Post on 25-Dec-2015
What You Need to Know about Outcomes Research
Susan Roberts, MS, RDN, LD, CNSCBaylor Scott & White HealthDallas, Texas
Objectives
1. Describe the importance of nutrition-related outcomes research2. Identify the types of outcomes commonly studied3. Relate the steps for and challenges encountered when conducting outcomes research
What is outcomes research? Emerged due to concerns about which
treatments work best and for whom Focuses on interrelationship between
quality and cost Clinical and population based research Study and optimize the end results of
healthcare in terms of benefits to patients and the population
Also can identify shortfalls in practice and develop strategies to improve care
http://en.wikipedia.org/wiki/Outcomes_research
Outcomes research can evaluate
Effectiveness of a medical, surgical or nutritional intervention
Impact of insurance status or reimbursement policies
Development and use of tools to measure health status
Best methods for disseminating outcomes research results to clinicians or patients to influence behavior change
Steps for conducting successful outcomes research
Study design Research question – descriptive or
analytical Define population using inclusion and
exclusion criteria Definitions:▪ Subsets▪ Outcome variables▪ Primary comparisons▪ Covariates/confounders
Steps for conducting successful outcomes research
IRB approval?Data collectionData analysisDetermine implications Communication of
resultsPlanning and
implementing changesNext study
Outcomes Research• Maximize quality of care• Carried out in the real world setting• Measure “the impact of an intervention
on one segment of the sample (intervention group) compared with the impact on a segment of the sample not receiving the intervention (comparison or control group)” Biesemeier, Support Line. 2003
• PICO – Population, Intervention, Control or Comparison, Outcome
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Example PICO Questions• Do inpatients on parenteral nutrition (P)
whose orders are written by the RDN (I) compared to inpatients on PN whose orders are written by the physician (C) experience less hyperglycemia and have a shorter hospital length of stay (O)?
• Do ICU patients (P) whose tube feeding is continued after extubation until oral intake is >75% of needs (I) compared to patients whose tube feeding is stopped at the time of extubation without regard for ability to consume oral nutrition (C) experience a shorter length of stay post-ICU and a better quality of life at 3 months post-discharge (O)?
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Quality Improvement Models
PDSA (Plan, Do, Study, Act)
Rapid Cycle Improvement
IHI Model for Improvement
Lean Six Sigmahttps://cahps.ahrq.gov/quality-improvement/improvement-guide/qi-steps/QI-Methods_Models/QI_Models.html
Who is influenced by outcomes research?
Practitioners Insurance companies Employers State and federal government Consumers
All are examining outcomes research to assist with decisions about what medical care should be provided/reimbursed/selected for whom and when
Why should RDNs conduct research?
Improve patient careContribute to evidence-
based guidelinesChange practice within our
own organizationEnhance collaboration with
other health care cliniciansElevate the value of the RDNCost savings – competition
for the healthcare dollar
Outcomes Research Strategies Consensus
knowledge building
Practice pattern profiling
Cohort studies (prospective & retrospective)
Clinical decision analysis
Effectiveness of interdisciplinary teams
Geographical analyses
Economic studies Ethical studies Defining and
testing interventions
Consensus Knowledge Building Interprofessional group Extensive literature search on the topic of
interest Meta-analyses or systematic critique and
synthesis of the available data Experts come to a consensus to develop
clinical guidelines Nutrition support
ASPEN/SCCM Critical Care Guidelines – 2009/2015? Critical Care Guidelines (CCGs) from Canada - 2015 Academy EAL Critical Illness Guideline - 2012
Nutrition therapy in the critical care setting: What is the “best achievable” practice? An international observational study. Cahill et al. CCM 2010
Describe current practices in ICUs & compare to CCGs
International, prospective, observational, cohort study – included 158 adult ICUs from 20 countries 2946 consecutively enrolled patients Mechanical ventilation ICU stay at least 72 hours
Data collected from admission to discharge or a maximum of 12 days
Compliance with guidelines
Guideline Outcome
Type of nutrition support: EN recommended over PN
• EN alone provided ~62% of days• PN alone provided ~12% of days• PN + EN provided ~7% of days• No contraindication to EN 50% of PN
days• No nutrition provided ~20% of days
Timing of nutrition intervention: start nutrition within 24 – 48 hrs
• EN started on average 46.5 hours from admission (range: 8.2 hrs to > 6 days)
Strategies to maximize delivery of EN: prokinetics + SB feedings in patients with high GRVs (27%)
• Motility agents - ~60%• Small bowel feedings - ~15%
Overall performance • One ICU achieved EN caloric adequacy >80%
• Four ICUs achieved EN protein adequacy > 80%
