Clinical trial NCT00132145: Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness (COMPETE III)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Diseases
Keywords: Vascular diseases
Computerized decision support systems
Shared care
Patient motivation
Quality of care
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2005-08-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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. 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:

1. the management of diabetes, hypertension, dyslipidemia and previous vascular events,
2. improving patient-clinician interactions,
3. the use of technology to enhance the quality, safety and efficiency of care and
4. motivational strategies to change both patient and clinician behaviour.

Specifically, the researchers will:

1. Expand the disease focus to a vascular risk population (diabetes, hypertension, dyslipidemia or previous vascular event);
2. Expand the electronic care network beyond patients and primary care providers to also include specialists (physician specialists, specialty nurse clinicians, etc);
3. 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;
4. 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,
5. 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;
6. Improve the researchers pharmacosurveillance network which pursues reasons for starting and stopping medications by seeking adherence information directly from patients;
7. Provide direct links via Internet for patients and clinicians to best evidence about vascular disease,
8. Improve the automated telephone support (ATS);
9. Support physicians in managing this advanced care network by providing clinical care coordinators, either nurse clinicians or clinical pharmacists;
10. Use HL-7 messaging standards as per Canada Health Infoway guidelines;
11. Rigorously evaluate the cost-effectiveness of our package intervention in order to provide specific advice to health planners and payers on costs and benefits.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Non-English speaking
* Cognitive impairment

Primary outcomes:
measure: The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups.
timeFrame: 6 months to 1 year
Secondary outcomes:
measure: Vascular outcome targets
timeFrame: 6 months to 1 year
measure: Provider satisfaction, perceived value
timeFrame: 6 months to 1 year
measure: Patient satisfaction, self-efficacy, access to care
timeFrame: 6 months to 1 year
measure: Health data privacy and security
timeFrame: 6 months to 1 year
measure: Patient Quality of Life
timeFrame: 6 months to 1 year
measure: Health care utilization
timeFrame: 6 months to 1 year
measure: Cost effectiveness
timeFrame: 6 months to 1 year
measure: Facilitators, predictors and barriers to the success of project
timeFrame: 1 year
measure: Scalability and sustainability
timeFrame: 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Centre for Evaluation of Medicines
state: Ontario
Study officials:
affiliation: Centre for Evaluation of Medicines
name: Anne M Holbrook, PharmD MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.