DiabetesNCT00914706
A Study of the Effect of a Chronic Disease Management System on Diabetes Care Within Multidisciplinary Primary Care Practices in Ontario
An observational study of Diabetes, run by St. Joseph's Healthcare Hamilton at 6 sites in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- P-PROMPT
- How many people
- 39 participants
- Where
- 6 sitesCanada
- Study dates
- Jun 2009to Mar 2012
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Brockville Family Health Team
Brockcillw, Ontario, K6C 0A5
Delhi Family Health Team
Delhi, Ontario, N4B 2L8
Summerville Family Health Team
Etobicoke, Ontario, M9C 5N2
Harrow Health Centre
Harrow, Ontario, N0R 1G0
Leamington and Area Family Health Team
Lemington, Ontario, N8H 1N9
Sherbourne Family Health Team
Toronto, Ontario, M5A 2S5
About this study
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.
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- P-PROMPT
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-PROMPTOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ron Goeree, St. Joseph's Healthcare Hamilton
- Investigators
- Ron Goeree, Principal investigator, St. Joseph's Healthcare Hamilton/McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914706
- Sponsor's protocol ID
- FEEAP-D0014a-2009-PTL
- Status last verified
- May 2013
- First submitted
- 4 Jun 2009
- Last updated
- 9 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00914706
- Acronym / sponsor ID
- FEEAP-D0014a-2009-PTL
- Conditions
- Diabetes
- Keywords
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 5 Jun 2009 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Ontario primary care practitioners involved in the QIIP Learning Collaboratives who are practicing in one of the following local health integration networks:
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 |
|---|---|---|
| P-PROMPTP-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. | Other | – |
Primary outcome
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
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 9 May 2013.
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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.
Ron Goeree principal investigator
St. Joseph's Healthcare Hamilton/McMaster University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by St. Joseph's Healthcare Hamilton at 6 sites 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 3 inclusion and 5 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 9 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Change in monitoring frequency (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2013.