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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00914706
Other study ID # FEEAP-D0014a-2009-PTL
Secondary ID
Status Completed
Phase N/A
First received June 4, 2009
Last updated May 7, 2013
Start date June 2009
Est. completion date March 2012

Study information

Verified date May 2013
Source St. Joseph's Healthcare Hamilton
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date March 2012
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada Brockville Family Health Team Brockcillw Ontario
Canada Delhi Family Health Team Delhi Ontario
Canada Summerville Family Health Team Etobicoke Ontario
Canada Harrow Health Centre Harrow Ontario
Canada Leamington and Area Family Health Team Lemington Ontario
Canada Sherbourne Family Health Team Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in monitoring frequency 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 No
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