Nudging Effective and Equitable Delivery of Specialty Palliative Care (NEEDS-PC)

Improving the Delivery and Equity of Inpatient Palliative Care: a Hybrid Type I Pragmatic Cluster Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Palliative; Serious Illness
• Intervention / Treatment: Behavioral: Palliative care needs information; Behavioral: Default consult order

• Study Type: Interventional
• Enrollment (Estimated): 18000
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Washington Health Center
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital
    • Baltimore, Maryland, United States, 21225
      • MedStar Harbor Hospital
    • Baltimore, Maryland, United States, 21237
      • Medstar Franklin Square Medical Center
    • Baltimore, Maryland, United States, 21239 ·
      • MedStar Good Samaritan Hospital
    • Clinton, Maryland, United States, 20735
      • MedStar Southern Maryland Hospital Center
    • Leonardtown, Maryland, United States, 20650
      • MedStar St. Mary's Hospital
    • Olney, Maryland, United States, 20832
      • MedStar Montgomery Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Behavioral: Palliative care needs information; clinician-directed EHR alert providing information about serious illness diagnosis(-es) and unmet palliative care needs; Other Names: PC needs information
Active Comparator: 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.	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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospice enrollment	Binary: hospice enrollment (any level of service)	enrollment through 6 months
Hospice duration	Continuous: total days enrolled in hospice (any level of service)	enrollment through 6 months
Community palliative care referral	Binary: order for community (home or outpatient clinic) palliative care consultation	enrollment through 6 months
Hospital all-cause mortality	Binary: (primary definition) death in the hospital; (secondary/sensitivity definition) death in the hospital or within 1 calendar day of discharge day.	enrollment to 1 day after hospital discharge
30-day hospital readmission	Binary: date of admission to an acute care hospital is within 30 days of hospital discharge	hospital discharge through 30 days
Number of readmissions	Count: number of acute care hospital admissions	enrollment through 6 months
Change in code status	Binary; any change in code status order at enrollment and code status order at hospital discharge	from enrollment up to 26 weeks
Time to palliative care consult	Continuous (hours): enrollment to documentation timestamp of first inpatient palliative care consult	from enrollment up to 26 weeks
Hospital length of stay	Continuous: enrollment time to hospital discharge order timestamp.	from enrollment up to 26 weeks
Hospital-free days	Count: days from enrollment spent alive and not in an acute care hospital through 6 months or death	Enrollment through 6 months
Discharge to hospice	Binary: (primary definition) hospital discharge disposition to hospice (any location or level of service); (secondary/sensitivity analysis definition) hospital discharge disposition to hospice or comfort-focused care orders in-hospital	from enrollment up to 26 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Aging (NIA); Medstar Health Research Institute
• Investigators: Principal Investigator: Katherine Courtright, MD, MS, University of Pennsylvania; Principal Investigator: Michael Harhay, PhD, MPH, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: September 5, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Palliative Care; Pragmatic Trial
• Other Study ID Numbers: 856359; 1R01AG082874-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be made available to researchers upon request and approval by the study investigators of a valid research proposal.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No