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

NCT00132145 | Completed

• 1 other identifier: G03-02820
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Diseases

Keywords

Vascular diseases; Computerized decision support systems; Shared care; Patient motivation; Quality of care

Outcome Measures

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.

  6 months to 1 year

Secondary Outcomes (9)

• Vascular outcome targets

  6 months to 1 year

• Provider satisfaction, perceived value

  6 months to 1 year

• Patient satisfaction, self-efficacy, access to care

  6 months to 1 year

• Health data privacy and security

  6 months to 1 year

• Patient Quality of Life

  6 months to 1 year

Study Arms (1)

Intervention

OTHER

Behavioural

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

Interventions

Vascular Management Program BEHAVIORAL

Intervention

Clinical Care Coordinators BEHAVIORAL

Intervention

Web-based Vascular Tracker for Patient and Physician BEHAVIORAL

Intervention

Automated Telephone Reminder System BEHAVIORAL

Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Non-English speaking
• Cognitive impairment

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (1)

Centre for Evaluation of Medicines

Hamilton, Ontario, L8N 1G6, Canada

Location

Related Publications (1)

• 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.

  PMID: 22025430 RESULT

MeSH Terms

Conditions

Vascular Diseases

Interventions

Physicians

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Anne M Holbrook, PharmD MD MSc

  Centre for Evaluation of Medicines

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Pharmacology & Toxicology

Study Record Dates

• First Submitted: August 17, 2005
• First Posted: August 19, 2005
• Study Start: April 1, 2003
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: October 19, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)