N/A
N=1,509
Automated Hovering to Improve Medication Adherence Among Myocardial Infarction Patients (Heartstrong)
Patients With Principal or Secondary Diagnosis Code of Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410 (Except When 5th Digit Was 2)
Bottom Line
View on ClinicalTrials.gov: NCT01800201 ↗Enrolled (actual)
1,509
Serious AEs
6.9%
Results posted
Jan 2020
Primary outcome: Primary: 1 -Year Survival Probability Rate: Vascular Readmissions or Death — .91; .91 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electronic Pill Bottle, Incentives, Social Influence (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1 -Year Survival Probability Rate: Vascular Readmissions or Death |
.91; .91 | — |
| SECONDARY 1 Year Survival Probability Rate All Cause Readmissions |
.65; .69 | — |
| SECONDARY Total Vascular Inpatient Readmissions |
62; 119 | — |
| SECONDARY Proportion of Days Covered (PDC) for a Subset of Patients for Whom we Have Prescription Information |
.58; .61 | — |
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:
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.
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)
Data sourced from ClinicalTrials.gov (NCT01800201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.