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Vascular Intervention Project (VIP)
This study has been completed.
First Received: October 7, 2005   Last Updated: July 9, 2007   History of Changes
Sponsors and Collaborators: Group Health Centre
Ontario Ministry of Health and Long Term Care
Hamilton Health Sciences
Cardiac Rehabilitation in the Community
Sault Area Hospital
Information provided by: Group Health Centre
ClinicalTrials.gov Identifier: NCT00236210
  Purpose

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 amongst patients who are intricately involved in a personalized directed program versus those being provided standard care by their physician. Low risk participants will be reviewed at the end of the study. Health care providers work collaboratively with the ‘VIP Team’ to improve the participant’s vascular health.


Condition Intervention
Vascular Disease
Diabetes
Hypertension
Hyperlipidemia
Obesity
Behavioral: Action Score goals

MedlinePlus related topics: Diabetes High Blood Pressure Obesity Vascular Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: The Vascular Intervention Program (VIP) -- A Sault Ste. Marie Community Demonstration Project From the Group Health Centre Health Promotion Initiative Program

Further study details as provided by Group Health Centre:

Primary Outcome Measures:
  • Effectiveness of a Vascular Intervention Program on the ACTION Score versus usual care (control) for patients at moderate/high risk for cardiovascular events [ Time Frame: 6 months and 12 months ]
  • High Risk Arm: 1. A minimum 5-point improvement in the ACTION Score. 2. Appropriate use of medications. 3. A composite of achieving #1 in ACTION Vascular Health risk score and the appropriate use of medications. [ Time Frame: 6 months and 12 months ]
  • Moderate risk arm: 1. A minimum of 25% improvement over the baseline FRS value. 2. A minimum 5-point improvement in ACTION Score from baseline. 3. Composite of both #1 and #2. [ Time Frame: 6 months and 12 months ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 6 months and 12 months ]

Enrollment: 645
Study Start Date: August 2004
Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men >30 years of age
  • Women > 40 years of age
  • History of vascular disease (as defined in Study Design, page 8)
  • FRS >/= 12 %
  • Capable of giving signed 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00236210

Locations
Canada, Ontario
Group Health Centre
Sault Ste. Marie, Ontario, Canada, P6B 1Y7
Sponsors and Collaborators
Group Health Centre
Ontario Ministry of Health and Long Term Care
Hamilton Health Sciences
Cardiac Rehabilitation in the Community
Sault Area Hospital
Investigators
Principal Investigator: David Crookston, MD CCFP Algoma District Medical Group and Group Health Centre
  More Information

Additional Information:
No publications provided

Study ID Numbers: Go3-03031
Study First Received: October 7, 2005
Last Updated: July 9, 2007
ClinicalTrials.gov Identifier: NCT00236210     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by Group Health Centre:
Vascular Intervention Program
Vascular Disease
Coronary Artery Disease
Diabetes
Lifestyle Modification
Modifiable Risk Factors

Study placed in the following topic categories:
Obesity
Hyperlipidemias
Metabolic Diseases
Vascular Diseases
Diabetes Mellitus
Overweight
Body Weight
Coronary Disease
Signs and Symptoms
Nutrition Disorders
Overnutrition
Metabolic Disorder
Coronary Artery Disease
Dyslipidemias
Hypertension
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Obesity
Hyperlipidemias
Metabolic Diseases
Vascular Diseases
Overweight
Body Weight
Signs and Symptoms
Nutrition Disorders
Cardiovascular Diseases
Overnutrition
Dyslipidemias
Hypertension
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009