Heartstrong Pilot Program

This pilot study is part of a larger study. Our plan for testing the implementation of a new
model for care delivery builds on infrastructure that we have developed and tested with NIH
Support (RC2 AG036592-01, Asch and Volpp, Multiple PIs). We aim to improve medication
adherence in patients following hospital admission for acute myocardial infarction (AMI).
Poor adherence to cardioprotective medications leads to worse medical treatment outcomes,
higher hospitalization and mortality rates, and increased health care costs among CAD
patients.20,21(references listed in full grant submission) Hence, medication adherence among
such patients is an important modifiable factor that affects the triple aim of improved
health care quality, improved health, and lower cost.

In this Pilot, we want to test an alternate approach to recruiting this patient population
in hopes of increasing the enrollment rates to greater than that in the main trial. Our
hypothesis is that if enrollment barriers are too high, the participants enrolling in the
study already possess a predisposition to medication adherence based on their interest in
research participation. By increasing the percentage of patients who enroll, we believe we
will enable the research results to be more generalizable including more of the patient
population, who may experience medication adherence problems as indicated in lack of
willingness to participate in research. By increasing the percentage of patients who enroll,
we are attempting to include more patients who may receive benefit of improved adherence
offered in this program. In this pilot study we plan to recruit patients from UPHS Health
System. Patients who decide to enroll will be placed into an abbreviated, 6-month version of
our HeartStrong research program offered in the main intervention. The modification in
recruitment procedures we are testing is the inclusion of the GlowCap electronic pill
bottles in the recruitment mailings that we send to prospective participants, thus lowering
the enrollment barrier by giving patients direct contact with the electronic pill bottles.
We will examine the enrollment rate using this method in comparison to the methods used in
the main intervention.

We believe including the GlowCaps in the recruitment packet will provide a couple of
benefits. First, participants will have the opportunity to see the pill bottles and have a
better understanding of the study intervention from the beginning of the recruitment
process. Second, our study team will be able to conduct the recruitment, verbal consent and
GlowCap set up in the space of a single phone call. While this will make the phone call
longer, the logistics of getting patients on the phone at multiple time points is
challenging, so the opportunity to encapsulate these efforts in one call are beneficial for
both the engagement advisors and the patients.

We are also testing the effect upon adherence rates that removing financial incentives has
on patient's medication adherence levels. Participants who choose to enroll in this research
program will receive a compound set of approaches including: (1) provision of up to 4
Vitality GlowCaps, a remote monitoring and medication bottle reminder device, for aspirin,
beta blockers, statins and, if they received a stent for plavix or similar anti-platelet
agents; (2) assignment of an engagement advisor from the study team; (3) enlisting a family
member or friend (patient choice) as a support person for medication adherence; (4)
engagement incentives that will use lotteries where winning will be dependent on medication
adherence; and (5) self-service/customization of the Way to Health platform communication
methods. Participants in this program will be offered all of these components; however, they
are still able to participate even if they opt not to use any of the list above. At the
3-month point, participants will be told the incentive portion has completed and they are to
continue using their electronic pill bottles for 3 more months and they will receive all
other components of the study.

Inclusion Criteria:

- Patients admitted to the University of Pennsylvania Health System who are discharged
(or scheduled to be discharged) to their homes with a principal or secondary
diagnosis code of International Classification of Diseases, 9th Revision, Clinical
Modification (ICD-9-CM) 410 (except when the fifth digit was 2) and a length of stay
of 1 to 180 days will be considered eligible for the study. Patients must be between
18 and 80 years old and have been discharged to home, 3) Patients are only eligible
to enroll in the study for up to 60 days after their hospital discharge for a heart
attack.

Exclusion Criteria:

- Patients will be excluded if they are less than 18 years old, will not or cannot give
consent, or have a markedly shortened life expectancy (diagnosis of metastatic
cancer, end-stage renal disease on dialysis, or dementia). Patients who have a known
allergy or history of side effects to any of the 4 targeted classes of medications
will be enrolled but provided GlowCaps only for the remaining medications.

Patients with insurance coverage of one of the main study partners. (Horizon, Independence
Blue Cross, Aetna, Keystone Mercy, and HealthFirst) (Please note, patients who are
prescribed the anti-platelet Effient® (prasugrel) will not be given a GlowCap to use for
this medication due to specific guidance about pill maintenance. The package insert for
Effient® (prasugrel) (http://pi.lilly.com/us/effientppi.pdf) indicates the medication
should remain in the original bottle, it should be kept at room temperature between 59°F
to 86°F (15°C to 30°C) and the container should be closed tightly with the gray cylinder
inside and be protected from moisture. This does not necessarily exclude these patients
from participation in the study, they will still be eligible as long as they have been
prescribed at least 2 of the remaining 3 medications being observed in this study. Also,
those who are taking an anti-platelet other than Effient® (prasugrel) (ie, Plavix) will be
given a GlowCap to use to take that medication.