- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01168128
PERFormance Enhancement of the Canadian Nutrition Guidelines by a Tailored Implementation Strategy: The PERFECTIS Study (PERFECTIS)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada
- Peter Lougheed
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Edmonton, Alberta, Canada
- Capital Health - University of Alberta Hospital (hospital general systems)
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Ontario
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Newmarket, Ontario, Canada
- Southlake Regional Health Centre
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-
-
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Maryland
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Annapolis, Maryland, United States
- Anne Arundel Medical Center
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South Carolina
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Spartanburg, South Carolina, United States
- Spartanburg Regional Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tailored Action Plan
A Tailored Action Plan is an intervention selected to overcome barriers identified before the design and delivery of the intervention.
|
e.g.
Education, decision support tools
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of the study design and intervention
Time Frame: 12 months post implementation of 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.
|
12 months post implementation of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in nutrition performance score
Time Frame: 20-24 months
|
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.
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20-24 months
|
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Change in barriers to implementation of critical care nutrition clinical practice guidelines
Time Frame: 12 months post implementation of intervention
|
Barriers questionnaire
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12 months post implementation of intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Heather Stuart, PhD, Queen's University
- Principal Investigator: Naomi E Cahill, RD, MSc, Queen's University, Clinical Evaluation Research Unit
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PERFECTIS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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