Comparing Optimized Models of Primary And Specialist Services for Palliative Care: Pilot Feasibility Trial
- Conditions
- Seriously Ill Hospitalized Patients
- Interventions
- Behavioral: Standardized Usual CareBehavioral: Default OrderBehavioral: Accountable Justification
- Registration Number
- NCT06629142
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 540
- Age 18 years of age or older; AND
- Predicted 1-year mortality risk of 60% or greater; AND
- Admitted to a study hospital.
- Patients who die or have an active or completed discharge order prior to enrollment time
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standardized Usual Care 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. Trained Generalist Palliative Care Default Order 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. Trained Generalist Palliative Care Accountable Justification 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. Specialist Palliative Care Default Order 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.
- Primary Outcome Measures
Name Time Method Appropriate Firings of All Our Practice Advisory (OPA) Interventions 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.
- Secondary Outcome Measures
Name Time Method Patient-Reported Outcome (PRO) Survey Response Rate at 1 month Enrollment - 1 month post-discharge Percentage of 1-month PRO surveys completed by alive patients or their surrogate proxies
PRO Survey Response Rate at 3 months Enrollment - 3 months post-discharge Percentage of 3-month PRO surveys completed by alive patients or their surrogate proxies
Default Specialist PC Consults 36 hours to 170 hours post admission Percentage of default specialist PC orders that resulted in an inpatient PC consult before hospital discharge
Default Specialist PC Order Cancellation Rate 36 hours to 60 hours post admission Percentage of default specialist PC orders in which a generalist clinician indicated they did not want the order to proceed.
Inappropriate Our Practice Advisory (OPA) Firings 0 to 60 hours post admission Percentage of all patient encounters in whom at least one Our Practice Advisory (OPA) fired inappropriately. This includes an OPA firing outside the allowed time window on a patient who is eligible, the firing of the wrong OPA on a patient who is eligible (e.g., firing of the Generalist PC OPA for a patient in the Specialist PC arm), and the firing of any OPA on a patient who is ineligible (e.g., who has an inappropriate mortality risk score or active discharge order at the time enrollment eligibility is assessed).
Generalist PC Training Completion Baseline Percentage of clinicians eligible for CAPC palliative care training in the Generalist PC arm who complete the 4 required training modules. Partial completion (1-3 required modules) and completion of optional CAPC modules will be secondarily reported.
Generalist PC Domain Completion 36 hours to 60 hours post admission Percentage of clinicians in the Generalist PC arm who say they are addressing patients' PC needs during the current encounter, and of those, the percentage who document at least 1 of 4 PC Domains in the EHR Our Practice Advisory Alert
Trial Locations
- Locations (2)
Kaiser Permanente Southern California
🇺🇸Pasadena, California, United States
Trinity Health
🇺🇸Livonia, Michigan, United States