Vascular DiseasesNCT00132145
Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness (COMPETE III)
A study testing Vascular Management Program, Clinical Care Coordinators and Web-based Vascular Tracker for Patient and Physician in people with Vascular Diseases, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
Vascular diseases (cardiac events, strokes, peripheral vascular disease) remain the number one killer in Canadian society as well as the leading cause of hospitalization and days spent in the hospital. A 1996 estimate placed Ontario's vascular disease financial burden at $5.5 billion in total. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Vascular Management Program, Clinical Care Coordinators and Web-based Vascular Tracker for Patient and Physician
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2003to Jun 2006
- Phase
- Interventional
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 55 years of age and over
- Regular patients of a family physician's office (at least one visit in the last 12 months)
- Vascular disease (previous myocardial infarction, stroke, peripheral vascular disease, coronary artery disease) or at least one of the following vascular risk factors (hypertension, hypercholesterolemia, diabetes)
Who cannot join
- Non-English speaking
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Electronic Integration of Care for Better Vascular Outcomes: The Compete III Study Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness (COMPETE III)
Vascular diseases (cardiac events, strokes, peripheral vascular disease) remain the number one killer in Canadian society as well as the leading cause of hospitalization and days spent in the hospital. A 1996 estimate placed Ontario's vascular disease financial burden at $5.5 billion in total. Any intervention which lowers vascular risk, will have a direct impact on the quantity and quality of life and costs of health care. Further integration of health professionals in teams focused on chronic disease management in individuals and populations is also ripe for further evaluation. Increased collaboration between family physicians, physician specialists, nurse practitioners, and pharmacists are generally thought to be beneficial for patient outcomes, but the literature is inconclusive and their cost-effectiveness is unproven. In addition, combining centralized electronic up-to-date information on the patient's status with evidence-based recommendations and the ability to communicate either electronically or by phone is expected to result in improved access to care, quality of care, continuity of care and increase cost-effectiveness of chronic disease management.
COMPETE III builds on the researchers' previous work to study an electronic vascular tracking and decision support system shared by patients and their physicians, combined with a clinical care coordinator and automated telephone support system. The researchers are evaluating its impact on vascular risk processes and outcomes, perceived usefulness, ease of use, need for improvement, medication adherence, quality of life and patient goals and motivation.
Study hypothesis: Patients at increased risk of vascular events, if connected with their family physicians, medical specialists and care coordinator via an electronic network (Web, fax and telephone) sharing an intensive tracking, advice and support program, will lower their vascular risk more than those in usual care.
Read the detailed description
COMPETE is Canada's original electronic medical record research network and specializes in the rigorous development, implementation and evaluation of electronic technologies in health care. COMPETE III will build on COMPETE II to incorporate the latest evidence on:
- the management of diabetes, hypertension, dyslipidemia and previous vascular events,
- improving patient-clinician interactions,
- the use of technology to enhance the quality, safety and efficiency of care and
- motivational strategies to change both patient and clinician behaviour.
Specifically, the researchers will:
- Expand the disease focus to a vascular risk population (diabetes, hypertension, dyslipidemia or previous vascular event);
- Expand the electronic care network beyond patients and primary care providers to also include specialists (physician specialists, specialty nurse clinicians, etc);
- Expand the geographical network from Hamilton area, and Ottawa to include other primary care reform (PCR), Ontario Family Health Networks (OFHN) or EHR using sites;
- Tighten the integration with the leading Ontario EHR products and concentrate on those meeting the new Ontario Smart Systems for Health Clinical Management System specifications,
- Strengthen the clinical decision support by offering evidence-based algorithms specific to the patient, provide specific formulary advice - drug listing, Limited Use prescriptions and codes, Section 8 criteria and form letters;
- Improve the researchers pharmacosurveillance network which pursues reasons for starting and stopping medications by seeking adherence information directly from patients;
- Provide direct links via Internet for patients and clinicians to best evidence about vascular disease,
- Improve the automated telephone support (ATS);
- Support physicians in managing this advanced care network by providing clinical care coordinators, either nurse clinicians or clinical pharmacists;
- Use HL-7 messaging standards as per Canada Health Infoway guidelines;
- Rigorously evaluate the cost-effectiveness of our package intervention in order to provide specific advice to health planners and payers on costs and benefits.
