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PERFormance Enhancement of the Canadian Nutrition Guidelines by a Tailored Implementation Strategy: The PERFECTIS Study (PERFECTIS)

Primary Purpose

Critically Ill, Intensive Care Unit

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Tailored Change Strategy
Sponsored by
Daren K. Heyland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Critically Ill focused on measuring Enteral Nutrition, Parenteral Nutrition, Critically ill, Nutrition Therapy, Nutrition Support, Practice Guidelines as Topic, Guideline Adherence, Quality Assurance, Health Care, Nutrition Surveys, Questionnaires

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ICUs must be affiliated with a registered dietitian.
  • ICUs must have a minimum of 8 beds.
  • ICUs must be located in Canada, Australia, or US.
  • ICUs have previously participated in the International Nutrition Survey.

Exclusion Criteria:

  • ICUs with less than 8 beds.
  • ICUs with high nutrition performance, as demonstrated previously in the International Nutrition Survey (i.e. average nutritional adequacy >60% and/or above 50th percentile when ranked against all participating ICUs according to nutrition practice performance score)

Sites / Locations

  • Anne Arundel Medical Center
  • Spartanburg Regional Medical Center
  • Peter Lougheed
  • Capital Health - University of Alberta Hospital (hospital general systems)
  • Southlake Regional Health Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tailored Action Plan

Arm Description

A Tailored Action Plan is an intervention selected to overcome barriers identified before the design and delivery of the intervention.

Outcomes

Primary Outcome Measures

Feasibility of the study design and intervention
Assessed by rate of completion of barriers questionnaires, development of unique tailored action plans at each site, compliance and satisfaction with the tailored action plans, and other user feedback.

Secondary Outcome Measures

Change in nutrition performance score
The nutrition performance score is a composite measure including use, timing and adequacy of nutrition, use of small bowel feeds and motility agents, and hyperglycemia. Nutrition performance scores will be calculated after each of the two nutrition practice audits.
Change in barriers to implementation of critical care nutrition clinical practice guidelines
Barriers questionnaire

Full Information

First Posted
July 21, 2010
Last Updated
December 15, 2020
Sponsor
Daren K. Heyland
Collaborators
Ministry of Research, Innovation and Science, Ontario, Canadian Foundation for Dietetic Research (CFDR)
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1. Study Identification

Unique Protocol Identification Number
NCT01168128
Brief Title
PERFormance Enhancement of the Canadian Nutrition Guidelines by a Tailored Implementation Strategy: The PERFECTIS Study
Acronym
PERFECTIS
Official Title
PERFormance Enhancement of the Canadian Nutrition Guidelines by a Tailored Implementation Strategy: The PERFECTIS Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 16, 2009 (Actual)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daren K. Heyland
Collaborators
Ministry of Research, Innovation and Science, Ontario, Canadian Foundation for Dietetic Research (CFDR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Canadian Critical Care Nutrition Guidelines assist health practitioners in identifying best practices for feeding critically ill patients. However, guidelines have resulted in little change in Intensive Care Unit (ICU) practices, possibly because barriers to change differ between ICUs. Change may be facilitated if strategies specifically address identified barriers. The investigators hypothesize that barriers are inversely related to nutrition performance. Tailoring change strategies to overcome barriers to change will reduce the presence of these barriers and lead to improvements in nutrition practice.
Detailed Description
A before-after study will be conducted in 7 Canadian and US ICUs. Each participating ICU will implement a tailored guideline implementation intervention aimed at narrowing the guideline-practice gap. The tailored implementation will consist of 4 phases: Audit of Nutrition Practices: The nutrition practice audit will be conducted as part of the data collection for our ongoing international nutrition quality improvement project. This involves collecting data on personal characteristics and nutrition therapy in a consecutive cohort of 20 mechanically-ventilated critically ill adult patients. Performance at each ICU will be assessed by a benchmarked report comparing the nutrition practices to individual recommendations of the Canadian Critical Care Nutrition CPGs, thus enabling identification of the ICUs strengths and weaknesses, and highlighting areas to target for improvement. Barriers Questionnaire: The barriers and enablers questionnaire will be completed by all physicians, all ICU leadership, the dietitian(s), and a random sample of 30 full- and part-time nurses. This questionnaire asks questions about barriers associated with guideline implementation, such as the characteristics of the guidelines, the care provider, the patient, and the context. Tailored Action Plan: Results of the audit of nutrition practices and barriers questionnaire will be evaluated by the investigators and representatives from the Canadian Critical Care Nutrition CPGs Committee. Committee members include research personnel, intensivists, ICU nurse educators, dietitians, and experts in knowledge translation and health services research. They will be responsible for reviewing the benchmarked reports for each participating ICU, identifying the gaps between the key guideline recommendations and what is actually happening in practice, and reviewing the results of the barriers questionnaire to identify the barriers associated with adhering to these specific recommendations at each site. In collaboration with the local opinion leaders, a tailored 12 month action plan will be developed for each individual ICU. The specific behavioral change strategies to be implemented as part of the tailored action plan will likely include powerpoint presentations and handouts, packages of key journal articles, reminders (e.g. posters, checklists), system tools (e.g. pre-printed orders, bedside algorithms), interactive web-based tutorials, guidelines on establishing local implementation teams and creating a culture of team work. Prior to the implementation of these behavioral change strategies in the context of the before-after study, focus groups will be conducted to elicit feedback, and revisions made accordingly. Audit of Nutrition Practices: The audit of nutrition practices will be repeated following the 12 month implementation period in order to evaluate changes in nutrition practices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill, Intensive Care Unit
Keywords
Enteral Nutrition, Parenteral Nutrition, Critically ill, Nutrition Therapy, Nutrition Support, Practice Guidelines as Topic, Guideline Adherence, Quality Assurance, Health Care, Nutrition Surveys, Questionnaires

