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A Study of the Effect of a Chronic Disease Management System on Diabetes Care Within Multidisciplinary Primary Care Practices in Ontario

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ron Goeree, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT00914706
First received: June 4, 2009
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the impact of using a web-based (P-PROMPT) chronic disease management system (CDMS) by primary care practitioners and their team members and on their care for patients with diabetes. The system will help to ensure that all patients have up-to-date laboratory monitoring and visits as recommended by the Canadian Diabetes Association Guidelines. The hypothesis is that the use of a CDMS in Ontario primary care practices, as a part of the routine clinical management of diabetes patients, can improve monitoring frequency of A1C, blood pressure (BP) and cholesterol levels. The results of this study will serve as a benchmark for the utilization of chronic disease management software tools in primary care diabetes management for patients in Ontario, establishing and providing evidence to inform decision-makers. If the results are favorable towards CDMS interventions for the management of diabetes, potential expansion and availability of these types of programs may be possible for other chronic diseases.


Condition Intervention
Diabetes
 Other: P-PROMPT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • Change in monitoring frequency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Enrollment: 39
Study Start Date: June 2009
Study Completion Date: March 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: P-PROMPT
    P-PROMPT is a web-based chronic disease management system. The system will help to ensure that all patients have up-to-date laboratory monitoring and visits as recommended by the Canadian Diabetes Association Guidelines.
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.

  1. Change in proportion of the patients in whom monitoring frequency is up to date for A1C, blood pressure and cholesterol.
  2. Change in proportion of patients who are well controlled with A1C < 0.07, blood pressure < 130/80 and LDL-cholesterol < 2.0.
  3. 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.
  4. Site questionnaires.
  5. Changes in physician MOHLTC diabetes incentive billings.
  6. Long-term cost-utility of the use of the CDMS.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The unit of evaluation or cluster for this study will be individual primary care practitioners. The study will analyze aggregate practice level data from all rostered diabetes patients within each practice. Between 33 and 61 primary care practitioners with a total number of patients with diabetes across all practices of 2,376 from across Ontario will be enrolled in the study.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914706

Locations
Canada, Ontario
Brockville Family Health Team
Brockcillw, Ontario, Canada, K6C 0A5
Delhi Family Health Team
Delhi, Ontario, Canada, N4B 2L8
Summerville Family Health Team
Etobicoke, Ontario, Canada, M9C 5N2
Harrow Health Centre
Harrow, Ontario, Canada, N0R 1G0
Leamington and Area Family Health Team
Lemington, Ontario, Canada, N8H 1N9
Sherbourne Family Health Team
Toronto, Ontario, Canada, M5A 2S5
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Ron Goeree St. Joseph's Healthcare Hamilton/McMaster University
  More Information

No publications provided

Responsible Party: Ron Goeree, Director, PATH Research Institute, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT00914706     History of Changes
Other Study ID Numbers: FEEAP-D0014a-2009-PTL
Study First Received: June 4, 2009
Last Updated: May 7, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Joseph's Healthcare Hamilton:
Diabetes

Additional relevant MeSH terms:
Chronic Disease
Diabetes Mellitus
Disease Attributes
Pathologic Processes
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013