Clinical trial NCT02139202: Heartstrong Pilot Program
Official title: HeartStrong Pilot Program - Automated Hovering to Improve Medication Adherence Among Myocardial Infarction Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Acute
Myocardial
Infarction
AMI
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment Uptake
timeFrame: up to 6 months
measure: Enrollment Uptake
timeFrame: up to 3 months
Secondary outcomes:
measure: Success of Process
timeFrame: up to 6 months
measure: Removing Incentives
timeFrame: up to 6 months
Other outcomes:
measure: Effects of Recruitment Methods on the Operational Processes
timeFrame: up to 6 months
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Shivan Mehta, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: