Clinical trial NCT06629142: Comparing Optimized Models of Primary And Specialist Services for Palliative Care: Pilot Feasibility Trial
Official title: Comparing Optimized Models of Primary And Specialist Services for Palliative Care: Pilot Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Seriously Ill Hospitalized Patients
Keywords: Palliative
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Duke Clinical Research Institute
First posted: 2024-10-08
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* Age 18 years of age or older; AND
* Predicted 1-year mortality risk of 60% or greater; AND
* Admitted to a study hospital.

Exclusion Criteria:

- Patients who die or have an active or completed discharge order prior to enrollment time

Primary outcomes:
measure: Appropriate Firings of All Our Practice Advisory (OPA) Interventions
timeFrame: 36 to 60 hours post admission
Secondary outcomes:
measure: Patient-Reported Outcome (PRO) Survey Response Rate at 1 month
timeFrame: Enrollment - 1 month post-discharge
measure: PRO Survey Response Rate at 3 months
timeFrame: Enrollment - 3 months post-discharge
measure: Default Specialist PC Consults
timeFrame: 36 hours to 170 hours post admission
measure: Default Specialist PC Order Cancellation Rate
timeFrame: 36 hours to 60 hours post admission
measure: Inappropriate Our Practice Advisory (OPA) Firings
timeFrame: 0 to 60 hours post admission
measure: Generalist PC Training Completion
timeFrame: Baseline
measure: Generalist PC Domain Completion
timeFrame: 36 hours to 60 hours post admission
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Kaiser Permanente Southern California
state: California
city: Livonia
country: United States
facility: Trinity Health
state: Michigan
Study officials:
affiliation: University of Pennsylvania
name: Katherine Courtright, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Scott Halpern, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: