Optimizing Audit and Feedback for Primary Care
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| First Received Date ICMJE | October 15, 2009 | ||||||||||||||||
| Last Updated Date | July 16, 2010 | ||||||||||||||||
| Start Date ICMJE | July 2010 | ||||||||||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Composite Process Index: % of the provider's patients with chronic disease who are have received appropriate laboratory testing and have had their blood pressure checked within the appropriate time-frame. [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT00996645 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Optimizing Audit and Feedback for Primary Care | ||||||||||||||||
| Official Title ICMJE | Cluster Randomized Trial of a Goal-Setting Intervention With Performance Feedback Reports Regarding Diabetes and Coronary Artery Disease for Family Physicians in Ontario | ||||||||||||||||
| Brief Summary | There remains a large gap between ideal and actual care provided to patients with chronic diseases. Performance feedback reports are often used as a foundation for quality improvement interventions. There have been hundreds of trials investigating the use of feedback reports; the important question to ask now is not whether performance feedback reports can help to improve quality of care, but how to optimize feedback interventions to accomplish that goal. The purpose of this study is to test whether a theory-based intervention added to feedback reports sent to primary care providers can result in improved outcomes for patients with chronic disease. |
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| Detailed Description | There remains a large gap between ideal and actual care provided to patients with chronic diseases such as type-2 diabetes (DM2) and coronary artery disease (CAD), making them a common focus for translational research. Quality improvement strategies such as audit and feedback, which can increase adoption and adherence to guidelines, may be a good choice for such problems. Audit and feedback is felt to be effective because it may overcome physicians' limited ability to accurately self-assess. A recent Cochrane review concluded that it may increase appropriate clinical practice by 5 to 10 percentage points. However, the authors noted great variability in the results of the trials. It is thought that optimal design and delivery of feedback will more consistently lead to improved results, but few studies have tested different designs of feedback. A more recent meta-analysis of feedback found that interventions incorporating theoretical principles from psychology in the design were more effective than intuitive feedback designs. The author of that study has urged the creation of more 'actionable' feedback. There is both theoretical and empirical reason to believe that feedback will be more effective if the recipients set goals and develop action plans. A group of family physicians across Ontario have previously signed data sharing agreements with ICES allowing their electronic medical records to be audited. These physicians will be invited to participate in this trial. Participants will receive performance feedback reports summarizing the percentage of their DM2 and CAD patients who are meeting evidence-based targets for quality of care. Participating physicians will be split into two groups at the level of their practice to reduce risk of contamination. Minimization software will be used to ensure balance at baseline in the primary outcomes between the intervention and control group. New potential participants that have signed data sharing agreements at ICES will be invited to join the trial for a maximum of six months after the first practices are allocated. The intervention group will receive in addition to the feedback reports a theoretically informed worksheet meant to facilitate goal-setting and the development of action plans. This will occur every six months for two years. Outcomes will be analyzed after 24 months. |
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| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Worksheet to facilitate goal-setting and action plans
Developed based on goal-setting theory and implementation intentions, the worksheet will be mailed out with the feedback reports and is expected to facilitate improved quality of care in response to feedback reports. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||||||
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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 | Enrolling by invitation | ||||||||||||||||
| Estimated Enrollment ICMJE | 55 | ||||||||||||||||
| Estimated Completion Date | June 2012 | ||||||||||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | 20 Years to 80 Years | ||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | Canada | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT00996645 | ||||||||||||||||
| Other Study ID Numbers ICMJE | 271-2006 | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | Noah Ivers, Institute for Clinical Evaluative Sciences, Sunnybrook Health Sciences Centre | ||||||||||||||||
| Study Sponsor ICMJE | Sunnybrook Health Sciences Centre | ||||||||||||||||
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| Investigators ICMJE |
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| Information Provided By | Sunnybrook Health Sciences Centre | ||||||||||||||||
| 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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