Cardiovascular Diseases Clinical Trial
Official title:
Design and Testing of a Mobile Cardiovascular Risk Service With Patient Partners
Risk factors for cardiovascular disease are poorly controlled even for patients who frequently visit their physician, leading to large numbers of preventable cardiovascular events such as heart attacks and strokes. Research from integrated healthcare systems suggests that risk factors can be controlled better and treatment strategies for cardiovascular disease can be markedly improved by using a centralized cardiovascular risk service (CVRS) managed by pharmacists. The investigators are confident that a pharmacist-managed mHealth CVRS can become a strategy in un-integrated healthcare settings to markedly reduce cardiovascular events in the United States.
Cardiovascular disease (CVD) causes 2,200 deaths in Americans every day with one death every
39 seconds. There is evidence that these deaths can be prevented with better risk factor
management, however, many risk factors remain uncontrolled. The Patient-Centered Medical Home
(Medical Home) which includes self-management, personalized health records and team-based
care, has been proposed as a strategy to reduce these gaps in care delivery. Several Cochrane
reviews and meta-analyses have found evidence that adding pharmacists to the primary care
team improves risk factor control and physician adherence to guidelines. Managed care
organizations have found that a centralized cardiovascular risk service (CVRS) managed by
pharmacists can reduce mortality. A gap in the literature is that it is not known whether a
comprehensive CVRS model would be implemented in typical office practices in un-integrated
settings. Simultaneously, systematic reviews of mobile health (mHealth) trials including
disease management apps have found no trial that has incorporated communication with a
pharmacist and this lack of evidence is a major gap in the mHealth literature.
The objective of this application is to develop and test a mobile app enabled, pharmacist
managed CVRS for disseminating and implementing evidence-based guidelines in practice. In
addition to developing the app with patients as design partners, the investigators will
conduct a multi-center individually randomized study nested within an ongoing NIH trial in
medical offices with large geographic, racial and ethnic diversity. The study team will
randomize 100 patients from primary care offices to mHealth CVRS (mobile app + web site +
pharmacist) or to CVRS only (web site + pharmacist) of whom 55 will be from racial/ethnic
minorities. The central hypothesis is that the mHealth CVRS designed with patients as
partners will be implemented and significantly improve patient engagement, leading to
improved CVD guideline adherence using the Get with The Guidelines and Guideline Advantage
metrics. The rationale for this proposed study is that a novel mHealth model that improves
secondary prevention of CVD with pharmacist assistance will lead to broader adoption by
health systems throughout the US.
The primary Aim is: to examine the feasibility of mHealth technology to disseminate
evidence-based risk reduction guidelines in a prospective randomized controlled trial among
diverse primary care offices. The investigators postulate that system engagement (primary
hypothesis) and adherence to guidelines for secondary prevention of CVD (secondary
hypothesis) will be significantly greater in patients randomized to the mHealth intervention
compared to the control group.
This study is expected to produce the following outcomes: unique mobile app features that
complement the standard CVRS, increased engagement with a CVRS and increased achievement of
guideline-concordant therapy.
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