Cardiovascular Disease Clinical Trial
Official title:
Denver Health Cardiovascular Prevention Program
The objective of the Denver Health CVD Prevention Program is to assess the effectiveness of developing an enhanced cardiovascular disease prevention program in a community health care setting.
Cardiovascular disease (CVD) is the leading cause of mortality in Colorado.[1] This is
especially true in the Latino population who are at greater risk for CVD compared to
non-Latino whites, and suffer more premature CVD deaths.[2] Among persons less than 34
years, Latinos are four times more likely to die from heart disease than non-Latino whites,
a disparity that lessens but does not disappear with age (1.5 ratios among persons 55 - 64
yrs old). Recently, the INTERHEART study demonstrated that 90% of the population
attributable risk is due to established modifiable risk factors (smoking, dyslipidemia,
hypertension, diabetes, obesity, psychosocial factors, daily consumption of fruits and
vegetables, regular alcohol consumption and regular physical activity).[3] Many individuals
in the general population have one or more risk factors for CVD and over 90% of CVD events
occur in individuals with at least one risk factor,[3, 4] with few events occurring in
individuals with no risk factors, thus supporting the notion of focusing prevention
activities on individuals at higher risk for CVD.
Reducing the risk of CVD is part of Colorado's strategic plan. Programs are needed that
offer provide enhanced patient-centered CVD prevention services using paraprofessionals and
thus assisting health care providers (i.e., physicians, midlevels) in addressing preventive
health care issues. Early identification of CVD risk is paramount in order to reach those
who need the appropriate treatment. In this regard, NCEP guidelines recommend the
utilization of the Framingham Risk Score (FRS) as the basis to identify patients with an
increased 10-year risk for CVD events.
Despite evidence of the effectiveness of preventive services and the development of
published national guidelines,[5, 6] rates of delivery of preventive services remain low.[7]
The most common barriers identified are the lack of time during the office visit, inadequate
insurance reimbursement, patient refusal to discuss or comply with recommendations, and lack
of physician expertise in counseling techniques.[8-12] At Denver Community Health Services
(DCHS), a department of Denver Health (DH), an additional barrier includes socioeconomic
issues associated with a low-income population with ethnically diverse issues. Thus,
delivering CVD preventive services often takes a lower priority during an office visit in a
busy clinical practice. However, proactively identifying individuals at risk of CVD and
involving them in their own care should increase awareness of CVD risk factors and as such
assist in reducing the burden of CVD in the community.
Denver Public Health (DPH) in collaboration with DCHS will implement a comprehensive
cardiovascular risk assessment and prevention treatment plan among three westside community
health centers. In order to improve CVD risk reduction, this demonstration project will a)
develop a CVD registry to be able to identify at risk individuals, b) engage high-risk
patients to participate in CVD prevention activities, c) implement a series of
evidence-based prevention strategies to be offered in the clinic and community, d) perform
both process and outcome evaluations of this demonstration project, and e) compare biologic
results (e.g., FRS, lipid levels) with sites not participating in the intervention to assess
the effectiveness of our intervention.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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