Critically IllPERFECTISNCT01168128
PERFormance Enhancement of the Canadian Nutrition Guidelines by a Tailored Implementation Strategy: The PERFECTIS Study
A study testing Tailored Change Strategy in people with Critically Ill and Intensive Care Unit, run by Daren K. Heyland at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Intensive Care Unit
- What is being tested?
- Tailored Change Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 16 Sep 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Canada3 sites
Peter Lougheed
Calgary, Alberta
Capital Health - University of Alberta Hospital (hospital general systems)
Edmonton, Alberta
Southlake Regional Health Centre
Newmarket, Ontario
United States2 sites
Anne Arundel Medical Center
Annapolis, Maryland
Spartanburg Regional Medical Center
Spartanburg, South Carolina
About this study
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.
Read the 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.
- Conditions
- Critically Ill, Intensive Care Unit
- Being tested
- Tailored Change Strategy
- Keywords
- Enteral Nutrition, Parenteral Nutrition, Critically ill, Nutrition Therapy, Nutrition Support, Practice Guidelines as Topic, Guideline Adherence, Quality Assurance, Health Care, Nutrition Surveys, Questionnaires
- Medical subject headings
- Critical Illness, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Change StrategyOther
e.g. Education, decision support tools
| Study group | Role | What they receive |
|---|---|---|
| Tailored Action Plan | Experimental | A Tailored Action Plan is an intervention selected to overcome barriers identified before the design and delivery of the intervention. Receives: Other: Tailored Change Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post implementation of intervention
Secondary outcomes (2)
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.
Measured: 20-24 months
Change in barriers to implementation of critical care nutrition clinical practice guidelines
Barriers questionnaire
Measured: 12 months post implementation of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study start16 Sep 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daren K. Heyland
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Research, Innovation and Science, Ontario, Canadian Foundation for Dietetic Research (CFDR)
- Responsible party
- Sponsor-investigator, Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
- Investigators
- Daren K Heyland, MD, Principal investigator, Clinical Evaluation Research UnitHeather Stuart, PhD, Principal investigator, Queen's UniversityNaomi E Cahill, RD, MSc, Principal investigator, Queen's University, Clinical Evaluation Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168128
- Sponsor's protocol ID
- PERFECTIS
- Acronym
- PERFECTIS
- Status last verified
- Dec 2020
- First submitted
- 21 Jul 2010
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18725033Jones 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.
PubMed 17644700Cahill 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.
PubMed 21097765Cahill 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.
PubMed 21097762Cahill 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.
PubMed 24887445Cahill 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.
PubMed 22981532
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERFormance Enhancement of the Canadian Nutrition Guidelines by a Tailored Implementation Strategy: The PERFECTIS Study
- ClinicalTrials.gov ID
- NCT01168128
- Acronym / sponsor ID
- PERFECTIS / PERFECTIS
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Daren K. HeylandUniversity, hospital or other
- Collaborators
- Ministry of Research, Innovation and Science, Ontario, Canadian Foundation for Dietetic Research (CFDR)
- Study start
- 16 Sep 2009 (actual)
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tailored Action Plan | Experimental | Other: Tailored Change StrategyA Tailored Action Plan is an intervention selected to overcome barriers identified before the design and delivery of the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored Change Strategye.g. Education, decision support tools | Other | Tailored Action Plan |
Primary outcome
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.
2 secondary outcomes
Change in nutrition performance score
Time frame: 20-24 months
Change in barriers to implementation of critical care nutrition clinical practice guidelines
Time frame: 12 months post implementation of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Background: PubMed 18725033Jones 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.
- Background: PubMed 17644700Jones 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.
- Background: PubMed 21097765Cahill 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.
- Background: PubMed 21097762Cahill 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.
- Derived from this study: PubMed 24887445Cahill 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.
- Derived from this study: PubMed 22981532Cahill 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.
- Clinical Evaluation Research Unit's Critical Care Nutrition websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daren K Heyland, MD principal investigator
Clinical Evaluation Research Unit
Heather Stuart, PhD principal investigator
Queen's University
Naomi E Cahill, RD, MSc principal investigator
Queen's University, Clinical Evaluation Research Unit
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Change Strategy in people with Critically Ill and Intensive Care Unit, run by Daren K. Heyland at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the study design and intervention (time frame: 12 months post implementation of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01168128, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.