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

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Completed

CT.gov ID

NCT01411865

Collaborator

Institute for Clinical Evaluative Sciences (Other)

933,789

Enrollment

Location

Arms

Duration (Months)

465937.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Cardiovascular Disease	Other: Toolkit Other: Control	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

933789 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention	Other: Toolkit 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.
Other: Control	Other: Control The Spring/Summer 2009 issue of the quarterly newsletter, Canadian Diabetes, mailed on its own. The Cardiovascular Toolkit was mailed with the May 2010 issue of the newsletter.

Arm

Intervention/Treatment

Experimental: Intervention

Other: Toolkit

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.

Other: Control

Other: Control

The Spring/Summer 2009 issue of the quarterly newsletter, Canadian Diabetes, mailed on its own. The Cardiovascular Toolkit was mailed with the May 2010 issue of the newsletter.

Outcome Measures

Primary Outcome Measures

Death or non-fatal myocardial infarction [Up to 10 months]

Secondary Outcome Measures

Death, non-fatal myocardial infarction or non-fatal stroke [Up to 10 months]
Death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for unstable angina or transient ischemic attack [Up to 10 months]
Death [Up to 10 months]
Hospitalization for myocardial infarction [Up to 10 months]
Hospitalization for myocardial infarction or unstable angina [Up to 10 months]
Hospitalization for stroke [Up to 10 months]
Hospitalization for stroke or transient ischemic attack [Up to 10 months]
Electrocardiogram [Up to 10 months]
Cardiac stress test or nuclear imaging [Up to 10 months]
Coronary angiography [Up to 10 months]
Coronary revascularization procedure [Up to 10 months]
Ambulatory cardiology or internal medicine visit [Up to 10 months]
Prescription for angiotensin converting enzyme inhibitor or angiotensin receptor blocker [Up to 10 months]
Prescription for at least one class of antihypertensive agent [Up to 10 months]
Prescription for at least two classes of antihypertensive agents [Up to 10 months]
Prescription for at least three classes of antihypertensive agents [Up to 10 months]
Prescription for statin [Up to 10 months]
Prescription for any glucose-lowering drug [Up to 10 months]
Prescription for insulin [Up to 10 months]
Prescription for nitrate [Up to 10 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Alive on 1 July 2009 with prevalent diabetes

Exclusion Criteria:

Age <= 39
Residing in long-term care

Secondary Analysis:

Analysis will be repeated using all people alive on 1 July 2009 without prevalent diabetes using the same exclusion criteria, to determine the spill-over effect of the Intervention on physicians' other patients.