A Randomized Controlled Trial of a Novel Community-based Primary and Secondary Cardiovascular Prevention Program

NCT ID: NCT00236210

Last Updated: 2009-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 422 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2006-07-31

Brief Summary

VIP is a demonstration project with a goal to decrease modifiable risk factors for those with a higher risk of having a vascular event such as a heart attack or stroke or of developing vascular disease. Introduced as a study, VIP compares whether there is a significant reduction of modifiable vascular risk factors among patients who are involved in a personalized directed program versus those being provided standard care by their physician. Health care providers work collaboratively with the 'VIP Team' to improve the participants' vascular health.

Detailed Description

This Northern Ontario, community-based demonstration project is a multi-disciplinary, primary care provider-based collaboration. The goals of the project are to:

1. Decrease the modifiable risk factors for primary care patients at risk for vascular disease in the Algoma District;

2. Increase collaboration between health care providers such as family physicians, pharmacists, physiotherapists, dietitians and nurses in the community;

3. Increase the participation of the patient and family in decision-making, self-care, and adherence to agreed-upon management plans;

4. Improve patient access to care, clinical outcomes and satisfaction;

5. Provide a business case for a practical, sustainable and generalizable model for the primary care of vascular disease in the community.

The Group Health Centre, a multi-disciplinary, not-for-profit community-based health organization with 56,000 rostered patients, leads the project. However, all Sault Ste Marie community patients are eligible to join the Vascular Intervention Program (VIP). This program has three key components: a registry of VIP patients with audit, recall and feedback; use of the novel ACTION score template, and the optional use of VIPNet, a personalized patient record tool that provides secure web access to optimize quality and continuity of care. The VIP project aims to empower patients and increase collaboration among the primary health care team. Patients with any vascular risk factors will be eligible for VIP.

The VIP project is a demonstration project that does not duplicate existing GHC chronic disease management programs because (1) the VIP is offered to all eligible community patients, not only GHC enrollees; (2) VIP integrates any patients with vascular risk, not just those with pre-defined conditions; (3) novel collaborative tools such as the ACTION template and VIPNet website are being piloted; and (4) explicit patient-centred decision making drives the process. The development and evaluation of the VIP demonstration project is a unique step in the evolution of primary care chronic disease management in Sault Ste Marie, and the rest of the province.

Conditions

Vascular Disease; Diabetes; Hypertension; Hyperlipidemia; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

VIP program

Risk assessment, lifestyle counselling, exercise program

Group Type: ACTIVE_COMPARATOR

Action Score

Intervention Type: BEHAVIORAL

Improvement in a novel 100-point score summarizing cardiovascular risk.

VIP program

Intervention Type: BEHAVIORAL

Risk assessment, lifestyle counselling, exercise program

Standard Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Action Score

Improvement in a novel 100-point score summarizing cardiovascular risk.

Intervention Type: BEHAVIORAL

VIP program

Risk assessment, lifestyle counselling, exercise program

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Men >30 years of age
• Women > 40 years of age
• History of vascular disease (as defined in Study Design, page 8)
• Framingham Risk Score >/= 12 %
• Capable of giving informed consent
• Ability and willingness to complete questionnaires and have study procedures done
• Willingness to belong to either the intervention or standard care arm

Exclusion Criteria

• FRS <12% (low risk) -- enrolled into the cohort arm (not randomized. Follow-up at study end only.)
• Any condition that will prevent the patient from participating in and completing the study
• Unable to come to the Group Health Centre for appointments
• Any factor likely to limit protocol compliance
• Unwilling to permit VIP staff to contact their primary physicians to communicate information about the study and the participant's data and treatment assignment
• Previous randomization into this study

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: collaborator

Coalition for the Acquisition of Sound Habits

OTHER

Sponsor Role: collaborator

Ministry of Northern Development and Mines Youth Internship Program

UNKNOWN

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Group Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Group Health Centre

Principal Investigators

David Crookston, MD CCFP

Role: PRINCIPAL_INVESTIGATOR

Algoma District Medical Group and Group Health Centre

Locations

Group Health Centre

Sault Ste. Marie, Ontario, Canada

Countries

Canada

Related Links

http://www.ghc.on.ca

(Group Health Centre website)

Other Identifiers

Go3-03031

Identifier Type: -

Identifier Source: org_study_id