A Phase 3 interventional study of Palliative care needs information and Default consult order in Serious Illness and Palliative, sponsored by University of Pennsylvania. Enrolling by invitation at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by University of Pennsylvania · Phase 3, Interventional, and Health services research
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.
University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
clinician-directed EHR alert providing information about serious illness diagnosis(-es) and unmet palliative care needs
Also known as: PC needs information
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
Inpatient palliative care consultation
Binary: at least 1 inpatient visit from a PC specialist during the hospital encounter
Time frame: from enrollment up to 26 weeks
Hospice enrollment
Binary: hospice enrollment (any level of service)
Time frame: enrollment through 6 months
Hospice duration
Continuous: total days enrolled in hospice (any level of service)
Time frame: enrollment through 6 months
Community palliative care referral
Binary: order for community (home or outpatient clinic) palliative care consultation
Time frame: 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.
Time frame: 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
Time frame: hospital discharge through 30 days
Number of readmissions
Count: number of acute care hospital admissions
Time frame: enrollment through 6 months
Hospital-free days
Count: days from enrollment spent alive and not in an acute care hospital through 6 months or death
Time frame: Enrollment through 6 months
Change in code status
Binary; any change in code status order at enrollment and code status order at hospital discharge
Time frame: from enrollment up to 26 weeks
Time to palliative care consult
Continuous (hours): enrollment to documentation timestamp of first inpatient palliative care consult
Time frame: from enrollment up to 26 weeks
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
Time frame: from enrollment up to 26 weeks
Hospital length of stay
Continuous: enrollment time to hospital discharge order timestamp.
Time frame: from enrollment up to 26 weeks
Plan to share: Yes — Individual participant data will be made available to researchers upon request and approval by the study investigators of a valid research proposal.
Supporting information: Study protocol, Sap
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