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| ID | Type | Description | Link |
|---|---|---|---|
| 1C1CMS331009-01-00 | Other Grant/Funding Number | Center for Medicare & Medicaid Innovation (CMMI) |
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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:
The specific aims of this study are to:
Patients will be randomized into 1 of the 2 study groups.
(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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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. | |
| Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Pill Bottle, Incentives, Social Influence | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 1 Year Survival Probability Rate All Cause Readmissions | 1 year survival probability rate for all cause readmissions | Date of enrollment + 12 months |
| Total Vascular Inpatient Readmissions | This is the number of vascular inpatient admission events control vs. intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin GM Volpp, MD, PhD | University of Pennsylvania | Principal Investigator |
| David A Asch, MD, MBA, AB | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28654972 | Background | 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. |
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No enrolled participants were excluded from the study before arm assignment
Participants were recruited by University of Pennsylvania research staff from March 2013 through January 2015 and followed for one year.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Date of enrollment + 12 months |
| 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 |
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) 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. The study team will contact these people in order listed until 1 agrees to serve in 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 medication adherence; and (5) will determine 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Intervention | 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) 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. The study team will contact these people in order listed until 1 agrees to serve in 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 medication adherence; and (5) will determine 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | proportion of participants | Date of enrollment + 12 months |
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| Secondary | 1 Year Survival Probability Rate All Cause Readmissions | 1 year survival probability rate for all cause readmissions | Posted | Number | proportion of participants | Date of enrollment + 12 months |
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| Secondary | Total Vascular Inpatient Readmissions | This is the number of vascular inpatient admission events control vs. intervention | Posted | Number | readmissions | Date of enrollment + 12 months |
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| 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 | Posted | Mean | Standard Deviation | PDC, mean | 12 months |
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1509 participants were enrolled starting in March 2013 through January 2015 and observed for one year. 6 patients withdrew. Adverse event data was collected for 1503 participants during all 12 months of their participation.
We only have a report of deaths from medical claims if the patient died in the hospital, as a result we did not report on deaths in our manuscript due to incomplete data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 4 | 503 | 37 | 503 | 0 | 503 |
| EG001 | Intervention | 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) 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. The study team will contact these people in order listed until 1 agrees to serve in 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 medication adherence; and (5) will determine 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. | 8 | 1,000 | 66 | 1,000 | 0 | 1,000 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intracranial Hemmorhage | Cardiac disorders | Systematic Assessment | intracranial hemorrhage as identified by ICD-9: 430, 431,432.0, 432.9, 853, 430, 431 |
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| Liver Failure | Renal and urinary disorders | Systematic Assessment | Liver Failure as defined by ICD-9: 570.0, 573.3 |
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| Heart Block | Cardiac disorders | Systematic Assessment | Heart Block as defined by following ICD-9: 426.9, 426.0, 426.12, 426.13 |
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| Rhabdomyolysis | Renal and urinary disorders | Systematic Assessment | Rhabdomyolysis as defined by ICD-9: 728.88, 791.2, 791.3 |
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| GI Hemmorhage/Ulcer | Gastrointestinal disorders | Systematic Assessment | GI Hemmorhage/Ulcer as identified by ICD-9: 578.0, 578.1, 578.9, 569.3, 531, 532, 533, 534: |
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| Syncope | Blood and lymphatic system disorders | Systematic Assessment | Synope as identifed by ICD-9: 780.2 |
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| Bradycardia | Cardiac disorders | Systematic Assessment | Bradycardia as identified by ICD-9: 427.89 |
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| Unspecified Hemmorhage | Blood and lymphatic system disorders | Systematic Assessment | Unspecified Hemmorhage as identified as ICD-9: 459.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Noora Marcus | University of Pennsylvania | 215-746-4429 | noora.marcus@uphs.upenn.edu |
| >=65 years |
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