Courtright Katherine R, Madden Vanessa, Gabler Nicole B, Cooney Elizabeth, Small Dylan S, Troxel Andrea, Casarett David, Ersek Mary, Cassel J Brian, Nicholas Lauren Hersch, Escobar Gabriel, Hill Sarah H, O'Brien Dan, Vogel Mark, Halpern Scott D
1 Pulmonary, Allergy, and Critical Care Medicine Division, Department of Medicine.
2 Center for Health Incentives and Behavioral Economics.
Ann Am Thorac Soc. 2016 Sep;13(9):1629-39. doi: 10.1513/AnnalsATS.201604-308OT.
The substantial nationwide investment in inpatient palliative care services stems from their great promise to improve patient-centered outcomes and reduce costs. However, robust experimental evidence of these benefits is lacking. The Randomized Evaluation of Default Access to Palliative Services (REDAPS) study is a pragmatic, stepped-wedge, cluster randomized trial designed to test the efficacy and costs of specialized palliative care consultative services for hospitalized patients with advanced chronic obstructive pulmonary disease, dementia, or end-stage renal disease, as well as the overall effectiveness of ordering such services by default. Additional aims are to identify the types of services that are most beneficial and the types of patients most likely to benefit, including comparisons between ward and intensive care unit patients. We hypothesize that patient-centered outcomes can be improved without increasing costs by simply changing the default option for palliative care consultation from opt-in to opt-out for patients with life-limiting illnesses. Patients aged 65 years or older are enrolled at 11 hospitals using an integrated electronic health record. As a pragmatic trial designed to enroll between 12,000 and 15,000 patients, eligibility is determined using a validated, electronic health record-based algorithm, and all outcomes are captured via the electronic health record and billing systems data. The time at which each hospital transitions from control, opt-in palliative care consultation to intervention, opt-out consultation is randomly assigned. The primary outcome is a composite measure of in-hospital mortality and length of stay. Secondary outcomes include palliative care process measures and clinical and economic outcomes. Clinical trial registered with www.clinicaltrials.gov (NCT02505035).
全国范围内对住院姑息治疗服务的大量投资源于其在改善以患者为中心的治疗效果和降低成本方面的巨大潜力。然而，目前缺乏关于这些益处的有力实验证据。姑息服务默认接入随机评估（REDAPS）研究是一项务实的、逐步推进的整群随机试验，旨在测试为患有晚期慢性阻塞性肺疾病、痴呆或终末期肾病的住院患者提供专科姑息治疗咨询服务的疗效和成本，以及默认订购此类服务的总体效果。其他目标是确定最有益的服务类型以及最可能受益的患者类型，包括比较病房患者和重症监护病房患者。我们假设，对于患有危及生命疾病的患者，只需将姑息治疗咨询的默认选项从选择加入改为选择退出，就可以在不增加成本的情况下改善以患者为中心的治疗效果。使用综合电子健康记录在11家医院招募65岁及以上的患者。作为一项旨在招募12000至15000名患者的务实试验，使用经过验证的基于电子健康记录的算法确定 eligibility，并通过电子健康记录和计费系统数据获取所有结局。每家医院从对照的选择加入姑息治疗咨询过渡到干预的选择退出咨询的时间是随机分配的。主要结局是住院死亡率和住院时间的综合指标。次要结局包括姑息治疗过程指标以及临床和经济结局。该临床试验已在www.clinicaltrials.gov注册（NCT02505035）。 （注：原文中“eligibility”未翻译，可能是有拼写错误，推测应为“eligibility”，意为“资格” ）
