Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Type 2 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): 1592
• 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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 to Control arm physicians with the May 2010 issue of the newsletter.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

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.
• Shah BR, Bhattacharyya O, Yu C, Mamdani M, Parsons JA, Straus SE, Zwarenstein M. Evaluation of a toolkit to improve cardiovascular disease screening and treatment for people with type 2 diabetes: protocol for a cluster-randomized pragmatic trial. Trials. 2010 Apr 23;11:44. doi: 10.1186/1745-6215-11-44.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: December 2, 2009
• First Submitted That Met QC Criteria: December 3, 2009
• First Posted (Estimate): December 4, 2009

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
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus
• Other Study ID Numbers: Shah-1