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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411865
• Other study ID #: Shah-2
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: November 21, 2014
• Start date: August 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2014
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 933789
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus

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.
• 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.

Locations

Country	Name	City	State
Canada	Institute for Clinical Evaluative Sciences	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Institute for Clinical Evaluative Sciences

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Shah BR, Bhattacharyya O, Yu CH, Mamdani MM, Parsons JA, Straus SE, Zwarenstein M. Effect of an educational toolkit on quality of care: a pragmatic cluster randomized trial. PLoS Med. 2014 Feb 4;11(2):e1001588. doi: 10.1371/journal.pmed.1001588. eCollecti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or non-fatal myocardial infarction		Up to 10 months	No
Secondary	Death, non-fatal myocardial infarction or non-fatal stroke		Up to 10 months	No
Secondary	Death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for unstable angina or transient ischemic attack		Up to 10 months	No
Secondary	Death		Up to 10 months	No
Secondary	Hospitalization for myocardial infarction		Up to 10 months	No
Secondary	Hospitalization for myocardial infarction or unstable angina		Up to 10 months	No
Secondary	Hospitalization for stroke		Up to 10 months	No
Secondary	Hospitalization for stroke or transient ischemic attack		Up to 10 months	No
Secondary	Electrocardiogram		Up to 10 months	No
Secondary	Cardiac stress test or nuclear imaging		Up to 10 months	No
Secondary	Coronary angiography		Up to 10 months	No
Secondary	Coronary revascularization procedure		Up to 10 months	No
Secondary	Ambulatory cardiology or internal medicine visit		Up to 10 months	No
Secondary	Prescription for angiotensin converting enzyme inhibitor or angiotensin receptor blocker		Up to 10 months	No
Secondary	Prescription for at least one class of antihypertensive agent		Up to 10 months	No
Secondary	Prescription for at least two classes of antihypertensive agents		Up to 10 months	No
Secondary	Prescription for at least three classes of antihypertensive agents		Up to 10 months	No
Secondary	Prescription for statin		Up to 10 months	No
Secondary	Prescription for any glucose-lowering drug		Up to 10 months	No
Secondary	Prescription for insulin		Up to 10 months	No
Secondary	Prescription for nitrate		Up to 10 months	No

External Links

•   Related study