- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00914706
A Study of the Effect of a Chronic Disease Management System on Diabetes Care Within Multidisciplinary Primary Care Practices in Ontario
Challenging the Ontario Diabetes Care Quality Gap: Evaluation and Long-Term Cost-Utility Analysis of Using a Chronic Disease Management System (CDMS) in Primary Health Care Practices in Ontario (ODIAC-CDMS): A Prospective, Observational, Comparative Study of the Effect of a CDMS on Diabetes Care Within Multidisciplinary Primary Care Practices in Ontario.
Study Overview
Detailed Description
Practice Guidelines recommend that patients with chronic diseases should be monitored with specified clinical measurements each with regular repeats at different specified time intervals or on specified conditions. It is virtually impossible for health care providers to adhere consistently to guidelines and to do so sustainability as well as equitably for "most if not all" of their patients with diabetes. Ontario Health Technology Advisory Committee (OHTAC) has requested the following study. Aggregate monthly primary care practice level data will form the basis of the analysis. Primary care practitioners in Ontario will be enrolled. Differences in 1-year outcome measures within will be performed. Baseline, 2 month, 6 month and 12 month site team member surveys will be completed. Using patient level data from each site, a cost-utility analysis will be conducted. Six aspects related to the use of the CDMS will be examined.
- Change in proportion of the patients in whom monitoring frequency is up to date for A1C, blood pressure and cholesterol.
- Change in proportion of patients who are well controlled with A1C < 0.07, blood pressure < 130/80 and LDL-cholesterol < 2.0.
- Change from baseline across sites in the percentage of patients with an up-to-date foot exam, retinopathy screening, use of angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB) and documentation of self-management goals.
- Site questionnaires.
- Changes in physician MOHLTC diabetes incentive billings.
- Long-term cost-utility of the use of the CDMS.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Brockcillw, Ontario, Canada, K6C 0A5
- Brockville Family Health Team
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Delhi, Ontario, Canada, N4B 2L8
- Delhi Family Health Team
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Etobicoke, Ontario, Canada, M9C 5N2
- Summerville Family Health Team
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Harrow, Ontario, Canada, N0R 1G0
- Harrow Health Centre
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Lemington, Ontario, Canada, N8H 1N9
- Leamington and Area Family Health Team
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Toronto, Ontario, Canada, M5A 2S5
- Sherbourne Family Health Team
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Ontario primary care practitioners able to provide a list of patients within their practice.
- High-speed internet access in the practice environment or willingness to obtain high-speed internet access.
- Physicians willing to use the CDMS or already using it currently.
Exclusion Criteria:
Ontario primary care practitioners involved in the QIIP Learning Collaboratives who are practicing in one of the following local health integration networks:
- LHIN 2 South West
- LHIN 7 Toronto Central
- LHIN 11 Champlain AND
- LHIN 14 North West so as to not interfere with other Provincial diabetes initiatives.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in monitoring frequency
Time Frame: 1 year
|
Change in proportion of patients, with up-to-date monitoring of A1C (6 months), blood pressure (annually) and cholesterol (6 months) in practices using a CDMS for 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ron Goeree, St. Joseph's Healthcare Hamilton/McMaster University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FEEAP-D0014a-2009-PTL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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