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Serious IllnessPhase 3NEEDS-PCNCT06596577

Nudging Effective and Equitable Delivery of Specialty Palliative Care

A Phase 3 study testing Palliative care needs information and Default consult order in people with Serious Illness and Palliative, run by University of Pennsylvania at 9 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Serious Illness, Palliative
What is being tested?
Palliative care needs information and Default consult order
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18,000 participants
Where
9 sitesUnited States
Study dates
6 Aug 2025to 28 Feb 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

9 sites in 1 country

United States9 sites

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218

  • MedStar Harbor Hospital

    Baltimore, Maryland, 21225

  • MedStar Franklin Square Medical Center

    Baltimore, Maryland, 21237

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21239 ·

  • MedStar Southern Maryland Hospital Center

    Clinton, Maryland, 20735

  • MedStar St. Mary's Hospital

    Leonardtown, Maryland, 20650

  • MedStar Montgomery Medical Center

    Olney, Maryland, 20832

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • MedStar Washington Health Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

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

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.

Being tested
Palliative care needs information, Default consult order
Keywords
Palliative Care, Pragmatic Trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palliative care needs informationBehavioural

    Also called PC needs information

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

  • Default consult orderBehavioural

    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

Study groups in NCT06596577
Study groupRoleWhat they receive
Palliative care needs information provisionActive comparatorClinicians will receive an EHR alert providing information about a patient's serious illness diagnosis(-es) and unmet palliative care needs
Receives: Behavioral: Palliative care needs information
Palliative care needs information provision + default consult orderActive comparatorThe 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.
Receives: Behavioral: Default consult order
Control/Usual CareNo interventionDuring 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inpatient palliative care consultation

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

    Measured: from enrollment up to 26 weeks

Secondary outcomes (11)

  1. Hospice enrollment

    Binary: hospice enrollment (any level of service)

    Measured: enrollment through 6 months

  2. Hospice duration

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

    Measured: enrollment through 6 months

  3. Community palliative care referral

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

    Measured: enrollment through 6 months

  4. 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.

    Measured: enrollment to 1 day after hospital discharge

  5. 30-day hospital readmission

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

    Measured: hospital discharge through 30 days

  6. Number of readmissions

    Count: number of acute care hospital admissions

    Measured: enrollment through 6 months

  7. Hospital-free days

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

    Measured: Enrollment through 6 months

  8. Change in code status

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

    Measured: from enrollment up to 26 weeks

  9. Time to palliative care consult

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

    Measured: from enrollment up to 26 weeks

  10. 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

    Measured: from enrollment up to 26 weeks

  11. Hospital length of stay

    Continuous: enrollment time to hospital discharge order timestamp.

    Measured: from enrollment up to 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start6 Aug 2025
  3. Primary completion1 Mar 2028 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
18,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06596577
Sponsor's protocol ID
856359
Other IDs
1R01AG082874-01A1
Acronym
NEEDS-PC
Status last verified
Oct 2026
First submitted
5 Sep 2024
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data will be made available to researchers upon request and approval by the study investigators of a valid research proposal.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Palliative care needs information and Default consult order in people with Serious Illness and Palliative, run by University of Pennsylvania at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inpatient palliative care consultation (time frame: from enrollment up to 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06596577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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