B E T H T A Y L O R , D C N , R D , F A N D

HOW TO CONDUCT A RESEARCH/PI/QI PROJECT

OBJECTIVES

• Understand common misconceptions about clinical

research

• Differentiate between projects that need

Investigational Review Board approval and those

that do not.

• Describe common obstacles and how to avoid

them.

DEFINITIONS

• Research • Outcomes based – “the study of the end results of health

services that takes patients’ experiences, preferences, and values into account—is intended to provide scientific evidence relating to decisions made by all who participate in health care.”1

• Patient Centered – “research that addresses the questions and concerns most relevant to patients, and ...” www.pcori.org

• Quality Improvement – focuses on process improvement2

• Performance Improvement – focuses on improving institutional and individual performance2

WHY SHOULD NUTRITION SUPPORT CLINICIANS DO NUTRITION

RESEARCH/PI/QI?

• Improve practices in order to improve patient

outcomes, reduce cost, etc.

• Improve skill set.

• Increase our value to the healthcare team.

• If we are left out, others won’t do it right.

WHY DON’T WE DO MORE?

• Not enough time

• No funding

• Lack of leadership support

• Lack of administrative support

• Knowledge deficits:

• Statistics

• Research methodology

• IRB process

JAND epub 2015: Why RDs are not doing research

RESEARCH VS. PI/QI

• To test a hypothesis or establish practice standards

• May put patients at risk

• Answers a research question.

• To assess or improve a process, program, or system or improve performance.

• Does not put patients at risk

• Improves or creates a process, program or system that increases safety, efficiency or satisfaction.

Modified from AND webinar by DellaValle DM 2015

RANDOMIZED TRIALS

• Assemble a group of individuals, randomly

assign them to intervention groups, follow them

forward for a period of time for outcome(s)

Control group

Disease No Disease

Treatment group

Disease No Disease

Group of study participants

Randomiz

e

RANDOMIZATION

• Goal of randomization:

• Make the intervention groups identical with respect to all

factors except for the intervention of interest

• Remove confounding factors

• Like “tossing a coin” to decide which group a study participant is assigned to.

• More labor intensive type of research.

COHORT STUDIES

• Assemble a group of individuals (the cohort),

collect data on exposure(s) and subsequent

outcome(s)

Unexposed

Disease No Disease

Exposed

Disease No Disease

Cohort of individuals

STEPS IN THE PI/QI OR RESEARCH PROJECT

• What outcomes to track/develop study question

• Literature review

• Brainstorming with key players

• Project Plan/Study protocol

• Approval from colleagues, MDs, involved depts

• Investigational Review Board (IRB), Human Subjects

Committee ?

• Implementation

• Data analysis

• Sharing the findings

IDEA FOR THE PROJECT – FINDING YOUR INSPIRATION

• Identify problems in systems, practices, equipment,

etc.

• Identify potential outdated systems, practices,

equipment, etc.

• Difference of opinion regarding best practice

• Find something you are excited about

• Look through poster abstracts from CNW, FNCE

• Pair and share

EXAMPLES OF OUR INSPIRATIONS

• A seemingly large number of inappropriate TPNs

• Prolonged periods of NPO to oral diet and/or no tube

feeding peri-op

• Difference of opinion of the nutrition support RDs regarding

the need to check serum triglycerides in PN patients

WHAT OUTCOMES WILL YOU TRACK ON WHICH PTS/WHAT IS YOUR STUDY

QUESTION?

• Don’t try to do too much at once.

• Narrow down your topic

• If you are doing research, use PICO

• If you are doing PI/QI, you can do a modification of

PICO to narrow your focus.

• Remember: If you cannot measure it, you cannot

improve it. William Edwards Deming

QUESTION/HYPOTHESIS

• PICO helps to structure the research idea (for an

observational or intervention study) into a

detailed clinical study question or hypothesis and

can be used for the literature review:

• Population of interest

• Intervention to be tested

• Comparison strategy

• Outcome(s)

EXAMPLE OF PICO

• P – In adult ICU trauma patients on tube feeding

• I – immune enhancing formula

• C- standard formula

• O- LOS, time on vent, infections, etc.

• Among adult ICU trauma patients, does the use of

an immune enhancing formula as compared to an

isocaloric, isonitrogenous standard formula have a

statistically significant effect on LOS, time on vent,

infections, etc?

PI/QI PROJECT IDEA

• P- in patients on tube feeding

• I - ready-to-hang formula delivery

• C- cans

• O- % of goal delivered, nursing satisfaction, waste of

tube feeding.

• Pair and share

OTHER IDEAS

• Percentage of patients discharged home on tube

feeding who are readmitted within 30 days with

nutrition-related problems.

• What percentage of malnourished patients are and

are not identified with your facility’s malnutrition

screening tool?

LITERATURE REVIEW

• Has your question already been answered?

Has your project already been done?

• Critically review the literature – look for

differences in methodologies.

• Maybe all you need is a literature review to

convince others to change practice.

• Get a librarian’s help, if available.

• Also check the Academy’s Evidence

Analysis Library

DOING YOUR SEARCH

Get search terms from your PICO

MeSH terms, keywords

Boolean terms OR, AND, NOT

Consider whether you want your search to be wide

or narrow. Usually start with wide.

