Mobile Cardiovascular Risk Service Trial
Condition: Cardiovascular Diseases; Personal Health Records; Pharmaceutical Care; Mobile Apps
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Pharmacist-led cardiovascular risk service (CVRS); Mobile access to study Personal Health Record; Web access to study Personal Health Record
Intervention type(s): Other; Other; Other
Intervention description(s): CVRS pharmacists will access the study database including patient baseline information obtained from the medical record and patient entered data to make their assessments and recommendations to onsite physicians and onsite clinical pharmacists and individualize their communication with patients. The intervention will provide patient-centered counseling and education to improve medication adherence, lifestyle modifications and/or smoking cessation. The CVRS pharmacist does not make changes to therapy independently but, rather, provides the physicians and on-site pharmacists with action plans and status updates about adherence to Guideline metrics, which should markedly reduce the gaps in guideline-concordant therapy that place patients at risk for CVD events.; Only subjects assigned to the intervention arm will have access to the mobile app version of the study personal Health Record.; Subjects assigned to both the intervention and control arms will have access to the standard website version of the study personal Health Record.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research