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

May 7, 2013 updated by: Ron Goeree, St. Joseph's Healthcare Hamilton

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Brockcillw, Ontario, Canada, K6C 0A5
        • Brockville Family Health Team
      • Delhi, Ontario, Canada, N4B 2L8
        • Delhi Family Health Team
      • Etobicoke, Ontario, Canada, M9C 5N2
        • Summerville Family Health Team
      • Harrow, Ontario, Canada, N0R 1G0
        • Harrow Health Centre
      • Lemington, Ontario, Canada, N8H 1N9
        • Leamington and Area Family Health Team
      • Toronto, Ontario, Canada, M5A 2S5
        • Sherbourne Family Health Team

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ron Goeree, St. Joseph's Healthcare Hamilton/McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

June 4, 2009

First Posted (Estimate)

June 5, 2009

Study Record Updates

Last Update Posted (Estimate)

May 9, 2013

Last Update Submitted That Met QC Criteria

May 7, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

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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