Conclusions
Adherence to CCGs is achievable Overall adequacy of nutrition
delivery is low Future quality improvement
strategies should focus on Early initiation of EN Use of prokinetics and small bowel
feedings in patients with EN intolerance Efforts to improve compliance with
EBGs may decrease morbidity and mortality
Baylor research: guideline compliance Objective: Analyze compliance with
ASPEN/SCCM critical care guidelines Conducted between February & April
2010 in 5 adult ICUs Inclusion criteria
ICU stay ≥ 3 days Required mechanical ventilation ≥ 18 years old No DNR status during the first 3 days in
ICU
Enteral Feeding Guidelines
Start EN NS EN preferred EN ≤ 24-48 hrs
Gastric or SBFT
0102030405060708090
100 92 88
59
86
0 0
22
38 12
1911
Compliant Non-compliant Not applicable
Perceived versus actual compliance
Grade A Grade B Grade C0
102030405060708090
100
16
34 3122 21
5
50
0
27
0
50
9
Compliant Non-compliantPerceived compliance Not implemented
Conclusion
Good adherence to initiation of EN guidelines Early EN initiation needs improvement
Perception of RDNs adherence with guidelines, particularly Grade A, are not in agreement with actual practice
Clinical judgement and practice culture affect compliance with guidelines
Ongoing education and monitoring essential
Barriers to EN delivery
Unstable clinical status Procedures and trips to the
operating room Gastrointestinal intolerance
Ileus Diarrhea Elevated gastric residual volume
Causes and Consequences of Interrupted Enteral Nutrition: A Prospective Observational Study in Critically Ill Surgical Patients. Peev et al. JPEN 2014
Patients with 1 or more interruptions compared to those with none: 3 times more likely to be underfed
(<66% of prescribed calories) Greater cumulative caloric deficit (5834
vs 3066, p = 0.001) More likely to have a prolonged ICU
and hospital LOS Non-significant trends for 30-day VFD,
in-hospital and 30-day mortality
Causes and Consequences of Interrupted Enteral Nutrition: A Prospective Observational Study in Critically Ill Surgical Patients. Peev et al. JPEN 2014
Reason for EN interruption
n Potentially avoidable / %
(Re)intubation/extubation
29 0/0
Tracheostomy/PEG 23 0/0
Imaging study 16 14/87.5
Ortho procedures 12 6/50.0
High GRV 10 0/0
Other 6 4/66.7
IR procedure 6 4/66.7
GI surgery 4 0/0
Total 106 28/26.4
GRV as a barrier to EN delivery Elevated GRV is a common reason for
cessation of enteral feedings – 62% incidence in one large international observational study1
Research has failed to show that GRV monitoring improves patient outcomes or reduces complications, such as aspiration and pneumonia2-5
Multicenter trial by Reigner et al found no difference in complication rates between patients who had GRV monitored versus those that did not5
1. Gungabissoon U. JPEN 2014; 2. Rice TW. JAMA 2013; 3. McClave SA. Crit Care Med 2005; 3. Flynn MB. Crit Care Nurs 2011; 4. Kuppinger DD. Nutr 2013; 5. Reigner J. JAMA 2013
GRV Practice change in the Baylor Health Care System
Discontinue GRV monitoring in patients fed through a gastric feeding tube unless S/P lung transplant or any
type of abdominal surgery within the past 2 weeks
Bedside RN will check GRV in patients who show signs of intolerance of feedings Distended abdomen Regurgitation or emesis of
enteral formula Absence of bowel sounds
and/or bowel movements
If regurgitation or vomiting occurs, RN should intervene with nasogastric suction and call the physician for further instructions Consider prokinetic agents
and/or small bowel feeding tube Promoting initiation of
feedings at target rate unless contraindicated New jejunostomy tube Fluid overloaded Gastroparesis Hypotensive, unstable clinical
condition Pre-existing GI dysfunction
GRV Research at Baylor
Study aim: To monitor nursing compliance to new practice and to collect data on patient outcomes (vomiting, diarrhea and aspiration)
Retrospective, observational study
Study MethodsPatients Identified•A total of 50 patients were randomly selected from 5 ICUs using the electronic health record
Patients Monitored•Monitored for 7 days starting on the first day of ICU admission
Data Recorded•Patient diagnosis, age and sex •# days on EN•EN route•EN formula/change in formula• Incidences of vomiting, diarrhea or aspiration •Use of prokinetics •Whether GRV were ordered•Whether nursing checked/recorded GRV
Inclusion & Exclusion Criteria
Inclusion Criteria Exclusion Criteria
Admission to one of the 5 ICU’s
GI surgery less than 2 weeks prior
Mechanically ventilated and sedated for ≥ 72 hours
History of Gastric Bypass
EN for ≥ 72 hours History of resection of the small intestine
EN via NG or OG tube Lung Transplant
Results: GRV monitoring practices and episodes of emesis
GRV Patients Emesis % of Total
Not checked
33 1 3%
Checked 17 3 18%
Total 50 4 8%
Additional Results
Prokinetics were not utilized in any of the study patients
Episodes of diarrhea were seen in 16% of patients
Formula changes related to ICU protocol vs. presence of intolerance 42% had formula changed
No orders for GRV monitoring identified
Conclusions
GRV monitoring continues to be practiced in 34% of patients without an order for GRV monitoring Frequency Did nursing document?
