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

Group Health Centre

Status

Completed

Conditions

Hypertension

Diabetes

Vascular Disease

Hyperlipidemia

Obesity

Treatments

Behavioral: Action Score

Behavioral: VIP program

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00236210

Go3-03031

Details and patient eligibility

About

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.

Full description

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

Decrease the modifiable risk factors for primary care patients at risk for vascular disease in the Algoma District;
Increase collaboration between health care providers such as family physicians, pharmacists, physiotherapists, dietitians and nurses in the community;
Increase the participation of the patient and family in decision-making, self-care, and adherence to agreed-upon management plans;
Improve patient access to care, clinical outcomes and satisfaction;
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.

Enrollment

422 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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