutter

Prosthetic Heart Valves

Deep Vein Thrombosis or Pulmonary Embolism

Post-op high-risk procedure for venous thromboembolism

Treatment of hypercoagulable conditions

Left Ventricular Dysfunction

(Hirsh, Fuster, Ansell, & Halperin, 2003, & Lip, 2007)

The anticoagulation clinic for the group practice is staffed by 4 registered nurses who

manage all of the patients in the group who receive anticoagulant therapy. The number of

patients followed by the clinic at any point in time typically averages 350 people. The RNs

in the clinic rotate through staffing the sessions leaving 1 RN in clinic while the others meet

the other nursing needs of the practice. Anticoagulation clinic sessions are 4 hours each,

open every weekday morning, with an additional afternoon session on Thursdays. In an

average clinic session, the nurse will manage between 15 and 30 patients. A majority of

patients managed by the clinic are treated with face-to-face visits with the nurse, and a

portion of home-bound patients are treated over the phone. The face-to-face patients are

tested with a point-of-care INR device, and the home-bound patients are tested by a home-


draw with either a visiting nurse service or the hospital lab. To increase the speed and

efficiency of the clinic, a medical assistant staffs the clinic with the RN to retrieve patients

from the waiting room, collect vital signs, and perform the INR testing.

In the nurse-managed anticoagulation protocol studied in this project, a treatment

model emerged over 10 years based upon the needs of the patients and providers. Initial

guidelines were based upon an original study published in the American Journal of Health-

System Pharmacy in 1966, and these were adapted to meet the unique circumstances of the

individual practice. Various quality improvement and systems changes were implemented

over the years following feedback from patients, nurses, physicians, and credentialing

organizations. The model that was in use by the practice at the start of this project had

emerged by an organic process of change, without a formalized analysis of its efficacy or

safety.

The anticoagulation protocol being evaluated was a developed tool that guided the

nurses in monitoring the INR and adjusting warfarin dosing appropriately. Depending on the

INR target-range, the nurse would follow one of two protocols: Protocol 1 for Goal INR 2-3

or Protocol 2 for Goal INR 2.5-3.5 (see Appendix E). The protocols listed ranges of INR

results and provided guidance on when to adjust the dosing, by how much the dosing should

be adjusted, when to seek assistance, and when to repeat testing. The recommended dose

adjustments were determined by a dosing formula previously developed by the British

Society for Haematology in 1989 which was adapted for the clinic (see Appendix E). The

nurse had a limited amount of flexibility surrounding dose adjustments provided within the

protocols to allow for individualized tailoring of care. Although the charting of patient

encounters was done within an electronic medical record, there was no computer based


decision-making support for the protocol. The clinic algorithm design was similar to two-

step protocols found within the literature (e.g. Kim et al., 2009).

The nurses had variable years of experience as nurses, and different educational

backgrounds (see Table 1). Additionally, the nurses had varying levels of experience with

anticoagulation monitoring, and one nurse provided similar services at a separate primary

care practice in the area. All of the nurses received their additional education, training, and

experience in anticoagulation management through employment at the practice. Since

anticoagulation monitoring is not an area of focus for most nursing programs, the nurses

depended upon members in the clinical site for advice and support in assimilating this new

role.

Problem

As the literature on nurse decision-making suggests, the nurses in the clinic appeared

use the anticoagulation protocol as a resource, but relied upon their knowledge base for an

ultimate decision on dosing and follow-up recommendations. The protocol was used as a

tool, but had significant limitations when applied to patients with various clinical issues. The

nurses appeared to make clinical assessments beyond those dictated by the protocol, and

responded to those assessments according to their clinical judgment or intuition. Their

clinical decision-making process was not well understood, and the outcomes associated with

their actions had not been formally evaluated. Although variations from protocol are made to

improve safety and create better outcomes, the validity of these variations was not known.

Some practice behaviors employed by the nurses anecdotally appeared to be clinically sound;

nevertheless, the variations in practice behaviors had not been described nor formally

assessed.


Over the years, the nurses had raised many questions relating to the structure of the

program and how this protocol compared to other nurse-managed clinics. Specific concerns

related to scope-of-practice regulations, patient safety, and clinic efficiency. These questions

had been raised both informally, and at regularly scheduled team meetings. The

anticoagulation clinic did not engage in any regular quality assessment procedure. There was

no tracking of outcome measures or adverse events. The clinic protocols had not been

revised since January, 2003. The frequency of nurses in the clinic appropriately following

the anticoagulation clinic protocol was not known, as it had never been quantified, nor had

the frequency of prescriber involvement been assessed.

Intended Improvement

The purpose of this project was to establish a baseline quantitative assessment of the

safety and efficiency of the clinic‟s ability to meet patients‟ INR goals and identify

vulnerabilities and deficiencies within the system. Additionally, the project assessed practice

behaviors that the clinic‟s nurses employed while working with the protocol and identified

potentially beneficial or detrimental decision-making patterns in anticoagulation care. Using

these data, this project recommended evidence-based improvements to increase the safety

and effectiveness of the anticoagulation clinic through the identification of the barriers to

safe, reliable, and efficient clinic workflow, and assessment of the nurses‟ decision-making

process in anticoagulation care.

This process was triggered by the identification of systems-deficiencies by the nurses

in the clinic and the clinic‟s Medical Director. The concerns regarding patient safety and

inefficient practices that were reported by the nurses prompted the Medical Director to

commission this program evaluation project.


Study Questions

In order to evaluate this operating model of a nurse-managed anticoagulation

protocol, this project addressed the following questions related to the protocol:

1. What are the clinical situations in which a nurse may find the anticoagulation

protocol to be inadequate, under-developed, or inappropriate for which she must seek

the guidance of a prescribing provider?

2. Where are the opportunities within the existing anticoagulation protocol to improve

safety, decrease nurse-workload, decrease the need for physician-involvement, and

decrease patient-visit-burden?

Specific Aims:

1. To identify aspects of the existing anticoagulation protocol that need improvement or

revision.

2. To explore the decision-making process employed by nurses in the management of

anticoagulation.

3. To identify clinical situations that lead to conflicts between the nurses‟ judgment and

protocols.

4. To recommend interventions to improve the nurse-managed anticoagulation protocol.


Methods

This project utilized evaluation research methods to provide summative and formative

evaluations of the anticoagulation protocols utilized by the Anticoagulation Clinic. The

overall method for the project was based upon the Center for Disease Control‟s (CDC)

framework for planning and implementing practical program evaluation. This framework

involves the following steps:

Engage stakeholders

Describe the program

Focus the evaluation design

Gather credible evidence

Justify conclusions

Ensure use and share lessons learned (Centers for Disease Control, 2005).

This framework was developed for programs of public health, but can be directly applied to

this clinical setting. It was particularly useful because it involves conducting an assessment

on a whole system rather than just its individual parts. A comprehensive anticoagulation

program is more complex than a dosing calculator, an algorithm, or a charting system alone.

This model allowed for a description of the current program, followed by a process that

identified the key features within this unique program that required further investigation and

the provision of recommendations for change.

Sample

For this project, there were no exclusion criteria. The 4 registered nurses who staff

the clinic were asked to participate in this program evaluation project, and there were no

additional inclusion criteria. This project was a census of staff, and there was no additional

sampling. The clinic‟s nurse practitioner, a doctoral candidate, conducted the formal

program evaluation and provided recommendations for change.


Setting

The project took place at the Anticoagulation Clinic in The Medical Group, Inc, a

large, multi-specialty medical practice on the North Shore of Massachusetts that is described

more fully in the background section above. The Anticoagulation Clinic provides

anticoagulation management services for patients who are followed by providers in this

multi-specialty practice. During each of the 4-hour sessions (6 sessions per week), an RN

manages the face-to-face patient encounters in which patients are tested with a point-of-care

INR device. The RN provides dosing and follow-up instructions to the patients according to

clinic protocols. For questions or concerns with dosing, the clinic nurse seeks the assistance

of the supervising physician or nurse practitioner.

Planning

The evaluation was conducted in several stages. The step of engaging stakeholders

was intrinsically complete before the formal evaluation began. The clinic RNs approached

the supervising physician and nurse practitioner with a request for more decision-making

support in the clinic protocol. The supervising physician charged the nurse practitioner to

conduct a quality improvement project to address the nurses‟ concerns. As the impetus for

this project arose from concerns expressed by the nurses and the supervising physician

during numerous planning meetings, the concept of program revision was fully supported by

these key stakeholders. The anticoagulation program that has been described in this

manuscript, and its operational functions, are provided in detail within the clinic‟s written

protocols and procedures manual (see Appendix E).

The program evaluation was completed through a series of 2 focus group sessions

with a data collection phase between them. Utilizing applied research methods (Kreuger,


1994), focus group interviews were conducted with RN clinic providers. This stage of

exploratory research identified key clinical phenomena involved in anticoagulation

management. According to Kreuger (1994) “The focus group interview works because it

taps into human tendencies. Attitudes and perceptions relating to concepts, products,

services, or programs are developed in part by interaction with other people” (p. 10). Due to

the complex interaction of clinical situations with inter-professional dynamics that is seen in

a clinic setting, this property of focus group interviewing proved particularly useful in this

analysis. As Kreuger (1994) stated, “The intent of the focus group is to promote self-

disclosure among participants” (p. 11). As a main goal of this study was to identify issues in

the decision-making process employed by nurses, self-disclosure on the part of the nurses

was vital to the success of this project. The focus group provided a collegial environment in

which the nurses felt comfortable discussing their personal practice behaviors.

Focus group research is uniquely suited for quickly identifying qualitative similarities

and differences among people. Focus groups also provide an efficient means for

determining the language people use when thinking and talking about specific issues

and objects, and for suggesting a range of hypotheses about the topic of interest.

Focus groups may be useful at virtually any point in a research program, but they are

particularly useful for exploratory research when rather little is known about the

phenomenon of interest. As a result, focus groups tend to be used very early in

research projects and are often followed by other types of research that provide more

quantifiable data from larger groups of respondents (Stewart, Shamdasani, & Rook,

2009, p. 590).

Data from the focus groups were incorporated into a clinic audit tool which was used

to assess adherence to protocol, reasons for deviation from protocol, and prescriber

involvement. The clinical audit tool contained key measures of quality in anticoagulation

management including time in therapeutic range, adverse events, and frequency of follow-up.

The audit tool was used to collect data on the significant clinical phenomena of interest as


derived from the focus group, and was designed to detect other cases of clinical conflict that

were not pre-identified by the focus group sessions.

The data from the clinical audit were analyzed and compiled. The analysis compared

the predicted clinical management process as described by the nurses in the first focus group

with the actual functioning of the clinic. The goal of this stage of analysis was to apply

quantitative data of actual clinic operation behaviors to verify or refute the nurses‟

hypotheses relating to their practice styles, and possibly uncover unexpected themes in

management issues. The audit also provided outcomes data associated with various clinical

practices, thus providing an assessment of the effectiveness of various clinical management

strategies.

The clinical decision-making strategies in cases detected by the audit tool that were

not self-explanatory or pre-described in the first focus group session were cycled into another

round of focus group analysis for further interpretation and for hypothesis/change-

recommendation development. Specific cases of interest were pulled for a chart review with

the focus group.

Focus groups have also been proven useful following analyses of large-scale,

quantitative surveys. In this use, the focus group facilitates interpretation of

quantitative results and adds depth to the responses obtained in the more structured

survey. Focus groups also have a place as a confirmatory method that may be used for

testing hypotheses. This application may arise when the researcher has strong

reasons to believe that a hypothesis is correct, and where disconfirmation by even a

small group would tend to result in rejection of the hypothesis (Stewart, Shamdasani,

& Rook, 2009, p. 590).

The justification of conclusions stage of the project began with analyzing the findings

of this data collection process, and comparing the findings to the existing evidence-based

literature. Through this process, recommendations for change and adaptation of the protocols

were made. Recommendations were made to include those clinical issues that were


appropriately managed as demonstrated by positive clinical outcomes and supporting

evidence for practice behavior in the literature. Clinical practices that were not evidence-

based and were not supported by positive outcomes were identified, and educational

remediation strategies were recommended. Clinical practices that were not evidence-based

but resulted in positive outcomes were identified as areas for future research. These stages of

data interpretation with comparison to the literature, and revision of protocols satisfied the

final steps in the CDC framework for justifying conclusions and ensuring use/sharing lessons

learned.

A graduate student assisted in this program evaluation project. This student is one of

the nurses in the clinic, and she was particularly interested and involved in this process of

program improvement. The student was responsible for assisting in the collection of

quantitative data using the audit tool. Her work was reviewed for accuracy by the primary

investigator.

Focus groups. The focus groups were conducted by the primary investigator (PI)

who served as the moderator of the discussion. Prior to involvement in the sessions, all

participants went through the process of informed consent (see Appendix B). The session

was audio taped and transcribed, and field notes were taken by the PI as per standard focus

group methods (Krueger, 1994). The first focus group session was approximately 90 minutes

in duration, and was conducted on site at The Medical Group. The discussions were guided

by a standard focus group interview guide that had an agenda of uncovering clinical issues

experienced by the nurses in this setting (see Appendix D). Based on typical focus group

guidelines, the tool contained 10 open-ended questions related to the topic of interest

(Stewart, Shamdasani, & Rook, 2009).


The qualitative description form of formal content analysis (Sandelowski, 2000) was

employed to identify the key clinical concepts described by participants. According to

Kreuger (1994, p. 153), “Ideally, the moderator or assistant moderator should also do the

analysis. These individuals have had firsthand exposure to each of the discussions, observed

the interactions of all participants, and likely have had the most intensive exposure to the

problem at hand”. As such, the PI was responsible for this stage of analysis.

Once compiled, the results of the content analysis were presented back to the focus

group for assessment of reliability of transcription and validity of analysis. This step was

supported by focus group research methodology and the principle that “analysis is improved

with feedback” (Kreuger, 1994, p.137).

