Diabetes MellitusNCT01411865
Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Diabetes
A study testing Toolkit in people with Diabetes Mellitus and Cardiovascular Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus, Cardiovascular Disease
- What is being tested?
- Toolkit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 933,789 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alive on 1 July 2009 with prevalent diabetes
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute for Clinical Evaluative Sciences
Toronto, Ontario, M4N 3M5
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Cardiovascular Disease
- Being tested
- Toolkit, Control
- Keywords
- Pragmatic randomized controlled trial, Cardiovascular risk reduction, Knowledge translation, Clinical practice guidelines, Administrative databases
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Toolkit |
| Control | Other | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or non-fatal myocardial infarction
Measured: Up to 10 months
Secondary outcomes (20)
Death, non-fatal myocardial infarction or non-fatal stroke
Measured: Up to 10 months
Death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for unstable angina or transient ischemic attack
Measured: Up to 10 months
Death
Measured: Up to 10 months
Hospitalization for myocardial infarction
Measured: Up to 10 months
Hospitalization for myocardial infarction or unstable angina
Measured: Up to 10 months
Hospitalization for stroke
Measured: Up to 10 months
Hospitalization for stroke or transient ischemic attack
Measured: Up to 10 months
Electrocardiogram
Measured: Up to 10 months
Cardiac stress test or nuclear imaging
Measured: Up to 10 months
Coronary angiography
Measured: Up to 10 months
Coronary revascularization procedure
Measured: Up to 10 months
Ambulatory cardiology or internal medicine visit
Measured: Up to 10 months
Prescription for angiotensin converting enzyme inhibitor or angiotensin receptor blocker
Measured: Up to 10 months
Prescription for at least one class of antihypertensive agent
Measured: Up to 10 months
Prescription for at least two classes of antihypertensive agents
Measured: Up to 10 months
Prescription for at least three classes of antihypertensive agents
Measured: Up to 10 months
Prescription for statin
Measured: Up to 10 months
Prescription for any glucose-lowering drug
Measured: Up to 10 months
Prescription for insulin
Measured: Up to 10 months
Prescription for nitrate
Measured: Up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 933,789 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Clinical Evaluative Sciences
- Responsible party
- Sponsor
- Investigators
- Baiju R Shah, MD, PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411865
- Sponsor's protocol ID
- Shah-2
- Status last verified
- Nov 2014
- First submitted
- 3 Aug 2011
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24505216
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Diabetes
- ClinicalTrials.gov ID
- NCT01411865
- Acronym / sponsor ID
- Shah-2
- Conditions
- Diabetes Mellitus, Cardiovascular Disease
- Keywords
- Pragmatic randomized controlled trial, Cardiovascular risk reduction, Knowledge translation, Clinical practice guidelines, Administrative databases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 933,789 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Institute for Clinical Evaluative Sciences
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 8 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Toolkit |
| Control | Other | Other: Control |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Alive on 1 July 2009 with prevalent diabetes
Key exclusion criteria (4 listed)
- Age <= 39
- Residing in long-term care
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ToolkitCardiovascular 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. | Other | Intervention |
| ControlThe 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. | Other | Control |
Primary outcome
Death or non-fatal myocardial infarction
Time frame: Up to 10 months
20 secondary outcomes
Death, non-fatal myocardial infarction or non-fatal stroke
Time frame: Up to 10 months
Death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for unstable angina or transient ischemic attack
Time frame: Up to 10 months
Death
Time frame: Up to 10 months
Hospitalization for myocardial infarction
Time frame: Up to 10 months
Hospitalization for myocardial infarction or unstable angina
Time frame: Up to 10 months
Hospitalization for stroke
Time frame: Up to 10 months
Hospitalization for stroke or transient ischemic attack
Time frame: Up to 10 months
Electrocardiogram
Time frame: Up to 10 months
Cardiac stress test or nuclear imaging
Time frame: Up to 10 months
Coronary angiography
Time frame: Up to 10 months
Coronary revascularization procedure
Time frame: Up to 10 months
Ambulatory cardiology or internal medicine visit
Time frame: Up to 10 months
Prescription for angiotensin converting enzyme inhibitor or angiotensin receptor blocker
Time frame: Up to 10 months
Prescription for at least one class of antihypertensive agent
Time frame: Up to 10 months
Prescription for at least two classes of antihypertensive agents
Time frame: Up to 10 months
Prescription for at least three classes of antihypertensive agents
Time frame: Up to 10 months
Prescription for statin
Time frame: Up to 10 months
Prescription for any glucose-lowering drug
Time frame: Up to 10 months
Prescription for insulin
Time frame: Up to 10 months
Prescription for nitrate
Time frame: Up to 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Results publication: PubMed 24505216Shah 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.
- Related studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baiju R Shah, MD, PhD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toolkit in people with Diabetes Mellitus and Cardiovascular Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or non-fatal myocardial infarction (time frame: Up to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01411865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.