Seriously Ill Hospitalized PatientsNCT06629142
Comparing Optimized Models of Primary And Specialist Services for Palliative Care: Pilot Feasibility Trial
A study testing Default Order and Accountable Justification in people with Seriously Ill Hospitalized Patients, run by University of Pennsylvania at 2 sites in United States.
Trial summary
Palliative care (PC) seeks to reduce suffering and improve quality of life for patients with serious illnesses and their families. National guidelines recommend that clinicians either provide palliative care themselves (generalist PC) or consult experts (specialist PC) as a standard part of serious illness care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seriously Ill Hospitalized Patients
- What is being tested?
- Default Order and Accountable Justification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,208 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Oct 2024to 1 Jul 2025
- 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 years of age or older; AND
- Predicted 1-year mortality risk of 60% or greater; AND
- Admitted to a study hospital.
Who cannot join
- Patients who die or have an active or completed discharge order prior to enrollment time
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Trinity Health
Livonia, Michigan, 48152
Kaiser Permanente Southern California
Pasadena, California, 91101
About this study
Palliative care (PC) seeks to reduce suffering and improve quality of life for patients with serious illnesses and their families. National guidelines recommend that clinicians either provide palliative care themselves (generalist PC) or consult experts (specialist PC) as a standard part of serious illness care. This feasibility pilot study will be conducted with 6 hospitals at two large U.S. health systems and enroll 540 seriously ill hospitalized patients. Eligibility is determined by a mortality prediction score where enrolled patients have at least a 60% risk of dying within 1 year. Enrollment assessment occurs as close as possible to 36 hours post admission. In this cluster-randomized trial, the 6 hospitals will be randomized to 3 arms: (1) standardized usual care, (2) trained generalist PC, or (3) specialist PC. Generalists are trained using the Center to Advance Palliative Care (CAPC) online trainings. The pilot study will only measure process outcomes to assess the feasibility of a larger clinical trial (e.g., are the interventions working as intended). This pilot feasibility study is the precursor to a much larger pragmatic, hybrid effectiveness-implementation parallel-cluster RCT that will assess the comparative effectiveness of triggering generalist PC and specialist PC on several patient-centered outcome measures.
- Conditions
- Seriously Ill Hospitalized Patients
- Being tested
- Default Order, Accountable Justification, Standardized Usual Care
- Keywords
- Palliative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Default OrderBehavioural
A specialist PC consult is automatically ordered for patients meeting a certain threshold of 1-year mortality risk (dependent on arm). An EHR-based Our Practice Advisory (OPA) alert on Open Chart informs clinicians when the default order will become active, and how to cancel an order within 24 hours if they elect to do so.
Accountable JustificationBehavioural
An EHR-based Our Practice Advisory alert asks generalist clinicians to self-report whether they have provided primary PC by clicking which of 4 key PC domains they have addressed or to provide a brief justification as to why not.
Standardized Usual CareBehavioural
Moderately high-risk patients (e.g., with a 1-year mortality risk between 60% and 94%) will receive usual care. For very high-risk patients (e.g., with a 1-year mortality risk of ≥ 95%), an EHR-based Our Practice Advisory (OPA) alert on Open Chart informs clinicians when the default order will become active, and how to cancel an order within 24 hours if they elect to do so.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Usual Care | Active comparator | Active control group, where moderately high-risk patients (e.g., with a 1-year mortality risk between 60% and 94%) will receive usual care. A specialist PC consult is ordered by default for the highest-risk patients (i.e., 1-year mortality risk ≥ 95%), unless clinicians cancel the order. Receives: Behavioral: Standardized Usual Care |
| Trained Generalist Palliative Care | Experimental | Generalist clinicians trained in PC domains receive an EHR-based alert to document whether or not they have addressed PC domains for moderately high-risk patients ('accountable justification intervention'). A specialist PC consult is ordered by default for the highest-risk patients unless clinicians cancel the order. Receives: Behavioral: Default Order; Behavioral: Accountable Justification |
| Specialist Palliative Care | Experimental | A specialist PC consult is ordered by default for all patients with a ≥ 60% 1-year mortality risk ('default order intervention'), unless clinicians cancel the order. Receives: Behavioral: Default Order |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate Firings of All Our Practice Advisory (OPA) Interventions
Percentage of all Intervention Our Practice Advisory (OPAs) that fired in the correct time window for patients with mortality risk thresholds eligible for each intervention.
