Shared Decision Making to Improve Goals-of-Care Decisions for Families of Severe Acute Brain Injury Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Recruitment
研究概览
简要总结
Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and disability in adults in the U.S. Due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is the most common cause of death in SABI, but occurs at a highly variable rate (for example in Traumatic Brain Injury (TBI) 45-89%). Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. The investigators have developed a pilot DA for goals-of-care decisions for surrogates of SABI patients. This was developed through qualitative research using semi-structured interviews in surrogate decision makers of TBI patients and physicians. The investigators now propose to pilot-test a DA for surrogates of SABI patients in a feasibility trial.
详细描述
Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and disability in adults in the U.S, accounting for more than 200,000 of the acute brain injury-related deaths in the U.S. annually. Patients with SABI are critically ill and most commonly require mechanical ventilation and supportive medical care with artificial nutrition to ensure survival. However, due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is by far the most common cause of death in SABI but occurs at a highly variable rate (for example in TBI 45-90%) at different trauma centers. Shared decision making is a collaborative process that enhances patients' and surrogates' understanding about prognosis, encourages them to actively weigh the risks and benefits of a treatment, and to match them to patient preferences, thereby decreasing decisional conflict and improving decision quality and health related outcomes. Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. No DA currently exists for goals-of-care decisions in SABI. Such a patient- and family-centered DA has the potential to improve decision-making for SABI patients by ensuring proxies receive consistent, evidence-based prognostication while also addressing patients' preferences and values. The investigators have developed a pilot DA for goals of care decisions by surrogates of SABI patients using qualitative research using semi-structured interviews in surrogate decision makers of TBI patients and physicians, followed by an iterative feedback process with feedback by surrogates, physicians, and other stakeholders (ICU nurses). The investigators now propose to pilot-test a DA for surrogates of SABI patients in a feasibility trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age; no upper age limit
- •Documented health care proxy or legal next of kin of admitted SABI patient with traumatic brain injury, intracerebral hemorrhage or acute ischemic stroke.
- •≥3 days after insult ("stabilization period"); clinical team may ask study team to wait longer if clinically indicated
- •SABI patient remains "critically ill" after 3 days defined as: either intubated and mechanically ventilated, or unable to swallow, needing feeding tube beyond hospital discharge (even if not intubated)
- •Surrogate is physically present in ICU to receive decision aid and participate in planned family meeting in person (not over phone)
排除标准
- •Devastating SABI near death
- •Patient will be extubated and pass swallow evaluation (as deemed by clinical team)
- •Surrogate is non-English speaking and no interpreter available to translate decision aid (no available validated, translated decision aid version)
- •Surrogate is illiterate
结局指标
主要结局
Recruitment
时间窗: From date of approaching surrogate decision maker for consent until the date of the first documented goals-of-care family meeting, assessed up to 1 month after admission.
Consent rate
Participation
时间窗: 1-36 hours after family meeting
Proportion of participants who read decision aid and completed worksheet
Retention
时间窗: 3 months
Number of participants who complete follow-up
次要结局
- Clinician-surrogate concordance scale score(Baseline and 1-36 hours after family meeting)
- AIS/Intracerebral Hemorrhage (ICH)/Traumatic Brain Injury (TBI) knowledge test(Baseline and 1-36 hours after family meeting)
- Hospital Anxiety and Depression Scale (HADS)(Baseline,1-36 hours after family meeting, and 3-months)
- Impact of Events Scale-revised(Baseline,1-36 hours after family meeting, and 3-months)
- Decision Self-Efficacy Scale(1-36 hours after family meeting)
- Decisional Conflict Scale(1-36 hours after family meeting)
- Cumulative duration of the goals-of-care family meetings(1-36 hours after family meeting)
- Total number of goals-of-care family meetings(1-36 hours after family meeting)
- Patient's survival status(3-months after goals of care decision)
- Patient-Perceived Centeredness of Care Scale(1-36 hours after family meeting)
- Patient's modified Rankin Scale(3-months after goals of care decision)
- Surrogate Decision Regret Scale(3-months after goals of care decision)
- Quality of Communications Scale(1-36 hours after family meeting)
- Patient's Glasgow Outcome Scale(3-months after goals of care decision)
研究者
Susanne Muehlschlegel
Associate Professor of Neurocritical Care
University of Massachusetts, Worcester