From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.
Neurology. 2020 Jul 14;95(2):e179-e193. doi: 10.1212/WNL.0000000000009770. Epub 2020 Jun 17.
To develop and demonstrate early feasibility of a goals-of-care decision aid for surrogates of patients who are critically ill with traumatic brain injury (ciTBI) that meets accepted international decision aid guidelines.
We developed the decision aid in 4 stages: (1) qualitative study of goals-of-care communication and decision needs of 36 stakeholders of ciTBI (surrogates and physicians), which informed (2) development of paper-based decision aid with iterative revisions after feedback from 52 stakeholders; (3) acceptability and usability testing in 18 neurologic intensive care unit (neuroICU) family members recruited from 2 neuroICU waiting rooms using validated scales; and (4) open-label, randomized controlled feasibility trial in surrogates of ciTBI. We performed an interim analysis of 16 surrogates of 12 consecutive patients who are ciTBI to confirm early feasibility of the study protocol and report recruitment, participation, and retention rates to date.
The resultant goals-of-care decision aid achieved excellent usability (median System Usability Scale 87.5 [possible range 0-100]) and acceptability (97% graded the tool's content as "good" or "excellent"). Early feasibility of the decision aid and the feasibility trial protocol was demonstrated by high rates of recruitment (73% consented), participation (100%), and retention (100% both after the goals-of-care clinician-family meeting and at 3 months) and complete data for the measurements of all secondary decision-related and behavioral outcomes to date.
Our systematic development process resulted in a novel goals-of-care decision aid for surrogates of patients who are ciTBI with excellent usability, acceptability, and early feasibility in the neuroICU environment, and meets international decision aid standards. This methodology may be a development model for other decision aids in neurology to promote shared decision-making.
开发并展示一种针对创伤性脑损伤(ciTBI)重症患者代理人的目标关怀决策辅助工具,该工具符合国际公认的决策辅助指南,旨在验证其早期应用的可行性。
我们分四个阶段开发了决策辅助工具:(1)对 36 名 ciTBI 利益相关者(包括代理人和医生)的目标关怀沟通和决策需求进行定性研究,为(2)基于文献的决策辅助工具的制定提供了信息,并在 52 名利益相关者的反馈后进行了迭代修订;(3)在 2 个神经重症监护病房(NICU)候诊室招募的 18 名神经 ICU 家属中进行可接受性和可用性测试,使用验证后的量表;(4)在 ciTBI 代理人中进行开放标签、随机对照可行性试验。我们对 12 名连续 ciTBI 患者的 16 名代理人进行了中期分析,以确认研究方案的早期可行性,并报告迄今为止的招募、参与和保留率。
最终的目标关怀决策辅助工具具有出色的可用性(中位数系统可用性量表为 87.5[可能范围为 0-100])和可接受性(97%的人将工具内容评为“好”或“优秀”)。决策辅助工具和可行性试验方案的早期可行性通过高招募率(73%的人同意)、参与率(100%)和保留率(在目标关怀临床医生-家属会议后和 3 个月时均为 100%)以及迄今为止所有次要决策相关和行为结果的测量数据的完整性得以证明。
我们的系统开发过程为 ciTBI 患者的代理人开发了一种新颖的目标关怀决策辅助工具,具有出色的可用性、可接受性,并且在神经 ICU 环境中具有早期可行性,符合国际决策辅助标准。这种方法可能是神经科其他决策辅助工具开发的一种模式,可促进共同决策。