Comparing Optimized Models of Primary And Specialist Services for Palliative Care (COMPASS-PC)

University of Pennsylvania

Status: Not yet enrolling

Conditions: Seriously Ill Hospitalized Patients

Treatments: Behavioral: Default Order; Behavioral: Accountable Justification; Behavioral: Standardized Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07224594

855378

PLACER-2022C3-30553 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 78,302 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78,302 participants in 3 patient groups

Standardized Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standardized Usual Care

Trained Generalist Palliative Care

Experimental group

Description:

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.

Treatment:

Behavioral: Accountable Justification

Behavioral: Default Order

Specialist Palliative Care

Experimental group

Description:

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.

Treatment:

Behavioral: Default Order