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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026688
• Other study ID #: Shah-1
• Status: Completed
• Phase: N/A
• First received: December 2, 2009
• Last updated: November 21, 2014
• Start date: June 2010
• Est. completion date: May 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: 1592
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Institute for Clinical Evaluative Sciences, St. Michael's Hospital, Toronto

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. eCollection 2014 Feb. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient is receiving a statin		July 2009 to April 2010	No
Secondary	Patient is receiving an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker		July 2009 to April 2010	No
Secondary	A1c level		Last observation between July 2009 and April 2010	No
Secondary	Blood pressure level		Last observation between July 2009 and April 2010	No
Secondary	LDL-cholesterol level		Last observation between July 2009 and April 2010	No
Secondary	Total- to HDL-cholesterol ratio		Last observation between July 2009 and April 2010	No
Secondary	Body mass index		Last observation between July 2009 and April 2010	No
Secondary	Waist circumference		Last observation between July 2009 and April 2010	No
Secondary	Change in treatment recommended following an A1c level above 0.070		At the next patient visit after the abnormal measurement	No
Secondary	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	No
Secondary	Change in treatment recommended following an LDL-cholesterol level above 2.0 mmol/L		At the next patient visit after the abnormal measurement	No