Duke University, Durham, North Carolina (C.E.C., D.M.J.).
University of Pittsburgh, Pittsburgh, Pennsylvania (D.B.W., J.M.K.).
Ann Intern Med. 2019 Mar 5;170(5):285-297. doi: 10.7326/M18-2335. Epub 2019 Jan 29.
Treatment decisions commonly have to be made in intensive care units (ICUs). These decisions are difficult for surrogate decision makers and often lead to decisional conflict, psychological distress, and treatments misaligned with patient preferences.
To determine whether a decision aid about prolonged mechanical ventilation improved prognostic concordance between surrogate decision makers and clinicians compared with a usual care control.
Multicenter, parallel, randomized, clinical trial. (ClinicalTrials.gov: NCT01751061).
13 medical and surgical ICUs at 5 hospitals.
Adult patients receiving prolonged mechanical ventilation and their surrogates, ICU physicians, and ICU nurses.
A Web-based decision aid provided personalized prognostic estimates, explained treatment options, and interactively clarified patient values to inform a family meeting. The control group received information according to usual care practices followed by a family meeting.
The primary outcome was improved concordance on 1-year survival estimates, measured with the clinician-surrogate concordance scale (range, 0 to 100 percentage points; higher scores indicate more discordance). Secondary and additional outcomes assessed the experiences of surrogates (psychological distress, decisional conflict, and quality of communication) and patients (length of stay and 6-month mortality). Outcomes assessors were blinded to group allocation.
The study enrolled 277 patients, 416 surrogates, and 427 clinicians. Concordance improvement did not differ between intervention and control groups (mean difference in score change from baseline, -1.7 percentage points [95% CI, -8.3 to 4.8 percentage points]; P = 0.60). Surrogates' postintervention estimates of patients' 1-year prognoses did not differ between intervention and control groups (median, 86.0% [interquartile range {IQR}, 50.0%] vs. 92.5% [IQR, 47.0%]; P = 0.23) and were substantially more optimistic than results of a validated prediction model (median, 56.0% [IQR, 43.0%]) and physician estimates (median, 50.0% [IQR, 55.5%]). Eighty-two intervention surrogates (43%) favored a treatment option that was more aggressive than their report of patient preferences. Although intervention surrogates had greater reduction in decisional conflict than control surrogates (mean difference in change from baseline, 0.4 points [CI, 0.0 to 0.7 points]; P = 0.041), other surrogate and patient outcomes did not differ.
Contamination among clinicians could have biased results toward the null hypothesis.
A decision aid about prolonged mechanical ventilation did not improve prognostic concordance between clinicians and surrogates, reduce psychological distress among surrogates, or alter clinical outcomes. Decision support in acute care settings may require greater individualized attention for both the cognitive and affective challenges of decision making.
National Institutes of Health.
在重症监护病房(ICU)中,经常需要做出治疗决策。这些决策对替代决策者来说很困难,往往会导致决策冲突、心理困扰以及治疗与患者偏好不符。
确定与常规护理对照组相比,一种关于延长机械通气的决策辅助工具是否能提高替代决策者和临床医生之间的预后一致性。
多中心、平行、随机临床试验。(ClinicalTrials.gov:NCT01751061)。
5 家医院的 13 个内科和外科 ICU。
接受延长机械通气的成年患者及其替代决策者、ICU 医生和 ICU 护士。
一个基于网络的决策辅助工具提供了个性化的预后估计,解释了治疗选择,并通过家庭会议交互式澄清了患者的价值观。对照组根据常规护理实践接受信息,然后进行家庭会议。
主要结局是使用临床医生-替代决策者一致性量表(范围为 0 至 100 个百分点;得分越高表示差异越大)来衡量 1 年生存率估计的改善一致性。次要和附加结局评估了替代决策者的体验(心理困扰、决策冲突和沟通质量)和患者的体验(住院时间和 6 个月死亡率)。结局评估者对分组分配情况不知情。
该研究纳入了 277 名患者、416 名替代决策者和 427 名临床医生。干预组和对照组的一致性改善没有差异(从基线变化的平均差异分数,-1.7 个百分点[95%置信区间,-8.3 至 4.8 个百分点];P=0.60)。干预组和对照组的替代决策者在干预后的患者 1 年预后估计没有差异(中位数,86.0%[四分位距{IQR},50.0%]与 92.5%[IQR,47.0%];P=0.23),且比验证后的预测模型(中位数,56.0%[IQR,43.0%])和医生估计(中位数,50.0%[IQR,55.5%])的结果更为乐观。82 名干预替代决策者(43%)选择了比他们报告的患者偏好更激进的治疗方案。尽管干预组的替代决策者的决策冲突比对照组的替代决策者的决策冲突减少了更多(从基线变化的平均差异分数,0.4 分[CI,0.0 至 0.7 分];P=0.041),但其他替代决策者和患者的结局没有差异。
临床医生之间的交叉污染可能使结果偏向于无效假设。
关于延长机械通气的决策辅助工具并没有提高临床医生和替代决策者之间的预后一致性,也没有减少替代决策者的心理困扰,或改变临床结局。急性护理环境中的决策支持可能需要对认知和情感决策挑战给予更大的个性化关注。
美国国立卫生研究院。