NCT06629142

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,208 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Seriously Ill Hospitalized Patients

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-10-17
• Primary completion: 2025-04-30
• Completion: 2025-07-01
• First posted: 2024-10-08
• Last updated: 2025-07-24

Locations

2 sites across 1 country: United States