Enhancing the Secondary Prevention of Coronary Artery Disease
NCT00175240
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Adult Trials: 18+ Years
- Alberta residents who undergo a cardiac catheterization and are diagnosed with coronary artery disease (> or equal to 50% stenosis in at least one vessel).
- no fasting lipid panel within the previous 6 weeks
- on a statin at maximal dose
- on a statin/lipid lowering drug and LDL-C is 2.5 mmol/L or less (prior to Sept 2006)
and LDL-C is 2.0 mmol/L or less (after Sept 2006)
- not on a statin and LDL-C is 1.8 mmol/L or less
- acute myocardial infarction or cardiogenic shock
- require emergency bypass surgery following catheterization
- contraindication to statins (e.g. cirrhosis, inflammatory muscle disease)
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- Edmonton, Alberta
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Enhancing the Secondary Prevention of Coronary Artery Disease | |||
| Official Title ICMJE | Enhancing the Use of Secondary Prevention Strategies in Patients With Coronary Artery Disease (The ESP-CAD Study) | |||
| Brief Summary | People with coronary artery disease can reduce their chance of having a heart attack by making healthy lifestyle choices (diet, exercise, quitting smoking,etc.). There are also many medications that have been proven to reduce the risk of heart attacks and may even help people live longer. This study will look at different ways of improving the use of these beneficial medications to enhance the quality of care for people with this condition. | |||
| Detailed Description | BACKGROUND: Despite the abundant evidence base for secondary prevention, practice audits consistently demonstrate substantial "care gaps" between this evidence and clinical reality such that many patients with Coronary Artery Disease (CAD) are not offered all possible therapies for the prevention of myocardial infarction or death. For example, even after an acute myocardial infarction, almost one fifth of patients continue to smoke; over half with hypertension or hyperlipidemia have poorly controlled pressure or lipid levels; and proven therapies such as statins, ACE inhibitors, beta-blockers and antiplatelet agents are under-prescribed. Multiple barriers are often responsible for the lack of implementation of proven efficacious therapies and traditional means of educating practitioners (journal articles, CME, conferences, etc) are usually ineffective in altering practice. Clearly novel interventions to improve the quality of prescribing are needed. Local opinion leaders are trusted by their peers to evaluate medical innovations and thus influence practice patterns within their community. Few controlled studies, however, have evaluated their effect on changing prescribing practices for common conditions such as CAD. HYPOTHESIS: This trial will test 2 quality improvement interventions. The principle hypothesis is: does a one-page evidence summary endorsed by local opinion leaders increase the provision of secondary prevention therapies in patients with CAD compared to usual care? The secondary hypotheses are: does the same intervention but without local opinion leader endorsement improve the provision of secondary prevention strategies in patients with CAD compared to usual care? Does local opinion leader endorsement increase the effectiveness of the quality improvement intervention? | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention | |||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Evidence summaries endorsed by local opinion leaders | |||
| Study Arms ICMJE | Not Provided | |||
| 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. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Estimated Enrollment ICMJE | 480 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | July 2015 | |||
| Actual Primary Completion Date | August 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Canada | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00175240 | |||
| Other Study ID Numbers ICMJE | UofA M2022 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | University of Alberta | |||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University of Alberta | |||
| Verification Date | July 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||