Nudging Effective and Equitable Delivery of Specialty Palliative Care

NCT06596577 — Phase 3, Enrolling by invitation, 18000 participants, University of Pennsylvania

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

Registry	NCT06596577, acronym NEEDS-PC
Status	Enrolling by invitation
Phase	Phase 3
Study type	Interventional; randomized, crossover, masking: triple, health services research
Enrollment	18000 (Estimated)
Sponsor	University of Pennsylvania (Other); collaborators: National Institute on Aging (NIA), Medstar Health Research Institute
Conditions	Serious Illness, Palliative
Interventions	Palliative care needs information, Default consult order (Behavioral)
Dates	start 2025-08-06, primary completion 2028-03-01 (estimated), completion 2029-02-28 (estimated), first posted 2024-09-19, last updated 2026-04-30
Locations	9 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Palliative care needs information provision	Active comparator	Behavioral: Palliative care needs information	Clinicians will receive an EHR alert providing information about a patient's serious illness diagnosis(-es) and unmet palliative care needs
Palliative care needs information provision + default consult order	Active comparator	Behavioral: 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.
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.

Palliative care needs information (Behavioral), also known as PC needs information: clinician-directed EHR alert providing information about serious illness diagnosis(-es) and unmet palliative care needs
Default consult order (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

+Outcome measures

Primary outcomes

Inpatient palliative care consultation [from enrollment up to 26 weeks]: Binary: at least 1 inpatient visit from a PC specialist during the hospital encounter

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (9)

Facility	City	Country
MedStar Georgetown University Hospital	Washington D.C., District of Columbia	United States
MedStar Washington Health Center	Washington D.C., District of Columbia	United States
MedStar Union Memorial Hospital	Baltimore, Maryland	United States
MedStar Harbor Hospital	Baltimore, Maryland	United States
MedStar Franklin Square Medical Center	Baltimore, Maryland	United States
MedStar Good Samaritan Hospital	Baltimore, Maryland	United States
MedStar Southern Maryland Hospital Center	Clinton, Maryland	United States
MedStar St. Mary's Hospital	Leonardtown, Maryland	United States
MedStar Montgomery Medical Center	Olney, Maryland	United States

+Investigators

Katherine Courtright, MD, MS, Principal investigator, University of Pennsylvania
Michael Harhay, PhD, MPH, Principal investigator, University of Pennsylvania

+Funding

NIH grants: R01AG082874