Following a formal clinic audit relating to the topics of interest identified in the first

focus group, a second focus group was conducted. During the second focus group session,

the results of the clinic audit along with highlighted cases for review and additional

observations made by the PI during the audit were presented back to the nurses. The nurses

were asked to provide feedback related to the findings of the audit process and to verify or

refute the assessments made by the auditor.

Audit tool development. The data obtained from the first focus group were

transformed into measurable factors related to these key clinical issues, and these factors

were incorporated into a clinical audit tool. The audit tool was divided into two distinct

sections (see Appendix G). The first was designed to be completed by the RNs at the point

of care with each clinic visit. This tool was designed to capture the frequency of the

described clinical issues. As such, the tool utilized key items from each of the themes

identified during the focus groups. The RN portion of the audit tool contained 31 distinct


decision-making factors and a comments section, all of which allowed the nurses to identify

clinical factors that affected their dosing recommendations at the time of the visit. The titles

of these items were created using the terminology used by the nurses, as the goal was to

capture the occurrence of various decision-making factors employed by the nurses. The

nurses were asked to identify on the audit tool which decision-making processes they used

that affected their warfarin regulation decisions immediately at the time of the visit.

The second section of the audit tool was completed by the PI and was designed to

capture the frequency of nurses deviating from clinic protocols for their stated rationales and

for any other reasons. The comprehensive tool was designed to identify the clinical

outcomes associated with various practice behaviors, specifically those which involved

variations from protocol. The PI portion of the audit tool contained 24 different data points

related to the patient presentation, dosing instructions, and patient outcomes. The PI audit

was completed after the patients‟ subsequent follow-up visits to the clinic in order to allow

for observation of dose response and any adverse outcomes.

Best practice outcomes measures previously defined by Fitzmaurice, Kesteven, Gee,

Murray, & McManus (2002) include a process of data collection that tracks the occurrences

of adverse events associated with anticoagulation therapy. For the purposes of this study,

generally accepted definitions of major adverse events were used related to bleeding and

thromboembolic events. Major bleeding includes intracerebral bleed, bleeding that

necessitates suspension or reversal of therapy, bleeding necessitates administration of blood

products, bleeding that leads to death (Ansell et al., 2001). Thromboembolic events include

thrombotic strokes, pulmonary embolism (PE), systemic embolism, and deep vein

thrombosis (DVT).


Analysis

Focus group analysis. The tape-recorded 90 minute focus group session was

transcribed for analysis. Data from the first nursing focus group were analyzed using

qualitative description, as described by Sandelowski (2000). Qualitative description was

selected because it is less interpretive than grounded theory and phenomenology, but more

interpretive than quantitative description (White & Ferszt, 2009). The moderator, clinic

nurse/MSN student, and PhD-prepared expert qualitative researcher all independently

reviewed the transcription of the focus group session to gain a general sense of the ideas and

themes reviewed in the discussion. On subsequent reads, the transcript was coded into

meaning units that consisted of words and phrases taken directly from the text. From these

meaning units, codebooks were created by the researchers. The codes were collapsed into

categories of higher meaning, and general descriptions of the categories were created.

After the research team members created their individual codebooks, the results were

shared as a team and reviewed for validity. The researchers found a high level of agreement

in the codes with very similar category descriptions. Disagreements in coding were rare, and

these cases were discussed until consensus was reached. Categories of similar content were

collapsed and refined until consensus was reached among the researchers. The various

codebooks at different stages provided an audit trail for the analysis.

The codes were arranged into categories of similar rationales for actions. Each of the

finalized categories represented situations where the nurses identified deficiencies in the

current operations of the anticoagulation clinic. Descriptive summaries of the categories

were written, and supporting participant quotes were incorporated.


Clinic audit analysis. The RN and PI portions of the audit were coded and merged

by individual visits, identified by both patient medical record number and visit date, into an

SPSS statistical software file for analysis. The use of codebooks assured consistency of

documentation. Each of the decision-making behaviors was a dichotomous variable with a

positive response indicating that the particular element played a role in the decision-making

process. Extensive data review and data cleaning was completed with the assistance of a

PhD-prepared statistician.

Descriptive statistics and crosstabs statistical analyses were utilized to interpret the

data. Continuous data were assessed using means and standard deviations. Categorical

variables were assessed using frequencies and Chi-square testing to determine statistical

significance. By monitoring the frequency of the clinical factors identified in the focus group

and the nurses‟ clinical actions in response to these situations, the tool allowed for

identification of variability in practice styles and uncovered additional clinical decision-

making factors that were not previously understood or identified. The audit tool was used to

track program performance and collect data on clinical outcomes which helped to support or

refute various clinical practice behaviors. After analysis, the results were then described and

presented in narrative form, tables and graphics.

Throughout the clinic audit process, the PI maintained a journal of observations that

added to the analysis of the data and contributed to the scope and depth of understanding of

the clinic practice behaviors. These significant observations from the journal were included

as findings in the project.


Second focus group analysis. The tape-recorded 60 minute focus group session was

transcribed for analysis in the same manner as the first focus group session. Utilizing the

same qualitative description methods used for analysis of the first focus group session, the

moderator (PI) and the PhD-prepared qualitative researcher analyzed the transcript. The

transcribed focus group session was assessed for statements that supported or contradicted

the findings of the audit. The investigators also analyzed the data looking for new clinical

management issues that were not previously identified in the preceding stages of the

evaluation process. These clinical management issues were collapsed into categories of

higher meaning, and the investigators provided descriptive summaries of the follow-up focus

group session.

Ethical Issues

Evaluation of the clinic practices involved comprehensive observation of the nurses

within the clinic. Prior to the initiation of this program evaluation, the project proposal was

submitted to and reviewed by the Simmons College Institutional Review Board (IRB).

Although the project was determined not to be human subjects research but rather

performance improvement, all ethical protections of participants were maintained.

The nurses were asked to divulge their practice behaviors as openly as possible. The

sharing of information regarding performance of job responsibilities opened the nurses to

criticism of their work. The nurses were informed of their potential vulnerability relating to

participation of this project, and they each went through a process of informed consent before

participating in the focus group sessions.

All abstracts from the transcripts of their conversations have been kept anonymous to

protect their privacy. The specific patient care-related cases of clinical concern were


addressed in a confidential manner to limit any job security or medical-legal liability

concerns. The nurses were encouraged to report any concerns with the process to either the

primary investigator, their supervisors, or to the Program Director at Simmons College.

Results

The results of the first focus group session addressed the first program evaluation

question: What are the clinical situations in which a nurse may find the anticoagulation

protocol to be inadequate, under-developed, or inappropriate for which she must seek the

guidance of a prescribing provider?

Specific aims of Q1:


revision.


anticoagulation.


protocols.

Outcomes of Focus Group

All 4 of the RNs involved in the clinic participated in the first focus group session.

The demographics of the sample are described in Table 1. The group discussed clinical

issues relating to the existing protocol that was last revised in 2002. This protocol was the

practice standard to which the nurses were held accountable when practicing in the

anticoagulation clinic. The group identified clinical decision-making factors that affected

their use of the protocol‟s dosing recommendations. The session was analyzed using formal

content analysis methods. From the content analysis, the following categories were

identified as the major topics of interest relating to the research questions and each will be

described in more depth (See Figure 1 and Table 2):


Medication Interactions

New to Warfarin/Suspension of therapy

Trending/History

Dosing Calculator Ineffective

High-Risk/Concerning Factors

Patient Factors and Extraneous Factors

Group Standard

Medication interactions. The nurses identified a lack of guidance within the

protocols in relation to how they should respond to potential interactions between warfarin

and other medications. Specific medications that were identified as particularly problematic

for which the nurses desired additional guidance included Amidoarone, Antibiotics,

Prednisone, Chemotherapeutics, and Blood Products.

The nurses reported a tendency to decrease the dose of warfarin preemptively for

patients starting on amiodarone. “Some of the doctors will cut, let‟s use amiodarone, they‟ll

cut the dose in half, others won‟t cut it that much, they‟ll cut it by maybe 25%. So, kinda

there‟s nothing set as to what to do” (D).

For all concerning medications, the nurses reported following up with the patient

sooner than recommended by the protocol. “Monitoring on antibiotics… you‟re gonna check

them weekly”(B). The nurses reported that they did not make any preemptive dose

adjustments for patients on any medication other than amiodarone, barring prior trending and

history as will be discussed below.

New to wafarin/suspension of therapy. The nurses identified that there is no acute

protocol for patients initiating therapy, or for patients suspending therapy. The nurses


reported that the protocol was not effective for patients naïve to warfarin, and only served as

guidance for patients who have been chronically receiving therapy. A similar concern was

raised for patients in the peri-operative period. The nurses felt that they would see the

patients back more frequently following a surgery once the warfarin was resumed.

The nurses identified a lack of guidance pertaining to the management of patients

receiving a low molecular weight heparin, specifically Lovenox, as a bridge therapy.

Trending/history. The nurses described using their assessment of a patient‟s

previous INR values as an indication for adjustment. There were several specific themes

within this category that described their assessment process. One concept frequently

described was self-designated by the nurses as “trending.” Trending was described as a

notable pattern of increasing or decreasing INR values over time. Based upon a patient‟s

values trending upwards or downwards, the nurses described straying from the dose

recommendations and time-to-follow-up provided by the protocol. Nurses described making

increases and decreases in the warfarin dose and following up sooner when the protocol

would make no dose change recommendation.

Another patient history factor that was identified as a source of clinical conflict

related to a patient being “sensitive” or having a labile INR. The nurses reported that a

history of a fluctuating INR or a dramatic response to a small change in weekly dose of

warfarin would cause the nurses to either avoid making a change in warfarin dose as

recommended by the protocol, or making a less substantial dose change than recommended

by the protocol. In all cases, the nurses reported following up more frequently with the

patients.


When assessing an out-of-range INR value, the nurses described looking at a patient‟s

history for variances, and if there is no clearly identified reason for the change in INR, they

reported being unclear on how to respond. The nurses reported increasing the frequency of

follow-up and making variable dose adjustments depending on the patient‟s history.

For a patient being started on a specific treatment or medication that was used in the

past on that patient, the nurses reported looking to the patient‟s previous response to that

treatment or therapy. How a patient responded to therapy in the past reportedly influenced

how the nurses would adjust and monitor therapy.

Dosing calculator ineffective. The nurses identified situations where the dosing

calculator would make miscalculation on a percentage change, and therefore failed to provide

them sufficient guidance. One issue that was identified as particularly problematic related to

patients in whom a dose of warfarin was held. Plugging the hold into the dosing resulted in

the dosing calculation being made off of a lower weekly warfarin dose. Also, a subsequent

INR within therapeutic range after a hold would not be identified by the dosing protocol.

The protocol would not assess the therapeutic INR as unstable, and would recommend a

longer return-to-clinic timeframe. The nurses also felt that holding a dose of warfarin made

the anticoagulation management decisions more complicated, and they would prefer to have

more limitations on situations that prompt holding therapy, preferring a decreased dose over

a hold.

Another situation that was identified as causing a miscalculation by the protocol was

having a follow-up appointing any sooner than 1 week from the last appointment. The less

than 1 week follow-up caused the calculator to include warfarin doses that had not yet been

administered to the patient.


High-risk/concerning factors. The nurses identified many considerations that

heighten their concern for the patient and cause them to vary from usual practice behaviors.

One such situation is a patient‟s risk for bleeding based upon certain conditions or a history

of bleeding. A similar concern related to a patient‟s risk of falling. The nurses reported

making dose adjustments to keep INRs within a lower therapeutic range and following

patients more frequently.

Situations that would cause the nurses to attempt to keep INRs within a higher

therapeutic range include a patient‟s risk of thromboembolism, specifically stroke, and a

history of a prior stroke. The nurses reported similar concerns for maintaining an INR in a

higher therapeutic range for patients anticipating a cardioversion in the near future. For these

situations, the nurses reported occasionally increasing warfarin doses more than

recommended by the protocol, and following-up more frequently with the patients.

The nurses reported varying comfort levels with following the protocol with patients

who have supratherapeutic INR values. Some of the nurses reported seeking assistance from

a provider with higher INR values, even though the protocol permitted adjustment in therapy

by the nurse alone.

The nurses reported a lack of understanding of the significance of certain clinical

findings and identified a need for further education. The nurses reported feeling unprepared

to assess and respond to abnormal lab values and vital signs observed during clinic. They

were unclear if and how an abnormal vital sign or lab affects a patient‟s warfarin therapy.

Patient factors and extraneous factors. Numerous variables were identified that

affect patients‟ INR values, the ability of the nurses to obtain an INR, and the ability of the

nurse to modify a warfarin dose. One issue related to patient reluctance or willingness to


follow recommendations. Reportedly some patients refuse to follow-up within the

recommended timeframe; some patients reportedly prefer to be seen soon, and some longer

than recommended. The nurses reported negotiating with patients over the recommendations

Weekends reportedly created scheduling conflicts for the nurses managing warfarin

dosing for patients who were being seen more frequently. The nurses reported having to

make decisions to see patients a few days sooner or a few days longer than they would like

because of the clinic‟s being closed over the weekend. Similar concerns were raised about

office holidays. Patients who had travel plans reportedly caused the nurses to make similar

sooner-or-later decisions, and also to consider having the INR tested at another location

while away.

When patients had missed doses of warfarin, the nurses reported having to make a

decision about how to respond to the subsequent INR value. The nurses reported looking at

history and trending factors to help in these decisions. Dietary changes and variable alcohol

use was identified as a troublesome issue for warfarin management. The nurses reported

providing the patients with variable recommendations and instructions relating to these

issues.

Identified situations that limit the nurses‟ ability to adjust the warfarin dose included

limited pill strengths on-hand, patients with pre-filled med packets that cannot be changed

immediately by the pharmacy or care provider, and patients who already took a dose of

warfarin on the day of testing. The nurses reported that these situations added to the

complexity of decision-making, and lead to numerous variations to practice patterns.


Patients known to be self-adjusting their anticoagulation therapy either through

dietary changes or dose changes were identified as being problematic. Suspicion of self-

adjustment reportedly caused the nurses to question the recommendations by the protocol.

