Heartstrong Pilot Program
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|ClinicalTrials.gov Identifier: NCT02139202|
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : May 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Behavioral: Social Influence Behavioral: Electronic Pill Bottles Behavioral: Financial Incentives||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||HeartStrong Pilot Program - Automated Hovering to Improve Medication Adherence Among Myocardial Infarction Patients|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||October 2016|
The intervention will (1) use the GlowCaps, a remote monitoring and reminder pill bottle; (2) be assigned an engagement advisor from the study team; (3) be asked to provide the study team with names and contact information of up to 3 family members or friends as support partners for medication adherence. The study team will contact these people in order listed until 1 agrees to serve in this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on medication adherence for the first three months; and (5) will determine their preferences for Way to Health platform communication methods during the study.
The group receiving the program intervention will also have their claims data analyzed for the 1 months post-enrollment.
Behavioral: Social Influence
Behavioral: Electronic Pill Bottles
Behavioral: Financial Incentives
- Recruitment Uptake [ Time Frame: up to 6 months ]Primary outcomes will be recruitment uptake of patients discharged with recent AMI from the UPHS.
- Enrollment Uptake [ Time Frame: up to 3 months ]Primary outcomes will be the enrollment rate of targeted patients in this study.
- Success of Process [ Time Frame: up to 6 months ]Secondary outcomes will be success of process outcomes as reported by the study team and reported by the recruited patients.
- Removing Incentives [ Time Frame: up to 6 months ]The effect of removing financial incentives on the medication adherence rate of participants.
- Effects of Recruitment Methods on the Operational Processes [ Time Frame: up to 6 months ]Additional outcomes will be success of process outcomes as reported by the study team and reported by the recruited patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139202
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Shivan Mehta, MD, MBA||University of Pennsylvania|