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临床试验/NCT01800201
NCT01800201已完成不适用

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

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 1,509 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,509
试验地点
2
主要终点
1 -Year Survival Probability Rate: Vascular Readmissions or Death

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • cannot give consent
  • have a markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or dementia)

结局指标

主要结局

1 -Year Survival Probability Rate: Vascular Readmissions or Death

时间窗: Date of enrollment + 12 months

Primary outcome variable(s): 1- year survival probability rate for vascular inpatient readmission or death

次要结局

  • 1 Year Survival Probability Rate All Cause Readmissions(Date of enrollment + 12 months)
  • Proportion of Days Covered (PDC) for a Subset of Patients for Whom we Have Prescription Information(12 months)
  • Total Vascular Inpatient Readmissions(Date of enrollment + 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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