A Behavioral Economics-Based Telehealth Intervention to Improve Post-MI Medication Adherence

Study Overview
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Brief Summary
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The proposed study is a pilot randomized clinical trial (RCT). Participants in the intervention arm will participate in a 90-day adherence promotion program based on the theory of behavioral economics and administered through the Wellth mobile phone application. Subjects will be provided a CleverCap® Lite BLE C035 smart pill bottle (electronic monitoring (EM), device) containing a 90-day supply of aspirin (90 pills) and those in the intervention arm will be offered $150 for app-based medication check-ins, which consist of uploading daily photos of pills at the time of administration through the Wellth app. Subjects will have $2 deducted from total rewards for each day that a medication check-in is missed. Subjects in the control arm will receive usual care and be monitored with the same EM device types used in the intervention arm.

Detailed Description
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Medication adherence is a quantifiable parameter detailing when and how consistently doses are taken. Elements of medication adherence include: 1) the proportion of prescribed drug taken or %PDT (primary outcome); 2) the proportion of days with the correct number of doses taken; 3) the proportion of doses taken on time, in relation to a prescription-defined time interval between successive doses; 4) the distribution of inter-dose intervals; 5) the number of drug holidays; and 6) the longest interval between two doses [Vrijens et al. British journal of clinical pharmacology. 2012;73(5):691-705]. Medication adherence will be assessed in all participants using EM technology manufactured by CleverCaps®. Electronic Monitoring (EM) is more sensitive, reliable and valid than other measurement techniques such as pill counts, self-reports, or clinical judgment [Vrijens et al. Expert review of clinical pharmacology. 2014;7(5):633-644]. In this study the investigators will monitor a single drug, aspirin, in MI patients prescribed aspirin on hospital discharge. In addition to measurement of medication adherence using an EM device, the investigators will measure adherence using the Wellth cell phone app in the intervention arm. Participants in the intervention arm will also be asked to track their medication-taking habits by uploading photos of their medications at the appropriate dosage times using the Wellth app. Readmissions will be measured using the EMR and by interview to capture events outside the Penn system. Events will be classified according to timing (e.g. 30-day readmission) and cause (e.g. cardiac, all-cause). This study is not designed to detect a statistically significant difference in readmissions.

Official Title
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A Behavioral Economics-Based Telehealth Intervention to Improve Post-MI Medication Adherence

Conditions
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Myocardial Infarction, Acute, Myocardial Infarction

Intervention / Treatment
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* Behavioral: Financial Incentive and Mobile Phone App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 21 years of age Admitted to one of the University of Pennsylvania hospitals for acute myocardial infarction (ICD-10 codes I21.xx) or unstable angina (ICD 10 codes I20.xxx) Prescribed once-per-day aspirin at discharge The patient administers his or her own medications Own a smartphone with a sufficient data plan or home Wi-Fi to enable app use and avoid overage charges Able to speak and understand English Exclusion Criteria: Diagnosis of MI following non-cardiac admission Discharge to any facility other than the patient's home Cognitive impairment that limits ability to understand and complete questionnaires Inability to operate a mobile phone and the Wellth app Physician-estimated life expectancy less than 6 months

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Participants receiving the Financial Incentive and Mobile Phone App will be given an smartphone app offering pill reminders and $50/month financial incentives for three months to upload photos of medication each day for 90 days. Medication adherence will be measured via a CleverCap(R) electronic monitoring pillbox. | Behavioral: Financial Incentive and Mobile Phone App<br>* Subjects receiving the Financial Incentive and Mobile Phone App will each participate in a 90-day adherence promotion program. When users first log in to the app, the screen will display an incentive of $150 that participants have earned by enrolling in the program. Participants will be told that each missed medication check-in will result in a $2 deduction from the account before it is paid out. Each $50 portion (minus any penalties) of the $150 incentive will be paid out in 30-day installments by remotely crediting a previously distributed debit card. Adherence will be measured simultaneously by app photos and CleverCap(R) electronic monitoring (EM) devices filled with a 90-day supply of aspirin. Claims data will be analyzed for a 90 day period to account for any hospital admissions.<br>* Other names: Mobile Phone App;|
| No Intervention: Usual Care Control Arm<br>Participants in the usual care control arm will receive the usual education about medications provided by hospital staff. Medication adherence will be measured via a CleverCap(R) electronic monitoring pillbox. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence | Better medication adherence at 90 days as Percentage of Doses Taken (%PDT) using CleverCap(R) electronic monitoring devices | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-Day All-cause Readmissions | Average rates of hospital readmissions within 30 days assessed by medical record review and patient interviews | 30 Days | 
| 90-Day All-cause Readmissions | Average rates of hospital readmissions within 90 days assessed by medical record review and patient interviews | 90 Days | 
| Medication adherence assessed using patient smartphone photos | % PDT will not differ between the app and electronic monitoring measurement approaches | 90 Days | 
| Self-reported self-care | Self-care of coronary heart disease inventory | 90 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aspirin, Adherence, CleverCap® Lite BLE C035, Smartphone App, Telehealth, Digital Health, Mobile Phone App, Behavioral Economics, Wellth App