Palliative CareNCT05502861
A Pragmatic Trial of an Active Choice Nudge for Generalist or Specialist Palliative Care for Seriously Ill Inpatients
A study testing Generalist + Specialist palliative care and Pre-Intervention phase in people with Palliative Care, run by University of Pennsylvania at 1 site in United States.
Trial summary
This stepped-wedge, cluster-randomized pragmatic trial among six hospitals at University of Pennsylvania Health System will test a behavioral intervention embedded within the electronic health record that nudges hospital clinicians to either provide palliative care (PC) themselves (generalist PC) or consult… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- Generalist + Specialist palliative care and Pre-Intervention phase
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,884 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2023to 17 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 or older
- Inpatient or observation admission status at a study hospital
- Predicted 6-month mortality risk moderate (e.g., ≥40%) or higher
Who cannot join
- Under 18 years of age
- Inpatient primary service: hospice, rehabilitation, obstetrics, psychiatry
- Patients that have died or been discharged before 0800 on hospital day 3 when the mortality risk is generated and enrollment occurs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pragmatic Trial of an Active Choice Nudge for Generalist or Specialist Palliative Care for Seriously Ill Inpatients: The Palliative Connect Trial
This stepped-wedge, cluster-randomized pragmatic trial among six hospitals at University of Pennsylvania Health System will test a behavioral intervention embedded within the electronic health record that nudges hospital clinicians to either provide palliative care (PC) themselves (generalist PC) or consult specialists (specialty PC) for inpatients at high risk of death within 6 months. The trial will evaluate the intervention's effect compared to usual care on the primary outcome of hospital-free days through 6 months, and other patient-centered, clinical, and economic outcomes. The trial also includes an embedded mixed methods study to understand clinician and hospital contextual factors that influence the intervention's uptake.
- Conditions
- Palliative Care
- Being tested
- Generalist + Specialist palliative care, Pre-Intervention phase
- Keywords
- Palliative Care, Pragmatic Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generalist + Specialist palliative careBehavioural
Also called Active choice generalist palliative care
Clinicians are alerted in the EHR to make an active choice whether to provide generalist palliative care themselves, consult PC specialist, or to defer PC at that time.
Pre-Intervention phaseBehavioural
Also called Usual care
Patients meeting eligibility criteria will be enrolled for study data collection but there will be no attempt to influence delivery of care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The study's intervention is a prognostic-triggered EHR alert to nudge clinicians to provide generalist or specialist PC. The alert notifies the clinician that the patient is likely to benefit from PC, and requires clinicians to actively choose to provide generalist PC themselves, consult PC specialist, or to defer PC. If a clinician chooses to consult specialist PC, a second alert will fire that enables them to easily and quickly place the consult order. The alert will trigger for all patients with moderate or higher 6-month mortality risk on second full hospital day at 8AM. Receives: Behavioral: Generalist + Specialist palliative care |
| Control/Usual Care | Active comparator | 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. The length of the control phase will differ at each hospital dependent on the sequence in which hospitals are randomly assigned to switch to the intervention phase. All hospitals contribute a minimum of 15 weeks of outcomes data prior to adopting the intervention. Receives: Behavioral: Pre-Intervention phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital-free days
Days from enrollment spent alive and not in an acute care hospital through 6 months or death
Measured: 6 months
Secondary outcomes (20)
Goals of Care (GOC) conversation within a discrete GOC note type
Presence or absence of documented GOC conversation after enrollment detected by natural language programming algorithm or by a discrete GOC note type
Measured: up to 6 weeks
Pain scores
pain level according to standardized scale across hospitals after enrollment
Measured: up to 6 weeks
Palliative care consultation note
Presence or absence of signed inpatient palliative care note after enrollment
Measured: up to 6 weeks
Time to palliative care consult
starts at time of enrollment until receipt of first documented inpatient palliative care consultation note
Measured: up to 6 weeks
Change in code status found in chart documentation
no change, new limitations on life support (e.g., DNAR, DNI) or discontinued limitations on life support
Measured: up to 6 weeks
Intensive care unit admission
admitted to any ICU during hospital encounter
Measured: up to 6 weeks
Hospital length of stay
number of days in hospital staring at enrollment
Measured: up to 6 weeks
Hospital all-cause mortality
death occurred in the hospital or within 1 day of discharge
Measured: up to 6 weeks
Hospice enrollment
yes if new hospice enrollment
Measured: up to 6 weeks
Home or clinic palliative care referral
yes if new home of clinic palliative care order after enrollment
Measured: up to 6 weeks
Hospital discharge disposition written in discharge order
Discharge to home, other acute facility, skilled nursing facility
Measured: up to 6 weeks
30-day hospital readmission
readmission within 30 days of discharge
Measured: 30 days
180-day all cause mortality
180 days after enrollment
Measured: 180 days
Hospital total costs
continuous hospital costs
Measured: up to 6 weeks
Future acute care costs
acute care costs over the 6 month follow up period
Measured: enrollment to 6 months post hospital discharge
Goal-concordant care
yes if treatments received over 6 month follow up align with goals documented in the EHR; no if treatments are misaligned with goals, or goals are unclear or undocumented
Measured: enrollment to 6 months post hospital discharge
McGill Quality of Life-Revised
14-item survey instrument; score 0-10; continuous
Measured: 1 month
