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

This study has been completed.
Sponsor:
Collaborators:
Ontario Ministry of Health and Long Term Care
McMaster University
Coalition for the Acquisition of Sound Habits
Ministry of Northern Development and Mines Youth Internship Program
Pfizer
Information provided by:
Group Health Centre
ClinicalTrials.gov Identifier:
NCT00236210
First received: October 7, 2005
Last updated: July 31, 2009
Last verified: July 2009

October 7, 2005
July 31, 2009
August 2004
July 2006   (final data collection date for primary outcome measure)
The percentage of patients who attained a significant reduction in their global cardiovascular risk at 6 and 12 months. This was determined a priori by the investigators to be an increase in the ACTION Score of 5 or more. [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • The primary outcomes of the moderate risk arm will be:
  • 2. A composite of achieving a 5-point improvement in ACTION Vascular Health risk score and the appropriate use of medications.
  • 1. A minimum of 25% improvement over the baseline FRS value.
  • Primary Outcomes for all participants:
  • 1. A minimum 5-point improvement in the ACTION Score.
  • The primary outcomes of the High Risk Arm will be:
  • 1. Appropriate use of medications (evidence-based medications pre-defined by team).
  • 2. Composite of both a 5-point improvement in ACTION from baseline and a 25% improvement over the baseline FRS value.
Complete list of historical versions of study NCT00236210 on ClinicalTrials.gov Archive Site
Secondary outcomes were change in the average ACTION Score, change in individual risk domains as measured by the ACTION Score, patient satisfaction, and quality of life, all after 6 months and 12 months, comparing intervention versus control. [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Secondary Outcomes:cardiovascular-specific and general quality of life and satisfaction measures, continuity of care from a system and patient perspective, clinical events, cost-effectiveness & health service utilization.
Not Provided
Not Provided
 
A Randomized Controlled Trial of a Novel Community-based Primary and Secondary Cardiovascular Prevention Program
The Vascular Intervention Project (VIP): a Randomized Controlled Trial of a Novel Community-based Primary and Secondary Cardiovascular Prevention Program in the Algoma District of Northern Ontario

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Vascular Disease
  • Diabetes
  • Hypertension
  • Hyperlipidemia
  • Obesity
  • Behavioral: Action Score
    Improvement in a novel 100-point score summarizing cardiovascular risk.
  • Behavioral: VIP program
    Risk assessment, lifestyle counselling, exercise program
  • Active Comparator: VIP program
    Risk assessment, lifestyle counselling, exercise program
    Interventions:
    • Behavioral: Action Score
    • Behavioral: VIP program
  • No Intervention: Standard Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
422
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00236210
Go3-03031
No
Dr. David Crookston, Group Health Centre
Group Health Centre
  • Ontario Ministry of Health and Long Term Care
  • McMaster University
  • Coalition for the Acquisition of Sound Habits
  • Ministry of Northern Development and Mines Youth Internship Program
  • Pfizer
Principal Investigator: David Crookston, MD CCFP Algoma District Medical Group and Group Health Centre
Group Health Centre
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP