Seriously Ill Hospitalized PatientsCOMPASS-PCNCT07224594
Comparing Optimized Models of Primary And Specialist Services for Palliative Care
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
- 78,302 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Feb 2026to 31 Jul 2030
- Phase
- Interventional
- 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 of age or older; AND Predicted 1-year mortality risk of 70% 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 OR
- Readmission within 182 days of an eligible encounter OR
- Ineligible service line, with current admission status labeled as: hospice, acute rehabilitation, skilled nursing facility, long-term acute care, psychiatry, obstetrics, surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
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 pragmatic clinical trial will be conducted with 48 hospitals at two large U.S. health systems and enroll more than 78,000 seriously ill hospitalized patients. Eligibility is determined by a mortality prediction score where enrolled patients have at least a 70% risk of dying within 1 year. Enrollment assessment occurs as close as possible to 36 hours post admission. The 48 hospitals will be randomized to 3 arms: (1) standardized usual care, (2) trained generalist PC, or (3) specialist PC. Generalist clinicians are trained using the Center to Advance Palliative Care (CAPC) online trainings. This pragmatic, hybrid effectiveness-implementation parallel-cluster RCT will assess the comparative effectiveness of triggering generalist PC and specialist PC on several patient-centered outcome measures, and follows a pilot feasibility study. We will collect Patient-Reported Outcomes (PROs) surveys from a random subset of enrolled patients.
- 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 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
High-risk patients (i.e., with a 1-year mortality risk between 70% and 94%) will receive usual care. For very high-risk patients (i.e., 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 if they elect to do so.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Usual Care | Active comparator | Active control group, where high-risk patients (i.e., with a 1-year mortality risk between 70% and 94%) will receive usual care. A specialist PC consult is ordered by default for the very high-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 high-risk patients ('accountable justification intervention'). A specialist PC consult is ordered by default for the very high risk patients (i.e., 1-year mortality risk ≥ 95%) 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 ≥ 70% 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.
Hospital free days
Count of days from enrollment spent alive outside of an acute care hospital through 182 days.
Measured: Enrollment- 182 days.
Secondary outcomes (15)
Patient quality of life
Patient or caregiver report of the patient's quality of life using the 15-item McGill Quality of Life survey instrument.
Measured: 1-month, 3-months, and 6-months post-enrollment
Clinician communication
Patient or caregiver report of how much patients feel heard and understood, using the 4-item CMS-MACRA survey instrument
Measured: 1-month post-enrollment
Pain management
Patient or caregiver report of whether patients receive desired help for pain, using the 3-item CMS-MACRA survey instrument.
Measured: 1-month post-enrollment
Goal concordant care
Patient or caregiver report of the patient's perception of whether their treatment matched what they wanted.
Measured: 1-month post-enrollment
Social interaction
Patient or caregiver report of patient's social support using the 4-item Duke Social Support Index's Social Interaction Sub-scale
Measured: 1-month post-enrollment
Loneliness
Patient or caregiver report of patient's loneliness using the 3-item Duke UCLA loneliness scale.
Measured: 1-month post-enrollment
Hospital free days at 3 months
Count of days from enrollment spent alive and not in an acute care hospital through 3 months.
Measured: Enrollment - 3-months post-enrollment
Institution free days at 3 months
Count of days from enrollment spent alive and not in any care facility through 3 months.
Measured: Enrollment - 3-months post-enrollment
Institution free days at 6 months
Count of days from enrollment spent alive and not in any care facility through 6 months.
Measured: Enrollment - 6-months post-enrollment
30-day hospital readmissions
Count of readmissions
Measured: Enrollment - 30 days post-enrollment
90-day hospital readmissions
Count of readmissions.
Measured: Enrollment - 90 days post-enrollment
Community-based palliative care use
Binary variable indicating any use (use/no use) captured through EHR and claims data and count of days of PC visits.
Measured: Enrollment - 6-months post-enrollment
Hospice use
Binary variable indicating any use (use/no use) captured through EHR and claims data and count of days of hospice.
Measured: Enrollment - 6-months post-enrollment
Change in code status
Binary indicator of whether code status changed from enrollment.
Measured: Enrollment- Discharge from hospital (an average of 7 days)
Time to palliative care consult
Time from enrollment until receipt of the first documented inpatient palliative care consultation note.
Measured: Enrollment- Discharge from hospital (an average of 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start16 Feb 2026
- Primary completion1 Nov 2029 (estimated)
- Study completion31 Jul 2030 (estimated)
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
- 78,302 participants (estimated)
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
- Scott Halpern, MD, PhD, Principal investigator, University of PennsylvaniaKatherine Courtright, MD, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224594
- Sponsor's protocol ID
- 855378
- Other IDs
- PLACER-2022C3-30553
- Acronym
- COMPASS-PC
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data (the Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan (including all amendments and all documentation for additional work processes)), and analytic code from a PCORI-funded research project from this PCORI-funded clinical trial will be made available on the Patient-Centered Outcomes Data Repository.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. 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
- ClinicalTrials.gov ID
- NCT07224594
- Acronym / sponsor ID
- COMPASS-PC / 855378
- Conditions
- Seriously Ill Hospitalized Patients
- Keywords
- Palliative
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 78,302 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 4 Nov 2025 (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 pragmatic clinical trial will be conducted with 48 hospitals at two large U.S. health systems and enroll more than 78,000 seriously ill hospitalized patients. Eligibility is determined by a mortality prediction score where enrolled patients have at least a 70% risk of dying within 1 year. Enrollment assessment occurs as close as possible to 36 hours post admission. The 48 hospitals will be randomized to 3 arms: (1) standardized usual care, (2) trained generalist PC, or (3) specialist PC. Generalist clinicians are trained using the Center to Advance Palliative Care (CAPC) online trainings. This pragmatic, hybrid effectiveness-implementation parallel-cluster RCT will assess the comparative effectiveness of triggering generalist PC and specialist PC on several patient-centered outcome measures, and follows a pilot feasibility study. We will collect Patient-Reported Outcomes (PROs) surveys from a random subset of enrolled patients.
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 high-risk patients (i.e., with a 1-year mortality risk between 70% and 94%) will receive usual care. A specialist PC consult is ordered by default for the very high-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 high-risk patients ('accountable justification intervention'). A specialist PC consult is ordered by default for the very high risk patients (i.e., 1-year mortality risk ≥ 95%) unless clinicians cancel the order. |
| Specialist Palliative Care | Experimental | Behavioral: Default OrderA specialist PC consult is ordered by default for all patients with a ≥ 70% 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 (1 listed)
- Age 18 years of age or older; AND Predicted 1-year mortality risk of 70% or greater; AND Admitted to a study hospital.
Key exclusion criteria (3 listed)
- Patients who die or have an active or completed discharge order prior to enrollment time OR
- Readmission within 182 days of an eligible encounter OR
- Ineligible service line, with current admission status labeled as: hospice, acute rehabilitation, skilled nursing facility, long-term acute care, psychiatry, obstetrics, surgery
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 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 CareHigh-risk patients (i.e., with a 1-year mortality risk between 70% and 94%) will receive usual care. For very high-risk patients (i.e., 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 if they elect to do so. | Behavioural | Standardized Usual Care |
Primary outcome
Hospital free days
Time frame: Enrollment- 182 days.
Count of days from enrollment spent alive outside of an acute care hospital through 182 days.
15 secondary outcomes
Patient quality of life
Time frame: 1-month, 3-months, and 6-months post-enrollment
Clinician communication
Time frame: 1-month post-enrollment
Pain management
Time frame: 1-month post-enrollment
Goal concordant care
Time frame: 1-month post-enrollment
Social interaction
Time frame: 1-month post-enrollment
Loneliness
Time frame: 1-month post-enrollment
Hospital free days at 3 months
Time frame: Enrollment - 3-months post-enrollment
Institution free days at 3 months
Time frame: Enrollment - 3-months post-enrollment
Institution free days at 6 months
Time frame: Enrollment - 6-months post-enrollment
30-day hospital readmissions
Time frame: Enrollment - 30 days post-enrollment
90-day hospital readmissions
Time frame: Enrollment - 90 days post-enrollment
Community-based palliative care use
Time frame: Enrollment - 6-months post-enrollment
Hospice use
Time frame: Enrollment - 6-months post-enrollment
Change in code status
Time frame: Enrollment- Discharge from hospital (an average of 7 days)
Time to palliative care consult
Time frame: Enrollment- Discharge from hospital (an average of 7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified data (the Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan (including all amendments and all documentation for additional work processes)), and analytic code from a PCORI-funded research project from this PCORI-funded clinical trial will be made available on the Patient-Centered Outcomes Data Repository.
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.
Scott Halpern, MD, PhD principal investigator
University of Pennsylvania
Katherine Courtright, MD, MS 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 1 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: enrolling by invitation, as of the sponsor's last update on 21 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 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?
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?
Hospital free days (time frame: Enrollment- 182 days.). 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 21 Oct 2026; AzTrials last refreshed its copy on 2 Nov 2026.