McGill Quality of Life-Revised
14-item survey instrument; score 0-10; continuous
Measured: 3 months
McGill Quality of Life-Revised
14-item survey instrument; score 0-10; continuous
Measured: 6 months
CMS-MACRA PC Quality
(1) felt heard and understood (4-items); (2) received desired help for pain (3-items); continuous
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start13 Nov 2023
- Primary completion17 May 2026
- Study completion17 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- stepped-wedge cluster (at hospital-level) randomized trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18,884 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Katherine Courtright, University of Pennsylvania
- Investigators
- Katherine R Courtright, MD, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502861
- Sponsor's protocol ID
- 848497
- Other IDs
- R01AG073384
- Status last verified
- Apr 2026
- First submitted
- 12 Aug 2022
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie published results will be made available to other researchers, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Trial of an Active Choice Nudge for Generalist or Specialist Palliative Care for Seriously Ill Inpatients: The Palliative Connect Trial
- ClinicalTrials.gov ID
- NCT05502861
- Acronym / sponsor ID
- 848497
- Conditions
- Palliative Care
- Keywords
- Palliative Care, Pragmatic Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,884 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 17 May 2026 (actual)
- Study completion
- 17 May 2026 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This stepped-wedge, cluster-randomized pragmatic trial among six hospitals at University of Pennsylvania Health System will test a behavioral intervention embedded within the electronic health record that nudges hospital clinicians to either provide palliative care (PC) themselves (generalist PC) or consult specialists (specialty PC) for inpatients at high risk of death within 6 months. The trial will evaluate the intervention's effect compared to usual care on the primary outcome of hospital-free days through 6 months, and other patient-centered, clinical, and economic outcomes. The trial also includes an embedded mixed methods study to understand clinician and hospital contextual factors that influence the intervention's uptake.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- stepped-wedge cluster (at hospital-level) randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Generalist + Specialist palliative careThe study's intervention is a prognostic-triggered EHR alert to nudge clinicians to provide generalist or specialist PC. The alert notifies the clinician that the patient is likely to benefit from PC, and requires clinicians to actively choose to provide generalist PC themselves, consult PC specialist, or to defer PC. If a clinician chooses to consult specialist PC, a second alert will fire that enables them to easily and quickly place the consult order. The alert will trigger for all patients with moderate or higher 6-month mortality risk on second full hospital day at 8AM. |
| Control/Usual Care | Active comparator | Behavioral: Pre-Intervention phaseDuring 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. The length of the control phase will differ at each hospital dependent on the sequence in which hospitals are randomly assigned to switch to the intervention phase. All hospitals contribute a minimum of 15 weeks of outcomes data prior to adopting the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Inpatient or observation admission status at a study hospital
- Predicted 6-month mortality risk moderate (e.g., ≥40%) or higher
Key exclusion criteria (3 listed)
- Under 18 years of age
- Inpatient primary service: hospice, rehabilitation, obstetrics, psychiatry
- Patients that have died or been discharged before 0800 on hospital day 3 when the mortality risk is generated and enrollment occurs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Generalist + Specialist palliative careAlso: Active choice generalist palliative careClinicians are alerted in the EHR to make an active choice whether to provide generalist palliative care themselves, consult PC specialist, or to defer PC at that time. | Behavioural | Intervention |
| Pre-Intervention phaseAlso: Usual carePatients meeting eligibility criteria will be enrolled for study data collection but there will be no attempt to influence delivery of care. | Behavioural | Control/Usual Care |
Primary outcome
Hospital-free days
Time frame: 6 months
Days from enrollment spent alive and not in an acute care hospital through 6 months or death
20 secondary outcomes
Goals of Care (GOC) conversation within a discrete GOC note type
Time frame: up to 6 weeks
Pain scores
Time frame: up to 6 weeks
Palliative care consultation note
Time frame: up to 6 weeks
Time to palliative care consult
Time frame: up to 6 weeks
Change in code status found in chart documentation
Time frame: up to 6 weeks
Intensive care unit admission
Time frame: up to 6 weeks
Hospital length of stay
Time frame: up to 6 weeks
Hospital all-cause mortality
Time frame: up to 6 weeks
Hospice enrollment
Time frame: up to 6 weeks
Home or clinic palliative care referral
Time frame: up to 6 weeks
Hospital discharge disposition written in discharge order
Time frame: up to 6 weeks
30-day hospital readmission
Time frame: 30 days
180-day all cause mortality
Time frame: 180 days
Hospital total costs
Time frame: up to 6 weeks
Future acute care costs
Time frame: enrollment to 6 months post hospital discharge
Goal-concordant care
Time frame: enrollment to 6 months post hospital discharge
McGill Quality of Life-Revised
Time frame: 1 month
McGill Quality of Life-Revised
Time frame: 3 months
McGill Quality of Life-Revised
Time frame: 6 months
CMS-MACRA PC Quality
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie published results will be made available to other researchers, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine R Courtright, MD, MS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Generalist + Specialist palliative care and Pre-Intervention phase in people with Palliative Care, run by University of Pennsylvania at 1 site 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 3 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: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hospital-free days (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.