Comparing Optimized Models of Primary And Specialist Services for Palliative Care

NCT07224594 | Enrolling By Invitation DMC

• 2 other identifiers: 855378PLACER-2022C3-30553
• Study Type: interventional
• Target: 78,302
• 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 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.

Conditions

Seriously Ill Hospitalized Patients

Keywords

Palliative

Outcome Measures

Primary Outcomes (1)

• Hospital free days

  Count of days from enrollment spent alive outside of an acute care hospital through 182 days.

  Enrollment- 182 days.

Secondary Outcomes (15)

• 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

• Goal concordant care

  1-month post-enrollment

• Social interaction

  1-month post-enrollment

Other Outcomes (1)

• End-of-Life Care

  3 months post-patient death

Study Arms (3)

Standardized Usual Care

ACTIVE COMPARATOR

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.

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 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.

Behavioral: Default Order; Behavioral: Accountable Justification

Specialist Palliative Care

EXPERIMENTAL

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.

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

High-risk patients (i.e., with a 1-year mortality risk between 70% and 94%) will receive usual care. For very high-risk patients (i.e., 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 70% 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 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

Sponsors & Collaborators

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

Study Sites (2)

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

Location

Trinity Health

Livonia, Michigan, 48152, United States

Location

Study Officials

• Scott Halpern, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Katherine Courtright, MD, MS

  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: October 24, 2025
• First Posted: November 4, 2025
• Study Start: February 16, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): July 31, 2030
• Last Updated: March 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The IPD and supporting information will be available between 3 and 6 months after the study completion date, and will be available on the Patient Centered Outcomes Data Repository in line with PCORI's policies for data retention.
• Access Criteria: Applicants will follow the guidelines as set out on the Patient Centered Outcomes Data Repository for accessing this data set.

Locations

US (2)