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Enrolling by Invitation

NCT Number: NCT06596577

Nudging Effective and Equitable Delivery of Specialty Palliative Care

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.

Enrolling by Invitation

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Key information

Conditions

Serious Illness Palliative

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

MedStar Georgetown University Hospital, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Palliative care needs information

Behavioral

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

Other names: PC needs information

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

Primary outcomes

  1. Inpatient palliative care consultation

    Time frame: from enrollment up to 26 weeks

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

Secondary outcomes

  1. Hospice enrollment

    Time frame: enrollment through 6 months

    Binary: hospice enrollment (any level of service)

  2. Hospice duration

    Time frame: enrollment through 6 months

    Continuous: total days enrolled in hospice (any level of service)

  3. Community palliative care referral

    Time frame: enrollment through 6 months

    Binary: order for community (home or outpatient clinic) palliative care consultation

  4. Hospital all-cause mortality

    Time frame: 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.

  5. 30-day hospital readmission

    Time frame: hospital discharge through 30 days

    Binary: date of admission to an acute care hospital is within 30 days of hospital discharge

  6. Number of readmissions

    Time frame: enrollment through 6 months

    Count: number of acute care hospital admissions

  7. Hospital-free days

    Time frame: Enrollment through 6 months

    Count: days from enrollment spent alive and not in an acute care hospital through 6 months or death

  8. Change in code status

    Time frame: from enrollment up to 26 weeks

    Binary; any change in code status order at enrollment and code status order at hospital discharge

  9. Time to palliative care consult

    Time frame: from enrollment up to 26 weeks

    Continuous (hours): enrollment to documentation timestamp of first inpatient palliative care consult

  10. Discharge to hospice

    Time frame: 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

  11. Hospital length of stay

    Time frame: from enrollment up to 26 weeks

    Continuous: enrollment time to hospital discharge order timestamp.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Medstar Health Research Institute
  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: NEEDS-PC

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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