Patients With Principal or Secondary Diagnosis Code of Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410 (Except When 5th Digit Was 2) Clinical Trial
— HeartstrongOfficial title:
Automated Hovering to Improve Medication Adherence Among Myocardial Infarction Patients (Heartstrong)
| Verified date | January 2020 |
| Source | University of Pennsylvania |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1509 |
| Est. completion date | June 2017 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| University of Pennsylvania |
United States,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 1 -Year Survival Probability Rate: Vascular Readmissions or Death | Primary outcome variable(s): 1- year survival probability rate for vascular inpatient readmission or death | Date of enrollment + 12 months | |
| Secondary | 1 Year Survival Probability Rate All Cause Readmissions | 1 year survival probability rate for all cause readmissions | Date of enrollment + 12 months | |
| Secondary | Total Vascular Inpatient Readmissions | This is the number of vascular inpatient admission events control vs. intervention | Date of enrollment + 12 months | |
| Secondary | 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 | 12 months |