Learn how to use Ovid, save searches

In PubMed, sign up for an account, save searches,

have search updates sent to you.

Check references from the articles you find

Click on “related articles”.

Save articles in Endnote or Refworks.

EXAMPLE OF A SEARCH

• Using our PICO example

• MeSH terms for P – adult;patients; wounds and

injuries

• MeSH terms for I – enteral nutrition;

• MeSH terms for O – length of stay;

respiration/artificial; infection

• Also look for relevant keywords – trauma; tube

feeding; mechanical ventilation; immune-

enhancing (no MeSH term for this), etc.

CRITIQUING THE LITERATURE

• To stay organized, keep track of info as you read

the studies

• Create a spreadsheet

• Patient Population, Sample size, Intervention,

Comparison, Results, Limitations

IT TAKES A VILLAGE

• Make it easier on yourself and increase your

chances of doing it right the first time.

• Don’t try to do it alone.

• Early in the process -Who can help you?

• Share your idea with colleagues. Maybe someone

has a similar idea. Maybe someone is already

doing the same thing.

• Get your manager’s support

• Internship at your facility? Suggest your project or

part of your project as an intern project.

YOUR TEAM

• Get input from those with more experience doing

research and PI projects.

• If you are new to this, ask for a mentor – MD, basic

scientist, another RD

• Identify team players, stakeholders, etc.

WHO TO INCLUDE?

• Pair and share

• Give examples of past projects and who you

collaborated with.

• Who would you collaborate with on a future

project?

BRAINSTORM

• Let the creative juices flow with “your team”.

• Work on the protocol with the team.

STATISTICIAN/RESEARCHER

• Get the help of a statistician, if possible.

• Better to know early how to record your data to be

most useful during the analysis phase, what sample

size you need (if it is more than a pilot study), etc.

• Bias

• Statistical inference/Sample size/Power

• Generalizability

DIETETICS PRACTICE BASED RESEARCH NETWORK

• Academy of Nutrition and Dietetics – Practice

Based Research Network – free to members

• MyAcademy profile, New Enrollment, and click on

this group.

• http://eatright.org/members/DPBRN/

• Webinar

• Research fact sheets

PROTOCOL

• Rationale

• Objective

• Methods

• Populations

• Time frame

• Expected outcomes

PROTOCOL DEVELOPMENT

• What type of study are you going to conduct?

• Observational? Interventional? Survey?

• If interventional: What is your “exposure” of interest? How will you measure it?

• What is your outcome of interest? How will you measure it?

• What is your study population?

• How will you collect the data for your study?

• What are methodological issues that you need to consider?

APPROVAL

• Before finalizing proposal, present proposal to

relevant departments (RDs, nursing, PCTs, MDs)

• for practical advice and approval of procedures that impact patient management

• suggestions about educating staff, flyers, reminders

IRB? PI/QI VS RESEARCH?

• Check with your institution’s IRB.

• Exempt (PI/QI), expedited or full committee

• Expedited or Full Committee if:

• Your intervention is not standard practice

• Randomizing

• Subjects’ anonymity can’t be guaranteed

• Risk

• Other institutions are involved.

• Results are going to be used for generalized knowledge.

QI

• http://www.hrsa.gov/quality/toolbox/methodology

/qualityimprovement/part3.html

• This site is a wealth of information about QI – how to

conduct, forming teams, etc.

IRB APPROVAL PROCESS

• Major considerations for IRB committee

• Risks to participants vs. benefits for participants and

society

• Consent process (should present risk/benefit information

adequately and fairly and minimize potential for coercion)

• All investigators must provide certificate of

Education on the Protection of Human Subjects

(CITI training) before beginning research.

• www.citiprogram.org

IMPLEMENTATION

• Follow the time frame that you set in your protocol.

• Use whatever method works for you to follow that

time frame – paper calendar, electronic reminders.

• Set up regular meetings with your “team”.

• Do a pilot of data collection to test your data

collection form. Modify it, if need be.

SHARE YOUR RESULTS

• Don’t be selfish with your results. Don’t file them away yet. Share them.

• Ask those who helped what they think the implications of your results are. What should be done next?

• Take results to relevant committees for their input.

• Submit a poster of your work to a conference– look for opportunities to display your poster at your facility.

• Write an article.

• Consider who you want your audience to be.

TAKE-HOMES

• Find your inspiration

• Do literature review

• Share your idea with others

• Enlist help of others

• Make a detailed plan – study question, PICO,

outcomes to track, data collection form

• Implement

• Share your results

REFERENCES

1. Clancy CM, Eisenberg JM. Outcomes research measuring the end results of health care. Science. 1998; 282: 245–246.

2. Bornstein, T. Quality Improvement and Performance Improvement: Different Means to the Same End. http://fkilp.iimb.ernet.in/pdf/Healthcare_Quality/Concepts

3. JAND epub 2015: Why RDs are not doing research

4. AND Webinar by DellaValle DM. Registered dietitian/nutritionist guidelines for successful quality improvement implementation: Getting started