Measured: 36 to 60 hours post admission
Secondary outcomes (7)
Patient-Reported Outcome (PRO) Survey Response Rate at 1 month
Percentage of 1-month PRO surveys completed by alive patients or their surrogate proxies
Measured: Enrollment - 1 month post-discharge
PRO Survey Response Rate at 3 months
Percentage of 3-month PRO surveys completed by alive patients or their surrogate proxies
Measured: Enrollment - 3 months post-discharge
Default Specialist PC Consults
Percentage of default specialist PC orders that resulted in an inpatient PC consult before hospital discharge
Measured: 36 hours to 170 hours post admission
Default Specialist PC Order Cancellation Rate
Percentage of default specialist PC orders in which a generalist clinician indicated they did not want the order to proceed.
Measured: 36 hours to 60 hours post admission
Inappropriate Our Practice Advisory (OPA) Firings
Percentage of all patient encounters in whom at least one Our Practice Advisory (OPA) fired inappropriately. This includes an OPA firing outside the allowed time window on a patient who is eligible, the firing of the wrong OPA on a patient who is eligible (e.g., firing of the Generalist PC OPA for a patient in the Specialist PC arm), and the firing of any OPA on a patient who is ineligible (e.g., who has an inappropriate mortality risk score or active discharge order at the time enrollment eligibility is assessed).
Measured: 0 to 60 hours post admission
Generalist PC Training Completion
Percentage of clinicians eligible for CAPC palliative care training in the Generalist PC arm who complete the 4 required training modules. Partial completion (1-3 required modules) and completion of optional CAPC modules will be secondarily reported.
Measured: Baseline
Generalist PC Domain Completion
Percentage of clinicians in the Generalist PC arm who say they are addressing patients' PC needs during the current encounter, and of those, the percentage who document at least 1 of 4 PC Domains in the EHR Our Practice Advisory Alert
Measured: 36 hours to 60 hours post admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start17 Oct 2024
- Primary completion30 Apr 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seriously Ill Hospitalized PatientsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Clinical Research Institute
- Responsible party
- Principal investigator, Scott Halpern, University of Pennsylvania
- Investigators
- Katherine Courtright, MD, MS, Principal investigator, University of PennsylvaniaScott Halpern, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629142
- Sponsor's protocol ID
- 100917710
- Other IDs
- PLACER-2022C3-30553
- Status last verified
- Jul 2025
- First submitted
- 26 Sep 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Optimized Models of Primary And Specialist Services for Palliative Care: Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT06629142
- Acronym / sponsor ID
- 100917710
- Conditions
- Seriously Ill Hospitalized Patients
- Keywords
- Palliative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,208 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 8 Oct 2024 (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.