Group standard. Throughout the conversation, the nurses reported many situations

where they were not aware of the instructions provided in the existing anticoagulation

protocol. Rather than following the protocol, the nurses described an informal group

standard which guided their regulation decisions. The nurses all identified knowing how the

others tend to regulate warfarin, and that the behaviors of others influenced their actions.

One such situation involved patients who were near their INR goal. For patients who

were out of range by a “small amount” (seemingly less than or equal to 0.2 out of range), the

nurses reported having a separate acceptable INR range for which they did not adjust the

dosing as recommended by the protocol. Although trending and high-risk/concerning factors

reportedly contributed to this decision, the nurses reported a tendency to accept a wider range

of INR values as being within target range.

Summary of focus group findings. The focus group data findings revealed

numerous reported clinical practice behaviors that resulted from the nurses‟ decision-making

process related to warfarin therapy. The nurses identified numerous perceived deficiencies in

the operating protocol of the clinic. These perceptions needed to be further described,

quantified, verified, and validated through additional data collection. Various practice

behaviors described by the nurses required comparison to the existing evidence in the

literature. Revisions to the protocol at this stage of evaluation would not have been

appropriate because these findings were only the perceived actions of the nurses, and not

verified practice behaviors. Additional knowledge relating to the actual practice behaviors


compared to the perceived issues was critical to the process of creating a protocol that is

more comprehensive and better serves the nursing management process.

Methodological considerations. The credibility of the study was assured in several

ways throughout the evaluation process. The interview guide was developed through review

of the literature on anticoagulation management and tailored to the practice setting by the PI

who is the resource provider for the clinic, who is consequently intimately aware of the

clinic‟s operations. Frequently during the analysis of the data, the researchers returned to the

transcript for confirmation of the interpretations. The code books created by the researchers

provided an audit trail for the analysis.

One of the members of the nursing team who participated in the focus group is also

an MSN student. This member was a member of the research team and was able to provide a

second peer evaluator audit. As Sandelowski (1986) stated, “The truth value of a qualitative

investigation generally resides in the discovery of human phenomena or experiences as they

are lived and perceived by subjects, rather than in the verification of a priori conceptions of

those experiences” (p 30). The nurse‟s verification of code meanings was of immeasurable

value in assuring validity, and her participation served as a member check. Beyond the MSN

student, an additional audit was done by a doctorally-prepared qualitative researcher in

nursing. Using investigator triangulation (Cohen & Crabtree, 2008), the codes were cross-

verified by multiple researchers. The ultimate results were reviewed with all the participants

for a final member check (Cohen & Crabtree, 2008). As all of the nurses employed by the

clinic actively participated in the focus group session, the data have additional power and

meaning.


It may have been beneficial to supplement the focus group data with individual

interviews. Such a step may have been beneficial in revealing additional topics that the

nurses were not comfortable discussing in a group setting. However, the nurses informally

reported that they enjoyed discussing these issues as a group, and were excited to compare

and contrast practice-style variations. The extent of nurse-reluctance to share information

related to decision-making remains unknown, and could be an area for future investigation.

Outcomes of Practice Audit

The outcomes of the practice audit provided additional depth from the focus group to

answer the first program evaluation question: What are the clinical situations in which a

nurse may find the anticoagulation protocol to be inadequate, under-developed, or

inappropriate for which she must seek the guidance of a prescribing provider? Additionally,

the audit allowed for preliminary answers to the second evaluation question: first program

evaluation question: Where are the opportunities within the existing anticoagulation protocol

to improve safety, decrease nurse-workload, decrease the need for physician-involvement,

and decrease patient-visit-burden?

The clinical decision-making factors were incorporated into an RN audit tool with a

supplemental definition of terms (see Appendix F). Following the development of the audit

tools, the RNs completed a month of data collection in the clinic using the RN audit tool. At

each patient visit, the nurses documented their decision-making factors that influenced their

dosing decisions on the audit tool. After the RN data collection phase was complete, the PI

utilized the investigator‟s audit tool to review each of the visits and assess the outcomes

associated with those visits. The data were analyzed using descriptive statistics and

crosstabs.


Description of sample. In total, 422 patient visits were assessed. One of the patient

visits was lost due to a charting error, leaving 421 visits for complete analysis. These 421

individual visits were comprised of 256 individual patients. At the 421 visits, 267 (63.4%)

presented with an in-range INR. An additional 58 (13.8%) presented with an INR within 0.2

above or below the goal range. A total of 52 (12.4%) presented with an INR above the

therapeutic goal range, and 102 (24.2%) presented with an INR below the therapeutic goal

range (See Table 3). These data were compared to a retrospective analysis of the preceding

month in order to assess consistency of the month‟s clinic population. For the month

preceding the clinic audit, there were a total of 411 patient visits with 265 (64.5%) presenting

with an INR in-range, and 92 (22.4%) presenting with an INR within 0.2 above or below the

goal range. The consistency seen between the two months of patient visits demonstrates that

the month assessed by the clinic audit was a typical month in terms of patient presentations

(See Table 4).

A total of 8 distinct indications for therapy were listed in the anticoagulation notes.

The predominant indication was for therapy was atrial fibrillation with 70.5% of the visits

having this indication (see Table 5). There were 7 goal ranges identified from the patient

charts despite the fact that our protocol only contains algorithms designed to manage goal

INR ranges of 2.0 to 3.0 and 2.5 to 3.5. A significant majority of the visits (89.3%) had a

goal INR range of 2.0 to 3.0 (see Table 6).

The same dosing instructions were maintained for 276 (65.6%) of the visits. The total

weekly dosing was increased in 87 (20.7%) of the visits, and decreased in 57 (13.5%) of the

visits. For a single clinic visit reviewed during the audit, the prior dosing instructions were


not known and could not be determined at the time of the visit. The nurses held doses of

warfarin in 8 (1.9%) of the clinic visits due to supratherapeutic INRs.

During this audit, there were a total of 7 (1.7%) adverse outcomes which resulted in 6

admissions and 1 out-patient management with suspension of therapy. There were 5 cases of

gastrointestinal bleeding, 2 of which occurred with the INR in-range, 1 with an INR below

range, 1 with an INR within 0.2 above range, and 1 with an INR well above goal range.

There was 1 admission for a critically high INR which did not result in transfusion or

bleeding complications. There was 1 case of post-operative bleeding complications during

the resumption of therapy with an INR remaining below therapeutic range. There were no

identified deaths related to therapy. A total of 8 patients (1.9%) were lost to follow-up

related to either relocation to another clinic or failure to return to clinic within the time

constraints of this audit.

The subsequent INR results were within therapeutic range in 258 (61.3%) of the

cases, and within 0.2 out of range in 55 (13.1%) of the cases. The follow-up INR was above

the goal range in 72 (17.1%) of the cases, and below the goal range in 83 (19.7%) of the

cases, when including all cases that fall out of range.

The nurses reported seeking the assistance of a prescribing provider in 7 (1.7%) of the

cases. There were 199 patients with no reported special considerations, and 1 patient with as

many as 7 special considerations (see Table 7).

The nurses‟ dosing instructions remained within protocol-recommended dosing range

91.2% of the time when assessed within the protocol‟s allowance of 3 mg leeway from the

dosing calculator determined dose. As a means of assessing when the nurses made

adjustments that were not captured by simply assessing weekly total dosing instructions, the


audit assessed if the nurse maintained the same dosing instructions, increased or decreased

the dose, or held the dose. The INRs were recorded as being subtherapeutic, therapeutic, or

supratherapeutic. Assessment of these parameters allowed for comparison of instructions to

the INR status. Where it is known that the protocol will recommend no change for a

therapeutic INR, increase of dose for a subtherapeutic INR, and decrease of dose or hold for

a supratherapeutic INR, the parameters would assess agreement of nursing instructions to the

protocol in terms of direction of change. The data revealed that of the 267 patients with a

presenting INR in range, the nurses maintained the same dose for 229 (85.8%) of those

patients. In other words, the nurses changed the dose for 14.2% of the patients with a

presenting INR that was within therapeutic range. These cases would be off-protocol dosing.

Of the cases of an in-range INR and the dose was changed, 24 (9%) of the patients were

instructed to increase the dose, and 14 (5.2%) were instructed to decrease the dose.

When assessing cases of the presenting INR being above range, there were 14 cases

(26.9%) where the INR was above range, but the same dose was maintained. There were no

cases where there INR was above range and the dose was increased. When assessing cases

of the presenting INR being below range, there were 33 cases (32.7%) where the same

dosing instructions were maintained. There were 5 cases (4.95%) where the INR was below

range, but the dose was decreased. In total, based on measures of direction of change, there

were 90 cases (21.3%) where the dosing was off-protocol.

When assessing adherence to protocol, the factor of time-to-follow-up was examined.

The recommended time to follow-up of the nursing instructions compared to the protocol

recommendations were in agreement 43.5% of the time for cases where the prescribed target


INR range was one of the standard ranges accepted in the clinic. Thus, 56.5% of follow-up

instructions were off-protocol for patients with standard INR ranges.

Medication interactions. The RN portion of the audit tool included fields for 4

concerning medications or classes of medications that were identified by the focus group as

problematic in relation to warfarin therapy dosing. These medications and classes of

medications were amiodarone, antibiotics, chemotherapeutics, and prednisone. In the audit,

the nurses identified 1 patient on amiodarone, 21 on antibiotics, 7 on chemotherapy, and 13

on prednisone. In addition to these pre-identified medication issues, the nurses recorded

additional concerns in the comments section of the audit with the addition of aspirin, Plavix

(clopidogrel), cochicine, phenazopyridine, Actonel (risedronate), Tylenol (acetaminophen),

and omeprazole. Of the 21 antibiotic cases, the next scheduled follow-up visit averaged 8

day in comparison to a traditional average (or group-average) time to follow-up of 17 days.

Out of the 21 patients on antibiotics, 16 (76.2%) returned with a subsequent INR in-range.

For patients on prednisone, the average time to follow-up was 9.5 days and 9 out of the 13

patients (69.2%) returned with a subsequent INR in-range.

Although the nurses had reported a habit of following-up with patients more

frequently rather than preemptively adjusting a dose when medication interactions were

suspected, the auditor noted several cases where preemptive dose adjustments were made for

medications other than just amiodarone. These cases were pulled for review individually

with the responsible nurse, and the finding was confirmed. These cases were highly

individualized and typically occurred in the presence of other decision-making factors which

will be discussed further.


New to warfarin/suspension of therapy. In the focus groups, the nurses identified

concern in relation to patients who were initializing therapy for the first time, patients who

were modifying therapy in the peri-operative period, and patients who were being bridged

with Lovenox (enoxaparin). In total, there were 12 (2.9%) cases that were identified as being

new to therapy, 10 (2.4%) cases that were identified as being in the peri-operative period, and

9 (2.1%) cases of patients receiving bridge therapy with Lovenox (enoxaparin). Due to the

small number of cases with these factors identified in the audit, the individual cases were

reviewed for identification of practice patterns. The time-to-follow-up and dosing

recommendations were highly variable for these patients, and no consistent patterns could be

identified.

Trending/history. The nurses identified 23 (5.5%) cases with a recognized pattern

of trending upwards, and 28 (6.7%) cases with a recognized pattern of trending downwards

that influenced their decision on dosing. The nurses identified 41 (9.7%) cases where the

INR results appeared labile, 34 (8.1%) where there was a history of being sensitive to small

dose adjustments, and 36 (8.6%) cases where the prior history and dose response played a

role in modifying the dosing recommendations.

Of the 36 cases where prior dose response guided treatment, 23 (63.9%) resulted in a

follow-up INR being within range, and an additional 6 (16.7%) were within 0.2 of

therapeutic range. Of the 23 cases of trending up, 14 (60.9%) resulted in a follow-up INR

being within range, and an additional 3 (13.0%) were within 0.2 of therapeutic range. There

were 244 (62.6%) of cases where the subsequent INR was in-range when no upward trending

was observed. A Chi-square analysis of the trending-up and in-range values reveals no

statistically significant difference with a p-value of 0.87. Of the 28 cases of trending down,


20 (71.4%) resulted in a follow-up INR being within range, and an additional 5 (17.9%) were

within 0.2 of therapeutic range. Here again, there was no statistically significant difference

with a p-value of 0.31; nevertheless there does appear to be a pattern of improved

achievement of goal INR with attention to the parameter of trending down, with achievement

of target INR range in 71.4% of patients with attention to trending versus overall

achievement of INR in 61.3% of patients.

Dosing calculator ineffective. The audit tool assessed situations where the patient

returned to clinic in less than 1 week from the prior visit, when the previous dosing

instructions included a hold. This category had overlap with other categories in the items of

patients being new to warfarin and patients who missed doses of warfarin. In total, there

were 21 (5%) cases of the patient being seen in less than 1 week from the time of the last

visit and 16 (3.8%) that had held a dose within the previous week‟s dosing instructions, with

both of these situations leading to misleading weekly totals for the dosing calculator.

Holding of warfarin doses proved to be particularly problematic for regulation, and only 3

(18.8%) presented in-range after a hold within the week prior, and 6 (37.5%) returned with

an INR in range at their subsequent visit. With Chi-square testing, this difference was

statistically significant with a p-value of 0.035.

High-risk/concerning factors. There were 11 (2.6%) case instances where the nurse

reported that the INR was above her comfort level for regulating on her own. Nurses

recorded certain factors that they believed placed the patient at higher than average risk for

complications related to therapy and subsequently resulted in their alteration of dosing

instructions. These factors included prior bleeding complications, a patient being at high risk

for falling, a history of thromboembolic complications, or a patient being at high risk for


thromboembolic complications. There were 11 (2.6%) case instances where heightened

bleeding concerns affected dosing considerations and 28 (6.7%) case instances where

heightened thromboembolic concerns affected dosing considerations. These cases

heightened concern resulted in a shorter time to follow-up, with an average of 12 days to

follow-up.

