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

This study has been completed.
Sponsor:
Collaborators:
Institute for Clinical Evaluative Sciences
St. Michael's Hospital, Toronto
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01026688
First received: December 2, 2009
Last updated: July 27, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Cardiovascular Disease
 Other: Toolkit
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Patient is receiving a statin [ Time Frame: July 2009 to April 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient is receiving an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker [ Time Frame: July 2009 to April 2010 ] [ Designated as safety issue: No ]
  • A1c level [ Time Frame: Last observation between July 2009 and April 2010 ] [ Designated as safety issue: No ]
  • Blood pressure level [ Time Frame: Last observation between July 2009 and April 2010 ] [ Designated as safety issue: No ]
  • LDL-cholesterol level [ Time Frame: Last observation between July 2009 and April 2010 ] [ Designated as safety issue: No ]
  • Total- to HDL-cholesterol ratio [ Time Frame: Last observation between July 2009 and April 2010 ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: Last observation between July 2009 and April 2010 ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: Last observation between July 2009 and April 2010 ] [ Designated as safety issue: No ]
  • Change in treatment recommended following an A1c level above 0.070 [ Time Frame: At the next patient visit after the abnormal measurement ] [ Designated as safety issue: No ]
  • Change in treatment recommended following a systolic blood pressure above 130 or a diastolic blood pressure above 80 [ Time Frame: At the patient visit of the abnormal measurement ] [ Designated as safety issue: No ]
  • Change in treatment recommended following an LDL-cholesterol level above 2.0 mmol/L [ Time Frame: At the next patient visit after the abnormal measurement ] [ Designated as safety issue: No ]

Enrollment: 1592
Study Start Date: June 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Other: Toolkit
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.
No Intervention: Control Other: Control
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026688

Locations
Canada, Ontario
Institute for Clinical Evaluative Sciences
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Institute for Clinical Evaluative Sciences
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Baiju R Shah, MD PhD Institute for Clinical Evaluative Sciences
  More Information

No publications provided by Sunnybrook Health Sciences Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Baiju Shah, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01026688     History of Changes
Other Study ID Numbers: Shah-1
Study First Received: December 2, 2009
Last Updated: July 27, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Pragmatic randomized controlled trial
Cardiovascular risk reduction
Knowledge translation
Clinical practice guidelines

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013