1. Susan Roberts, MS, RDN, LD, CNSC Baylor Scott & White Health Dallas, Texas

2. 1. Describe the importance of nutrition- related outcomes research 2. Identify the types of outcomes commonly studied 3. Relate the steps for and challenges encountered when conducting outcomes research

3.  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

4.  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

5.  Study design  Research question – descriptive or analytical  Define population using inclusion and exclusion criteria  Definitions: ▪ Subsets ▪ Outcome variables ▪ Primary comparisons ▪ Covariates/confounders

6.  IRB approval?  Data collection  Data analysis  Determine implications  Communication of results  Planning and implementing changes  Next study

7. 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 7

8. 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)? 8

9.  PDSA (Plan, Do, Study, Act)  Rapid Cycle Improvement  IHI Model for Improvement  Lean  Six Sigma https://cahps.ahrq.gov/quality-improvement/improvement-guide/qi-steps/QI- Methods_Models/QI_Models.html

10.  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

11.  Improve patient care  Contribute to evidence-based guidelines  Change practice within our own organization  Enhance collaboration with other health care clinicians  Elevate the value of the RDN  Cost savings – competition for the healthcare dollar

12.  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

13.  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

14.  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

15. GuidelineOutcome 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%

16.  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

17.  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

20.  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

21.  Unstable clinical status  Procedures and trips to the operating room  Gastrointestinal intolerance  Ileus  Diarrhea  Elevated gastric residual volume

22.  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

23. Reason for EN interruptionnPotentially avoidable / % (Re)intubation/extubation290/0 Tracheostomy/PEG230/0 Imaging study1614/87.5 Ortho procedures126/50.0 High GRV100/0 Other64/66.7 IR procedure64/66.7 GI surgery40/0 Total10628/26.4

24.  Elevated GRV is a common reason for cessation of enteral feedings – 62% incidence in one large international observational study 1  Research has failed to show that GRV monitoring improves patient outcomes or reduces complications, such as aspiration and pneumonia 2-5  Multicenter trial by Reigner et al found no difference in complication rates between patients who had GRV monitored versus those that did not 5 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

25.  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

26.  Study aim: To monitor nursing compliance to new practice and to collect data on patient outcomes (vomiting, diarrhea and aspiration)  Retrospective, observational study

27. Patients 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

28. Inclusion CriteriaExclusion Criteria Admission to one of the 5 ICU’sGI 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 tubeLung Transplant

29. GRVPatientsEmesis% of Total Not checked3313% Checked17318% Total5048%

30.  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

31.  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

32. 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

34.  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.

36.  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

37.  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

38.  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

39.  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

40.  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

41.  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