Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01620996 |
| Other study ID # |
CD-2005-267 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2006 |
| Est. completion date |
September 2010 |
Study information
| Verified date |
June 2008 |
| Source |
Nova Scotia Health Authority |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
