An Advance Care Planning Intervention in the Emergency Department: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month
研究概览
简要总结
This is a two-armed, parallel-design, pre-/post-intervention assessment study. The investigators will conduct a randomized controlled trial for ED GOAL on a cohort of 120 older adults with serious illness to collect patient-centered outcomes and determine preliminary efficacy on increasing advance care planning engagement (self-reported and/or in the electronic medical record) one month after leaving the emergency department. The investigators will also conduct qualitative interviews with participants of ED GOAL.
详细描述
ED GOAL, a 6-minute motivational interview conducted in the emergency department (ED), which engages participants to address advance care planning (ACP) conversations with their outpatient clinicians and avoids a time-consuming, sensitive conversation in the time-pressured ED environment. This study is designed to determine the preliminary efficacy of ED GOAL on increasing ACP engagement (by self-report and in the electronic medical record) one month after leaving the ED.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •≥50 years of age AND ≥1 Serious illness* OR ED clinician would not be surprised if patient died in the next 12 months (a validated prognostic sign)
- •English-speaking
- •Capacity to consent
- •Patient with mild cognitive impairment or mild dementia with capacity to consent (requires a caregiver/study partner to enroll)
- •Caregiver of patient with moderate/severe dementia with capacity to consent
- •(*) NYHA Stage III/IV congestive heart failure, chronic obstructive lung disease on home oxygen, chronic kidney disease on dialysis, or metastatic solid tumor cancer. In addition, patients with NYHA Stage I/II congestive heart failure, chronic obstructive lung disease not on home oxygen, chronic kidney disease not on dialysis will be included if recent hospitalization in the last 12 months exists.
排除标准
- •Acute physical or emotional distress
- •Determined by treating or study clinician not to be appropriate
- •Clearly documented goals for medical care** (Unless the treating or study clinician recommends that the intervention is clinically indicated)
- •Delirium (assessed using 3D-CAM)
- •Already enrolled in this study
- •Unable/unwilling to schedule the follow-ups on the calendar
- •Receive both the outpatient care for serious illness and primary care outside of the Mass General Brigham health system
- •(**)e.g., MOLST, medical order for life-sustaining treatment, documented serious illness conversations in clinician notes within the last 3 months, etc.
研究组 & 干预措施
Intervention Arm
The intervention will take place in the emergency department or days after an emergency department visit at home/hospital virtually using zoom or phone by our trained clinicians. At the time of follow-up assessments, participants may also receive additional counseling by our trained clinicians as needed.
干预措施: ED GOAL (Behavioral)
Control Arm
No intervention will be conducted (standard of care).
结局指标
主要结局
Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month
时间窗: Change from baseline ACP engagement at one month
ACP engagement is a one-item question from the validated ACP engagement survey that measures participants' self-reported readiness to discuss their values and preferences with their doctors. The instrument is a 5-point Likert scale ranging from "I have never thought about it (1)" to "I have already done it (5)." A higher score indicates a better outcome. Sudore RL, Heyland DK, Barnes DE, Howard M, Fassbender K, Robinson CA, Boscardin J, You JJ. Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. J Pain Symptom Manage. 2017 Apr;53(4):669-681.e8. doi: 10.1016/j.jpainsymman.2016.10.367. Epub 2016 Dec 29. PMID: 28042072; PMCID: PMC5730058.
次要结局
- Healthcare Utilization(At 6 and 12 months before and 1, 6, 12 months after enrollment)
- Mortality(At 1, 3, and 6 months)
- Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL(At 1, 3, and/or 6 months)
- Electronic Medical Record Documentation of Advance Care Planning (ACP) Conversations(At 1, 3, and 6 months)
- Change in Advance Care Planning (ACP) Engagement With Clinicians at Three Months(Change from baseline ACP engagement at three months)
- Change in Advance Care Planning (ACP) Engagement With Clinicians at Six Months(Change from baseline ACP engagement at six months)
- Participant-reported Completion of Advance Care Planning (ACP) Conversations(At 1, 3, and 6 months)
- Feeling Heard and Understood Survey(Surveys were done at baseline and once at 1, 3, or 6 months. If participants reported discussing end-of-life wishes with their doctor during a follow-up, the survey was given then or at 6 months, whichever came first. Follow-up results were summed.)
- Quality of Communication Survey(Baseline & 1, 3, or 6 months (same as Outcome 2). Additionally, the baseline questionnaire was asked with respect to the study clinician, whereas the follow-up was asked with respect to the primary doctor. Thus, only the follow-up value is reported.)
研究者
Kei Ouchi
Assistant Professor of Emergency Medicine
Brigham and Women's Hospital