A Novel Approach to Cardiovascular Health by Optimizing Risk Management (ANCHOR)

NCT01620996

Last updated date
Study Location
Duffus Health Centre
Halifax, Nova Scotia, B3L 2C2, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cardiovascular Risk Reduction of Having a Coronary Event
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 30 years of age

- a patient of the primary care practices involved in the study

- able to provide informed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- under the age of 30


- not a patient of the primary care practices


- unable to provide informed consent

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Cardiovascular Risk Reduction of Having a Coronary EventA Novel Approach to Cardiovascular Health by Optimizing Risk Management (ANCHOR)
NCT01620996
  1. Halifax, Nova Scotia
ALL GENDERS
30 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Novel Approach to Cardiovascular Health by Optimizing Risk Management (ANCHOR)
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Risk Reduction of Having a Coronary Event
Intervention  ICMJE
  • Behavioral: Minimal Intervention
    There is no clear definition of this term and it has been used by many different groups to refer to attempts to alter behavior by providing very brief, focused interventions. A slightly more developed model guiding intervention is called the 5-A model. This refers to the acronym Ask, Advise, Assess, Assist and Arrange. This model has been endorsed by the US Public Health Department, who has incorporated the 5-A approach into their clinical practice guidelines (A Clinical Practice Guideline for Treating Tobacco Use and Dependence; A US Public Health Service Report. JAMA, June 20, 2000 - Vol 283 No. 24; see also http://www.surgeongeneral.gov/tobacco/tobaqrg.htm).
  • Behavioral: Motivational Interviewing

    Motivational Interviewing has its roots in alcohol abuse counseling and was pioneered by Miller and Rollnick. It is an approach to counseling that is geared toward increasing an individual's motivation, or buy-in, to the work that needs to be done to reduce substance dependence. Miller and Rollnick offer the approach as a brief intervention (hence some confusion with the term minimal intervention) guided by the following mediators of change, which they call ingredients of change, summarized by the Acronym FRAMES:

    FEEDBACK of personal risk or impairment Emphasis on personal RESPONSIBILITY for change Clear ADVICE to change A MENU of alternative change options Therapist EMPATHY Facilitation of client SELF-EFFICACY or optimism

    These mediators/ingredients are delivered by the clinician using the following principles:

    Express Empathy Develop Discrepancy Avoid Argumentation Roll with Resistance Support Self-Efficacy

  • Behavioral: Motivational Enhancement

    Motivational enhancement is the most comprehensive term and reflects the integration of two major theorists; Millner and Rollnick on the one hand, and Prochaska and his colleagues on the other. The work of Miller and Rollnick occurred within substance abuse, primarily alcohol abuse and is best summarized in the section above on motivational interviewing. As Prochaska's work, which initially began in the area of smoking cessation but quickly expanded to include wide-ranging health behaviours, developed Miller and Rollnick incorporated his work with theirs.Prochaska's model derives from his long term study of the process of behaviour change regardless of the model of intervention implemented.The model is often referred to as the stages of change model, or readiness to change model.

    The stages of change model identifies five separate stages; precontemplation,contemplation, preparation, action, and maintenance

    These stages are specific to different behaviours.

Study Arms  ICMJE
  • Active Comparator: 1
    Duffus Street Medical Centre
    Interventions:
    • Behavioral: Minimal Intervention
    • Behavioral: Motivational Interviewing
    • Behavioral: Motivational Enhancement
  • Active Comparator: 2
    Sydney Family Practice
    Interventions:
    • Behavioral: Minimal Intervention
    • Behavioral: Motivational Interviewing
    • Behavioral: Motivational Enhancement
  • No Intervention: no counseling
    HRA assessment pre and post but no counselling
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2012)
1708
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01620996
Other Study ID Numbers  ICMJE CD-2005-267
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nova Scotia Health Authority
Study Sponsor  ICMJE Nova Scotia Health Authority
Collaborators  ICMJE
  • Cape Breton District Health Authority
  • Pfizer
Investigators  ICMJE Not Provided
PRS Account Nova Scotia Health Authority
Verification Date June 2008

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