Patient factors and extraneous factors. The audit tool captured patient preference

factors for dosing or follow-up, patient dietary changes, patient alcohol intake changes,

missed doses of warfarin, fixed pill strength, weekend or holiday interference with return

visits, and patient travel considerations. There were 17 (4.1%) instances where the weekend,

a holiday, or patient travel plans caused variations from the nurses preferred

recommendations. The weekend and holiday issues occurred mostly (84.6%) with an out of

range INR, when the preferred time to follow-up was within several days and could not be

accommodated due to the scheduling issue. Two of the 4 patient travel issues related to

subtherapeutic INRs resulted in longer than desired return to clinic times. The remaining 2

patient travel issues were cases of patients transferring care to a Florida clinic, yet both were

within therapeutic range at the time of visit. There were at total of 13 visits with reported

patient preference modifications. The issues associated with this report were difficult to

interpret as only one of the visits provided documentation of the patient preference, and in

that case it was an issue with restricted days for transportation. Only 3 (23.1%) of these

visits had a presenting INR within range, and there were no identifiable conflicts with the

dosing recommendations for these visits.

No specific pattern of behavior could be identified in relation to how the nurses

responded to these factors. There were various strategies described by the nurses in how they


handled dietary and alcohol factors in relation to warfarin. Some reported that the variation

was temporary, and the dosing schedule was maintained with shorter time-to-follow-up.

Some reported that the variation was ongoing and made adjustments in therapy.

There were 18 (4.3%) identified cases where there were significant dietary changes,

11 (2.6%) others with significant changes in alcohol intake, and 12 (2.9%) patients who

reported missing doses of warfarin. The average time to follow-up for cases of dietary

changes was 11.5 days as compared to 17.14 days for those without dietary changes. The

average time to follow-up for cases of alcohol factors was 13.27 days as compared to 16.99

days for those without alcohol factors. The average time to follow-up for cases with missed

doses was 11.83 days as compared to 17.04 days for those without missed doses.

Group standard. The nurses recognized that they were unfamiliar with the protocol

recommendations for change and for follow-up. In the process of completing this audit,

several of the nurses reported that they rarely utilized the dosing calculator to make dosing

adjustments.

The average time to follow-up recommended by the protocol according the two

standard INR goal ranges was 22.7 days, and the average time to follow-up recommended by

the nurses was 17.0 days for patients with these standard INR ranges. Patients with non-

standard INR ranges will be discussed separately. There were 22 occasions where the nurses

recommended longer return-to-clinic times, with the recommendation being an average of

8.9 days longer for these 22 cases as compared to protocol recommendations. A total of 14

(63.6%) of the longer return-to-clinic cases were in relation to INRs within the 0.2 out of

range parameter. In cases where the INR was within 0.2 of the target range and the nurses

recommended a longer time to follow-up than the protocol, the subsequent INRs were within


therapeutic range in 8 (57.1%) of the cases. Nurses were far more likely to recommend

(N=203) a shorter return-to-clinic time, with the recommendation being an average of 12.2

days shorter for these cases than the average time to follow-up recommended by the protocol

despite the presenting INR being within range in 137 (67.5%) of the cases. The subsequent

INR was within therapeutic range in 126 (62.1%) of these cases of shorter time to follow-up.

There were 25 cases of the INR being less than or equal to 0.2 out of range where the

nurses did not adjust the dosing, and 33 cases of the INR being less than or equal to 0.2 out

of range where the nurses did adjust the dosing. The Of the 25 cases where the INR was less

than or equal to 0.2 out of range and the nurses did not adjust the dosing, 1 had a listed

rationale of trending up, and 2 had a listed rationale of trending down. Two of those cases

(one being the trending up case) resulted in the INR being within therapeutic range on

subsequent check, and 1 with an INR being within 0.2 out of range. Five of the 25 cases of

INR within 0.2 of goal range, but no adjustment made had a rationale of the INRs being

labile, 3 with a rationale of the INR response being sensitive, 4 of significant dietary changes,

1 of a missed dose. Subsequently, 16 (64%) of the 25 cases returned with an INR in range,

and 3 (12%) returned with an INR within 0.2 out of range. Of the 33 cases where the INR

was within 0.2 out of range where the dose was adjusted, of which 21 (63.6%) resulted in an

in range INR, and an additional 3 (9.1%) were within 0.2 out of range. When looking at the

patients who were within 0.2 out of range, there were 25 cases where the nurses did not

document any additional concerning factors that played into their decision-making. For

those cases, the nurses kept the same dosing for 11 (44%) of the cases. Thus, for those 11

cases there was no documentation of any supporting rationale for not changing the dose as

recommended by protocol.


Previously unidentified issues. The process of the practice audit raised numerous

issues that were previously unidentified. These issues were uncovered through discussions

with the nurses, observation of clinic practices, analysis of audit data, and the journaling

process. These insights into clinic operations were helpful in understanding the strengths and

shortcomings of the clinic operations.

The nurses revealed during the audit process that the dosing calculator was not used

on a regular basis. The nurses often adjusted using percentage change as a reference, but did

not enter the data into the dosing calculator. This may partially have been a result of the

calculator being in a separate computer program that was not part of the electronic medical

record (EMR), as the nurses reported being bothered by having to switch to different screens.

Numerous goal ranges other than the protocol standard goal ranges of INR=2-3 and

INR= 2.5-3.5 were identified and did not fall within the clinic dosing protocols. The use of

the clinic‟s dosing calculator for these non-standard INR goal ranges would not be reliable as

the calculator is intended to determine a dose that will target a resultant INR within 20%

above or below the target INR. If the goal range is narrow, the calculator will not

recommend adjustments when the INR is out of range until the 20% threshold is reached.

The protocol did not have any recommendations for time to follow-up for these non-standard

ranges either. As such, the nurses functioned without protocol guidance for all of these non-

standard INR goal range regulations. The appropriateness of these non-standard INR ranges

requires additional investigation as they are not evidence based. It appears that patients were

enrolled into the clinic with these non-standard goal ranges by orders of outside providers,

and their orders had not been revised to be consistent with acceptable clinic protocol targets.


There were several indications for therapy provided in the anticoagulation records

that were not clear indications for therapy and these documented indications for therapy may

have been the result of incorrect or incomplete documentation relating to the patients‟

diagnoses. Peripheral vascular disease, stroke, and coronary artery disease are not standard

indications for therapy unless there are additional factors related to these issues.

Additionally, the duration of therapy may be limited to a finite time span for some of the

indications associated with these issues. As such, the appropriateness of ongoing warfarin

therapy for some of the patients in the clinic could not easily be assessed with the existing

level of documentation in the clinic notes.

Patient tracking issues surfaced during this clinic audit. Some patients were found to

be overdue for INR follow-up through the data collection methods involved in the clinic

audit process. The nurses utilized a paper tracking system to assure that patients were being

appropriately monitored. During the data collection period, patients were identified as being

lost to follow-up and these patients would not have otherwise been found by the paper

tracking system.

There was a common theme of incomplete documentation related to rationales for

dosing instructions. The nurses made note of various clinical considerations on the audit tool

that were not reflected in their documentation for the clinic visits in the patient charts. In

terms of outsiders‟ abilities to assess appropriateness of dosing instructions, the lack of

documentation is a significant hindrance. This has implications for practice and patient

safety as well as legal liability. This is particularly an issue in cases where nurses accept

INRs outside of therapeutic range or otherwise adjust warfarin dosing outside of protocol

standards.


The nurses identified issue where certain illnesses raised their level of concern in

monitoring the patient. This concern may have been related to possible treatments and

interactions with warfarin, dietary changes related to illness, or other metabolic factors. The

nurses‟ rationale for being concerned with illness states was not clarified.

A variation within the concept of “trending” was another issue identified within the

review process. The idea of trending was used to describe both short-term as well as long-

term fluctuations in INRs. Short-term fluctuations and long-term fluctuations may need to be

addressed differently as they may represent different underlying causes, with the long-term

trends more likely being a more stable situation. A change from a low-normal INR to a high-

normal INR is less concerning in the long-term follow-up as the rate of change may be more

gradual. There was one identified case of a nurse failing to recognize the intended increase

of an INR with a prior dose increase. The INR at the visit was in-range, but the dose was

decreased to the prior dosing schedule due to a perceived trending issue.

There were several outdated features of the protocol that were noted upon close

review. The protocol referenced an EMR system that was no longer in use, and a point-of-

care INR system that was obsolete. The protocol indicated that the medical assistant was

assessing the patient and the patient‟s INR, reviewing the appropriate dose, and consulting

with the nurse or physician, which was not the case.

The protocol advised the RN to be aware of the possible effects of medications and

dietary changes on warfarin dosing, but did not give nurses authority to modify dosing

instructions based on these data. The protocol does allowed for a 3 mg leeway based on

available pill strengths; however, this amount of flexibility could be as much as 75% of the

weekly dose as is the case for the patients on 4 mg/week. This difference of 3 mg could be


so significant in relation to the total weekly dose that it could potentially mean dramatically

increasing a dose rather than decreasing a dose, or vice versa. If the only parameter used to

assess dosing on protocol was the total prescribed weekly dose being within 3 mg of

recommended weekly dose, significant deviations from protocol would be missed.

One particularly interesting finding during this audit was a flaw in the protocol

recommendations relating to dosing calculator results and protocol instructions. The dosing

calculator advised no adjustment be made for anything within 0.6 of the 3.0 target, keeping in

line with the adjustments for doses beyond 20% of the target INR. This has the effect of the

calculator aiming to maintain a target range of 2.4 to 3.6 rather than 2.5 to 3.5 as ordered.

Nevertheless, the protocol instructions advised that an adjustment should be made for INRs

of 2.4 or 3.6 for patients with an INR target of 3.0, leaving no guidance for the nurses from

the dosing calculator. This incongruence in the recommendations had not been identified

until this point.

Limitations. The patient visits were assessed using aggregate data. Multiple patients

did have more than one visit during the audit, and they were treated as separate visits for

analysis. Out of the 421 visits that were analyzed, there were 256 unique patients. The

repeat patients may have distinctive individual confounding factors that could have a

disproportionate impact when assessing the clinic population. The repeat patient visits were

treated as separate visits because they each represented a unique dosing challenge for the

nurses based upon their presentation for that day, and often were treated by different nurses

at their repeat visits. The nurses employed different decision-making rationales for these

visits based upon their clinical judgment in regards to the patient history and presenting

factors which included different INRs at the clinic visit.


For the RN portion of the audit, the nurses needed to be able to identify factors that

contributed to their dosing recommendations. Subconscious thought processes or failure to

record a factor would result in failure to identify instances of certain decision-making

rationales. Use of the terminology, as captured by the focus group session, that was normally

employed by the nurses allowed for improved identification of the decision-making factors at

the time of the visits, and may have helped to minimize this issue. Where the terms used on

the audit were the natural words that the nurses used to describe their thought processes,

these were more likely to be identified on the audit tool.

The RN portion of the audit was subjective to each nurse. The tool did not assess if

there was an objectively observable factor involved, and solely assessed the nurses‟

perception of those factors being present. This distinction was beneficial in that it allowed

for an understanding of how the nurse responded when she perceived a certain factor being

present, but did not assess how often there was objective evidence for these factors being

present.

As there were 5 additional non-standard goal ranges found in the audit (5% of total

visits), cases with these ranges could not be accurately assessed by the standards of the

existing protocol. The dosing calculator used in the protocol would provide dosing

recommendations for any single goal INR value, but the acceptable range may differ from

the prescribed range as previously discussed; nevertheless, follow-up recommendations did

not exist within the protocol for non-standard goal ranges. This factor decreased the number

of cases that could be compared to the protocol‟s standards from a total of 421 cases to 400

cases.


The frequency of many patient factors that affect the nurses‟ decision-making was too

low to allow for statistical analysis of these items. As such, certain items could only be

assessed in terms of individual case analysis. Longer periods of data collection may have

been beneficial to capture additional cases of these less frequent decision-making factors.

Additionally, the evaluation was not a randomized-controlled trial of the impact of the

decision-making factors on patient results. The observational design of this study limits the

strength of the findings.

Outcomes of Second Focus Group

At the completion of the clinic audit, a second focus group session was conducted.

The second focus group session allowed the nurses to review the findings from the clinical

audit so that they may provide informative feedback. All 4 of the clinic RNs participated in

this focus group review of the results from the audit and the observations made by the

auditor. Additionally, the nurses reviewed a total of 5 cases that were identified in the audit

where the auditor could not determine supporting rationales for the off-protocol dosing

advice from the patient charts or from the RN audit tool. The results were analyzed using

qualitative description. The following categories of were identified as major topics of

interest related to the evaluation questions and will be discussed in depth (See Table 8):

Agreement with findings

Documentation hindrances

EMR deficiencies

Routinized patterns of behavior


Agreement with findings. The nurses generally agreed with the assessments and the

overall findings of the clinic audit. They did not identify any areas of dissonance of the

findings with their notions of clinic functioning.

In terms of medication interactions, the nurses agreed that they require additional

support in determining appropriate warfarin dosing with specific medication interaction

concerns. When discussing the available drug interaction reference, one of the nurses

reported, “The problem is that it doesn‟t tell you how badly the interaction is and how many

days, and it doesn‟t give you any guidance” (D). The nurses‟ made multiple comments

describing their uncertainty with how to handle certain medication interactions. Their

statements of uncertainty supported the finding of the need for further nursing education in

this realm.

Relating to trending, the nurses recognized the variations on their understandings of

the concept of trending, and the differences between a perceived trend over a long period of

therapy versus a trend over several days. “She went 3.4, 3.2, 2.9, 2.3. So that‟s what I was

looking at. But that‟s over a 2 month time period” (B).

There were many occasions where the nurses identified problems with the dosing

calculator being ineffective, especially in relation to a hold in the previous week. “If you

look at the flow sheet, this is where he was 3.8 and then, yup. Well it‟s deceiving because it

looks like the dose was increased, but it really was just plugging in that hold” (B). The

nurses also recognized some inconsistencies in thought processes relating to the management

of held doses. “And, I‟m just kind of leery. So technically we did increase the dose” (C).

