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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Clinical Evaluation Research Unit at Kingston General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Ontario Ministry of Research and Innovation under the International Strategic Opportunities Program
Canadian Foundation for Dietetic Research (CFDR)
Information provided by:
Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier:
NCT01168128
First received: July 21, 2010
Last updated: July 22, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Critically Ill
Intensive Care Unit
Other: Tailored Change Strategy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: PERFormance Enhancement of the Canadian Nutrition Guidelines by a Tailored Implementation Strategy: The PERFECTIS Study

Resource links provided by NLM:


Further study details as provided by Clinical Evaluation Research Unit at Kingston General Hospital:

Primary Outcome Measures:
  • Feasibility of the study design and intervention [ Time Frame: 12 months post implementation of intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 20-24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months post implementation of intervention ] [ Designated as safety issue: No ]
    Barriers questionnaire


Estimated Enrollment: 280
Study Start Date: September 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tailored Action Plan
A Tailored Action Plan is an intervention selected to overcome barriers identified before the design and delivery of the intervention.
Other: Tailored Change Strategy
e.g. Education, decision support tools

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168128

Locations
United States, Maryland
Anne Arundel Medical Center
Annapolis, Maryland, United States
United States, South Carolina
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Canada, Alberta
Peter Lougheed
Calgary, Alberta, Canada
Capital Health - University of Alberta Hospital (hospital general systems)
Edmonton, Alberta, Canada
Canada, Ontario
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Sponsors and Collaborators
Clinical Evaluation Research Unit at Kingston General Hospital
Ontario Ministry of Research and Innovation under the International Strategic Opportunities Program
Canadian Foundation for Dietetic Research (CFDR)
Investigators
Principal Investigator: Daren K Heyland, MD Clinical Evaluation Research Unit
Principal Investigator: Heather Stuart, PhD Queen's University
Principal Investigator: Naomi E Cahill, RD, MSc Queen's University, Clinical Evaluation Research Unit
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Naomi Cahill, Queen's University
ClinicalTrials.gov Identifier: NCT01168128     History of Changes
Other Study ID Numbers: PERFECTIS
Study First Received: July 21, 2010
Last Updated: July 22, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Clinical Evaluation Research Unit at Kingston General Hospital:
Enteral Nutrition
Parenteral Nutrition
Critically ill
Nutrition Therapy
Nutrition Support
Practice Guidelines as Topic
Guideline Adherence
Quality Assurance, Health Care
Nutrition Surveys
Questionnaires

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014