Troxel Andrea B, Asch David A, Mehta Shivan J, Norton Laurie, Taylor Devon, Calderon Tirza A, Lim Raymond, Zhu Jingsan, Kolansky Daniel M, Drachman Brian M, Volpp Kevin G
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
Am Heart J. 2016 Sep;179:166-74. doi: 10.1016/j.ahj.2016.06.006. Epub 2016 Jul 8.
Coronary artery disease is the single leading cause of death in the United States, and medications can significantly reduce the rate of repeat cardiovascular events and treatment procedures. Adherence to these medications, however, is very low.
HeartStrong is a national randomized trial offering 3 innovations. First, the intervention is built on concepts from behavioral economics that we expect to enhance its effectiveness. Second, the implementation of the trial takes advantage of new technology, including wireless pill bottles and remote feedback, to substantially automate procedures. Third, the trial's design includes an enhancement of the standard randomized clinical trial that allows rapid-cycle innovation and ongoing program enhancement.
Using a system involving direct data feeds from 6 insurance partners followed by mail, telephone, and email contact, we enrolled 1,509 patients discharged from the hospital with acute myocardial infarction in a 2:1 ratio of intervention:usual care. The intervention period lasts 1 year; the primary outcome is time to first fatal or nonfatal acute vascular event or revascularization, including acute myocardial infarction, unstable angina, stroke, acute coronary syndrome admission, or death.
Our randomized controlled trial of the HeartStrong program will provide an evaluation of a state-of-the-art behavioral economic intervention with a number of important pragmatic features. These include a tailored intervention responding to patient activity, streamlining of consent and implementation processes using new technologies, outcomes centrally important to patients, and the ability to implement rapid-cycle innovation.
冠状动脉疾病是美国单一的首要死因，药物治疗可显著降低心血管事件复发率和治疗程序的使用频率。然而，患者对这些药物的依从性很低。
“强心”（HeartStrong）是一项全国性随机试验，采用了三项创新举措。其一，干预措施基于行为经济学理念构建，我们期望借此提高其有效性。其二，试验实施利用了新技术，包括无线药瓶和远程反馈，以大幅实现程序自动化。其三，试验设计改进了标准随机临床试验，允许进行快速循环创新和持续的项目优化。
通过一个涉及从6家保险合作伙伴直接获取数据馈送，随后进行邮件、电话和电子邮件联系的系统，我们以2∶1的干预组与常规治疗组比例，招募了1509名因急性心肌梗死出院的患者。干预期为1年；主要结局指标是首次发生致命或非致命急性血管事件或血运重建的时间，包括急性心肌梗死、不稳定型心绞痛、中风、急性冠状动脉综合征入院或死亡。
我们对“强心”项目进行的随机对照试验将对一项具有诸多重要实用特征的先进行为经济学干预措施进行评估。这些特征包括根据患者活动量身定制的干预措施、利用新技术简化同意和实施流程、对患者至关重要的结局指标，以及实施快速循环创新的能力。
