Mobile Cardiovascular Risk Service Trial

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.

INCLUSION CRITERIA:

1. Patients age 55 and older;

2. Owns and uses a smartphone;

3. Any ONE of the following guideline-related needs in the past 18 months:

1. Most recent encounter LDL >= 100 mg/dl

2. Most recent encounter BP > 140/90 mmHg (or > 150/90 for persons age 60+)

3. Most recent encounter not taking recommended post-stroke medications

4. Most recent encounter not taking recommended post-MI medications

5. Diabetics with most recent encounter not on ACE inhibitor or ARB blocker

6. Any patient with most recent A1c > 8.0%

7. Diabetics with no urine microalbumin screening, past 18 months

EXCLUSION CRITERIA:

1. Non-English speaking (app available only in English for this study)

2. No encounter in the past 18 months (they may be receiving care elsewhere and
guideline-related needs may not be reliably assessed) at the clinic itself

3. Most recent systolic BP >200 or diastolic BP > 110 mm Hg

4. Any history of significant hepatic disease, including cirrhosis, Hepatitis B or C
infection, or laboratory abnormalities (serum ALT or AST > 3 times normal (either AST
above 96 U/L or ALT above 99 U/L or total bilirubin > 2.0 mg/dl))

5. History of hemorrhagic stroke

6. Pulmonary hypertension

7. Stage 4 or metastatic cancer

8. Current nursing home residence or has plans to move to one within the next 12 months

9. Has plans to transfer care from the current clinic within the next 6 months

10. Inability to give informed consent or impaired cognitive function

11. Currently pregnant (females only)

12. Currently a prisoner