Nudging Effective and Equitable Delivery of Specialty Palliative Care

Phase 3

Not yet recruiting

• Conditions: Serious Illness; Palliative

• Registration Number: NCT06596577
• Lead Sponsor: University of Pennsylvania

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 receipt of a PC consult and other secondary outcomes. The trial also includes an embedded mixed methods study to explore factors influencing the effectiveness and equity of intervention implementation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-12
• Study First Posted: 2024-09-19
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-30
• Study Start: 2025-08-30
• Primary Completion: 2028-03-25
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 19980

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Receipt of a PC consultation	from enrollment up to 26 weeks	Binary: at least 1 inpatient visit from a PC specialist during the hospital encounter

Secondary Outcome Measures

Name	Time	Method
Hospice duration	enrollment through 6 months	Continuous: total days enrolled in hospice (any level of service)
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
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
Hospice enrollment	enrollment through 6 months	Binary: hospice enrollment (any level of service)
Community palliative care referral	enrollment through 6 months	Binary: order for community (home or outpatient clinic) palliative care consultation
Palliative care consultation order	from enrollment up to 26 weeks	Binary: presence or absence of signed inpatient palliative care note after enrollment
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
Hospice discharge	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 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.
Number of readmissions	enrollment through 6 months	Count: number of acute care hospital admissions
Hospital length of stay	from enrollment up to 26 weeks	Continuous: enrollment time to hospital discharge order timestamp.

Trial Locations

Locations (9)

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

MedStar Washington Health Center; 🇺🇸 Washington, 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