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tailored Action Plan
Arm Type
Experimental
Arm Description
A Tailored Action Plan is an intervention selected to overcome barriers identified before the design and delivery of the intervention.
Intervention Type
Other
Intervention Name(s)
Tailored Change Strategy
Intervention Description
e.g. Education, decision support tools
Primary Outcome Measure Information:
Title
Feasibility of the study design and intervention
Description
Assessed by rate of completion of barriers questionnaires, development of unique tailored action plans at each site, compliance and satisfaction with the tailored action plans, and other user feedback.
Time Frame
12 months post implementation of intervention
Secondary Outcome Measure Information:
Title
Change in nutrition performance score
Description
The nutrition performance score is a composite measure including use, timing and adequacy of nutrition, use of small bowel feeds and motility agents, and hyperglycemia. Nutrition performance scores will be calculated after each of the two nutrition practice audits.
Time Frame
20-24 months
Title
Change in barriers to implementation of critical care nutrition clinical practice guidelines
Description
Barriers questionnaire
Time Frame
12 months post implementation of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ICUs must be affiliated with a registered dietitian. ICUs must have a minimum of 8 beds. ICUs must be located in Canada, Australia, or US. ICUs have previously participated in the International Nutrition Survey. Exclusion Criteria: ICUs with less than 8 beds. ICUs with high nutrition performance, as demonstrated previously in the International Nutrition Survey (i.e. average nutritional adequacy >60% and/or above 50th percentile when ranked against all participating ICUs according to nutrition practice performance score)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daren K Heyland, MD
Organizational Affiliation
Clinical Evaluation Research Unit
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heather Stuart, PhD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naomi E Cahill, RD, MSc
Organizational Affiliation
Queen's University, Clinical Evaluation Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Peter Lougheed
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Capital Health - University of Alberta Hospital (hospital general systems)
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18725033
Citation
Jones NE, Dhaliwal R, Day AG, Ouellette-Kuntz H, Heyland DK. Factors predicting adherence to the Canadian Clinical Practice Guidelines for nutrition support in mechanically ventilated, critically ill adult patients. J Crit Care. 2008 Sep;23(3):301-7. doi: 10.1016/j.jcrc.2007.08.004. Epub 2007 Dec 11.
Results Reference
background
PubMed Identifier
17644700
Citation
Jones NE, Suurdt J, Ouelette-Kuntz H, Heyland DK. Implementation of the Canadian Clinical Practice Guidelines for Nutrition Support: a multiple case study of barriers and enablers. Nutr Clin Pract. 2007 Aug;22(4):449-57. doi: 10.1177/0115426507022004449.
Results Reference
background
PubMed Identifier
21097765
Citation
Cahill NE, Heyland DK. Bridging the guideline-practice gap in critical care nutrition: a review of guideline implementation studies. JPEN J Parenter Enteral Nutr. 2010 Nov-Dec;34(6):653-9. doi: 10.1177/0148607110361907.
Results Reference
background
PubMed Identifier
21097762
Citation
Cahill NE, Suurdt J, Ouellette-Kuntz H, Heyland DK. Understanding adherence to guidelines in the intensive care unit: development of a comprehensive framework. JPEN J Parenter Enteral Nutr. 2010 Nov-Dec;34(6):616-24. doi: 10.1177/0148607110361904.
Results Reference
background
PubMed Identifier
24887445
Citation
Cahill NE, Murch L, Cook D, Heyland DK; Canadian Critical Care Trials Group. Implementing a multifaceted tailored intervention to improve nutrition adequacy in critically ill patients: results of a multicenter feasibility study. Crit Care. 2014 May 11;18(3):R96. doi: 10.1186/cc13867.
Results Reference
derived
PubMed Identifier
22981532
Citation
Cahill NE, Murch L, Cook D, Heyland DK; Canadian Critical Care Trials Group. Barriers to feeding critically ill patients: a multicenter survey of critical care nurses. J Crit Care. 2012 Dec;27(6):727-34. doi: 10.1016/j.jcrc.2012.07.006. Epub 2012 Sep 13.
Results Reference
derived
Links:
URL
http://www.criticalcarenutrition.com
Description
Clinical Evaluation Research Unit's Critical Care Nutrition website

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PERFormance Enhancement of the Canadian Nutrition Guidelines by a Tailored Implementation Strategy: The PERFECTIS Study

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