Comparing Optimized Models of Primary And Specialist Services for Palliative Care: Pilot Feasibility Trial

NCT06629142 | Completed DMC

• 2 other identifiers: 100917710PLACER-2022C3-30553
• Study Type: interventional
• Target: 1,208
• Locations: 1 country
• Sites: 2

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.

Conditions

Seriously Ill Hospitalized Patients

Keywords

Palliative

Outcome Measures

Primary Outcomes (1)

• Appropriate Firings of All Our Practice Advisory (OPA) Interventions

  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.

  36 to 60 hours post admission

Secondary Outcomes (7)

• 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

Study Arms (3)

Standardized Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Standardized Usual Care

Trained Generalist Palliative Care

EXPERIMENTAL

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.

Behavioral: Default Order; Behavioral: Accountable Justification

Specialist Palliative Care

EXPERIMENTAL

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.

Behavioral: Default Order

Interventions

Default Order BEHAVIORAL

A specialist PC consult is automatically ordered for patients meeting a certain threshold of 1-year mortality risk (dependent on arm). An EHR-based Our Practice Advisory (OPA) alert on Open Chart informs clinicians when the default order will become active, and how to cancel an order within 24 hours if they elect to do so.

Specialist Palliative Care; Trained Generalist Palliative Care

Accountable Justification BEHAVIORAL

An EHR-based Our Practice Advisory alert asks generalist clinicians to self-report whether they have provided primary PC by clicking which of 4 key PC domains they have addressed or to provide a brief justification as to why not.

Trained Generalist Palliative Care

Standardized Usual Care BEHAVIORAL

Moderately high-risk patients (e.g., with a 1-year mortality risk between 60% and 94%) will receive usual care. For very high-risk patients (e.g., with a 1-year mortality risk of ≥ 95%), an EHR-based Our Practice Advisory (OPA) alert on Open Chart informs clinicians when the default order will become active, and how to cancel an order within 24 hours if they elect to do so.

Standardized Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Duke Clinical Research Institute: collaborator

Study Sites (2)

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

Location

Trinity Health

Livonia, Michigan, 48152, United States

Location

Study Officials

• Katherine Courtright, MD, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Scott Halpern, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics & Health Policy

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 8, 2024
• Study Start: October 17, 2024
• Primary Completion: April 30, 2025
• Study Completion: July 1, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

US (2)