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Nudging Effective and Equitable Delivery of Specialty Palliative Care

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

Status
Enrolling by invitation
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06596577
Acronym
NEEDS-PC
Enrollment
18000
Registered
2024-09-19
Start date
2025-08-06
Completion date
2029-02-28
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palliative, Serious Illness

Keywords

Palliative Care, Pragmatic Trial

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.

Interventions

BEHAVIORALPalliative care needs information

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

BEHAVIORALDefault 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

Sponsors

University of Pennsylvania
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
Medstar Health Research Institute
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Inpatient palliative care consultationfrom enrollment up to 26 weeksBinary: at least 1 inpatient visit from a PC specialist during the hospital encounter

Secondary

MeasureTime frameDescription
Hospice enrollmentenrollment through 6 monthsBinary: hospice enrollment (any level of service)
Hospice durationenrollment through 6 monthsContinuous: total days enrolled in hospice (any level of service)
Community palliative care referralenrollment through 6 monthsBinary: order for community (home or outpatient clinic) palliative care consultation
Hospital all-cause mortalityenrollment to 1 day after hospital dischargeBinary: (primary definition) death in the hospital; (secondary/sensitivity definition) death in the hospital or within 1 calendar day of discharge day.
30-day hospital readmissionhospital discharge through 30 daysBinary: date of admission to an acute care hospital is within 30 days of hospital discharge
Number of readmissionsenrollment through 6 monthsCount: number of acute care hospital admissions
Hospital-free daysEnrollment through 6 monthsCount: days from enrollment spent alive and not in an acute care hospital through 6 months or death
Change in code statusfrom enrollment up to 26 weeksBinary; any change in code status order at enrollment and code status order at hospital discharge
Time to palliative care consultfrom enrollment up to 26 weeksContinuous (hours): enrollment to documentation timestamp of first inpatient palliative care consult
Discharge to hospicefrom enrollment up to 26 weeksBinary: (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
Hospital length of stayfrom enrollment up to 26 weeksContinuous: enrollment time to hospital discharge order timestamp.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKatherine Courtright, MD, MS

University of Pennsylvania

PRINCIPAL_INVESTIGATORMichael Harhay, PhD, MPH

University of Pennsylvania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026