Nudging Effective and Equitable Delivery of Specialty Palliative Care

NCT ID: NCT06596577

Last Updated: 2025-11-10

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

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

18000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-06

Study Completion Date

2029-03-31

Brief Summary

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This stepped-wedge, cluster randomized pragmatic trial among 9 MedStar hospitals for patients with serious illness and unmet palliative care (PC) needs will test two interventions embedded within the electronic health record (EHR): (1) a PC needs triggered alert to opt-in to PC consults nudging hospital clinicians to order specialty PC consults for eligible inpatients, and (2) a palliative care needs triggered alert with an opt-out to palliative care consults. The trial will compare the interventions effects to usual care, focusing on completed PC consults during the hospital encounter and other secondary outcomes. The trial also includes an embedded mixed methods study to explore factors influencing the effectiveness and equity of intervention implementation.

Detailed Description

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Conditions

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Serious Illness Palliative

Keywords

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Palliative Care Pragmatic Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Palliative care needs information provision

Clinicians will receive an EHR alert providing information about a patient's serious illness diagnosis(-es) and unmet palliative care needs

Group Type ACTIVE_COMPARATOR

Palliative care needs information

Intervention Type BEHAVIORAL

clinician-directed EHR alert providing information about serious illness diagnosis(-es) and unmet palliative care needs

Palliative care needs information provision + default consult order

The palliative care needs information provision intervention will be supplemented with a default palliative care consult order such that clinicians will receive an EHR alert providing information about a patient's serious illness diagnosis(-es) and unmet palliative care needs, and offered the choice to cancel the default consult order.

Group Type ACTIVE_COMPARATOR

Default consult order

Intervention Type BEHAVIORAL

clinician-directed EHR alert providing information about serious illness diagnosis(-es) and unmet palliative care needs + a choice to cancel the default palliative care consult order

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. All hospitals will contribute a minimum of 9 weeks of outcomes data prior to adopting the intervention. The total duration of the control phase will differ for each hospital dependent on their randomly assigned time to adopt Intervention 1 in this stepped-wedge trial design.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Palliative care needs information

clinician-directed EHR alert providing information about serious illness diagnosis(-es) and unmet palliative care needs

Intervention Type BEHAVIORAL

Default consult order

clinician-directed EHR alert providing information about serious illness diagnosis(-es) and unmet palliative care needs + a choice to cancel the default palliative care consult order

Intervention Type BEHAVIORAL

Other Intervention Names

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PC needs information

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or older; AND
2. Admitted to inpatient status at 1 of the 9 participating hospitals
3. Meets validated score threshold of 8 from the MedStar unmet PC needs patient identification algorithm, utilizing empirically-derived weights for each PC need domain within the algorithm.

Exclusion Criteria

1. Primary inpatient service: hospice, rehabilitation, psychiatry, obstetrics, neonatal
2. Signed hospital discharge order
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

Medstar Health Research Institute

OTHER

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 Courtright, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Michael Harhay, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

MedStar Washington Health Center

Washington D.C., District of Columbia, United States

Site Status

MedStar Union Memorial Hospital

Baltimore, Maryland, United States

Site Status

MedStar Harbor Hospital

Baltimore, Maryland, United States

Site Status

MedStar Franklin Square Medical Center

Baltimore, Maryland, United States

Site Status

MedStar Good Samaritan Hospital

Baltimore, Maryland, United States

Site Status

MedStar Southern Maryland Hospital Center

Clinton, Maryland, United States

Site Status

MedStar St. Mary's Hospital

Leonardtown, Maryland, United States

Site Status

MedStar Montgomery Medical Center

Olney, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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1R01AG082874-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

856359

Identifier Type: -

Identifier Source: org_study_id