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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Diabetes Mellitus
• Intervention / Treatment: Other: Toolkit; Other: Control

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 Type: Interventional
• Enrollment (Actual): 933789
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Institute for Clinical Evaluative Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Death or non-fatal myocardial infarction	Up to 10 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Institute for Clinical Evaluative Sciences
• Investigators: Principal Investigator: Baiju R Shah, MD, PhD, Sunnybrook Health Sciences Centre

Publications and helpful links

General Publications

• 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. eCollection 2014 Feb.

Helpful Links

• Related study

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: August 3, 2011
• First Submitted That Met QC Criteria: August 5, 2011
• First Posted (Estimate): August 8, 2011

Study Record Updates

• Last Update Posted (Estimate): November 24, 2014
• Last Update Submitted That Met QC Criteria: November 21, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Cardiovascular risk reduction; Clinical practice guidelines; Knowledge translation; Pragmatic randomized controlled trial; Administrative databases
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus
• Other Study ID Numbers: Shah-2