There was significant agreement among the nurses that that the patients‟ reports of

various issues alter their dosing instructions, but that this information is often not captured in


the visit note. “Sometimes it depends on the chat that you‟re having with the patient” (A).

“Absolutely. But I even notice myself, I‟ll look back and I‟ll go, „Who the hell did that?!‟

And I‟ll go, oh, I did it! You know, and I would never have done that today, but geez, but

they made me do it then” (B).

The nurses acknowledged their practice of accepting INRs that were close to the

target therapeutic targets but out of range as normal values. “But I think what we are looking

at is the 2.5 to 3.5, and saying, „3.5 is fine,‟ So what is 3.8? That‟s fine. And that‟s where

we‟re seeing it, and that‟s how we have been doing it all along” (A). “And 1.9 doesn‟t get

me too excited because they‟re still pretty close” (A). The nurses agreed with the assessment

that they tend to view the endpoints of the target therapeutic ranges as the actual targets

rather than the target INR which is in the middle of those endpoints. “I have not looked at it

as 2-3 seeing 2.5. I have not” (A). “And that‟s why I can understand accepting ranges, but

it‟s almost like we should just be saying TARGET 3.0. Okay if you are 2.5 to 3.5, but

TARGET is …” (B).

The nurses reported various practices relating to changes in dietary vitamin K intake,

and also discussed their recommendations to the patients relating to this issue. “They‟ll say

oh geez, I want to increase my greens when can I do it? And then, okay you‟re 2.8 today,

now‟s a good time. Or you‟re 3.3, today‟s your day” (B). The nurses also suggested that they

will advise patients to increase dietary intake at times beyond just accommodating patient

preferences. “I will write preference versus instructed in my notes, or I try to…” (B).

A habit of following intuition and feelings rather than adhering to a standard protocol

or methodology was also noted. “Yeah, and looking at this today, this is the other thing is,

even myself, I can look at the same case two different days and do two different things with it


Umm, and yeah, today I would say no, I probably would have just left it alone and checked it

again in 3 weeks. So it depends on which way the wind‟s blowing that day on how I do

things sometimes” (B).

There was recognition of the various non-standard goal INR ranges and the

incomplete documentation surrounding indication for therapy and duration of therapy. “Also,

when we have someone on the template, we have no idea who put that target range in there,

when it was changed, or whose whim it was on” (B).

Documentation hindrances. The nurses identified numerous issues that hindered

their abilities to provide adequate documentation. They recognized the need for improved

documentation. “In Coumadin Clinic, that‟s our biggest issue” (A). “It‟s confusing to read

the note. I appreciate us coming in and seeing it” (C).

Part of the rationale for not including certain elements of the decision-making process

was reported to be due to a different concept of what needed to be documented in the note.

“But in all honesty, I don‟t often, and I can‟t even imagine writing that the dose was held last

visit when you‟ve got it right there on the flow sheet. I‟m kind of writing things that aren‟t

apparent from the flow sheet. I assume that you can see that, that it was held” (B). The

nurses also reported a lack of consistency in documentation due to provider preferences for

placement of information within the documentation. “And also have all of the providers on

the same page about where they want us to put the information” (D).

Once the nurses recognized the need for more clear documentation, they had concerns

about the impact of that on their workload. “That‟s gonna take a lot more concentration”

(B). “I‟m overwhelmed sitting here right now because you have no idea how many of those

make sure you click that button, make sure you report the INR, you know what I mean?” (B).


The available amount of time to see a patient and document the care was a significant

concern for the nurses. “Again we‟re down to a very very small fraction of the time being

seeing the patient” (A). Being busy with multiple patients was a reported reason for failing

to provide complete documentation. “It‟s like plenty of time when things are going well, and

when you‟ve got 5 people that come in that are way off track and everything‟s happening to

them, and that‟s how you don‟t chart sometimes” (A). One nurse made suggestions to

another on how to slow down the pace of clinic to make things more manageable.

One rationale for not documenting information in the patient charts was the format of

the EMR system. The computer system would print the information entered by the nurses

into the instructions the patient received at the end of the visit. “Unfortunately, if we write a

lot of that into the note now, the patient receives that also. It‟s part of his instructions” (A).

The absence of standardized documentation templates was another identified

hindrance to charting. The nurses felt that addition of a charting template would be a step

towards improved charting. “I‟ve seen examples of different documentation from different

clinics where there‟s areas, you know, different questions that you have to ask to make sure

that you kind of document, like makes you include it in the note” (D).

EMR deficiencies. There were numerous deficiencies within the EMR system that

were identified by the nurses. One particularly troubling issue for the nurses related to how

the system charted dosing instructions at the visit after a hold. Because the system would

compare the current week‟s dosing total to the prior week‟s dosing total, the system would

automatically record that there was a dose increase, even though the total weekly dosing was

lower than the week prior to the hold. The nurses identified that they would have to

manually delete out the text created by the system to clarify the overall dosing changes.


The weekly dosing calculator did not automatically update the total weekly dosing

without the nurses clicking a box to recalculate the dose. If the nurse forgot to update the

dosing total, the following visit would be confusing to the nurse reviewing the instructions.

“These are the things that drive us out of our minds. Because even just trying to figure things

out, that day I‟m trying to read it across and I would have been looking at total weekly doses,

and when you realize they don‟t match…” (B).

The nurses felt that the deficiencies of the EMR impaired their abilities to see patients

more efficiently. “[I] think a lot of the problem with me is computer program. Because we

are always having to fix something. Something doesn‟t come out in the flow sheet, something

doesn‟t come out show up. We spend more time babysitting the computer sometimes than we

do with the patient” (A).

Routinized patterns of behavior. There was recognition of engrained patterns of

behavior with patients, nurses, and prescribers relating to warfarin therapy that would require

additional attention. The nurses felt that these routines would be difficult to change.

In relation to the patients, the nurses reported a need to change their expectations

relating to dosing instructions. “I don‟t think patients who have been on it a long time are

going to come back sooner. I don‟t think the compliance will be there” (A). In considering

their own habits, the nurses reported that this would be a process of change, as well. “It‟s

tough to teach an old dog new tricks” (B).

Changing prescriber habits was another issue of concern for the nurses. They

identified variable understandings on the part of prescribers of the established clinic policies.

The nurses felt that prescribers needed additional training in the operations of the clinic and


the preferred dosing instructions. They felt that certain providers had expectations of the

clinic and the clinic nurses that were not consistent with the established policies.

Summary of second focus group findings. The second focus group confirmed

many of the findings and observations made during the clinic audit process. The nurses

agreed with the need for various changes to the clinic protocols and the patterns of behavior.

They recognized the need for additional education relating to certain areas of practice that

were found to be problematic in the audit. Factors that contributed to inadequate

documentation were identified, as were some strategies to reduce the impact of these factors.

Additionally, the nurses identified deficiencies within the system that negatively affected

their quality of care.

Discussion and Recommendations for Change

Assessment of the clinic outcomes data with comparison of the focus group items and

the observed patterns of behavior to the existing literature comprehensively addressed the

second program evaluation question: Where are the opportunities within the existing

anticoagulation protocol to improve safety, decrease nurse-workload, decrease the need for

physician-involvement, and decrease patient-visit-burden?

The process of analyzing the findings and looking to the evidence in the literature for

support of recommendations for change further supported the associated aims of the research.

Specific Aims of Q2:


revision.


anticoagulation.


protocols.

4. To recommend interventions to improve the nurse-managed anticoagulation protocol.


The concept of nurse decision-making processes superseding a clinic protocol as

identified in the literature was supported in the findings of this program evaluation. The

nurses utilized a process of patient assessment that went beyond what was dictated by the

protocol. This process of assessment caused the nurses to use the protocol as a reference, but

not the deciding factor for patient care. As reported by O‟Cathain et al., “the nurse

interpreted the software recommendation in the light of information the software could not

process” (p. 283).

Overall, the baseline data from the clinic audit revealed that this anticoagulation

clinic had typical therapeutic success rates with a total of 63.4% of patients presenting with

an INR within therapeutic range during the audit when compared to findings of other clinics

in the literature maintaining patients in therapeutic range an average of 66% of the time (van

Walraven, Jennings, Oake, Fergusson, & Forrester, 2006). The adverse events data were in-

line with prior meta-analyses that demonstrate half of adverse events occur while the INR is

within therapeutic range (Oake, Fergusson, Forster, & van Walraven, 2007). In the literature,

frequency of major hemorrhage is approximately 7.7% per patient-year of therapy (Ansell et

al., 2001), which would translate to an expected 1.64 patient events per month in a

population of 264 individual patients, as was the size of this sample. The event rate was

higher (7 patients as compared to a predicted 1.64 patients) in the month studied as compared

to these statistics. Additional months of data collection would be necessary to assess if the

sampled month had typical rates of complications for this clinic. This is certainly an

outcome measure that must be monitored very closely.

The clinic nurses remained within protocol standards for dosing 91.2% of the time

when looking at weekly dosing totals, which is greater than the frequency reported by


Shimbukuro and Kramer (2004) of 86.4% of dose instructions being on-protocol. However,

when assessing adherence by measures of direction of change (i.e. absolute instruction of

dose increased, decreased, or maintained the same as determined by the nurse versus the

protocol), the rate of adherence to protocol recommendations was 78.7% (see Table 9). Even

more significantly, the recommended time to follow-up was only in agreement with the

protocol recommendations 43.5% of the time for cases where the prescribed target INR range

was one of the standard ranges accepted in the clinic. It was this significant difference

between protocol instructions and nursing recommendations that demonstrated the need for

systems improvements.

Medication interactions. It has long been recognized that the anticoagulant response

of warfarin is influenced by pharmacokinetic factors of drug interactions that alter absorption

and metabolic clearance of the drug (Hirsh et al., 2003). Although the protocol did recognize

the possible effects of various medications on warfarin dosing, it did not provide the nurses

with the authority to adjust warfarin dosing recommendations based on those potential

interactions. In the initial focus group session, the nurses appropriately identified a need for

preemptive dose adjustments for certain medications as well as a need to follow patients

more closely when there was a concern for medication interactions. As discussed previously,

the nurses followed patients with medication concerns more frequently than recommended

by protocol standards.

Prednisone was identified as a medication of particular concern. Case reports in the

literature have found prednisone to increase INR to varying degrees (Stading, 2006). The

nurses were using sound clinical judgment in monitoring these patients more closely.


Although amiodarone was only an issue in a single case during the audit, this is

certainly an example of a medication that requires special attention in a modified

anticoagulation protocol. Amiodarone inhibits the metabolic clearance of both S- and R-

isomers of warfarin and potentiates wafarin anticoagulation, but other medications, such as

omeprazole, only inhibit clearance of R-isomers and potentiate the anticoagulation only

modestly (Hirsh et al., 2003). This distinction in the pharmacologic pathways of various

medication interactions with warfarin is helpful in determining the anticipated strength of

effect of an interaction, and can guide a provider in decisions regarding preemptive dose

changes versus more frequent follow-up.

The benefits of preemptive dose adjustments when initiating medications with a

known effect on warfarin have been demonstrated in numerous studies. As the nurses

reported a practice of not preemptively adjusting warfarin for antibiotics and demonstrated

more frequent follow-up, this area deserved particular attention. Ahmed, Stephens, Kaus,

and Fay (2008) demonstrated that with trimethoprim-sulfamethoxazole and levofloxacin, a

strategy of preemptive dose reduction for the former and no change with short-term follow

up for the latter is an effective strategy for maintaining therapeutic range. Treating

“antibiotics” as a class of medications in relation to warfarin management is not sufficient.

An additional understanding of pharmacologic principles must be applied to improve

outcomes.

The nurses confirmed the need for additional education surrounding medication

interaction at the second focus group. They also identified a need for additional decision

support tools to assist them in making dose determinations and follow-up instructions when

there are potential medication interactions.


As it is impractical to create a protocol for every potential medication interaction with

warfarin therapy, it is necessary to design a more targeted approach to dealing with this issue.

The anticoagulation protocol advised consulting a drug reference to determine the potential

interaction of other drugs. A fairly comprehensive list of common medications along with

their strength and direction of interaction could be developed. It would then be necessary to

give the nurses the authority to make appropriate preemptive dose adjustments in response to

potential significant drug interactions, and to alter the time-to-follow-up plan as necessary.

This will require additional nurse education in the area of pharmacologic principles, and

educational planning strategies are needed. Use of summarized tools that include the

strength and direction of an interaction, such as the tables presented in Holbrook et al.

(2005), may prove useful to the nurses in understanding potential medication interaction

issues. These tables could supplement a nurses understanding of potential interactions and

help guide their course of action.

New to warfarin/suspension of therapy. According to Hirsh et al. (2003),

“Warfarin dosing may be separated into initial and maintenance phases. After treatment is

started, the INR response is monitored frequently until a stable dose-response relationship is

obtained; thereafter, the frequency of INR testing is reduced” (p. 1637). Upon investigation

of the clinic protocol, it is strikingly evident that there are no separate instructions for the

initiation of warfarin from the chronic management instructions. The current protocol has a

chronic maintenance algorithm, but does not provide dosing guidelines for the patient naïve

to warfarin. In the clinical audit, the nurses had various recommendations for patients in this

phase of therapy with no standardized approach.


Numerous start-up protocols are in existence (e.g. Anderson et al., 2002, Kovacs et

al., 2003, and Dalere, Coleman, & Lum, 1999). Many of the existing acute start-up protocols

have been designed for in-hospital use when the INR can easily be monitored daily, such as

the protocol employed at the clinic‟s affiliated hospital. This in-hospital warfarin protocol

(Northeast Hospital Corporation Pharmacy & Therapeutics Committee, 2010) employs a

basic dosing nomogram with dosing recommendations based on daily INR changes.

Strategies for outpatient initiation of warfarin are numerous and less well defined in the

literature. Trial of a tested and validated start-up protocol would address the current protocol

deficiency in this area; however, no such outpatient tool has been identified in the literature.

