A Pragmatic Trial of an Active Choice Nudge for Generalist or Specialist Palliative Care for Seriously Ill Inpatients

NCT05502861 | Active Not Recruiting DMC

• 2 other identifiers: 848497R01AG073384
• Study Type: interventional
• Target: 18,884
• Locations: 1 country
• Sites: 1

Brief Summary

This stepped-wedge, cluster-randomized pragmatic trial among six hospitals at University of Pennsylvania Health System will test a behavioral intervention embedded within the electronic health record that nudges hospital clinicians to either provide palliative care (PC) themselves (generalist PC) or consult specialists (specialty PC) for inpatients at high risk of death within 6 months. The trial will evaluate the intervention's effect compared to usual care on the primary outcome of hospital-free days through 6 months, and other patient-centered, clinical, and economic outcomes. The trial also includes an embedded mixed methods study to understand clinician and hospital contextual factors that influence the intervention's uptake.

Conditions

Palliative Care

Keywords

Palliative Care, Pragmatic Trial

Outcome Measures

Primary Outcomes (1)

• Hospital-free days

  Days from enrollment spent alive and not in an acute care hospital through 6 months or death

  6 months

Secondary Outcomes (20)

• Goals of Care (GOC) conversation within a discrete GOC note type

  up to 6 weeks

• Pain scores

  up to 6 weeks

• Palliative care consultation note

  up to 6 weeks

• Time to palliative care consult

  up to 6 weeks

• Change in code status found in chart documentation

  up to 6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The study's intervention is a prognostic-triggered EHR alert to nudge clinicians to provide generalist or specialist PC. The alert notifies the clinician that the patient is likely to benefit from PC, and requires clinicians to actively choose to provide generalist PC themselves, consult PC specialist, or to defer PC. If a clinician chooses to consult specialist PC, a second alert will fire that enables them to easily and quickly place the consult order. The alert will trigger for all patients with moderate or higher 6-month mortality risk on second full hospital day at 8AM.

Behavioral: Generalist + Specialist palliative care

Control/Usual Care

ACTIVE COMPARATOR

During the control phase, patients meeting eligibility criteria will be enrolled for study data collection but there will be no attempt to influence delivery of care. The length of the control phase will differ at each hospital dependent on the sequence in which hospitals are randomly assigned to switch to the intervention phase. All hospitals contribute a minimum of 15 weeks of outcomes data prior to adopting the intervention.

Behavioral: Pre-Intervention phase

Interventions

Generalist + Specialist palliative care BEHAVIORAL

Clinicians are alerted in the EHR to make an active choice whether to provide generalist palliative care themselves, consult PC specialist, or to defer PC at that time.

Also known as: Active choice generalist palliative care

Intervention

Pre-Intervention phase BEHAVIORAL

Patients meeting eligibility criteria will be enrolled for study data collection but there will be no attempt to influence delivery of care.

Also known as: Usual care

Control/Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Inpatient or observation admission status at a study hospital
• Predicted 6-month mortality risk moderate (e.g., ≥40%) or higher

You may not qualify if:

• Under 18 years of age
• Inpatient primary service: hospice, rehabilitation, obstetrics, psychiatry
• Patients that have died or been discharged before 0800 on hospital day 3 when the mortality risk is generated and enrollment occurs

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

General Practitioners

Intervention Hierarchy (Ancestors)

Physicians; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Katherine R Courtright, MD, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: stepped-wedge cluster (at hospital-level) randomized trial

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 16, 2022
• Study Start: November 13, 2023
• Primary Completion: May 17, 2026
• Study Completion: May 17, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 9 months after publication and up to 36 months following publication. After 36 months the data will be available in our University's data warehouse but without support, except for deposited metadata.
• Access Criteria: Proposals for data use will be reviewed by Principal Investigator and independent review boards (such as Institutional Review Board and Data Safety and Monitoring Board). Approved data requestors will need to sign data use agreements to access and use data

Locations

US (1)