NCT01411865

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
933,789

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

2 months

First QC Date

August 3, 2011

Last Update Submit

November 21, 2014

Conditions

Diabetes MellitusCardiovascular Disease

Keywords

Pragmatic randomized controlled trialCardiovascular risk reductionKnowledge translationClinical practice guidelinesAdministrative databases

Outcome Measures

Primary Outcomes (1)

  • Death or non-fatal myocardial infarction

    Up to 10 months

Secondary Outcomes (20)

  • Death, non-fatal myocardial infarction or non-fatal stroke

    Up to 10 months

  • Death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for unstable angina or transient ischemic attack

    Up to 10 months

  • Death

    Up to 10 months

  • Hospitalization for myocardial infarction

    Up to 10 months

  • Hospitalization for myocardial infarction or unstable angina

    Up to 10 months

  • +15 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL
Other: Toolkit

Control

OTHER
Other: Control

Interventions

ToolkitOTHER

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.

Intervention
ControlOTHER

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.

Control

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Alive on 1 July 2009 with prevalent diabetes

You may not qualify if:

  • Age \<= 39
  • Residing in long-term care
  • Secondary Analysis:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Clinical Evaluative Sciences

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

  • 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: 24505216RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusCardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Baiju R Shah, MD, PhD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

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

August 3, 2011

First Posted

August 8, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 24, 2014

Record last verified: 2014-11

Locations

CA(1)