Goldstein Nathan E, Kalman Jill, Kutner Jean S, Fromme Erik K, Hutchinson Mathew D, Lipman Hannah I, Matlock Daniel D, Swetz Keith M, Lampert Rachel, Herasme Omarys, Morrison R Sean
Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA; James J. Peters Veterans Affairs Medical Center, Bronx, New York, USA.
Division of Cardiology, Samuel Bronfman Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
J Pain Symptom Manage. 2014 Dec;48(6):1236-46. doi: 10.1016/j.jpainsymman.2014.03.005. Epub 2014 Apr 21.
We report the challenges of the Working to Improve Discussions About Defibrillator Management trial, our novel, multicenter trial aimed at improving communication between cardiology clinicians and their patients with advanced heart failure (HF) who have implantable cardioverter defibrillators (ICDs). The study objectives are (1) to increase ICD deactivation conversations, (2) to increase the number of ICDs deactivated, and (3) to improve psychological outcomes in bereaved caregivers. The unit of randomization is the hospital, the intervention is aimed at HF clinicians, and the patient and caregiver are the units of analysis. Three hospitals were randomized to usual care and three to intervention. The intervention consists of an interactive educational session, clinician reminders, and individualized feedback. We enroll patients with advanced HF and their caregivers, and then we regularly survey them to evaluate whether the intervention has improved communication between them and their HF providers. We encountered three implementation barriers. First, there were institutional review board concerns at two sites because of the palliative nature of the study. Second, we had difficulty in creating entry criteria that accurately identified an HF population at high risk of dying. Third, we had to adapt our entry criteria to the changing landscape of ventricular assist devices and cardiac transplant eligibility. Here we present our novel solutions to the difficulties we encountered. Our work has the ability to enhance conduct of future studies focusing on improving care for patients with advanced illness.
我们报告了“致力于改善除颤器管理讨论”试验所面临的挑战，这是我们一项新颖的多中心试验，旨在改善心脏病临床医生与患有晚期心力衰竭（HF）且植入了植入式心脏复律除颤器（ICD）的患者之间的沟通。该研究目标包括：（1）增加关于停用ICD的讨论；（2）增加停用ICD的数量；（3）改善丧亲照顾者的心理结局。随机分组单位是医院，干预对象是HF临床医生，患者和照顾者是分析单位。三家医院被随机分配至常规护理组，三家医院被分配至干预组。干预措施包括一次互动式教育课程、临床医生提醒和个性化反馈。我们招募晚期HF患者及其照顾者，然后定期对他们进行调查，以评估干预措施是否改善了他们与HF医护人员之间的沟通。我们遇到了三个实施障碍。首先，由于研究的姑息性质，两个研究地点的机构审查委员会存在顾虑。其次，我们难以制定准确识别高死亡风险HF人群的纳入标准。第三，我们不得不根据心室辅助装置和心脏移植资格的不断变化调整我们的纳入标准。在此，我们展示我们针对所遇到困难的新颖解决方案。我们的工作有能力加强未来专注于改善晚期疾病患者护理的研究的开展。
