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STUDY PROTOCOL
Year : 2018  |  Volume : 131  |  Issue : 12  |  Page : 1480-1489

Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence (MISSION-2)


1 National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100073, China
2 National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100073, China
3 Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100073, China
4 Department of Thoracic and Cardiovascular Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China
5 Department of Cardiovascular Surgery, General Hospital of Shenyang Military Region, Shenyang, Liaoning 110016, China
6 Department of Cardiovascular Surgery, TEDA International Cardiovascular Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Tianjin 300457, China
7 Department of Cardiovascular Surgery, Henan Provincial People's Hospital, Fuwai Central China Cardiovascular Hospital, Zhengzhou, Henan 450003, China

Correspondence Address:
Dr. Zhe Zheng
National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, #167 Beilishi Road, Beijing 100037
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0366-6999.233767

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Background: Secondary preventive therapies play a key role in the prevention of adverse outcomes after coronary artery bypass grafting (CABG). However, medication adherence after CABG is often poor, and conventional interventions for improving adherence have limited success. With increasing penetration of smartphones, health-related smartphone applications might provide an opportunity to improve adherence. Carefully designed trials are needed to provide reliable evidence for the use of these applications in patients after CABG. Methods: The Measurement and Improvement Studies of Surgical Coronary Revascularization: Medication Adherence (MISSION-2) study is a multicenter randomized controlled trial, aiming to randomize 1000 CABG patients to the intervention or control groups in a 1:1 ratio. We developed the multifaceted, patient-centered, smartphone-based Heart Health Application to encourage medication adherence in the intervention group through a health self-management program initiated during hospital admission for CABG. The application integrated daily scheduled reminders to take the discharge medications, cardiac educational materials, a dynamic dashboard to review cardiovascular risk factors and secondary prevention targets, and weekly questionnaires with interactive feedback. The primary outcome was secondary preventive medication adherence measured by the Chinese version of the 8-item Morisky Medication Adherence Scale at 6 months after randomization. Secondary outcomes included all-cause death, cardiovascular rehospitalization, and a composite of death, myocardial infarction, stroke, and repeat revascularization. Discussion: Findings will not only provide evidence regarding the feasibility and effectiveness of the described intervention for improving adherence to CABG secondary preventive therapies but also explore a model for outpatient health self-management that could be translated to various chronic diseases and widely disseminated across resource-limited settings. Trial Registration: https://clinicaltrials.gov (NCT02432469).

 

 Abstract in Chinese

冠脉搭桥质量改善研究:患者二级预防用药依从性研究(MISSION-2


摘要


背景: 冠脉搭桥术后的二级预防药物治疗,对减少术后心血管不良事件发生至关重要。然而,既往研究显示患者二级预防用药依从性差,并且传统提高依从性的干预手段效果有限。智能手机在全球范围内的普及,将有望改变传统的医疗模式,低成本、高效率地提供更多诊疗机会,改善搭桥术后二级预防水平和患者预后。但目前亟需相关的高质量临床研究提供可靠的临床应用证据。

方法: MISSION-2研究是一个前瞻性、多中心、开放标签、随机对照的临床试验,计划入选1000例搭桥术后患者,采用1:1随机分组。根据“用户中心”设计思路,我们研发了手机应用“心健康”APP,对干预组患者从术后住院期间开始提供用药提醒,心脏术后健康宣教,心脏康复指导,交互式个体化生活方式建议。该研究的一级终点为术后6个月的依据8-MMAS量表测量的用药依从性。二级终点包括全因死亡、心血管再住院以及死亡、心梗、中风、再次血运重建的复合终点。

讨论: 该研究的结果,将为移动医疗技术在冠脉搭桥术后二级预防中应用的可行性和有效性提供可靠的临床证据。另外,试验的实施经验将为在医疗资源相对不足条件下,发展移动医疗技术改善慢病患者预后,探索患者院外自我管理新模式提供重要的借鉴。



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