Comparing Optimized Models of Primary And Specialist Services for Palliative Care
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 78,302
- 试验地点
- 2
- 主要终点
- Hospital free days
研究概览
简要总结
Palliative care (PC) seeks to reduce suffering and improve quality of life for patients with serious illnesses and their families. National guidelines recommend that clinicians either provide palliative care themselves (generalist PC) or consult experts (specialist PC) as a standard part of serious illness care. This pragmatic clinical trial will be conducted with 48 hospitals at two large U.S. health systems and enroll more than 78,000 seriously ill hospitalized patients. Eligibility is determined by a mortality prediction score where enrolled patients have at least a 70% risk of dying within 1 year. Enrollment assessment occurs as close as possible to 36 hours post admission. The 48 hospitals will be randomized to 3 arms: (1) standardized usual care, (2) trained generalist PC, or (3) specialist PC. Generalist clinicians are trained using the Center to Advance Palliative Care (CAPC) online trainings. This pragmatic, hybrid effectiveness-implementation parallel-cluster RCT will assess the comparative effectiveness of triggering generalist PC and specialist PC on several patient-centered outcome measures, and follows a pilot feasibility study. We will collect Patient-Reported Outcomes (PROs) surveys from a random subset of enrolled patients.
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
- 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
- •Age 18 years of age or older; AND Predicted 1-year mortality risk of 70% or greater; AND Admitted to a study hospital.
排除标准
- •Patients who die or have an active or completed discharge order prior to enrollment time OR
- •Readmission within 182 days of an eligible encounter OR
- •Ineligible service line, with current admission status labeled as: hospice, acute rehabilitation, skilled nursing facility, long-term acute care, psychiatry, obstetrics
研究组 & 干预措施
Standardized Usual Care
Active control group, where high-risk patients (i.e., with a 1-year mortality risk between 70% and 94%) will receive usual care. A specialist PC consult is ordered by default for the very high-risk patients (i.e., 1-year mortality risk ≥ 95%), unless clinicians cancel the order.
干预措施: Standardized Usual Care (Behavioral)
Trained Generalist Palliative Care
Generalist clinicians trained in PC domains receive an EHR-based alert to document whether or not they have addressed PC domains for high-risk patients ('accountable justification intervention'). A specialist PC consult is ordered by default for the very high risk patients (i.e., 1-year mortality risk ≥ 95%) unless clinicians cancel the order.
干预措施: Default Order (Behavioral)
Trained Generalist Palliative Care
Generalist clinicians trained in PC domains receive an EHR-based alert to document whether or not they have addressed PC domains for high-risk patients ('accountable justification intervention'). A specialist PC consult is ordered by default for the very high risk patients (i.e., 1-year mortality risk ≥ 95%) unless clinicians cancel the order.
干预措施: Accountable Justification (Behavioral)
Specialist Palliative Care
A specialist PC consult is ordered by default for all patients with a ≥ 70% 1-year mortality risk ('default order intervention'), unless clinicians cancel the order.
干预措施: Default Order (Behavioral)
结局指标
主要结局
Hospital free days
时间窗: Enrollment- 182 days.
Count of days from enrollment spent alive outside of an acute care hospital through 182 days.
次要结局
- Patient quality of life(1-month, 3-months, and 6-months post-enrollment)
- Clinician communication(1-month post-enrollment)
- Pain management(1-month post-enrollment)
- Social interaction(1-month post-enrollment)
- Loneliness(1-month post-enrollment)
- Hospital free days at 3 months(Enrollment - 3-months post-enrollment)
- Institution free days at 3 months(Enrollment - 3-months post-enrollment)
- Institution free days at 6 months(Enrollment - 6-months post-enrollment)
- 30-day hospital readmissions(Enrollment - 30 days post-enrollment)
- 90-day hospital readmissions(Enrollment - 90 days post-enrollment)
- Community-based palliative care use(Enrollment - 6-months post-enrollment)
- Hospice use(Enrollment - 6-months post-enrollment)
- Change in code status(Enrollment- Discharge from hospital (an average of 7 days))
- Goal concordant care(1-month post-enrollment)
- Time to palliative care consult(Enrollment- Discharge from hospital (an average of 7 days))
研究者
Scott Halpern
John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics & Health Policy
University of Pennsylvania