PERFormance Enhancement of the Canadian Nutrition Guidelines by a Tailored Implementation Strategy: The PERFECTIS Study
Recruitment status was Active, not recruiting
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| First Received Date ICMJE | July 21, 2010 | ||||||||||||
| Last Updated Date | July 22, 2010 | ||||||||||||
| Start Date ICMJE | September 2009 | ||||||||||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01168128 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | PERFormance Enhancement of the Canadian Nutrition Guidelines by a Tailored Implementation Strategy: The PERFECTIS Study | ||||||||||||
| Official Title ICMJE | PERFormance Enhancement of the Canadian Nutrition Guidelines by a Tailored Implementation Strategy: The PERFECTIS Study | ||||||||||||
| 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. |
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| 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:
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Tailored Change Strategy
e.g. Education, decision support tools |
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| Study Arm (s) | Experimental: Tailored Action Plan
A Tailored Action Plan is an intervention selected to overcome barriers identified before the design and delivery of the intervention.
Intervention: Other: Tailored Change Strategy |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 280 | ||||||||||||
| Estimated Completion Date | August 2011 | ||||||||||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States, Canada | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01168128 | ||||||||||||
| Other Study ID Numbers ICMJE | PERFECTIS | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Naomi Cahill, Queen's University | ||||||||||||
| Study Sponsor ICMJE | Clinical Evaluation Research Unit at Kingston General Hospital | ||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Clinical Evaluation Research Unit at Kingston General Hospital | ||||||||||||
| Verification Date | July 2010 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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