A Randomized Clinical Trial of Scenario Planning for Older Adults With Serious Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 7,600
- 试验地点
- 16
- 主要终点
- Family-reported Quality of Communication (QOC) within 5-7 days of ICU admission
研究概览
简要总结
The purpose of this study is to test the effectiveness of the Best Case/Worst Case-ICU communication tool on quality of communication, clinician moral distress, and ICU length of stay for older adults with serious traumatic injury. Investigators will follow an estimated 4500 patients aged 50 years and older who are in the ICU for 3 or more days and survey 1500 family members and up to 1600 clinicians from 8 sites nationwide.
详细描述
This is a multisite, stepped-wedge, randomized clinical trial. At the start of the study, investigators will randomly assign each site to the time when the intervention team will train all trauma surgeons, trainees, and ICU clinicians to use the Best Case/Worst Case-ICU tool. Participants in the intervention group will receive care from a trauma team that routinely uses the Best Case/Worst Case-ICU communication tool. Participants in the control group will receive usual care.
The study team will follow an estimated 4,500 patients with the highest post-injury mortality: aged 50 years and older with an ICU length of stay of 3 or more days. They will administer surveys to family members (quality of communication) and clinicians (moral distress) and obtain patient-level outcomes (ICU length of stay (LOS)), clinical data, and demographics from the Trauma Quality Improvement Program (TQIP) national registry.
Objectives:
- Aim 1: To test the effectiveness of the Best Case/Worst Case-ICU communication tool on improving the quality of communication in the trauma ICU.
- Aim 2: To test the effectiveness of the Best Case/Worst Case-ICU communication tool on reducing clinician moral distress in the ICU.
- Aim 3: To test the effectiveness of the Best Case/Worst Case-ICU communication tool on reducing ICU length of stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 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
- •Inclusion Criteria:
- •aged 50 and older
- •admitted to the ICU for 3 or more days after serious injury
排除标准
- •Family Members
- •Inclusion Criteria:
- •aged 18 and older
- •patient's family member or informally designated "like family" or primary surrogate decision maker
- •speak English or Spanish
- •Exclusion Criteria:
- •does not have decision-making capacity
- •Inclusion Criteria:
- •provide care in the trauma ICU (including attending trauma surgeons, fellows, residents, advance practice providers, bedside nurses and medical assistants, respiratory techs and physical therapists, social workers, and chaplains)
- •Exclusion Criteria:
- •do not provide care in the trauma ICU
研究组 & 干预措施
Best Case/Worst Case-ICU Communication Tool
Patients in the intervention group will receive care from a trauma team that routinely uses the Best Case/Worst Case-ICU communication tool.
干预措施: Best Case/Worst Case-ICU Communication Tool (Other)
Usual Care
Prior to implementation of the intervention, patients admitted to the trauma ICU will receive usual care. Usual care typically includes conversations focused on isolated problems, disarticulated from the patient's overall health trajectory. This is typified by the systems-base review, routinely summarizing each patient on rounds where the clinician lists each physiologic system, (e.g., neuro, cardiac, pulmonary…) with an assessment and plan to "fix" each abnormality with a new treatment. Deliberation about how these individual treatments align with patient preferences is typically prompted by major events like failure to liberate from a ventilator or imminent death. This pattern of usual care is well characterized and differs from daily scenario planning with the Best Case/Worst Case-ICU communication tool.
结局指标
主要结局
Family-reported Quality of Communication (QOC) within 5-7 days of ICU admission
时间窗: up to 10 days after patient admission, one-time survey for family members
Family-reported quality of communication will be measured using the 20-item Quality of Communication (QOC) scale. The QOC is a validated self-report instrument. The average composite score will be given with a possible range of 0-10. Higher scores indicate higher perceived quality of communication.
次要结局
- Patient Total Time on Ventilator(during hospitalization, provided by TQIP at study completion (estimated up to 2 years))
- Family-reported proportion of Goal Concordant Care (GCC) at 5-7 days post ICU admission(up to 10 days after patient admission, one-time survey for family members)
- Patient ICU Length of Stay (LOS)(during hospitalization, provided by TQIP at study completion (estimated up to 2 years))
- Family-reported General Quality of Communication (QOC), within 5-7 days of ICU admission(up to 10 days after patient admission, one-time survey for family members)
- Family-reported End-of-Life (EOL) Quality of Communication (QOC), within 5-7 days of ICU admission(up to 10 days after patient admission, one-time survey for family members)
- Clinician-reported Emotional Exhaustion (EE) - Maslach Burnout Inventory (MBI)(3 months prior to each implementation wave and again 12 months later)
- Clinician-reported Depersonalization (DP) - Maslach Burnout Inventory (MBI)(3 months prior to each implementation wave and again 12 months later)
- Clinician-reported Measure of Moral Distress for Healthcare Professionals (MMD-HP)(3 months prior to each implementation wave and again 12 months later)
- Clinician-reported Personal Accomplishment (PA) - Maslach Burnout Inventory (MBI)(3 months prior to each implementation wave and again 12 months later)
- Patient 6-month Mortality(6 months after patient admission, provided by TQIP at study completion (estimated up to 2 years))
- Patient Time to In-hospital Death(during hospitalization, provided by TQIP at study completion (estimated up to 2 years))
- Patient Time to Withdrawal of Life Supporting Treatment(during hospitalization, provided by TQIP at study completion (estimated up to 2 years))