Clinical trial NCT01026688: Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Type 2 Diabetes
Official title: Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Type 2 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
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Institute for Clinical Evaluative Sciences
name: Unity Health Toronto
First posted: 2009-12-04
Enrollment: 1592
Sex: ALL
Minimum age (years): 18
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:

* 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

Primary outcomes:
measure: Patient is receiving a statin
timeFrame: July 2009 to April 2010
Secondary outcomes:
measure: Patient is receiving an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker
timeFrame: July 2009 to April 2010
measure: A1c level
timeFrame: Last observation between July 2009 and April 2010
measure: Blood pressure level
timeFrame: Last observation between July 2009 and April 2010
measure: LDL-cholesterol level
timeFrame: Last observation between July 2009 and April 2010
measure: Total- to HDL-cholesterol ratio
timeFrame: Last observation between July 2009 and April 2010
measure: Body mass index
timeFrame: Last observation between July 2009 and April 2010
measure: Waist circumference
timeFrame: Last observation between July 2009 and April 2010
measure: Change in treatment recommended following an A1c level above 0.070
timeFrame: At the next patient visit after the abnormal measurement
measure: Change in treatment recommended following a systolic blood pressure above 130 or a diastolic blood pressure above 80
timeFrame: At the patient visit of the abnormal measurement
measure: Change in treatment recommended following an LDL-cholesterol level above 2.0 mmol/L
timeFrame: At the next patient visit after the abnormal measurement
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Institute for Clinical Evaluative Sciences
state: Ontario
Study officials:
affiliation: Institute for Clinical Evaluative Sciences
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.
citation: 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.