Clinical Trials Directory

Trials / Enrolling By Invitation

Enrolling By InvitationNCT07224594

Comparing Optimized Models of Primary And Specialist Services for Palliative Care

Status
Enrolling By Invitation
Phase
N/A
Study type
Interventional
Enrollment
78,302 (estimated)
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 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

Interventions

TypeNameDescription
BEHAVIORALDefault OrderA 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.
BEHAVIORALAccountable JustificationAn 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.
BEHAVIORALStandardized Usual CareHigh-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.

Timeline

Start date
2026-02-16
Primary completion
2029-11-01
Completion
2030-07-31
First posted
2025-11-04
Last updated
2026-03-12

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT07224594. Inclusion in this directory is not an endorsement.