Automated Hovering to Improve Medication Adherence Among Myocardial Infarction Patients (Heartstrong)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01800201
First received: February 25, 2013
Last updated: May 8, 2013
Last verified: April 2013
  Purpose

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.

Condition Intervention
Patients With Principal or Secondary Diagnosis Code of Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410 (Except When 5th Digit Was 2)
Behavioral: Electronic Pill Bottle, Incentives, Social Influence

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Automated Hovering to Improve Medication Adherence Among Myocardial Infarction Patients (Heartstrong)

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Patient Claims Data [ Time Frame: Date of enrollment + 12 months ] [ Designated as safety issue: No ]
    Primary outcome variable(s) Primary outcomes will be vascular events (AMI, stroke, acute coronary syndrome admission, or death)


Secondary Outcome Measures:
  • Patient Claims Data [ Time Frame: Date of enrollment + 12 months ] [ Designated as safety issue: No ]
    Secondary outcome variable(s) Secondary outcomes will be hospitalization, repeat or new cardiovascular procedures, medication possession/gap ratios (for those patients for whom we can link to CVS Caremark pharmacy benefits data) and total cost of care.


Estimated Enrollment: 1500
Study Start Date: March 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.
Experimental: 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.

Behavioral: Electronic Pill Bottle, Incentives, Social Influence
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800201

Contacts
Contact: Laurie Norton, MA 215-615-0168 Laurie.Norton@uphs.upenn.edu
Contact: Christopher Meussner, BS 215-573-4934 Christopher.Meussner@uphs.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Laurie Norton, MA    215-615-0168    laurie.norton@uphs.upenn.edu   
Contact: Christopher Meussner, BS    215-573-4934    christopher.meussner@uphs.upenn.edu   
Principal Investigator: Kevin Volpp, M.D., Ph.D.         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Kevin GM Volpp, MD, PhD University of Pennsylvania
Principal Investigator: David A Asch, MD, MBA, AB University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01800201     History of Changes
Other Study ID Numbers: 817179, 1C1CMS331009-01-00
Study First Received: February 25, 2013
Last Updated: May 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Initial occurrence Acute Myocardial Infarction (AMI)

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014