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