The existing protocol does not address management of patients in the perioperative

period. Certainly, the perioperative patient will require assessment by a prescribing provider

for determination of risk and appropriate perioperative anticoagulation management.

Nevertheless, the anticoagulation clinic is lacking a standard of care for these situations that

can guide both the prescribers and the nurses. Development of a standard of care statement

with guidelines for prescribers and clinic nurses will help assure consistency and safety in the

delivery of care to patients in the perioperative period. These standards should be consistent

with the recommendations published jointly by the American Heart Association and the

American College of Cardiology (Hirsh et al., 2003). Although these recommendations do

not provide specific dosing recommendations, they do provide general statements of dosing

principles that the prescriber should consider when determining a dose.

Trending/history. The concept of trending patterns is not well described in the

literature. Numerous anticoagulation protocols utilize dose-response trends in the acute

phase of anticoagulation initiation. Warfarin initiation protocols will often provide a


recommendation to increase the dose for a small INR response early on in therapy, or to

decrease the dose if a rapid response to anticoagulation therapy is observed even if the INR

remains subtherapeutic (e.g. Kayser, 2005). These protocols recognize a trending pattern in

relation to initial doses of warfarin therapy. The practice of monitoring for trending once

chronic therapy has been established is not well studied. Certainly there is a general

recognition of the lag time of INR response in relation to a change in therapy, diet, or other

influencing factors. This understanding notwithstanding, there is no recommendation

provided in the literature for tracking of INR trends when the INR is within therapeutic range

and there is no identified alteration in factors affecting warfarin.

Although no statistically significant difference could be determined when trending

was observed and this factor impacted dosing recommendations, these data need to be

interpreted carefully. The patient data to which the indentified trending cases were compared

are not paired data sets. The cases of identified trending were selected by the nurses as being

at risk for returning out of range, thus the dosing instructions were modified preemptively.

The failure to see a difference in outcomes for the identified trending patients as compared to

other patients may actually be a positive finding in support of this method of decision-

making. The practice of monitoring for and tailoring to patterns of trending may be an

effective strategy in warfarin regulation, and is a topic that requires further research.

Within the second focus group, the nurses identified various applications of the

concept of trending, and recognized the distinction between acute trending and chronic

trending. This area will require further nurse education relating the appropriateness of the

use of trending as a decision-making tool.


Dosing calculator ineffective. The dosing calculator does not have the capability of

assessing situations where a weekly dose total does not represent a complete week of

warfarin dosing. Creation of a start-up protocol and a perioperative management strategy are

steps that would be expected to decrease the frequency of this issue.

Holds and missed doses will continue to present particular challenges. The time to

follow-up after a hold is typically shorter due to concerns related to the very high INR that

prompted the hold. At the rapid follow-up visit after hold, the INR will not have reached a

steady state. The INR dosing calculator is only appropriate for use in steady state situations

due to the known acute trending issue with dosing adjustments. As such, a clinical

determination will need to be made as to the appropriate dosing instructions which takes into

account the highest INR value; prior dosing schedule that resulted in the supratherapeutic

state; other influencing factors that lead to the INR elevation, including current and

anticipated future status of these issues; number of days held; number of days since last INR

value; risks for both bleeding and thromboembolic events; and the current INR.

During the second focus group, the nurses reported uncertainty in how to address a

hold and calculate new dosing instructions. They identified that they were confused by the

dosing calculator‟s advice for total weekly dosing when there had been a recent hold. They

also found that documentation of dosing instructions relating to recent holds was a

problematic area for them, and could lead to confusion at subsequent visits. Additional

standards of care need to be developed, and the nurses require further education relating to

this subject. Furthermore, prescriber consultation would be appropriate in these instances.

As stated previously, there were a total of 16 (3.6%) clinic visits in which there was a hold

within the previous week. Although this would have an impact on time resources and


provider burden, this was the area that was identified as having the smallest proportion of in-

range INRs, and deserves additional dedication of these resources.

Adherence to therapy and missed doses must be addressed on an individualized basis.

As discussed by Jaffer and Bragg (2003), the missed dose of warfarin is usually reflected in

the INR within 2 to 5 days after the missed dose. Subtherapeutic INRs after missed doses

may be appropriately low, and increasing the weekly dosing schedule would be

inappropriate. INRs within therapeutic range may represent a previously supratherapeutic

INRs, and dose reduction may be an appropriate intervention. As is the case with doses that

were held intentionally, the INR value must be assessed within the clinical context in which

it occurred. More frequent follow-up of these cases is appropriate to determine ongoing

patient adherence to therapy and reassess stability of INR values.

High-risk/concerning factors. Ongoing assessment of patients‟ individual risks

associated with anticoagulation therapy is of critical importance in steps to assure patient

safety on therapy. Lip (2007) highlights that although many diseases associated with stroke

and thromboembolism are more common with increasing age, many conditions associated

with higher risk of bleeding are also more common with increasing age. The nurses were

correct to have additional concerns for patients at higher risk of falling, patients with higher

risk of bleeding, and patient at higher risk for thromboembolic events, and Lip (2007)

recommends “meticulous attention to the degree of anticoagulation” as a strategy to

minimize the risk of complications of therapy. Control of hypertension is highly relevant as

improved blood pressure control reduces the risk of stroke and systemic embolism in patients

on warfarin (Lip, 2007). Incorporating parameters for these high-risk factors into the clinic

may help to improve patient safety and increase the consistency of nurse recommendations.


Patient factors and extraneous factors. The nurses managed specific patient-

related factors and extraneous factors on an individualized basis. The literature describes

best practice guidelines for managing dietary factors surrounding vitamin K intake. Patients

with relative low intake of vitamin K tend to have unstable warfarin control, and there is the

suggestion that supplementation of low-dose oral vitamin K may improve control (Valentine

& Hull, 2008). Patient education on the importance of consistent dietary intake of vitamin K

is a key initial step in dealing with these concerns. Clinicians should provide education to

patients regarding therapy through face-to-face interactions, written materials, and other

audio-visual resources that are at an appropriate level for the patients‟ learning needs (Garcia

et al., 2008). Instructions to temporarily increase or decrease vitamin K intake are not

consistent with best practices, and warfarin dosing should be tailored to match the patients‟

intake of vitamin K (Valentine & Hull, 2008). Use of supplemental vitamin K for correction

of critically high INRs is a separate topic of discussion.

In the clinic audit, various patient instructions were detected in relation to vitamin K

intake. Some of the nurses reported that the patients were instructed to increase their intake

of vitamin K. At the second focus group, the nurses reported various patterns of behavior

relating to their instructions on this issue. These reports verified the need for additional

nursing education on appropriate dietary vitamin K instructions.

Group standard. The practice of more frequent follow-up is not entirely

unsubstantiated in the evidence. Although there is a desire to decrease the patient visit

burden and cost of care, this must be balanced with safety. Conversely, very frequent INR

testing can lead to confusing situations with warfarin dosing as the time to achieve a steady

state can be more than several days, and also results in inefficient use of office resources and


increases patient visit burden. The optimal frequency of monitoring is dependent on many

factors which include patient compliance, fluctuations in comorbid conditions, alteration of

other medication therapies, changes in diet, and established stability on therapy.

More frequent follow-up visits are often employed to assess patient factors beyond

just INR values, including the development of complications and the appropriate trending of

INR values in extreme out-of-range INR situations. As such the time to follow-up is not

always determined based on when the expected dose changes will reach intended INR

targets. A nurse may request a short time-to-follow-up recognizing that the INR is not likely

to have reached target yet with the intention of physically assessing the patient or assuring

that the INR is trending appropriately. This practice behavior of following-up more

frequently to assure patient safety may have caused certain clinical decision-making factors

to appear less useful in the clinic audit. The audit tool was designed to assess if the

subsequent INR after a dosing recommendation was in-range, and did not account for

situations where the subsequent INR was not expected to be in-range.

As reported in a consensus statement by Ansell et al. (2001), several clinical trials

have suggested that fewer adverse events and increased time in therapeutic range can be

achieved with more frequent monitoring. The nurses‟ shorter time to follow-up as compared

to the protocol recommendations may be appropriate and beneficial to patient outcomes. A

revised protocol should recommend more frequent follow-up appointments when there are

additional factors present that may cause INR values to be unsteady.

The results from the clinic audit did demonstrate that the nurses will accept INRs

within 0.2 outside of range, even without supporting rationales. This finding supports the

nurses‟ report in the focus group of having more lenient ranges. Through the observations


made by the PI during the audit process and the reports by the nurses at the second focus

group, a specific thought process relating to goal ranges was identified as a possible

contributor to this issue. The nurses had been targeting the upper and lower limits of the INR

goal range when making dosing decisions rather than the actual target INR which falls in the

middle of those limits. For this reason, the nurses were more likely to accept an INR that

was considered to be just slightly out of range.

The results of the clinic audit demonstrated less favorable control with the longer

return to clinic times for patients with INRs within 0.2 out of range. This demonstrates the

need for more intensive management of patients with INRs out of goal range. The practice

of accepting INRs that are considered to be slightly out of range without an identifiable cause

should not continue.

The finding of less favorable outcomes in patients with shorter than recommended

return-to-clinic times must be interpreted with caution. The first caution is the limited

sample size, and the statistical limitations that relate to this. The second caution is that the

sample has an inherent bias towards instability. The nurses determined that the patients

required more frequent monitoring out of suspicion that the patient has the increased

potential to be out of range. Although the subsequent INR was out of range in 37.9% of the

cases where the follow-up time was sooner than advised by the protocol, by following up

more frequently, the nurses have the potential to correct the INR and increase the time spent

in therapeutic range. Had the nurses followed the recommended return-to-clinic guidelines,

these patients would ostensibly have remained outside of therapeutic range for longer periods

of time, an average of 15 additional days for these specific cases.


Previously unidentified issues. The concept of patient illnesses raising cause for

concern in relation to warfarin therapy is supported by evidence in the literature. Not only do

the medications associated with illness often interact with warfarin, the fluctuations of

Vitamin K intake and hypermetabolic effects related to illness can have variable impacts on

anticoagulation stability (Hirsh et al., 2003). Jaffer and Bragg (2003) recommend more

frequent follow-up when there are concerns of illness.

The protocol states that the medical assistants are involved in the assessment and

formulation of a plan of care. These actions fall outside the scope of practice of a medical

assistant, and these instructions do not represent the current operations of the clinic. This

wording must be removed from the protocol.

The 3 mg leeway for adjusting based on available pill strengths is a feature that

allows for off-protocol dosing without detection of the issue. As it is difficult to track when

the pill strength issue is causing a dose change versus the nurse deliberately changing the

dose when it falls within this 3 mg parameter, monitoring adherence to protocol dosing is

made more complicated. A 3 mg variance in dosing is very significant for some patients, and

modification of the protocol to for a smaller total allowable percentage variance from

recommended weekly dose to accommodate pill strength concerns would decrease the

potential impact of this protocol allowance.

The need for a computerized, automated tracking system is evident, as there were

identified cases of patients being lost to follow-up through the audit process. A

recommendation of the consensus statement from the Anticoagulation Forum is that an

efficient system for scheduling and tracking patients should be utilized (Garcia et al., 2008).

During this audit process, the nurses described the significant amount of time that is spent


manually tracking patients, and they expressed concerns over possible oversights that can

occur in their tracking procedures.

Summary and recommendations. All of the findings of this evaluation process

have confirmed the assumption that clinician assessment and judgment are vital to assuring

the quality and safety of an anticoagulation program. Wittkowsky, Spinler, Dager, Gulseth

and Netescu (2010) explained that, “it is simply impossible to construct a mathematically

based warfarin dosing protocol that calculates a dose for every clinical scenario.” The

authors advocate for implementation of dosing guidelines rather than protocols that adhere to

strict nomograms for dosing decisions. Anticoagulation guidelines may suggest doses that

may be appropriate, but Wittowsky et al. stress that “the responsible clinician needs to ensure

that any guideline-suggested dosage is appropriate for the specific situation before any

dosage is prescribed” (p. 1555). Rich (2010) reported, “A good protocol is created from

evidence-based medical practices agreed on by medical staff involved in anticoagulation

therapy (i.e., all stakeholders) and addresses key decision points and respective courses of

action integrated with the clinical judgment and experience of the practitioner” (p. 1557).

From the findings of the various stages of this program evaluation, numerous action

items have been developed (see table below). These items have been categorized according

to the following headings: Tracking and quality assurance; Documentation of care; Protocol

revisions; and Areas for nursing staff and clinic development. Tracking and quality

assurance items relate to the development of systems that will maintain a process patient

tracking and quality monitoring that was previously lacking in the clinic. Documentation of

care items relate to improved communication of nurses‟ rationales as well as other critical

patient care information. Protocol revisions items relate to identified deficiencies in the


existing protocol that require the development of new or improved algorithms for dosing.

Areas for nursing staff and clinic development items are issues that were identified as being

problematic that require additional staff education and enforcement of existing standards of

clinic operations. Key participants have been identified for each of these action items, and a

timeline for phases of implementation has been developed (see Proposed Phases of

Implementation table below). Through critically assessing the anticoagulation clinic policies

and procedures, applying additional evidence-based changes to the protocols, and involving

all stakeholders in the process, consistency of care and quality of care provided may improve.


Process Improvement Recommendations

Tracking and quality assurance.

Address goals of improving safety and decreasing nurse workload

1. Develop tracking system for quality assurance measures of time in

therapeutic range and complications of therapy

2. Develop patient tracking system in EMR for adherence to follow-up

Documentation of care.

Address goals of improving safety and decreasing physician workload

1. Improved documentation of indication for therapy

2. Improved documentation of expected duration of therapy (with date of

initiation of therapy)

3. Improved documentation of patient factors affecting current INR

4. Improved documentation of rationales for varied dosing instructions

Protocol revisions.

