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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Institute for Clinical Evaluative Sciences
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01411865
First received: August 3, 2011
Last updated: August 5, 2011
Last verified: August 2011
  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 Diabetes

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Death or non-fatal myocardial infarction [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death, non-fatal myocardial infarction or non-fatal stroke [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for unstable angina or transient ischemic attack [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Death [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Hospitalization for myocardial infarction [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Hospitalization for myocardial infarction or unstable angina [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Hospitalization for stroke [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Hospitalization for stroke or transient ischemic attack [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Electrocardiogram [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Cardiac stress test or nuclear imaging [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Coronary angiography [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Coronary revascularization procedure [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Ambulatory cardiology or internal medicine visit [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Prescription for angiotensin converting enzyme inhibitor or angiotensin receptor blocker [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Prescription for at least one class of antihypertensive agent [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Prescription for at least two classes of antihypertensive agents [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Prescription for at least three classes of antihypertensive agents [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Prescription for statin [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Prescription for any glucose-lowering drug [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Prescription for insulin [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Prescription for nitrate [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 800000
Study Start Date: August 2011
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 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 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:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411865

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
Investigators
Principal Investigator: Baiju R Shah, MD, PhD Sunnybrook Health Sciences Centre
  More Information

Additional 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: NCT01411865     History of Changes
Other Study ID Numbers: Shah-2
Study First Received: August 3, 2011
Last Updated: August 5, 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
Administrative databases

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

ClinicalTrials.gov processed this record on September 29, 2014