Transcript What You Need to Know about Outcomes Research

Susan Roberts, MS, RDN, LD, CNSC
Baylor Scott & White Health
Dallas, Texas
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





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




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

Study design
 Research question – descriptive or analytical
 Define population using inclusion and exclusion
criteria
 Definitions:
▪
▪
▪
▪
Subsets
Outcome variables
Primary comparisons
Covariates/confounders
IRB approval?
Data collection
Data analysis
Determine implications
Communication of
results
 Planning and
implementing changes
 Next study 





• 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
•
•
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





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/QIMethods_Models/QI_Models.html





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
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


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
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


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
Guideline
Outcome
Type of nutrition support: EN
recommended over PN
•
•
•
•
•
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)
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
Strategies to maximize
• Motility agents - ~60%
delivery of EN: prokinetics + SB • Small bowel feedings - ~15%
feedings in patients with high
GRVs (27%)
Overall performance
• One ICU achieved EN caloric adequacy >80%
• Four ICUs achieved EN protein adequacy > 80%



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



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
100
90
80
70
60
50
40
30
20
10
0
92
88
86
59
22 19
12
8
0
11
3
0
Start EN NS
EN preferred
Compliant
EN ≤ 24-48 hrs
Non-compliant
Gastric or SBFT
Not applicable
100
90
80
70
60
50
40
30
20
10
0
50
50
34
22
16
27
21
0
Grade A
Compliant
31
Non-compliant
0
5
9
Grade B
Grade C
Perceived compliance
Not implemented

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



Unstable clinical status
Procedures and trips to the operating room
Gastrointestinal intolerance
 Ileus
 Diarrhea
 Elevated gastric residual volume

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, inhospital and 30-day mortality
Reason for EN interruption
n
Potentially avoidable
/%
(Re)intubation/extubation
29
0/0
Tracheostomy/PEG
23
0/0
Imaging study
Ortho procedures
16
12
14/87.5
6/50.0
High GRV
Other
IR procedure
GI surgery
10
6
6
4
0/0
4/66.7
4/66.7
0/0
Total
106
28/26.4
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

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
Study aim: To monitor nursing
compliance to new practice and to
collect data on patient outcomes
(vomiting, diarrhea and aspiration)
 Retrospective, observational study

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
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
GRV
Patients
Emesis
% of Total
Not checked
33
1
3%
Checked
17
3
18%
Total
50
4
8%



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

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
• 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
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.
50
45
40
35
30
25
20
15
10
5
0
47.4
43.6
34.2 33.6 34 33.8
Control ICUs
32
33.6
Intervention ICUs
Baseline EN kcals
Follow-up EN kcals
Baseline EN pro
Follow-up pro

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



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
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




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
 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
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