Address goals of improving safety, and decreasing need for physician involvement

and nurse workload

1. Address issue of dosing calculator 3.0 target goal of 2.4-3.6

2. Incorporate start-up protocol for warfarin-naïve patients

3. Incorportate standards for peri-operative management

4. Develop parameters for abnormal vital signs and laboratory data with

guidelines for course of action

5. Incorporate RN authority to adjust recommendations in response to

medication interactions and other influencing factors

6. Incorporate advise for dosing after hold within previous week

Areas for nursing staff and clinic development.

Address goals of improving safety and decreasing visit burden

1. Address issue of numerous (non-standard) INR goal ranges

2. Enforce requirement for specialist evaluation upon enrollment to clinic

3. Address issues of preemptive dose adjustment and frequency of

follow-up for various medication interactions

4. Advise for increased frequency of follow-up for patients with

increased potential for INR fluctuations

5. Further education regarding concept of trending and when it may be

appropriate to apply

6. Education on need to stop practice of accepting INRs out of range as

normal without documentation of appropriate rationale. Also,

education on need for closer monitoring of these patients.

7. Standardize dietary vitamin K recommendations provided to patients

8. Additional nursing education regarding pharmacologic principles of

medication interactions


Proposed Phases of Implementation

Phase Milestone Participants Target date of

completion

1 1. Incorporate start-up protocol

for warfarin-naïve patients

2. Incorportate standards for peri-

operative management

3. Develop tracking system for

quality assurance measures of

time in therapeutic range and

complications of therapy

4. Develop patient tracking

system in EMR for adherence

to follow-up

5. Nurse education plan for

development items

2,3,4,5,6,7,8

6. Revisions to protocol for items

1,4,5,6

7. Create plan for revision of

non-standard INR ranges

1. NWS, DES

2. NWS, DES

3. NWS, DES,

LG, IT

Consultants

4. NWS, DES,

LG, IT

Consultants

5. NWS, RNs

6. NWS, DES

7. NWS, DES

4/1/2011

2 1. Nurse education on protocol

revisions and implementation

of revisions into clinic practice

2. Non-standard INR ranges

corrected

1. NWS, RNs

2. NWS, RNs

4/15/2011

3 1. EMR tracking system

implemented and employed by

nurses

1. NWS, DES,

LG, IT

Consultants,

RNs

5/1/2011

4 1. Formal review of all phases of

process improvement and

evaluation of clinic

performance – first of new

practice of quarterly reviews

1. NWS, DES,

RNs

6/1/2011


Tables and Graphics

Table 1

Demographics of Clinic Nurses

Participant Education # of years

as nurse

# of years

working at The

Medical Group

# of years

regulating

warfarin

1 RN 3 Year Diploma-1965 45 years 31 years 20+

2 Associate Degree - 1992 18 8 years 8

3 Associate Degree-1991 19 years 9 years 9

4 Bachelors of art-2005

Accelerated Nursing program-

2009

< 1 year < 1 year < 1


Table 2

Participant Quotes from Focus Group 1

Factors affecting nurse decision-

making

Participants Comments

Medication Interactions

Antibiotics

Amiodarone

Prednisone

Chemotherapuetics

Blood products

“You‟re stopping somebody‟s Amiodarone.

What‟s the protocol? Do you wait til it turns

downward or do you cut „em then? …. same

with antibiotics – you do not always know how

they are going to affect individual people so is

it better to anticipate the change or to wait for

the change?” (C).

“If someone is started on a new med or a med‟s

changed, knowing what day, how long after

they have started that drug we need to see him

in the clinic to make an adjustment?”

“Do you make any dose adjustments based on

the fact that they are starting antibiotics? (PI)*

“No” (B).

New to warfarin/suspension of

therapy

Patients new to warfarin

Perioperative period

Suspension of therapy

“New patients on Coumadin just can‟t fall into

the protocol. They just can‟t.” (A).

“If they‟ve restarted after a procedure, we‟ll

check them sooner” (D).

“They were started on it 3 days ago and they

went from a 1.1 to a 2.8. You‟re definitely

going to dose down that one” (C).

We want at least 1 or 2 weeks of a steady

leveling before we‟ll let them go 4” (A).


Trending/patient history

Assessment of previous INR

values

Trending

Labile responses to dose

adjustment

History of variances

Previous INR response to

medication

“Sometime we look at a history on their

flowsheet to see what goes on when this

happens before. And it takes a while you look

back and say, well the last time they were off

their Coumadin for a surgical procedure, thus

and so happened and it‟s happening again. You

might bet that‟s gonna happen again with this

person. And again, part of it unfortunately is an

educated guess at that point (A).

“What prompts you to question return to

clinic?” (PI) “trending up or down” (C).

“Where one patient you would change it 1% ,

and she goes through the roof or drops so you

have to look at the flowsheet and see how she

responded” (D).

“Sensitivity of knowing that even though they

are outside of range, dropping „em 1-mg a week

might make him sub-therapeutic “ (C).

Dosing calculator ineffective

Previous hold

INR check less than one week

apart

So if you had a hold in the previous week, the

calculator you have to put in the dose for the

previous week and if it includes a hold (B:

Mmmmm), then it (C: right) really messes up..”

(D). “Well it is a true previous week total, but

it doesn‟t account for that one day that you have

them skip it” (C) “Exactly” (B).

“I‟m just thinking you really can‟t use that

calculator if do have someone come in on a

Monday and then you see them again on

Thursday, you‟re not gonna get an accurate

reading, you just can‟t” (A).

“This patient was 4.22 for no reason so we did a

hold and in one week later he had dropped to

2.86 which was within range and the protocol


say stay the same for four weeks. However

there was a hold in the previous dosing so then

we had to adjust her week dose not to include a

hold, but we didn‟t want it to be as high as it

was before because she had jumped so much.

So we did (make an adjustment), instead of

bringing her back in four weeks with no

change, because she was in range, we changed

it and we brought her back in one week“ (D).

High risk/concerning factors

Symptomatic patients

History of bleeding

Risk for fall

Risk for stroke

Upcoming cardioversion

Abnormal vital signs or Labs

“Be a little more aggressive with a valve” or “a

stroke” (A).

“If they have a history of a bleed, also we‟ll

check it sooner (A).

“You‟re trying to keep somebody therapeutic

for cardioversion, you‟re gonna check them

weekly” (C).

Patient factors and extraneous

factors

Compliance

Missed doses

Weekends/Holidays

Dietary changes

Self adjustment

Pill strength/prefilled blister packs

“Weekends are a challenge on antibiotics” (C).

“They don‟t want it – they won‟t take 4 weeks.

I guess you have to consider their comfort level

with this too”

“So when the summer especially if patient start

eating a lot of greens, um if people drink a lot

of alcohol and now they are trying to cut down

on their alcohol use…” (D). And how would

that cause you to question the protocol? (PI). “

Because if you know that the cause is going

away, they have a lot of greens last week but

now they‟re going to go back to their normal

diet” (C).

“You‟re also making a change based on what


strength pills they have and what increments

you can work with. So if working in 2.5 mg

increments, that‟s what the patient has to work

with without trying to be too confusing to them.

And give them 10 strength pills” (C).

“And if you are worried about compliance?”

(PI). “We check sooner” (D) “Yes” (B).

Group standard

Unfamiliar with protocol

Own parameters

“If somebody came into clinic and they have

only been back on the Coumadin one day,

umm, and they‟re pretty low I might let them go

a week – Actually, I don‟t even know what it

says on that” (C) “no it says two weeks” (A).

“If person has been stable for you know months

and they have an INR at 3.2 the protocol would

tell you to make a dose adjustment but

oftentimes we won‟t make, won‟t want to do

the adjustment and (instead) check them soon.”

(D) “Mmm hm” (C).

“It‟s kinda like if your‟re seeing it‟s 3.1 and you

drop it, you‟re gonna drop them too low.

Especially if someone tends to be 3.1, 3, 3.1”

(A).

“ If somebody stays on the higher side and

they‟re normal and no major changes, then I‟d

leave them up to a 3.3” (C)


Table 3

Description of Patient Visit Presentations

Total Visits 421

Individual patients 256

Presenting INR in-range 267 visits (63.4%)

Presenting INR within 0.2 of range 58 visits (13.8%)

Presenting INR above range 53 visits (12.6%)

Presenting INR below range 101 visits (24%)


Table 4

Comparison of Patient Presentations across Months

November December

# Patient visits 411 421

INR in-range 265 (64.5%) 267 (63.4%)

INR within 0.2 of range 99 (22.4%) 58 visits (13.8%)


Table 5

Listed Indications for Therapy

Indication Total Visits

Atrial Fibrillation (AF) 297 (70.5%)

Mechanical Valve Replacement (MVR) 23 (5.5%)

Pulmonary Embolism (PE) 29 (6.9%)

Deep Vein Thrombosis (DVT) 22 (5.2%)

Cerebrovascular Accident (CVA) 34 (8.1%)

Hypercoaguability 3 (0.7%)

Coronary Artery Disease (CAD) 10 (2.4%)

Peripheral Vascular Disease (PVD) 3 (0.7%)


Table 6

Listed Goal Ranges

Goal Range Total Visits

2.0 – 3.0 376 (89.3%)

2.5 – 3.5 24 (5.7%)

3.0 – 3.5 4 (1%)

3.0 – 4.0 4 (1%)

2.0 – 2.5 11 (2.6%)

1.5 – 2.5 1 (0.2%)

1.8 – 2.2 1 (0.2%)


Table 7

Number of Decision-Making Factors Present per Patient Visit

# Considerations* Frequency (# cases) Percent (%)

0 199 47.3

1 111 26.4

2 60 14.3

3 32 7.6

4 13 3.1

5 2 0.5

6 3 0.7

7 1 0.2

*Considerations refer to the individual decision-making factors identified by the nurses by

category on the audit form


Table 8

Participant Quotes from Focus Group 2.

Category Participants Comments

Agreement with findings “The problem is that it doesn‟t tell you how

badly the interaction is and how many days, and

it doesn‟t give you any guidance” (D).

“She went 3.4, 3.2, 2.9, 2.3. So that‟s what I was

looking at. But that‟s over a 2 month time

period” (B).

“If you look at the flow sheet, this is where he

was 3.8 and then, yup. Well it‟s deceiving

because it looks like the dose was increased, but

it really was just plugging in that hold” (B).

“Sometimes it depends on the chat that you‟re

having with the patient” (A).

“Absolutely. But I even notice myself, I‟ll look

back and I‟ll go, “Who the hell did that?!” And

I‟ll go, oh, I did it! You know, and I would

never have done that today, but geez, but they

made me do it then” (B).

“But I think what we are looking at is the 2.5 to

3.5, and saying, “3.5 is fine,” So what is 3.8?

That‟s fine. And that‟s where we‟re seeing it,

and that‟s how we have been doing it all along”

(A).

“And 1.9 doesn‟t get me too excited because

they‟re still pretty close” (A).

“I have not looked at it as 2-3 seeing 2.5. I have

not” (A).

“And that‟s why I can understand accepting

ranges, but it‟s almost like we should just be

saying TARGET 3.0. Okay if you are 2.5 to 3.5,

but TARGET is …” (B).

“They‟ll say oh geez, I want to increase my

greens when can I do it? And then, okay you‟re

2.8 today, now‟s a good time. Or you‟re 3.3,

today‟s your day” (B).

“I will write preference versus instructed in my

notes, or I try to…” (B).

“Yeah, and looking at this today, this is the other

thing is, even myself, I can look at the same case

two different days and do two different things


with it Umm, and yeah, today I would say no, I

probably would have just left it alone and

checked it again in 3 weeks. So it depends on

which way the wind‟s blowing that day on how I

do things sometimes” (B).

Documentation hindrances “And there‟s also the flow of clinic. Already this

patient is up and walking away, I start to

document, and this one is already talking to me

about, you know, what they did last week. So

it‟s, you don‟t have that down time in the

middle” (B).

“In Coumadin Clinic, that‟s our biggest issue”

(A).

“It‟s confusing to read the note. I appreciate us

coming in and seeing it” (C).

“But in all honesty, I don‟t often, and I can‟t

even imagine writing that the dose was held last

visit when you‟ve got it right there on the flow

sheet. I‟m kind of writing things that aren‟t

apparent from the flow sheet. I assume that you

can see that, that it was held” (B).

“And also have all of the providers on the same

page about where they want us to put the

information” (D).

“That‟s gonna take a lot more concentration”

(B).

“I‟m overwhelmed sitting here right now

because you have no idea how many of those

make sure you click that button, make sure you

report the INR, you know what I mean?” (B).

“Again we‟re down to a very very small fraction

of the time being seeing the patient” (A).

“It‟s like plenty of time when things are going

well, and when you‟ve got 5 people that come in

that are way off track and everything‟s

happening to them, and that‟s how you don‟t

chart sometimes” (A).

“Unfortunately, if we write a lot of that into the

note now, the patient receives that also. It‟s part

of his instructions” (A).

“I‟ve seen examples of different documentation

from different clinics where there‟s areas, you

know, different questions that you have to ask to

make sure that you kind of document, like makes

you include it in the note” (D).


EMR deficiencies “These are the things that drive us out of our

minds. Because even just trying to figure things

out, that day I‟m trying to read it across and I

would have been looking at total weekly doses,

and when you realize they don‟t match…” (B).

“[I] think a lot of the problem with me is

computer program. Because we are always

having to fix something. Something doesn‟t

come out in the flow sheet, something doesn‟t

come out show up. We spend more time

babysitting the computer sometimes than we do

with the patient” (A).

Engrained patterns of behavior “I don‟t think patients who have been on it a

long time are going to come back sooner. I don‟t

think the compliance will be there” (A).

“It‟s tough to teach an old dog new tricks” (B).


