Patients With Principal or Secondary Diagnosis Code of Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410 (Except When 5th Digit Was 2)
Conditions
Keywords
Initial occurrence Acute Myocardial Infarction (AMI)
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.
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.
Interventions
BEHAVIORALElectronic Pill Bottle, Incentives, Social Influence
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.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1 -Year Survival Probability Rate: Vascular Readmissions or Death | Date of enrollment + 12 months | Primary outcome variable(s): 1- year survival probability rate for vascular inpatient readmission or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1 Year Survival Probability Rate All Cause Readmissions | Date of enrollment + 12 months | 1 year survival probability rate for all cause readmissions |
| Total Vascular Inpatient Readmissions | Date of enrollment + 12 months | 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 | 12 months | 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 |
Countries
United States
Participant flow
Recruitment details
Participants were recruited by University of Pennsylvania research staff from March 2013 through January 2015 and followed for one year.
Pre-assignment details
No enrolled participants were excluded from the study before arm assignment
Participants by arm
| Arm | Count |
|---|---|
| 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. | 503 |
| 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. | 1,000 |
| Total | 1,503 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not want to use device | 0 | 1 |
| Overall Study | patient privacy concerns | 1 | 1 |
| Overall Study | PI withdrawal, cognitive concerns | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 399 Participants | 171 Participants | 570 Participants |
| Age, Categorical Between 18 and 65 years | 601 Participants | 332 Participants | 933 Participants |
| Age, Continuous | 61.2 years STANDARD_DEVIATION 10.4 | 60.6 years STANDARD_DEVIATION 10.2 | 61.0 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment United States | 1000 participants | 503 participants | 1503 participants |
| Sex: Female, Male Female | 343 Participants | 190 Participants | 533 Participants |
| Sex: Female, Male Male | 657 Participants | 313 Participants | 970 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 503 | 8 / 1,000 |
| other Total, other adverse events | 0 / 503 | 0 / 1,000 |
| serious Total, serious adverse events | 37 / 503 | 66 / 1,000 |
Outcome results
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
Time frame: Date of enrollment + 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | 1 -Year Survival Probability Rate: Vascular Readmissions or Death | .91 proportion of participants |
| Intervention | 1 -Year Survival Probability Rate: Vascular Readmissions or Death | .91 proportion of participants |
Secondary
1 Year Survival Probability Rate All Cause Readmissions
1 year survival probability rate for all cause readmissions
Time frame: Date of enrollment + 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | 1 Year Survival Probability Rate All Cause Readmissions | .65 proportion of participants |
| Intervention | 1 Year Survival Probability Rate All Cause Readmissions | .69 proportion of participants |
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
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Proportion of Days Covered (PDC) for a Subset of Patients for Whom we Have Prescription Information | .58 PDC, mean | Standard Deviation 0.35 |
| Intervention | Proportion of Days Covered (PDC) for a Subset of Patients for Whom we Have Prescription Information | .61 PDC, mean | Standard Deviation 0.33 |
Secondary
Total Vascular Inpatient Readmissions
This is the number of vascular inpatient admission events control vs. intervention
Time frame: Date of enrollment + 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Total Vascular Inpatient Readmissions | 62 readmissions |
| Intervention | Total Vascular Inpatient Readmissions | 119 readmissions |