Automated Hovering to Improve Medication Adherence Among Myocardial Infarction Patients (Heartstrong) (Heartstrong)

January 3, 2020 updated by: University of Pennsylvania

The goal of this proposal is to test the implementation of an innovative approach to improving health and lowering cost for a high risk population of patients with acute myocardial infarction (AMI) immediately post-hospitalization. The investigators will implement a new service delivery approach that will provide a foundation for a payment system that rewards keeping high-risk patients healthy and that deploys technology and a health care workforce of the future to implement prevention, care coordination, care process re-engineering, team-based care, and the use of data to support new care delivery models. This program is focused on coronary artery disease (CAD), but we expect that a successful implementation of this model will demonstrate a sustainable pathway to the three-part aim not just for CAD, but for many other conditions whose outcomes are highly sensitive to post-discharge coordination.

This proposal has three main principles:

  1. Principles of behavioral economics that have been developed, refined, and tested over the past decade offer practical insights into health behaviors that were previously unavailable and are not reflected in existing care models.
  2. New technology, typically wireless devices for pill bottles, and mobile telephones, make engagement with patients substantially easier and more immediate now than ever before.
  3. While randomized clinical intervention trials provide exceptional confidence of comparative effectiveness in narrow interventions, they are slow and rigid and dont reflect the urgency that health care transformation currently requires. Principles of rapid cycle innovation are gaining acceptance as an alternative to or supplement of these traditional methods in supporting evidence for implementation success.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The specific aims of this study are to:

  1. Test the effectiveness of a state-of-the-art web-based portal with home-based wireless medication adherence devices and behavioral economic feedback mechanisms in preventing vascular events or re-hospitalization in the 12 months following hospital admission for AMI
  2. Deploy a new model of evidence based evolutionary learning that uses rapid cycle innovation in 3 successive planning cycles over the 36 months of this proposal

Patients will be randomized into 1 of the 2 study groups.

  1. The control group will have their health insurance claims records analyzed over a 12 month period for comparison to the participants in the intervention arm.
  2. The intervention group:

(1) will use the GlowCaps, a remote monitoring and reminder pill bottle; (2) will 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; (4) will be eligible for daily sweepstakes-based engagement incentives in which eligibility to win will be conditional on medication adherence; (5) can choose to modify 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 12 months post-enrollment.

Study Type

Interventional

Enrollment (Actual)

1509

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients admitted to hospitals throughout New Jersey or at 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)
  • a length of stay of 1 to 180 days
  • Aged 18 to 80 years
  • Be discharged to home
  • Prescribed at least 2 of these 4 medication categories (statin, aspirin, beta-blocker, anti-platelet)

Exclusion Criteria:

  • cannot give consent
  • have a markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or dementia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
The control group will have their claims data analyzed for a 12 month period. We will be examining these data for hospital admissions, new vascular events (AMI, stroke, acute coronary syndrome admission), or repeat or new cardiovascular procedures.
Experimental: Intervention
The intervention group (1) will use GlowCaps, a remote monitoring and reminder pill bottle; (2) assigned an engagement advisor from the study team; (3) asked to provide study team with names and contact information of up to 3 family members or friends as support partners for med adherence. The study team will contact these people in order listed until 1 agrees to 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 med adherence; and (5) will determine preferences for Way to Health platform communication methods.The group receiving the program intervention will also have their claims data analyzed for the 12 months post-enrollment.
Behavioral: Electronic Pill Bottle, Incentives, Social Influence
The intervention group (1) will use GlowCaps, a remote monitoring and reminder pill bottle; (2) assigned an engagement advisor from the study team; (3) asked to provide study team with names and contact information of up to 3 family members or friends as support partners for med adherence. The study team will contact these people in order listed until 1 agrees to 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 med adherence; and (5) will determine preferences for Way to Health platform communication methods.The group receiving the program intervention will also have their claims data analyzed for the 12 months post-enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1 -Year Survival Probability Rate: Vascular Readmissions or Death
Time Frame: Date of enrollment + 12 months
Primary outcome variable(s): 1- year survival probability rate for vascular inpatient readmission or death
Date of enrollment + 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1 Year Survival Probability Rate All Cause Readmissions
Time Frame: Date of enrollment + 12 months
1 year survival probability rate for all cause readmissions
Date of enrollment + 12 months
Total Vascular Inpatient Readmissions
Time Frame: Date of enrollment + 12 months
This is the number of vascular inpatient admission events control vs. intervention
Date of enrollment + 12 months
Proportion of Days Covered (PDC) for a Subset of Patients for Whom we Have Prescription Information
Time Frame: 12 months
Calculated by the proportion of days in which a patient has an active medication for all three medications (statin, beta blocker and antiplatelet). It is not the weighted average of the individual medication. This reflects the "intermediate" definition of adherence: our intermediate definition assumed that patients had been prescribed a medication for the entire study period if they ever filled that medication after discharge
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Kevin GM Volpp, MD, PhD, University of Pennsylvania
  • Principal Investigator: David A Asch, MD, MBA, AB, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

February 25, 2013

First Submitted That Met QC Criteria

February 26, 2013

First Posted (Estimate)

February 27, 2013

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 3, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 817179
  • 1C1CMS331009-01-00 (Other Grant/Funding Number: Center for Medicare & Medicaid Innovation (CMMI))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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