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Completed

NCT Number: NCT00132145

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Evaluation of Medicines

Hamilton, Ontario, L8N 1G6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vascular Management Program

Behavioral

Clinical Care Coordinators

Behavioral

Web-based Vascular Tracker for Patient and Physician

Behavioral

Automated Telephone Reminder System

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Collaborators

  • Ontario Ministry of Health and Long Term Care

Registry information

Official study 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)

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Aug 19, 2005
Registry last updated
Oct 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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