Palliative care (PC) seeks to reduce suffering and improve quality of life for patients with serious illnesses and their families. National guidelines recommend that clinicians either provide palliative care themselves (generalist PC) or consult experts (specialist PC) as a standard part of serious illness care. This feasibility pilot study will be conducted with 6 hospitals at two large U.S. health systems and enroll 540 seriously ill hospitalized patients. Eligibility is determined by a mortality prediction score where enrolled patients have at least a 60% risk of dying within 1 year. Enrollment assessment occurs as close as possible to 36 hours post admission. In this cluster-randomized trial, the 6 hospitals will be randomized to 3 arms: (1) standardized usual care, (2) trained generalist PC, or (3) specialist PC. Generalists are trained using the Center to Advance Palliative Care (CAPC) online trainings. The pilot study will only measure process outcomes to assess the feasibility of a larger clinical trial (e.g., are the interventions working as intended). This pilot feasibility study is the precursor to a much larger pragmatic, hybrid effectiveness-implementation parallel-cluster RCT that will assess the comparative effectiveness of triggering generalist PC and specialist PC on several patient-centered outcome measures.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standardized Usual Care | Active comparator | Behavioral: Standardized Usual CareActive control group, where moderately high-risk patients (e.g., with a 1-year mortality risk between 60% and 94%) will receive usual care. A specialist PC consult is ordered by default for the highest-risk patients (i.e., 1-year mortality risk ≥ 95%), unless clinicians cancel the order. |
| Trained Generalist Palliative Care | Experimental | Behavioral: Default Order, Behavioral: Accountable JustificationGeneralist clinicians trained in PC domains receive an EHR-based alert to document whether or not they have addressed PC domains for moderately high-risk patients ('accountable justification intervention'). A specialist PC consult is ordered by default for the highest-risk patients unless clinicians cancel the order. |
| Specialist Palliative Care | Experimental | Behavioral: Default OrderA specialist PC consult is ordered by default for all patients with a ≥ 60% 1-year mortality risk ('default order intervention'), unless clinicians cancel the order. |
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 years of age or older; AND
- Predicted 1-year mortality risk of 60% or greater; AND
- Admitted to a study hospital.
Key exclusion criteria (1 listed)
- Patients who die or have an active or completed discharge order prior to enrollment time
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 |
|---|---|---|
| Default OrderA specialist PC consult is automatically ordered for patients meeting a certain threshold of 1-year mortality risk (dependent on arm). An EHR-based Our Practice Advisory (OPA) alert on Open Chart informs clinicians when the default order will become active, and how to cancel an order within 24 hours if they elect to do so. | Behavioural | Specialist Palliative Care, Trained Generalist Palliative Care |
| Accountable JustificationAn EHR-based Our Practice Advisory alert asks generalist clinicians to self-report whether they have provided primary PC by clicking which of 4 key PC domains they have addressed or to provide a brief justification as to why not. | Behavioural | Trained Generalist Palliative Care |
| Standardized Usual CareModerately high-risk patients (e.g., with a 1-year mortality risk between 60% and 94%) will receive usual care. For very high-risk patients (e.g., with a 1-year mortality risk of ≥ 95%), an EHR-based Our Practice Advisory (OPA) alert on Open Chart informs clinicians when the default order will become active, and how to cancel an order within 24 hours if they elect to do so. | Behavioural | Standardized Usual Care |
Primary outcome
Appropriate Firings of All Our Practice Advisory (OPA) Interventions
Time frame: 36 to 60 hours post admission
Percentage of all Intervention Our Practice Advisory (OPAs) that fired in the correct time window for patients with mortality risk thresholds eligible for each intervention.
7 secondary outcomes
Patient-Reported Outcome (PRO) Survey Response Rate at 1 month
Time frame: Enrollment - 1 month post-discharge
PRO Survey Response Rate at 3 months
Time frame: Enrollment - 3 months post-discharge
Default Specialist PC Consults
Time frame: 36 hours to 170 hours post admission
Default Specialist PC Order Cancellation Rate
Time frame: 36 hours to 60 hours post admission
Inappropriate Our Practice Advisory (OPA) Firings
Time frame: 0 to 60 hours post admission
Generalist PC Training Completion
Time frame: Baseline
Generalist PC Domain Completion
Time frame: 36 hours to 60 hours post admission
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 24 Jul 2025.
Related trials for Seriously Ill Hospitalized Patients
Enrolling by invitation
Comparing Optimized Models of Primary And Specialist Services for Palliative Care
Seriously Ill Hospitalized Patients
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 Courtright, MD, MS principal investigator
University of Pennsylvania
Scott Halpern, MD, PhD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Default Order and Accountable Justification in people with Seriously Ill Hospitalized Patients, run by University of Pennsylvania at 2 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 1 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 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Appropriate Firings of All Our Practice Advisory (OPA) Interventions (time frame: 36 to 60 hours post admission). 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 24 Jul 2025.