- Conditions
- Vascular Diseases
- Being tested
- Vascular Management Program, Clinical Care Coordinators, Web-based Vascular Tracker for Patient and Physician, Automated Telephone Reminder System
- Keywords
- Vascular diseases, Computerized decision support systems, Shared care, Patient motivation, Quality of care
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular Management ProgramBehavioural
Clinical Care CoordinatorsBehavioural
Web-based Vascular Tracker for Patient and PhysicianBehavioural
Automated Telephone Reminder SystemBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Behavioural Receives: Behavioral: Vascular Management Program; Behavioral: Clinical Care Coordinators; Behavioral: Web-based Vascular Tracker for Patient and Physician; Behavioral: Automated Telephone Reminder System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups.
Measured: 6 months to 1 year
Secondary outcomes (9)
Vascular outcome targets
Measured: 6 months to 1 year
Provider satisfaction, perceived value
Measured: 6 months to 1 year
Patient satisfaction, self-efficacy, access to care
Measured: 6 months to 1 year
Health data privacy and security
Measured: 6 months to 1 year
Patient Quality of Life
Measured: 6 months to 1 year
Health care utilization
Measured: 6 months to 1 year
Cost effectiveness
Measured: 6 months to 1 year
Facilitators, predictors and barriers to the success of project
Measured: 1 year
Scalability and sustainability
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 posted19 Aug 2005 (estimated)
- Study startApr 2003
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Principal investigator, Dr. Anne Holbrook, St. Joseph's Healthcare Hamilton
- Investigators
- Anne M Holbrook, PharmD MD MSc, Principal investigator, Centre for Evaluation of Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132145
- Sponsor's protocol ID
- G03-02820
- Status last verified
- Oct 2016
- First submitted
- 17 Aug 2005
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Holbrook A, Pullenayegum E, Thabane L, Troyan S, Foster G, Keshavjee K, Chan D, Dolovich L, Gerstein H, Demers C, Curnew G. Shared electronic vascular risk decision support in primary care: Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness (COMPETE III) randomized trial. Arch Intern Med. 2011 Oct 24;171(19):1736-44. doi: 10.1001/archinternmed.2011.471.
PubMed 22025430
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Electronic Integration of Care for Better Vascular Outcomes: The Compete III Study Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness (COMPETE III)
- ClinicalTrials.gov ID
- NCT00132145
- Acronym / sponsor ID
- G03-02820
- Conditions
- Vascular Diseases
- Keywords
- Vascular diseases, Computerized decision support systems, Shared care, Patient motivation, Quality of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Apr 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 19 Aug 2005 (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.
Vascular diseases (cardiac events, strokes, peripheral vascular disease) remain the number one killer in Canadian society as well as the leading cause of hospitalization and days spent in the hospital. A 1996 estimate placed Ontario's vascular disease financial burden at $5.5 billion in total. Any intervention which lowers vascular risk, will have a direct impact on the quantity and quality of life and costs of health care. Further integration of health professionals in teams focused on chronic disease management in individuals and populations is also ripe for further evaluation. Increased collaboration between family physicians, physician specialists, nurse practitioners, and pharmacists are generally thought to be beneficial for patient outcomes, but the literature is inconclusive and their cost-effectiveness is unproven. In addition, combining centralized electronic up-to-date information on the patient's status with evidence-based recommendations and the ability to communicate either electronically or by phone is expected to result in improved access to care, quality of care, continuity of care and increase cost-effectiveness of chronic disease management.
COMPETE III builds on the researchers' previous work to study an electronic vascular tracking and decision support system shared by patients and their physicians, combined with a clinical care coordinator and automated telephone support system. The researchers are evaluating its impact on vascular risk processes and outcomes, perceived usefulness, ease of use, need for improvement, medication adherence, quality of life and patient goals and motivation.
Study hypothesis: Patients at increased risk of vascular events, if connected with their family physicians, medical specialists and care coordinator via an electronic network (Web, fax and telephone) sharing an intensive tracking, advice and support program, will lower their vascular risk more than those in usual care.
