Comparing Optimized Models of Primary And Specialist Services for Palliative Care

NCT ID: NCT07224594

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2030-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standardized Usual Care

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.

Group Type: ACTIVE_COMPARATOR

Standardized Usual Care

Intervention Type: 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.

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 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.

Group Type: EXPERIMENTAL

Default Order

Intervention Type: 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.

Accountable Justification

Intervention Type: 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.

Specialist Palliative Care

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.

Group Type: EXPERIMENTAL

Default Order

Intervention Type: 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.

Interventions

Default Order

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.

Intervention Type: BEHAVIORAL

Accountable Justification

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.

Intervention Type: BEHAVIORAL

Standardized Usual Care

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18 years of age or older; AND Predicted 1-year mortality risk of 70% 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke Clinical Research Institute

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Scott Halpern

John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics & Health Policy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott Halpern, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Katherine Courtright, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Kaiser Permanente Southern California

Pasadena, California, United States

Trinity Health

Livonia, Michigan, United States

Countries

United States

Central Contacts

Vanessa Madden, B.S.

Role: CONTACT

COMPASS-PC@pennmedicine.upenn.edu

(215) 746-4923

Dorothy Sheu, MPH

Role: CONTACT

dorothy.sheu@pennmedicine.upenn.edu

3014613385

Other Identifiers

PLACER-2022C3-30553

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

855378

Identifier Type: -

Identifier Source: org_study_id