Clinical trial NCT01620996: A Novel Approach to Cardiovascular Health by Optimizing Risk Management (ANCHOR)
Official title: A Novel Approach to Cardiovascular Health by Optimizing Risk Management (ANCHOR): A Primary Prevention Initiative Examining The Impact Of Global Risk Factor Assessment & Management On Health Care In Nova Scotia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Reduction of Having a Coronary Event
Keywords: preintervention and postintervention cohort longitudinal prospective study
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Cape Breton District Health Authority
name: Pfizer
First posted: 2012-06-15
Enrollment: 1708
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study Purpose and Design

The goal of this study is to improve CVD risk in a primary care adult population, with the following primary objectives

1. To improve management of global cardiovascular risk of patients within two primary care practices, thereby improving their overall cardiac health.
2. To increase patient compliance with lifestyle aimed at pharmaceutical interventions aimed at decreasing global cardiovascular risk.

Secondary objectives of the study are:

1. To examine the utility of a process to improve the management of global cardiovascular risk of patients within two primary care practices.
2. To explore the utility of a process that links primary care practices with existing community resources in order to manage cardiac risk factors better among individuals within those primary care practices.
3. To determine the economic impact of a global risk assessment and management process within a primary care setting.

Detailed description: The Burden of Cardiovascular Disease

Cardiovascular disease (CVD) remains the major cause of mortality in the developed world, accounting for almost 40% of all deaths in both the United States and Canada. It represents a substantial financial drain on society and contributes a significant burden to health care systems that are already under strain. Major modifiable risk factors for CVD include elevated blood pressure, cigarette smoking, elevated total plasma cholesterol and low high-density lipoproteins, diabetes, obesity, and sedentary lifestyle, at least one of which is present in 80% of Canadians. Circulatory diseases (particularly heart disease, stroke and hypertension) cost the Nova Scotia health care system an estimated $961 million dollars per year. In Nova Scotia cardiovascular disease kills an estimated 2,900 Nova Scotians every year accounting for nearly 36% of all deaths in the province.

Cardiovascular Disease Prevention in Primary Care Settings

There is strong evidence linking improved risk factors among populations to improved health outcomes, and both epidemiological and community research have illustrated that the bulk of non-communicable diseases (NCDs) such as CVD are preventable, or at least their occurrence can be postponed. Because primary care physicians are most often the first point of contact for individuals in need of health care, general practice is well placed to facilitate change in patients' risk factor status and ensure more effective treatment of risk factors such as hypertension and hyperlipidemia. Currently primary care service delivery is expanding to include a broader network of providers such as nurses, dieticians, and pharmacists to enable more effective risk factor identification and management, and health promotion and disease prevention efforts across the continuum of care.

Nova Scotia Context

Currently in Nova Scotia, population health and disease prevention initiatives are underway that will support and reinforce the work of the current study, including primary health care transition fund initiatives, and strategic directions from the Office of Health Promotion that address major risk factors for cardiovascular disease. These provincial initiatives together with local projects ongoing in several communities provide an ideal opportunity for interfacing with a primary care global risk reduction initiative.

Study Purpose and Design

The goal of this study is to improve CVD risk in a primary care adult population, with the following primary objectives

1. To improve management of global cardiovascular risk of patients within two primary care practices, thereby improving their overall cardiac health.
2. To increase patient compliance with lifestyle and pharmaceutical interventions aimed at decreasing global cardiovascular risk.

Secondary objectives of the study are:

1. To examine the utility of a process to improve the management of global cardiovascular risk of patients within two primary care practices.
2. To explore the utility of a process that links primary care practices with existing community resources in order to manage cardiac risk factors better among individuals within those primary care practices.
3. To determine the economic impact of a global risk assessment and management process within a primary care setting.

The intervention will be led by a study coordinator in each primary care setting and consist of a recruitment strategy, global risk factor assessment, behaviour change counseling, and risk factor management strategies based on the 5A's framework (assess, advise, agree, assist and arrange follow-up). Supports will be provided to study participants in making behaviour changes including counseling and follow-up, behaviour change tools, print resources, group education sessions, and an inventory of and links to community programs. Medication reviews and physician referrals will also be completed as required.

A Steering Committee will guide the project and includes membership from the Principal Investigators, representatives from Pfizer Canada, Capital District Health Authority, the Cape Breton District Health Authority and the Nova Scotia Department of Health; and community stakeholders including community pharmacy, a physician and/or nurse from each site, other relevant allied health professionals (e.g., nutritionist) and the CEO from the Heart and Stroke Foundation of Nova Scotia. The initiative will be conducted over a three-year period and will comprise three phases as outlined in the following table.

Research Methodology

This is a pre-intervention and post-intervention longitudinal, prospective pilot study to evaluate study participants achievement of CVD risk factor reduction. The research will include a combination of quantitative and qualitative data to judge effectiveness of the interventions and to describe the intervention as it is implemented. The effectiveness of the approach will be examined using pre and post measures of key outcome variables. In addition to these outcome measures, process evaluation will monitor and assess the implementation of the interventions. The study will include baselines measurement, periodic assessments of process measures, outcome measurement and follow-up measurement. Following the baseline measurement through the GRA, patients will receive risk management interventions.

The data will be analyzed using both quantitative and qualitative methods. Pre and post outcome measures will be analyzed using descriptive analytical techniques comparing means for continuous measures and proportions for categorical measures. Qualitative data will be managed and analyzed either manually or via QSR NUD\*IST (Qualitative Solutions and Research Non-numerical Unstructured Data Indexing Searching and Theory-building) software. The qualitative analysis will consist of both content and thematic analysis.

Sustainability and Dissemination

The project will involve collaboration and integration with primary health care renewal efforts and community resources to build on existing infrastructure and thereby help to facilitate sustainability. Capacity building within primary care settings and mobilization of existing resources will also help to ensure a sustainable resource. Steering Committee members and other partners will ensure the project results and products are shared with their organizations and networks, and also more widely across the province. Project findings will be published in appropriate peer reviewed publications to further share the learning and disseminate findings.

Eligibility criteria: Inclusion Criteria:

* 30 years of age
* a patient of the primary care practices involved in the study
* able to provide informed consent

Exclusion Criteria:

* under the age of 30
* not a patient of the primary care practices
* unable to provide informed consent

Primary outcomes:
measure: achievement of targeted mean reductions in overal global risk within patient risk strata Proportion of patients achieving their targeted mean reduction in global risk within risk strata
timeFrame: 12 months
Secondary outcomes:
measure: determine the economic impact of a global risk assessment management process within a primary care setting
timeFrame: 12 months
measure: percentage of patients that reduced at least one risk category from baseline
timeFrame: 12 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Duffus Health Centre
state: Nova Scotia
Study officials:
References:
citation: Cox JL, Vallis TM, Pfammatter A, Szpilfogel C, Carr B, O'Neill BJ. A novel approach to cardiovascular health by optimizing risk management (ANCHOR): behavioural modification in primary care effectively reduces global risk. Can J Cardiol. 2013 Nov;29(11):1400-7. doi: 10.1016/j.cjca.2013.03.007. Epub 2013 Jun 21.