Table 9

Direction of dose change

Total

Number of

Patients

Dose

Maintained

Dose Increased Dose

Decreased

Presenting INR In-

Range

267 229 (85.8%) 24 (9%) 14 (5.2%)

Presenting INR

within 0.2 Above

Range

23 11 (47.8%) 0 (0%) 12 (52.2%)

Presenting INR

within 0.2 Below

Range

35 14 (40.0%) 18 (51.4%) 3 (8.6%)

Presenting INR

Above Range

52

29* 14 (26.9%)

3 (10.3%)*

0 (0%)

0 (0%)*

38 (73.1%)

26 (89.7%)*

Presenting INR

Below Range

102

67*

33 (32.4%)

19 (28.3%)*

64 (62.7%)

46 (68.7%)* 5 (4.9%)

2 (3.0%)*

*excluding values within 0.2 out-of-range

Bold value indicates off-protocol dosing


Figure 1

Model of Factors in Nurse Decision-making


Figure 2

Conceptual Design of Project


Appendices

Appendix A: Timeline of Events

August 31st Milestone: Proposal Accepted and IRB Release Obtained

September 27th

Milestone: 1st round of focus groups complete

Participants: Clinic Staff including: RNs, MAs, MD

Organizer: PI

Method: Audio recording of focus group w/ objective of identifying

concepts of quality of care that are important to the anticoagulation

clinic and problematic clinical situations that will help in the

development of a comprehensive audit tool.

November 17th

Milestone: Results of focus group compiled and verified by

participants

Participants/Method: Compilation of data from focus group by me.

Key markers of factors derived from this process will be included in

comprehensive audit tool.

Audit tool will be reviewed by the focus group for content validity

marking

December 1st Milestone: Data collection begins

Participants: Clinic RNs will complete audit tool with each patient

visit.

January 1st Milestone: RN Data collection complete. Follow-up audit begins

Participants: PI and MSN student

February 10th

Milestone: Data collection complete

February 23rd

Milestone: Compiled data reviewed by focus group

Method: Data analysis of audit performed by PI. Results compiled

and necessary charts pulled for focus group review.

Discussion/analysis of data w/ focus group to determine cause of

variation from protocols without clear reason documented. Analysis

of all cases with variation from protocols for validity as compared to

evidence in literature, and assessment of outcomes.

March 1st Milestone: Final Assessment and Recommendations reviewed by

participants. Evaluation presented to Medical Director.

Method: Assessment of data from audit and second focus group.

Review of literature for supporting evidence.

April 1st Milestone: Revised anticoagulation protocol implemented

May 1st Milestone: Data tracking system in place

Method: Modifications to EMR system with IT support


Appendix B: Informed Consent

PURPOSE OF PROJECT

I have been informed that this process improvement project will investigate the benefits and limitations of the

existing Anticoagulation Protocol utilized the nurses at The Medical Group, Inc. This project will help direct

efforts for improvements in the protocol.

PROCEDURE

I understand that I will be participating in a series of focus group sessions. During these sessions, I will be

asked to provide feedback on various aspects of the Anticoagulation Clinic. These sessions will be audio taped

and transcribed. During this process, information about my clinical experience, as well as certain demographic

data about me will be obtained. I will be reviewing the summaries of the transcribed data before they are

published to assure accuracy of the findings.

RISKS AND DISCOMFORTS

I understand that discussion of clinical situations in the group settings is not anonymous. Anything said during

these sessions is being shared with all of those present, including supervisors or administrators. No names will

be published or made available to those not actively participating in the project; however, complete anonymity

in compiled data may not be possible due to the limited number of participants, and the open-identities of

providers in the clinic.

BENEFITS

I understand that participation in this project will have no direct benefit to me other than the potential for having

my concerns heard in the improvement process, and my ideas incorporated into revised clinic protocols.

CONFIDENTIALITY

I understand that sensitive, personal information will not be included in any publication.

REQUEST FOR MORE INFORMATION

I understand that I may ask more questions about this project at any time. Nathan Samuels at x7192 is available

to answer my questions or concerns. If during the project, or later, I wish to discuss my participation in or

concerns regarding this project with a person not directly involved, I am aware that Dr. Susan Neary, Director

of the Doctor of Nursing Practice program at Simmons College (617-521-2140) is available to talk with me. A

copy of this consent form will be given to me to keep for my own records.

REFUSAL OR WITHDRAWAL OF PARTICIPATION

I understand that my participation is voluntary and that I may refuse to participate or may withdraw consent and

discontinue participation in the project at any time without jeopardy to my employment status at The Medical

Group. I also understand that Nathan Samuels may terminate my participation in this project at any time after

he has explained the reasons for so doing.

ATTESTATIONS

I have explained to __________________________ the purpose of the project, the procedures required, and the

possible risks and benefits to the best of my ability.

__________________________________ ___________

Investigator Date

I confirm that Nathan Samuels has explained to me the purpose of the project, the investigation procedures that

I will undergo, and the possible risks as well as benefits that I may experience. I have read and I understand this

consent form. Therefore, I agree to give my consent to participate in this research project.

__________________________________ ____________

Participant Signature Date


Appendix C: Confidentiality Agreement

Transcription Services

I, ________________________, transcriptionist, agree to maintain full confidentiality in regards to any and all audiotapes and documentation received from Nathan Samuels related to his doctoral study on Evaluation of a Nurse-Managed Anticoagulation Clinic. Furthermore, I agree:

1. To hold in strictest confidence the identification of any individual that may be inadvertently revealed during the transcription of audio-taped interviews, or in any associated documents;

2. To not make copies of any audiotapes or computerized files of the transcribed

interview texts, unless specifically requested to do so by Nathan Samuels;

3. To store all study-related audiotapes and materials in a safe, secure location as long as they are in my possession;

4. To return all audiotapes and study-related documents to Nathan Samuels in a

complete and timely manner.

5. To delete all electronic files containing study-related documents from my computer hard drive and any backup devices.

I am aware that I can be held legally liable for any breach of this confidentiality agreement, and for any harm incurred by individuals if I disclose identifiable information contained in the audiotapes and/or files to which I will have access. Transcriber’s name (printed) ___________________________________________________ Transcriber’s signature ________________________________________________________ Date ______________________________________________________________________


Appendix D: Focus Group Guide (Session 1)

1) What are some common reasons you might find it necessary to challenge the clinic

protocol?

2) What parts of the clinic protocols do you find to be most problematic when regulating

warfarin dosing?

3) What types of clinic situations that are not already included in the clinic protocol

would cause you to seek assistance or question the dosing recommendations as

provided in the protocol?

4) What clinical situations would cause you to question the dosing recommendations as

provided in the protocol when a patient‟s INR is subtherapeutic?


provided in the protocol when a patient‟s INR is supratherapeutic?


provided in the protocol when a patient‟s INR is in therapeutic range?

7) What elements do you believe could be incorporated into the clinic protocol that

would enhance patient safety?

8) What elements do you believe could be incorporated into the clinic protocol that

would enhance nurse autonomy?

9) What clinical situations would cause you to have a patient return to clinic sooner than

recommended by the protocol?

10) What clinical situations would cause you to have a patient return to clinic later than

recommended by the protocol?


Appendix E: Existing Protocol


Appendix F: Definition of Terms

Definition of Terms – RN Audit Tool Patient ID

Patient‟s TMG medical record number

The following terms relate to factors that influence the nurse’s warfarin dosing decision.

The nurse should only document factors that affected her decision-making at the

time of the visit. A checkmark on the audit tool indicates that the issue was a factor in decision-making.

A blank on the audit tool indicates that the issue was not a factor in decision-making.

New

Patient is new to warfarin. Patient‟s who have not received warfarin therapy before, and who are

newly enrolled in the anticoagulation clinic.

Peri-op

Patients who are in the peri-operative period.

Bridge

Patients who are being treated with bridge therapy (Lovenox or other injectable) while warfarin

therapy is suspended or while INR is below therapeutic range.

Trending

The recognition of a pattern of INR values increasing (trending-up) or decreasing (trending-down)

Med

Alteration in patient‟s medication plan (other than warfarin).

□ Amiod = Amiodarone □ Antibx = Antibiotic therapy

□ Chemo = Chemotherapy □ Pred = Prednisone

Labile

Patient has a history of variable INR values without clear cause.

Sensitive

Small dose adjustments in the past have caused more severe responses in INR than typically expected

in the average patient.

Prior Tx

The patient has an established pattern of response to a specific dosing schedule that is being used to

guide adjustment

Hold

The patient had been instructed to hold a dose of warfarin in the preceding visit

<1 week

Today‟s follow-up is occurring less than 1 week from the last visit.

Stroke

The patient has a prior history of a stroke, or the nurse considers the patient to be at increased risk for

a stroke. (Specify concern under comments).


Bleed The patient has a prior history of a bleed, or the nurse considers the patient to be at increased risk for

a bleed. (Specify concern under comments).

Valve

The patient has a mechanical heart valve.

CVN

The patient is anticipating a cardioversion procedure in the near future.

Vitals/Labs

The patient presents with abnormal lab values or vital signs at the time of the visit. (Specify concern

under comments).

High INR

The INR is alarmingly high to the nurse, and is beyond her comfort level for management without

consultation.

Pt Pref

The patient prefers a different dose or time-to-follow-up than ideally recommended by the nurse.

Diet

The patient has modified dietary habits in a way that is affecting therapy.

Alcohol

The patient‟s consumption of alcohol is thought to be altering therapy.

Missed dose

The patient inadvertently missed a dose of warfarin.

Fixed pills

The patient has limited pill strengths on hand that alter the ideal weekly dosing total.

Weekend/Holiday

Upcoming weekend or holiday interferes with ideal return-to-clinic recommendation.

Pt travel

The patient has upcoming travel plans that may interfere with return-to-clinic recommendation.

Assist. Sought

The nurse seeks guidance on dosing instructions prior to advising patient.

Adverse Event

The patient has experienced a new adverse event since the last clinic evaluation. Adverse events

include major bleeding and thromboembolic events. Major bleeding includes: intracerebral bleed,

bleeding that necessitates suspension or reversal of therapy, bleeding necessitates administration of

blood products, bleeding that leads to death. Thromboembolic events include: thrombotic strokes,

pulmonary embolism (PE), systemic embolism, deep vein thrombosis (DVT)


Definition of Terms – Auditor’s Audit Tool

Date/Patient ID

Date of patient visit and patient‟s TMG medical record number

Current INR

INR obtained at point-of-care testing (numerical value)

Goal Range

Target INR range in patient‟s record (numerical value)

In range

Current INR falls within target INR range on record (checkmark indicates „yes‟ – blank indicates

„no‟)

≤0.2out

The current INR falls within 0.2 INR units above or below the target INR range on record

(checkmark indicates „yes‟ – blank indicates „no‟)

Indication

Listed indication for therapy (nominal response)

Protocol Dose

Weekly dose of warfarin recommended by following exisiting protocol (numerical value or nominal

if „hold‟)

Protocol Follow-up

Return-to-clinic time as recommended by following protocol. (numerical value w/ specified

weeks/days)

RN Dose

Weekly dose as recommended by RN (numerical value or nominal if „hold‟)

RN Follow-up

Return-to-clinic time as recommended by RN. (numerical value w/ specified weeks/days)

Protocol Followed

□ Dose – Dosing instructions of RN in agreement with protocol recommendation within 3 mg

□ Follow-up – Follow-up instructions of RN in agreement with protocol recommendation

Follow-up in-range

Subsequent INR at next clinic visit within target INR range (checkmark indicates „yes‟ – blank

indicates „no‟)

Subsequent Adverse The patient experienced an adverse event in the period after the visit up to the next clinic visit.

Adverse events include major bleeding and thromboembolic events. Major bleeding includes:

intracerebral bleed, bleeding that necessitates suspension or reversal of therapy, bleeding necessitates

administration of blood products, bleeding that leads to death. Thromboembolic events include:

thrombotic strokes, pulmonary embolism (PE), systemic embolism, deep vein thrombosis (DVT)

(nominal response).


Appendix G: Audit Tools

DATE: ________________ AUDITOR: ________________________

Patient ID Current

INR

Goal Range In range ≤0.2out Indication Protocol

Dose

Protocol

Follow-up

RN

Dose

RN

Follow-up

Protocol

Followed

Follow-up

in-range

Subsequent

Adverse

□ Dose

□ Follow-up

Patient ID Current

INR


Dose

Protocol

Follow-up

RN

Dose

RN

Follow-up

Protocol

Followed

Follow-up

in-range

Subsequent

Adverse

□ Dose

□ Follow-up

Patient ID Current

INR


Dose

Protocol

Follow-up

RN

Dose

RN

Follow-up

Protocol

Followed

Follow-up

in-range

Subsequent

Adverse

□ Dose

□ Follow-up

Patient ID Current

INR


Dose

Protocol

Follow-up

RN

Dose

RN

Follow-up

Protocol

Followed

Follow-up

in-range

Subsequent

Adverse

□ Dose

□ Follow-up

Patient ID Current

INR


Dose

Protocol

Follow-up

RN

Dose

RN

Follow-up

Protocol

Followed

Follow-up

in-range

Subsequent

Adverse

□ Dose

□ Follow-up

Patient ID Current

INR


Dose

Protocol

Follow-up

RN

Dose

RN

Follow-up

Protocol

Followed

Follow-up

in-range

Subsequent

Adverse

□ Dose

□ Follow-up

DATE: __________________ RN: _____________________

Patient ID

New Peri-op Bridge Trending Med Labile Sensitive Prior Tx Hold <1 week Stroke Bleed Valve CVN

□ Up

□Down

□ Amiod

□ Antibx

□ Chemo

□ Pred

Vitals/ Labs

High INR Pt Pref Diet Alcohol Missed dose

Fixed pills

Weekend/Holiday

Pt travel Assist. Sought

Adverse Event

Other Comments

Patient ID

New Peri-op Bridge Trending up/down

Med Labile Sensitive Prior Tx Hold <1 week Stroke Bleed Valve CVN

□ Up

□Down

□ Amiod

□ Antibx

□ Chemo

□ Pred

Vitals/ Labs


Fixed pills

Weekend/Holiday


Adverse Event

Other Comments

Patient ID

New Peri-op Bridge Trending up/down

Med Labile Sensitive Prior Tx Hold <1 week Stroke Bleed Valve CVN

□ Up

□Down

□ Amiod

□ Antibx

□ Chemo

□ Pred

Vitals/ Labs


Fixed pills

Weekend/Holiday


Adverse Event

Other Comments


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