Clinical trial NCT01411865: Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Diabetes
Official title: Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Cardiovascular Disease
Keywords: Pragmatic randomized controlled trial
Cardiovascular risk reduction
Knowledge translation
Clinical practice guidelines
Administrative databases
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Institute for Clinical Evaluative Sciences
First posted: 2011-08-08
Enrollment: 933789
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Death or non-fatal myocardial infarction
timeFrame: Up to 10 months
Secondary outcomes:
measure: Death, non-fatal myocardial infarction or non-fatal stroke
timeFrame: Up to 10 months
measure: Death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for unstable angina or transient ischemic attack
timeFrame: Up to 10 months
measure: Death
timeFrame: Up to 10 months
measure: Hospitalization for myocardial infarction
timeFrame: Up to 10 months
measure: Hospitalization for myocardial infarction or unstable angina
timeFrame: Up to 10 months
measure: Hospitalization for stroke
timeFrame: Up to 10 months
measure: Hospitalization for stroke or transient ischemic attack
timeFrame: Up to 10 months
measure: Electrocardiogram
timeFrame: Up to 10 months
measure: Cardiac stress test or nuclear imaging
timeFrame: Up to 10 months
measure: Coronary angiography
timeFrame: Up to 10 months
measure: Coronary revascularization procedure
timeFrame: Up to 10 months
measure: Ambulatory cardiology or internal medicine visit
timeFrame: Up to 10 months
measure: Prescription for angiotensin converting enzyme inhibitor or angiotensin receptor blocker
timeFrame: Up to 10 months
measure: Prescription for at least one class of antihypertensive agent
timeFrame: Up to 10 months
measure: Prescription for at least two classes of antihypertensive agents
timeFrame: Up to 10 months
measure: Prescription for at least three classes of antihypertensive agents
timeFrame: Up to 10 months
measure: Prescription for statin
timeFrame: Up to 10 months
measure: Prescription for any glucose-lowering drug
timeFrame: Up to 10 months
measure: Prescription for insulin
timeFrame: Up to 10 months
measure: Prescription for nitrate
timeFrame: Up to 10 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Institute for Clinical Evaluative Sciences
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Baiju R Shah, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.