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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01026688
Enrollment
1592
Registered
2009-12-04
Start date
2010-06-30
Completion date
2011-05-31
Last updated
2014-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Diabetes Mellitus

Keywords

Pragmatic randomized controlled trial, Cardiovascular risk reduction, Knowledge translation, Clinical practice guidelines

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.

Interventions

OTHERToolkit

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.

OTHERControl

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.

Sponsors

Institute for Clinical Evaluative Sciences
CollaboratorOTHER
Unity Health Toronto
CollaboratorOTHER
Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Patient is receiving a statinJuly 2009 to April 2010

Secondary

MeasureTime frame
A1c levelLast observation between July 2009 and April 2010
Blood pressure levelLast observation between July 2009 and April 2010
LDL-cholesterol levelLast observation between July 2009 and April 2010
Total- to HDL-cholesterol ratioLast observation between July 2009 and April 2010
Patient is receiving an angiotensin-converting enzyme inhibitor or angiotensin receptor blockerJuly 2009 to April 2010
Waist circumferenceLast observation between July 2009 and April 2010
Change in treatment recommended following an A1c level above 0.070At the next patient visit after the abnormal measurement
Change in treatment recommended following a systolic blood pressure above 130 or a diastolic blood pressure above 80At the patient visit of the abnormal measurement
Change in treatment recommended following an LDL-cholesterol level above 2.0 mmol/LAt the next patient visit after the abnormal measurement
Body mass indexLast observation between July 2009 and April 2010

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026