Comparing Optimized Models of Primary And Specialist Services for Palliative Care: Pilot Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,208
- 试验地点
- 2
- 主要终点
- Appropriate Firings of All Our Practice Advisory (OPA) Interventions
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 feasibility pilot study will be conducted with 6 hospitals at two large U.S. health systems and enroll 540 seriously ill hospitalized patients. Eligibility is determined by a mortality prediction score where enrolled patients have at least a 60% risk of dying within 1 year. Enrollment assessment occurs as close as possible to 36 hours post admission. In this cluster-randomized trial, the 6 hospitals will be randomized to 3 arms: (1) standardized usual care, (2) trained generalist PC, or (3) specialist PC. Generalists are trained using the Center to Advance Palliative Care (CAPC) online trainings. The pilot study will only measure process outcomes to assess the feasibility of a larger clinical trial (e.g., are the interventions working as intended). This pilot feasibility study is the precursor to a much larger pragmatic, hybrid effectiveness-implementation parallel-cluster RCT that will assess the comparative effectiveness of triggering generalist PC and specialist PC on several patient-centered outcome measures.
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 60% 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
研究组 & 干预措施
Standardized Usual Care
Active control group, where moderately high-risk patients (e.g., with a 1-year mortality risk between 60% and 94%) will receive usual care. A specialist PC consult is ordered by default for the highest-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 moderately high-risk patients ('accountable justification intervention'). A specialist PC consult is ordered by default for the highest-risk patients 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 moderately high-risk patients ('accountable justification intervention'). A specialist PC consult is ordered by default for the highest-risk patients 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 ≥ 60% 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
Appropriate Firings of All Our Practice Advisory (OPA) Interventions
时间窗: 36 to 60 hours post admission
Percentage of all Intervention Our Practice Advisory (OPAs) that fired in the correct time window for patients with mortality risk thresholds eligible for each intervention.
次要结局
- Patient-Reported Outcome (PRO) Survey Response Rate at 1 month(Enrollment - 1 month post-discharge)
- PRO Survey Response Rate at 3 months(Enrollment - 3 months post-discharge)
- Default Specialist PC Consults(36 hours to 170 hours post admission)
- Default Specialist PC Order Cancellation Rate(36 hours to 60 hours post admission)
- Inappropriate Our Practice Advisory (OPA) Firings(0 to 60 hours post admission)
- Generalist PC Training Completion(Baseline)
- Generalist PC Domain Completion(36 hours to 60 hours post admission)
研究者
Scott Halpern
John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics & Health Policy
University of Pennsylvania