Heartstrong Pilot Program

NCT02139202 | Completed

• 2 other identifiers: 819466CMS561871
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 6-month pilot study intended to test the effect of financial incentives on improving medication adherence in AMI patients; to test the effect on adherence of removing financial incentives; and to test the effect on the enrollment rate of modifying recruitment procedures.

Conditions

Acute Myocardial Infarction

Keywords

Acute; Myocardial; Infarction; AMI

Outcome Measures

Primary Outcomes (2)

• Recruitment Uptake

  Primary outcomes will be recruitment uptake of patients discharged with recent AMI from the UPHS.

  up to 6 months

• Enrollment Uptake

  Primary outcomes will be the enrollment rate of targeted patients in this study.

  up to 3 months

Secondary Outcomes (2)

• Success of Process

  up to 6 months

• Removing Incentives

  up to 6 months

Other Outcomes (1)

• Effects of Recruitment Methods on the Operational Processes

  up to 6 months

Study Arms (1)

Full Program

OTHER

The intervention will (1) use the GlowCaps, a remote monitoring and reminder pill bottle; (2) 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. 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 for the first three months; 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 1 months post-enrollment.

Behavioral: Social Influence; Behavioral: Electronic Pill Bottles; Behavioral: Financial Incentives

Interventions

Social Influence BEHAVIORAL

Full Program

Electronic Pill Bottles BEHAVIORAL

Full Program

Financial Incentives BEHAVIORAL

Full Program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to 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) and a length of stay of 1 to 180 days will be considered eligible for the study. Patients must be between 18 and 80 years old and have been discharged to home, 3) Patients are only eligible to enroll in the study for up to 60 days after their hospital discharge for a heart attack.

You may not qualify if:

• Patients will be excluded if they are less than 18 years old, will not or cannot give consent, or have a markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or dementia). Patients who have a known allergy or history of side effects to any of the 4 targeted classes of medications will be enrolled but provided GlowCaps only for the remaining medications.
• Patients with insurance coverage of one of the main study partners. (Horizon, Independence Blue Cross, Aetna, Keystone Mercy, and HealthFirst) (Please note, patients who are prescribed the anti-platelet Effient® (prasugrel) will not be given a GlowCap to use for this medication due to specific guidance about pill maintenance. The package insert for Effient® (prasugrel) (http://pi.lilly.com/us/effientppi.pdf) indicates the medication should remain in the original bottle, it should be kept at room temperature between 59°F to 86°F (15°C to 30°C) and the container should be closed tightly with the gray cylinder inside and be protected from moisture. This does not necessarily exclude these patients from participation in the study, they will still be eligible as long as they have been prescribed at least 2 of the remaining 3 medications being observed in this study. Also, those who are taking an anti-platelet other than Effient® (prasugrel) (ie, Plavix) will be given a GlowCap to use to take that medication.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Infarction

Condition Hierarchy (Ancestors)

Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Shivan Mehta, MD, MBA

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 15, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2016
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

US (1)