Time-limited Trials in the Emergency Department: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to complete TLT conversations
研究概览
简要总结
A randomized controlled trial of a structured conversation between clinicians and patients/surrogates to facilitate shared decision-making for intensive care use in seriously ill older adults being admitted to the intensive care unit from the emergency department.
详细描述
A randomized controlled trial of a structured conversation between clinicians and patients/surrogates to facilitate shared decision-making for intensive care use (i.e., Time-Limited Trial, TLT) in seriously ill older adults being admitted to the intensive care unit from the emergency department (ED).
The goal is to evaluate the feasibility and acceptability of TLT initiated in the ED for seriously ill older adults who are starting intensive care.
The main questions it aims to answer are:
- Is TLT feasible to be conducted by trained ED clinicians?
- Do patients or their surrogates find TLT acceptable in understanding and respecting their end-of-life care preferences?
Participants will be:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •Physician's eligibility:
- •Inclusion Criteria:
- •Attending physicians, resident physicians, or mid-level providers working in the ED who are willing to be randomized to become the study interventionists.
排除标准
- •Emergency clinicians unwilling to consent and be randomized to intervention TLT training.
- •Patient's eligibility:
- •The subjects will be seriously ill older adults, or their surrogates being cared for by the participating emergency clinicians (both the intervention or control arms). If the emergency clinicians determine that the patient is not able to provide consent due to cognitive impairment, dementia, delirium, or critical illness, the surrogates will participate in the TLT conversations.
- •Inclusion Criteria:
- •≥50 years or older with ≥one serious life-limiting illness* being admitted to the intensive care unit in the ED; or
- •≥75 years or older being admitted to intensive care unit in the ED; or
- •ED clinicians will not be surprised if the patient died in the current hospital admission or in the near future; and
- •English speaking *Serious illness criteria with high one-year mortality are selected based on best practice recommendations such as 1) stage III/IV or metastatic cancer; 2) end-stage renal disease on dialysis; 3) chronic heart/lung disease requiring home oxygen supplementation or experiencing shortness of breath with walking; 4) moderate to severe dementia (surrogate required for enrollment); or 5) ≥2 hospitalizations or ED visits in the past six months.
- •Exclusion Criteria:
- •Unable or unwilling to provide informed consent; or
- •Non-English speaking; or
- •Clinically inappropriate, determined by emergency clinicians, and no surrogate is available
研究组 & 干预措施
Intervention group
Attending physicians, resident physicians, or mid-level providers working in the ED who are willing to be randomized to become the study interventionists.
干预措施: TLT training (Other)
Control group
Attending physicians, resident physicians, or mid-level providers working in the ED who are willing to be randomized to become the study interventionists.
结局指标
主要结局
Time to complete TLT conversations
时间窗: Immediately after the intervention (TLT conversation)
With direct observation, the study team will record how long (e.g., minutes) it takes to complete the TLT conversations by the interventionist ED clinicians.
Patient-reported acceptability of TLT conversations
时间窗: Immediately after the intervention (TLT conversation)
A 5-point Likert scale (i.e., "How acceptable was it for your doctor to talk to you about your expectations for ICU care?" and "How likely would you recommend this conversation for other patients like you?" "Not at all (1)" to "Completely (5)"). A higher score indicates a better outcome.
次要结局
- Intervention fidelity(Immediately after the intervention (TLT conversation))
- Clinician-reported feasibility(Immediately after the intervention (TLT conversation))
- Clinician-reported satisfaction(Immediately after the intervention (TLT conversation))
- Clinician-reported likelihood of recovery(At enrollment)
- EHR documentation by inpatient clinicians(After 24 hours, 48 hours, and 1 week)
- Heard and understood(Immediately after the intervention (TLT conversation))
- Patient-reported end-of-life quality of communication(Immediately after the intervention (TLT conversation))
- Patient-reported likelihood of recovery(At enrollment)
- Needs at the end-of-life screening tool(At enrollment, after 24 hours, after 48 hours, and after 1 week)
- Patient-reported anxiety scale(At enrollment, after 48 hours, and after 1 week)
- Decisional regret scale(After 24 hours, 48 hours, and 1 week)
- The number of days to the first family meeting in ICU(Immediately after patient's discharge or death)
- ICU length of stay (LOS)(Immediately after patient's discharge or death)
- Hospital LOS(Immediately after patient's discharge or death)
- The number of family meetings(Immediately after patient's discharge or death)
- ICU procedures (e.g., CPR, pressors, etc.)(Immediately after patient's discharge or death)
- ICU mortality(Immediately after patient's discharge or death)
- Patterns of hospital disposition(Immediately after patient's discharge or death)
- Rate of hospice utilization(Immediately after patient's discharge or death)
研究者
Kei Ouchi
Associate Professor of Emergency Medicine
Brigham and Women's Hospital