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

University of Pennsylvania

Status: Completed

Conditions: Seriously Ill Hospitalized Patients

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06629142

100917710

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 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.

Enrollment: 1,208 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 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,208 participants in 3 patient groups

Standardized Usual Care

Active Comparator group

Description:

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.

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 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.

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 ≥ 60% 1-year mortality risk ('default order intervention'), unless clinicians cancel the order.

Treatment:

Behavioral: Default Order