NCT06596577

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,000

participants targeted

Target at P75+ for phase_3

Timeline
34mo left

Started Aug 2025

Typical duration for phase_3

Geographic Reach
1 country

9 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Aug 2025Feb 2029

First Submitted

Initial submission to the registry

September 5, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

August 6, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

April 30, 2026

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

September 5, 2024

Last Update Submit

April 29, 2026

Conditions

Serious IllnessPalliative

Keywords

Palliative CarePragmatic Trial

Outcome Measures

Primary Outcomes (1)

  • Inpatient palliative care consultation

    Binary: at least 1 inpatient visit from a PC specialist during the hospital encounter

    from enrollment up to 26 weeks

Secondary Outcomes (11)

  • Hospice enrollment

    enrollment through 6 months

  • Hospice duration

    enrollment through 6 months

  • Community palliative care referral

    enrollment through 6 months

  • Hospital all-cause mortality

    enrollment to 1 day after hospital discharge

  • 30-day hospital readmission

    hospital discharge through 30 days

  • +6 more secondary outcomes

Study Arms (3)

Palliative care needs information provision

ACTIVE COMPARATOR

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

Behavioral: Palliative care needs information

Palliative care needs information provision + default consult order

ACTIVE COMPARATOR

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.

Behavioral: Default consult order

Control/Usual Care

NO INTERVENTION

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.

Interventions

Palliative care needs informationBEHAVIORAL

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

Also known as: PC needs information
Palliative care needs information provision
Default consult orderBEHAVIORAL

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

Palliative care needs information provision + default consult order

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older; AND
  • Admitted to inpatient status at 1 of the 9 participating hospitals
  • 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.

You may not qualify if:

  • Primary inpatient service: hospice, rehabilitation, psychiatry, obstetrics, neonatal
  • Signed hospital discharge order

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MedStar Washington Health Center

Washington D.C., District of Columbia, 20010, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

MedStar Harbor Hospital

Baltimore, Maryland, 21225, United States

Location

MedStar Franklin Square Medical Center

Baltimore, Maryland, 21237, United States

Location

MedStar Good Samaritan Hospital

Baltimore, Maryland, 21239 ·, United States

Location

MedStar Southern Maryland Hospital Center

Clinton, Maryland, 20735, United States

Location

MedStar St. Mary's Hospital

Leonardtown, Maryland, 20650, United States

Location

MedStar Montgomery Medical Center

Olney, Maryland, 20832, United States

Location

Study Officials

  • Katherine Courtright, MD, MS

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Michael Harhay, PhD, MPH

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
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

Study Record Dates

First Submitted

September 5, 2024

First Posted

September 19, 2024

Study Start

August 6, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

February 28, 2029

Last Updated

April 30, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Individual participant data will be made available to researchers upon request and approval by the study investigators of a valid research proposal.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Individual participant data generated from this project will be made available no later than 1 year after publication of the primary trial manuscript.
Access Criteria
Proposals for data use will be reviewed by Principal Investigator and independent review boards (such as Institutional Review Board, Data Safety and Monitoring Board, and a Stakeholder Advisory Committee). Approved data requestors will need to sign data use agreements to access and use de-identified data.

Locations

US(9)