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

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.

Study Overview

• Status: Completed
• Conditions: Seriously Ill Hospitalized Patients
• Intervention / Treatment: Behavioral: Standardized Usual Care; Behavioral: Default Order; Behavioral: Accountable Justification

• Study Type: Interventional
• Enrollment (Actual): 1208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91101
      • Kaiser Permanente Southern California
  • Michigan
    • Livonia, Michigan, United States, 48152
      • Trinity Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standardized Usual Care; 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; 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.
Experimental: 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 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; 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.; 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.
Experimental: Specialist Palliative Care; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcome (PRO) Survey Response Rate at 1 month	Percentage of 1-month PRO surveys completed by alive patients or their surrogate proxies	Enrollment - 1 month post-discharge
PRO Survey Response Rate at 3 months	Percentage of 3-month PRO surveys completed by alive patients or their surrogate proxies	Enrollment - 3 months post-discharge
Default Specialist PC Consults	Percentage of default specialist PC orders that resulted in an inpatient PC consult before hospital discharge	36 hours to 170 hours post admission
Default Specialist PC Order Cancellation Rate	Percentage of default specialist PC orders in which a generalist clinician indicated they did not want the order to proceed.	36 hours to 60 hours post admission
Inappropriate Our Practice Advisory (OPA) Firings	Percentage of all patient encounters in whom at least one Our Practice Advisory (OPA) fired inappropriately. This includes an OPA firing outside the allowed time window on a patient who is eligible, the firing of the wrong OPA on a patient who is eligible (e.g., firing of the Generalist PC OPA for a patient in the Specialist PC arm), and the firing of any OPA on a patient who is ineligible (e.g., who has an inappropriate mortality risk score or active discharge order at the time enrollment eligibility is assessed).	0 to 60 hours post admission
Generalist PC Training Completion	Percentage of clinicians eligible for CAPC palliative care training in the Generalist PC arm who complete the 4 required training modules. Partial completion (1-3 required modules) and completion of optional CAPC modules will be secondarily reported.	Baseline
Generalist PC Domain Completion	Percentage of clinicians in the Generalist PC arm who say they are addressing patients' PC needs during the current encounter, and of those, the percentage who document at least 1 of 4 PC Domains in the EHR Our Practice Advisory Alert	36 hours to 60 hours post admission

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Duke Clinical Research Institute
• Investigators: Principal Investigator: Scott Halpern, MD, PhD, University of Pennsylvania; Principal Investigator: Katherine Courtright, MD, MS, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: October 4, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Palliative
• Other Study ID Numbers: 100917710; PLACER-2022C3-30553 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No