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

NCT ID: NCT05502861

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

16000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-13

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Palliative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

stepped-wedge cluster (at hospital-level) randomized trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Generalist + Specialist palliative care

Intervention Type 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.

Control/Usual Care

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.

Group Type ACTIVE_COMPARATOR

Pre-Intervention phase

Intervention Type BEHAVIORAL

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

Interventions

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Generalist + Specialist palliative care

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.

Intervention Type BEHAVIORAL

Pre-Intervention phase

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Active choice generalist palliative care Usual care

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Katherine Courtright

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katherine R Courtright, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R01AG073384

Identifier Type: NIH

Identifier Source: secondary_id

View Link

848497

Identifier Type: -

Identifier Source: org_study_id

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