Increased GRV monitoring with emesis (3/17 vs. 1/33) In line with protocol
Still high GRV monitoring without presence of emesis (14 cases) Other signs of intolerance not recorded?
No negative outcomes recorded under new protocol No episodes of aspiration or VAP identified Vomiting not increased without GRV monitoring
Volume-based enteral nutrition
• Enteral nutrition order for the volume prescribed for a 24-hour period - Infuse 1440 mL over each 24-hour period
• Traditional rate-based enteral nutrition order - Infuse 60 mL/hour
PEP UP MULTICENTER TRIAL
Cluster randomized trial - Prospective multi-center randomized trial in mechanically-ventilated ICU patients
Purpose: To determine whether the PEP uP protocol versus traditional care improves calorie and protein delivery in the ICU without increasing complications
18 ICUs, N = 1059 9 intervention sites and 9 control sites
Age and APACHE II scores were not different for the study and control groups
Age ranged from 61.4 to 65.1 years, APACHE II score ranged from 21.1 to 23.5
Outcomes: EN delivery compared to prescription, incidence of vomiting, aspiration, and ICU-acquired pneumonia
Heyland DK, et al. Enhanced protein-energy provision via the enteral route feeding protocol in critically ill patients: results of a cluster randomized trial. Crit Care Med. 2013;41:2743-2753.
Pep up multicenter trial
Control ICUs Intervention ICUs05
101520253035404550
34.2 3233.6
43.6
34 33.633.8
47.4
Baseline EN kcals Follow-up EN kcalsBaseline EN pro Follow-up pro
Pep up multicenter trial
No differences between the control and intervention groups for the following outcomes: Vomiting or regurgitation Macroaspiration or ICU-acquired
pneumonia Days on mechanical ventilation ICU or hospital LOS ICU or 60 day mortality
Pep up multicenter trial summary
The change in enteral nutrition caloric delivery was significantly higher in the protocol group (32% vs. 43.6%), following protocol implementation, compared to the usual care group (34.2% vs 33.6%) (p = 0.004)
There was no difference in the change in incidence of vomiting (p = 0.45), regurgitation (p = 0.39), microaspiration (p = 0.11), or ICU-acquired pneumonia (p = 0.43)
Study results may have been impacted by inclusion of patients who required mechanical
ventilation but never received enteral nutrition less than optimal implementation of the protocol at
some study sites
Baylor Volume-based Feeding Study - 2013
117 mixed ICU patients on VBF Overall, in the first week in the ICU, patients
received 67% of prescribed volume of enteral nutrition
72/117 (62%) received an average of 78% of prescribed volume of enteral nutrition
No difference in enteral delivery between those on a concentrated, non-concentrated or mixed enteral formula
No difference in incidence of hyperglycemia or elevated gastric residual volume
Baylor Volume-based Feeding Study - 2015
100 mixed ICU patients on VBF Before and after study design
Intervention: nurse focus groups, new volume based feeding chart placed on feeding pumps, individual RN education
Overall, in the first week in the ICU, patients received ~84% of prescribed volume of enteral nutrition during both time periods
Nursing compliance with VBF order not apparent in documentation
Other outcomes research/quality improvement initiatives
Nutrition management protocol Bedside placement of small bowel
feeding tubes by RDNs Malnutrition identification and
coding Collaborative Care Model Growth in the NICU Presence of malnutrition in
readmitted oncology patients
Keep in mind…..
What matters to you, your patients and health care team
What is the focus of leaders & administrators at your organization – consider using the QI process adopted by your organization
Narrow the area to one that your processes or practices are more likely to impact
Select relevant and important outcomes Engage a physician and/or nurse champion Include other disciplines Involve students and interns
Questions/Group Activity