Mobile Cardiovascular Risk Service Trial
- Conditions
- Cardiovascular DiseasesPersonal Health RecordsMobile AppsPharmaceutical Care
- Interventions
- Other: Pharmacist-led cardiovascular risk service (CVRS)Other: Mobile access to study Personal Health RecordOther: Web access to study Personal Health Record
- Registration Number
- NCT03081871
- Lead Sponsor
- University of Iowa
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Web and mobile app access Mobile access to study Personal Health Record Subjects will have access to both the mobile and web-app versions of the study Personal Health Record to communicate with the study pharmacist and enter and track their health data. Web and mobile app access Web access to study Personal Health Record Subjects will have access to both the mobile and web-app versions of the study Personal Health Record to communicate with the study pharmacist and enter and track their health data. Web app only access Pharmacist-led cardiovascular risk service (CVRS) Subjects will have access to the web-app version of the study Personal Health Record (and not the mobile app version) to communicate with the study pharmacist and enter and track their health data. Web and mobile app access Pharmacist-led cardiovascular risk service (CVRS) Subjects will have access to both the mobile and web-app versions of the study Personal Health Record to communicate with the study pharmacist and enter and track their health data. Web app only access Web access to study Personal Health Record Subjects will have access to the web-app version of the study Personal Health Record (and not the mobile app version) to communicate with the study pharmacist and enter and track their health data.
- Primary Outcome Measures
Name Time Method Mean number of days on which a patient interacts with the cardiovascular risk service (using either mobile app or web-site) 4 months post enrollment Mean number of days on which a patient interacts with the cardiovascular risk service (using either mobile app or web-site)
Mean number of contacts with a pharmacist 4 months post enrollment Mean number of contacts with a pharmacist
- Secondary Outcome Measures
Name Time Method Guideline Adherence score calculated on the subset of guidelines amenable to intervention during the 4 month intervention 4 months post enrollment Guideline Adherence score calculated on the subset of guidelines amenable to intervention during the 4 month intervention
Trial Locations
- Locations (2)
University of Iowa
🇺🇸Iowa City, Iowa, United States
Siouxland Community Health Center
🇺🇸Sioux City, Iowa, United States
University of Iowa🇺🇸Iowa City, Iowa, United States