Heartstrong Pilot Program
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      This is a 6-month pilot study intended to test the effect of financial incentives on
      improving medication adherence in AMI patients; to test the effect on adherence of removing
      financial incentives; and to test the effect on the enrollment rate of modifying recruitment
      procedures.
    

Detailed description: 
      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.
    

Intervention name(s): Social Influence; Electronic Pill Bottles; Financial Incentives
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Acute; Myocardial; Infarction; AMI