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

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Cardiovascular Disease
• Interventions: Other: Toolkit; Other: Control

• Registration Number: NCT01026688
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

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 Timeline

• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-03
• Study First Posted: 2009-12-04
• Study Start: 2010-06
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-21
• Last Update Posted: 2014-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1592

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:

    1. Macrovascular disease (silent myocardial infarction, or evidence of peripheral arterial, carotid or cerebrovascular disease)
    2. Microvascular disease (nephropathy or retinopathy)
    3. Family history of premature coronary or cerebrovascular disease in a first-degree relative
    4. Duration of diabetes > 15 years with age > 30 years

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Toolkit	-
Control	Control	-

Primary Outcome Measures

Name	Time	Method
Patient is receiving a statin	July 2009 to April 2010

Secondary Outcome Measures

Name	Time	Method
Patient is receiving an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker	July 2009 to April 2010
LDL-cholesterol level	Last observation between July 2009 and April 2010
Body mass index	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 an LDL-cholesterol level above 2.0 mmol/L	At the next patient visit after the abnormal measurement
A1c level	Last observation between July 2009 and April 2010
Blood pressure level	Last observation between July 2009 and April 2010
Total- to HDL-cholesterol ratio	Last observation between July 2009 and April 2010
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
Waist circumference	Last observation between July 2009 and April 2010

Trial Locations

Locations (1)

Institute for Clinical Evaluative Sciences; 🇨🇦 Toronto, Ontario, Canada