Benoit Dominique D, De Pauw Aglaja, Jacobs Celine, Moors Ine, Offner Fritz, Velghe Anja, Van Den Noortgate Nele, Depuydt Pieter, Druwé Patrick, Hemelsoet Dimitri, Meurs Alfred, Malotaux Jiska, Van Biesen Wim, Verbeke Francis, Derom Eric, Stevens Dieter, De Pauw Michel, Tromp Fiona, Van Vlierberghe Hans, Callebout Eduard, Goethals Katrijn, Lievrouw An, Liu Limin, Manesse Frank, Vanheule Stijn, Piers Ruth
Faculty of Medicine and Health Care Sciences, Ghent University, Ghent, Belgium.
Department of Intensive Care Medicine, Ghent University Hospital, Ghent, Belgium.
Intensive Care Med. 2024 Oct;50(10):1635-1646. doi: 10.1007/s00134-024-07588-0. Epub 2024 Sep 4.
The aim of this study was to assess whether coaching doctors to enhance ethical decision-making in teams improves (1) goal-oriented care operationalized via written do-not-intubate and do-not attempt cardiopulmonary resuscitation (DNI-DNACPR) orders in adult patients potentially receiving excessive treatment (PET) during their first hospital stay and (2) the quality of the ethical climate.
We carried out a stepped-wedge cluster randomized controlled trial in the medical intensive care unit (ICU) and 9 referring internal medicine departments of Ghent University Hospital between February 2022 and February 2023. Doctors and nurses in charge of hospitalized patients filled out the ethical decision-making climate questionnaire (ethical decision-making climate questionnaire, EDMCQ) before and after the study, and anonymously identified PET via an electronic alert during the entire study period. All departments were randomly assigned to a 4-month coaching. At least one month of coaching was compared to less than one month coaching and usual care. The first primary endpoint was the incidence of written DNI-DNACPR decisions. The second primary endpoint was the EDMCQ before and after the study period. Because clinicians identified less PET than required to detect a difference in written DNI-DNACPR decisions, a post-hoc analysis on the overall population was performed. To reduce type I errors, we further restricted the analysis to one of our predefined secondary endpoints (mortality up to 1 year).
Of the 442 and 423 clinicians working before and after the study period, respectively 270 (61%) and 261 (61.7%) filled out the EDMCQ. Fifty of the 93 (53.7%) doctors participated in the coaching for a mean (standard deviation [SD]) of 4.36 (2.55) sessions. Of the 7254 patients, 125 (1.7%) were identified as PET, with 16 missing outcome data. Twenty-six of the PET and 624 of the overall population already had a written DNI-DNACPR decision at study entry, resulting in 83 and 6614 patients who were included in the main and post hoc analysis, respectively. The estimated incidence of written DNI-DNACPR decisions in the intervention vs. control arm was, respectively, 29.7% vs. 19.6% (odds ratio 4.24, 95% confidence interval 4.21-4.27; P < 0.001) in PET and 3.4% vs. 1.9% (1.65, 1.12-2.43; P = 0.011) in the overall study population. The estimated mortality at one year was respectively 85% vs. 83.7% (hazard ratio 2.76, 1.26-6.04; P = 0.011) and 14.5% vs. 15.1% (0.89, 0.72-1.09; P = 0.251). The mean difference in EDMCQ before and after the study period was 0.02 points (- 0.18 to 0.23; P = 0.815).
This study suggests that coaching doctors regarding ethical decision-making in teams safely improves goal-oriented care operationalized via written DNI-DNACPR decisions in hospitalized patients, however without concomitantly improving the quality of the ethical climate.
本研究旨在评估指导医生提升团队中的伦理决策能力是否能改善以下两点:(1)通过书面的不插管和不尝试心肺复苏(DNI-DNACPR)医嘱实施的目标导向性照护,这些医嘱针对的是首次住院期间可能接受过度治疗(PET)的成年患者;(2)伦理氛围的质量。
2022年2月至2023年2月期间,我们在根特大学医院的医学重症监护病房(ICU)和9个附属内科科室开展了一项阶梯式楔形整群随机对照试验。负责住院患者的医生和护士在研究前后填写了伦理决策氛围问卷(ethical decision-making climate questionnaire, EDMCQ),并在整个研究期间通过电子警报匿名识别PET患者。所有科室被随机分配接受为期4个月的指导。将至少接受1个月指导的情况与接受少于1个月指导及常规护理的情况进行比较。第一个主要终点是书面DNI-DNACPR决策的发生率。第二个主要终点是研究前后的EDMCQ得分。由于临床医生识别出的PET患者数量少于检测书面DNI-DNACPR决策差异所需的数量,因此对总体人群进行了事后分析。为减少I型错误,我们进一步将分析限制在一个预先定义的次要终点(1年内的死亡率)上。
在研究前后工作的442名和423名临床医生中,分别有270名(61%)和261名(61.7%)填写了EDMCQ。93名医生中有50名(53.7%)参与了指导,平均(标准差[SD])接受了4.36(2.55)次指导。在7254名患者中,125名(1.7%)被识别为PET患者,其中16名患者缺失结局数据。PET患者中有26名以及总体人群中有624名在研究开始时已有书面的DNI-DNACPR决策,分别有83名和6614名患者被纳入主要分析和事后分析。干预组与对照组中书面DNI-DNACPR决策的估计发生率在PET患者中分别为29.7%和19.6%(优势比4.24,95%置信区间4.21 - 4.27;P < 0.001),在总体研究人群中分别为3.4%和1.9%(1.65,1.12 - 2.43;P = 0.011)。1年时的估计死亡率分别为85%和83.7%(风险比2.76,1.26 - 6.04;P = 0.011)以及14.5%和15.1%(0.89,0.72 - 1.09;P = 0.251)。研究前后EDMCQ的平均差异为0.02分(-0.18至0.23;P = 0.815)。
本研究表明,指导医生进行团队中的伦理决策能够安全地改善通过书面DNI-DNACPR决策实施的住院患者的目标导向性照护,然而并未同时改善伦理氛围的质量。