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

December 15, 2020 updated by: Daren K. Heyland
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.

Study Overview

Status

Completed

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:

  1. 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.
  2. 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.
  3. 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.

  4. 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

Interventional

Enrollment (Actual)

278

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada
        • Peter Lougheed
      • Edmonton, Alberta, Canada
        • Capital Health - University of Alberta Hospital (hospital general systems)
    • Ontario
      • Newmarket, Ontario, Canada
        • Southlake Regional Health Centre
    • Maryland
      • Annapolis, Maryland, United States
        • Anne Arundel Medical Center
    • South Carolina
      • Spartanburg, South Carolina, United States
        • Spartanburg Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
20-24 months
Change in barriers to implementation of critical care nutrition clinical practice guidelines
Time Frame: 12 months post implementation of intervention
Barriers questionnaire
12 months post implementation of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

July 21, 2010

First Submitted That Met QC Criteria

July 22, 2010

First Posted (Estimate)

July 23, 2010

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 15, 2020

Last Verified

December 1, 2020

More Information

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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