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

Primary Purpose

Patients With Principal or Secondary Diagnosis Code of Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410 (Except When 5th Digit Was 2)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic Pill Bottle, Incentives, Social Influence
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Patients With Principal or Secondary Diagnosis Code of Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410 (Except When 5th Digit Was 2) focused on measuring Initial occurrence Acute Myocardial Infarction (AMI)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

1 -Year Survival Probability Rate: Vascular Readmissions or Death
Primary outcome variable(s): 1- year survival probability rate for vascular inpatient readmission or death

Secondary Outcome Measures

1 Year Survival Probability Rate All Cause Readmissions
1 year survival probability rate for all cause readmissions
Total Vascular Inpatient Readmissions
This is the number of vascular inpatient admission events control vs. intervention
Proportion of Days Covered (PDC) for a Subset of Patients for Whom we Have Prescription Information
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

Full Information

First Posted
February 25, 2013
Last Updated
January 3, 2020
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01800201
Brief Title
Automated Hovering to Improve Medication Adherence Among Myocardial Infarction Patients (Heartstrong)
Acronym
Heartstrong
Official Title
Automated Hovering to Improve Medication Adherence Among Myocardial Infarction Patients (Heartstrong)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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: 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. New technology, typically wireless devices for pill bottles, and mobile telephones, make engagement with patients substantially easier and more immediate now than ever before. 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.
Detailed Description
The specific aims of this study are to: 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 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Principal or Secondary Diagnosis Code of Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410 (Except When 5th Digit Was 2)
Keywords
Initial occurrence Acute Myocardial Infarction (AMI)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1509 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Electronic Pill Bottle, Incentives, Social Influence
Intervention Description
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.
Primary Outcome Measure Information:
Title
1 -Year Survival Probability Rate: Vascular Readmissions or Death
Description
Primary outcome variable(s): 1- year survival probability rate for vascular inpatient readmission or death
Time Frame
Date of enrollment + 12 months
Secondary Outcome Measure Information:
Title
1 Year Survival Probability Rate All Cause Readmissions
Description
1 year survival probability rate for all cause readmissions
Time Frame
Date of enrollment + 12 months
Title
Total Vascular Inpatient Readmissions
Description
This is the number of vascular inpatient admission events control vs. intervention
Time Frame
Date of enrollment + 12 months
Title
Proportion of Days Covered (PDC) for a Subset of Patients for Whom we Have Prescription Information
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin GM Volpp, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David A Asch, MD, MBA, AB
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28654972
Citation
Volpp KG, Troxel AB, Mehta SJ, Norton L, Zhu J, Lim R, Wang W, Marcus N, Terwiesch C, Caldarella K, Levin T, Relish M, Negin N, Smith-McLallen A, Snyder R, Spettell CM, Drachman B, Kolansky D, Asch DA. Effect of Electronic Reminders, Financial Incentives, and Social Support on Outcomes After Myocardial Infarction: The HeartStrong Randomized Clinical Trial. JAMA Intern Med. 2017 Aug 1;177(8):1093-1101. doi: 10.1001/jamainternmed.2017.2449.
Results Reference
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Automated Hovering to Improve Medication Adherence Among Myocardial Infarction Patients (Heartstrong)

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