Detailed description
COMPETE is Canada's original electronic medical record research network and specializes in the rigorous development, implementation and evaluation of electronic technologies in health care. COMPETE III will build on COMPETE II to incorporate the latest evidence on:
- the management of diabetes, hypertension, dyslipidemia and previous vascular events,
- improving patient-clinician interactions,
- the use of technology to enhance the quality, safety and efficiency of care and
- motivational strategies to change both patient and clinician behaviour.
Specifically, the researchers will:
- Expand the disease focus to a vascular risk population (diabetes, hypertension, dyslipidemia or previous vascular event);
- Expand the electronic care network beyond patients and primary care providers to also include specialists (physician specialists, specialty nurse clinicians, etc);
- Expand the geographical network from Hamilton area, and Ottawa to include other primary care reform (PCR), Ontario Family Health Networks (OFHN) or EHR using sites;
- Tighten the integration with the leading Ontario EHR products and concentrate on those meeting the new Ontario Smart Systems for Health Clinical Management System specifications,
- Strengthen the clinical decision support by offering evidence-based algorithms specific to the patient, provide specific formulary advice - drug listing, Limited Use prescriptions and codes, Section 8 criteria and form letters;
- Improve the researchers pharmacosurveillance network which pursues reasons for starting and stopping medications by seeking adherence information directly from patients;
- Provide direct links via Internet for patients and clinicians to best evidence about vascular disease,
- Improve the automated telephone support (ATS);
- Support physicians in managing this advanced care network by providing clinical care coordinators, either nurse clinicians or clinical pharmacists;
- Use HL-7 messaging standards as per Canada Health Infoway guidelines;
- Rigorously evaluate the cost-effectiveness of our package intervention in order to provide specific advice to health planners and payers on costs and benefits.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Vascular Management Program, Behavioral: Clinical Care Coordinators, Behavioral: Web-based Vascular Tracker for Patient and Physician, Behavioral: Automated Telephone Reminder SystemBehavioural |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 55 years of age and over
- Regular patients of a family physician's office (at least one visit in the last 12 months)
- Vascular disease (previous myocardial infarction, stroke, peripheral vascular disease, coronary artery disease) or at least one of the following vascular risk factors (hypertension, hypercholesterolemia, diabetes)
Key exclusion criteria (2 listed)
- Non-English speaking
- Cognitive impairment
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 |
|---|---|---|
| Vascular Management Program | Behavioural | Intervention |
| Clinical Care Coordinators | Behavioural | Intervention |
| Web-based Vascular Tracker for Patient and Physician | Behavioural | Intervention |
| Automated Telephone Reminder System | Behavioural | Intervention |
Primary outcome
The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups.
Time frame: 6 months to 1 year
9 secondary outcomes
Vascular outcome targets
Time frame: 6 months to 1 year
Provider satisfaction, perceived value
Time frame: 6 months to 1 year
Patient satisfaction, self-efficacy, access to care
Time frame: 6 months to 1 year
Health data privacy and security
Time frame: 6 months to 1 year
Patient Quality of Life
Time frame: 6 months to 1 year
Health care utilization
Time frame: 6 months to 1 year
Cost effectiveness
Time frame: 6 months to 1 year
Facilitators, predictors and barriers to the success of project
Time frame: 1 year
Scalability and sustainability
Time frame: 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 19 Oct 2016.
- Results publication: PubMed 22025430Holbrook A, Pullenayegum E, Thabane L, Troyan S, Foster G, Keshavjee K, Chan D, Dolovich L, Gerstein H, Demers C, Curnew G. Shared electronic vascular risk decision support in primary care: Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness (COMPETE III) randomized trial. Arch Intern Med. 2011 Oct 24;171(19):1736-44. doi: 10.1001/archinternmed.2011.471.
- Individual participant dataSharing planned: No
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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.
Anne M Holbrook, PharmD MD MSc principal investigator
Centre for Evaluation of Medicines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular Management Program, Clinical Care Coordinators and Web-based Vascular Tracker for Patient and Physician in people with Vascular Diseases, run by St. Joseph's Healthcare Hamilton at 1 site 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 2 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 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups. (time frame: 6 months to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00132145, which also lists 1 linked publication.
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 19 Oct 2016.