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Completed

NCT Number: NCT01411865

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Clinical Evaluative Sciences

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Toolkit

Other

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

Other

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.

Primary outcomes

  1. Death or non-fatal myocardial infarction

    Time frame: Up to 10 months

Secondary outcomes

  1. Death, non-fatal myocardial infarction or non-fatal stroke

    Time frame: Up to 10 months

  2. Death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for unstable angina or transient ischemic attack

    Time frame: Up to 10 months

  3. Death

    Time frame: Up to 10 months

  4. Hospitalization for myocardial infarction

    Time frame: Up to 10 months

  5. Hospitalization for myocardial infarction or unstable angina

    Time frame: Up to 10 months

  6. Hospitalization for stroke

    Time frame: Up to 10 months

  7. Hospitalization for stroke or transient ischemic attack

    Time frame: Up to 10 months

  8. Electrocardiogram

    Time frame: Up to 10 months

  9. Cardiac stress test or nuclear imaging

    Time frame: Up to 10 months

  10. Coronary angiography

    Time frame: Up to 10 months

  11. Coronary revascularization procedure

    Time frame: Up to 10 months

  12. Ambulatory cardiology or internal medicine visit

    Time frame: Up to 10 months

  13. Prescription for angiotensin converting enzyme inhibitor or angiotensin receptor blocker

    Time frame: Up to 10 months

  14. Prescription for at least one class of antihypertensive agent

    Time frame: Up to 10 months

  15. Prescription for at least two classes of antihypertensive agents

    Time frame: Up to 10 months

  16. Prescription for at least three classes of antihypertensive agents

    Time frame: Up to 10 months

  17. Prescription for statin

    Time frame: Up to 10 months

  18. Prescription for any glucose-lowering drug

    Time frame: Up to 10 months

  19. Prescription for insulin

    Time frame: Up to 10 months

  20. Prescription for nitrate

    Time frame: Up to 10 months

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Institute for Clinical Evaluative Sciences

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 8, 2011
Registry last updated
Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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