Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Type 2 Diabetes
1 other identifier
interventional
1,592
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2009
CompletedFirst Posted
Study publicly available on registry
December 4, 2009
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedNovember 24, 2014
November 1, 2014
11 months
December 2, 2009
November 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient is receiving a statin
July 2009 to April 2010
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALControl
OTHERInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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:
- Macrovascular disease (silent myocardial infarction, or evidence of peripheral arterial, carotid or cerebrovascular disease)
- Microvascular disease (nephropathy or retinopathy)
- Family history of premature coronary or cerebrovascular disease in a first-degree relative
- Duration of diabetes \> 15 years with age \> 30 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sunnybrook Health Sciences Centrelead
- Institute for Clinical Evaluative Sciencescollaborator
- Unity Health Torontocollaborator
Study Sites (1)
Institute for Clinical Evaluative Sciences
Toronto, Ontario, M4N 3M5, Canada
Related Publications (2)
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.
PMID: 24505216BACKGROUNDShah 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.
PMID: 20416080DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baiju R Shah, MD PhD
Institute for Clinical Evaluative Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2009
First Posted
December 4, 2009
Study Start
June 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
November 24, 2014
Record last verified: 2014-11