Ignite Creation Date:
2024-05-06 @ 1:25 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01800201
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2013-02-25
Brief Title:
Automated Hovering to Improve Medication Adherence Among Myocardial Infarction Patients Heartstrong
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Automated Hovering to Improve Medication Adherence Among Myocardial Infarction Patients Heartstrong
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Heartstrong
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
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1C1CMS331009-01-00 | OTHER_GRANT | Center for Medicare Medicaid Innovation CMMI | None |