Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness (COMPETE III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00132145
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : October 19, 2016
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Dr. Anne Holbrook, St. Joseph's Healthcare Hamilton

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.

Condition or disease Intervention/treatment Phase
Vascular Diseases Behavioral: Vascular Management Program Behavioral: Clinical Care Coordinators Behavioral: Web-based Vascular Tracker for Patient and Physician Behavioral: Automated Telephone Reminder System Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 Start Date : April 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Behavioral: Vascular Management Program
Behavioral: Clinical Care Coordinators
Behavioral: Web-based Vascular Tracker for Patient and Physician
Behavioral: Automated Telephone Reminder System

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Vascular outcome targets [ Time Frame: 6 months to 1 year ]
  2. Provider satisfaction, perceived value [ Time Frame: 6 months to 1 year ]
  3. Patient satisfaction, self-efficacy, access to care [ Time Frame: 6 months to 1 year ]
  4. Health data privacy and security [ Time Frame: 6 months to 1 year ]
  5. Patient Quality of Life [ Time Frame: 6 months to 1 year ]
  6. Health care utilization [ Time Frame: 6 months to 1 year ]
  7. Cost effectiveness [ Time Frame: 6 months to 1 year ]
  8. Facilitators, predictors and barriers to the success of project [ Time Frame: 1 year ]
  9. Scalability and sustainability [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00132145

Canada, Ontario
Centre for Evaluation of Medicines
Hamilton, Ontario, Canada, L8N 1G6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Ontario Ministry of Health and Long Term Care
Principal Investigator: Anne M Holbrook, PharmD MD MSc Centre for Evaluation of Medicines

Publications of Results:
Responsible Party: Dr. Anne Holbrook, Director, Division of Pharmacology & Toxicology, St. Joseph's Healthcare Hamilton Identifier: NCT00132145     History of Changes
Other Study ID Numbers: G03-02820
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. Anne Holbrook, St. Joseph's Healthcare Hamilton:
Vascular diseases
Computerized decision support systems
Shared care
Patient motivation
Quality of care

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases