Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Type 2 Diabetes

Study Overview
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Brief Summary
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Diabetes is a common and serious chronic disease. However, there is a large gap between the level of care that people should receive (based on research and guidelines) and the level of care they actually receive. With the release of their 2008 Clinical Practice Guidelines, the Canadian Diabetes Association has a strategy to improve heart disease screening and treatment for people with diabetes. This study will evaluate whether the strategy works. The focus of the strategy was to give all family physicians in Canada a Toolkit in June 2009 to help them delivery better care for their diabetic patients. In Ontario, only half of doctors received this Toolkit. We will compare the quality of care received by diabetic patients whose doctors received this Toolkit versus those who doctors did not.

Detailed Description
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A cardiovascular disease Toolkit was developed by the Canadian Diabetes Association and mailed to family physician with the Spring/Summer 2009 edition of the newsletter, Canadian Diabetes. The Toolkit was packaged in a brightly-coloured box with Canadian Diabetes Association branding, and contained: 1) an introductory letter from the Chair of the practice guidelines' Dissemination and Implementation Committee; 2) an eight page summary of selected sections of the practice guidelines targeted towards primary care physicians; 3) a four page synopsis of the key guideline elements pertaining to cardiovascular disease risk; 4) a small double-sided laminated card with a simplified algorithm for cardiovascular risk assessment, vascular protection strategies and screening for cardiovascular disease; and 5) a pad of tear-off sheets for patients with a cardiovascular risk self-assessment tool and a list of recommended risk reduction strategies.

Official Title
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Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Cardiovascular Disease

Intervention / Treatment
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* Other: Toolkit
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with diagnosed diabetes Seen in the office of a participating family physician at least once between July 2009 and April 2010 At high risk for cardiovascular events: Previous cardiovascular disease (including AMI, angina, stroke, TIA, claudication); or Men aged >= 45 years, women aged >= 50 years; or Men aged < 45 years, women aged < 50 years with at least one of the following: Macrovascular disease (silent myocardial infarction, or evidence of peripheral arterial, carotid or cerebrovascular disease) Microvascular disease (nephropathy or retinopathy) Family history of premature coronary or cerebrovascular disease in a first-degree relative Duration of diabetes > 15 years with age > 30 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Other: Toolkit<br>* Cardiovascular Disease Toolkit mailed by the Canadian Diabetes Association to family physicians, accompanying the Spring/Summer 2009 edition of the quarterly newsletter, Canadian Diabetes. (Mailed in June 2009.) The Toolkit includes a summary of selected sections of the practice guidelines targeted towards primary care physicians; a synopsis of the key messages pertaining to cardiovascular disease risk; a laminated card with a simplified algorithm for cardiovascular risk assessment and treatment; and a pad of tear-off sheets for patients with a cardiovascular risk self-assessment tool.<br>|
| Other: Control<br> | Other: Control<br>* The Spring/Summer 2009 issue of the quarterly newsletter, Canadian Diabetes, mailed on its own. The Cardiovascular Toolkit was mailed to Control arm physicians with the May 2010 issue of the newsletter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient is receiving a statin |  | July 2009 to April 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient is receiving an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker |  | July 2009 to April 2010 | 
| A1c level |  | Last observation between July 2009 and April 2010 | 
| Blood pressure level |  | Last observation between July 2009 and April 2010 | 
| LDL-cholesterol level |  | Last observation between July 2009 and April 2010 | 
| Total- to HDL-cholesterol ratio |  | Last observation between July 2009 and April 2010 | 
| Body mass index |  | Last observation between July 2009 and April 2010 | 
| Waist circumference |  | Last observation between July 2009 and April 2010 | 
| Change in treatment recommended following an A1c level above 0.070 |  | At the next patient visit after the abnormal measurement | 
| Change in treatment recommended following a systolic blood pressure above 130 or a diastolic blood pressure above 80 |  | At the patient visit of the abnormal measurement | 
| Change in treatment recommended following an LDL-cholesterol level above 2.0 mmol/L |  | At the next patient visit after the abnormal measurement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pragmatic randomized controlled trial, Cardiovascular risk reduction, Knowledge translation, Clinical practice guidelines