Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT07224594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-04
First Post:
2025-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Optimized Models of Primary And Specialist Services for Palliative Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78302}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2025-10-24', 'studyFirstSubmitQcDate': '2025-10-31', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital free days', 'timeFrame': 'Enrollment- 182 days.', 'description': 'Count of days from enrollment spent alive outside of an acute care hospital through 182 days.'}], 'secondaryOutcomes': [{'measure': 'Patient quality of life', 'timeFrame': '1-month, 3-months, and 6-months post-enrollment', 'description': "Patient or caregiver report of the patient's quality of life using the 15-item McGill Quality of Life survey instrument."}, {'measure': 'Clinician communication', 'timeFrame': '1-month post-enrollment', 'description': 'Patient or caregiver report of how much patients feel heard and understood, using the 4-item CMS-MACRA survey instrument'}, {'measure': 'Pain management', 'timeFrame': '1-month post-enrollment', 'description': 'Patient or caregiver report of whether patients receive desired help for pain, using the 3-item CMS-MACRA survey instrument.'}, {'measure': 'Goal concordant care', 'timeFrame': '1-month post-enrollment', 'description': "Patient or caregiver report of the patient's preferences for either extending life or ensuring comfort and the patient's perception of treatment."}, {'measure': 'Social interaction', 'timeFrame': '1-month post-enrollment', 'description': "Patient or caregiver report of patient's social support using the 4-item Duke Social Support Index's Social Interaction Sub-scale"}, {'measure': 'Loneliness', 'timeFrame': '1-month post-enrollment', 'description': "Patient or caregiver report of patient's loneliness using the 3-item Duke UCLA loneliness scale."}, {'measure': 'Hospital free days at 3 months', 'timeFrame': 'Enrollment - 3-months post-enrollment', 'description': 'Count of days from enrollment spent alive and not in an acute care hospital through 3 months.'}, {'measure': 'Institution free days at 3 months', 'timeFrame': 'Enrollment - 3-months post-enrollment', 'description': 'Count of days from enrollment spent alive and not in any care facility through 3 months.'}, {'measure': 'Institution free days at 6 months', 'timeFrame': 'Enrollment - 6-months post-enrollment', 'description': 'Count of days from enrollment spent alive and not in any care facility through 6 months.'}, {'measure': '30-day hospital readmissions', 'timeFrame': 'Enrollment - 30 days post-enrollment', 'description': 'Count of readmissions'}, {'measure': '90-day hospital readmissions', 'timeFrame': 'Enrollment - 90 days post-enrollment', 'description': 'Count of readmissions.'}, {'measure': 'Community-based palliative care use', 'timeFrame': 'Enrollment - 6-months post-enrollment', 'description': 'Binary variable indicating any use (use/no use) captured through EHR and claims data and count of days of PC visits.'}, {'measure': 'Hospice use', 'timeFrame': 'Enrollment - 6-months post-enrollment', 'description': 'Binary variable indicating any use (use/no use) captured through EHR and claims data and count of days of hospice.'}, {'measure': 'Change in code status', 'timeFrame': 'Enrollment- Discharge from hospital (an average of 7 days)', 'description': 'Binary indicator of whether code status changed from enrollment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Palliative'], 'conditions': ['Seriously Ill Hospitalized Patients']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years of age or older; AND Predicted 1-year mortality risk of 70% or greater; AND Admitted to a study hospital.\n\nExclusion Criteria:\n\n* Patients who die or have an active or completed discharge order prior to enrollment time OR\n* Readmission within 182 days of an eligible encounter OR\n* Ineligible service line, with current admission status labeled as: hospice, acute rehabilitation, skilled nursing facility, long-term acute care, psychiatry, obstetrics'}, 'identificationModule': {'nctId': 'NCT07224594', 'acronym': 'COMPASS-PC', 'briefTitle': 'Comparing Optimized Models of Primary And Specialist Services for Palliative Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Comparing Optimized Models of Primary And Specialist Services for Palliative Care', 'orgStudyIdInfo': {'id': '855378'}, 'secondaryIdInfos': [{'id': 'PLACER-2022C3-30553', 'type': 'OTHER_GRANT', 'domain': 'Patient-Centered Outcomes Research Institute (PCORI)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standardized Usual Care', 'description': '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.', 'interventionNames': ['Behavioral: Standardized Usual Care']}, {'type': 'EXPERIMENTAL', 'label': 'Trained Generalist Palliative Care', 'description': "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.", 'interventionNames': ['Behavioral: Default Order', 'Behavioral: Accountable Justification']}, {'type': 'EXPERIMENTAL', 'label': 'Specialist Palliative Care', 'description': "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.", 'interventionNames': ['Behavioral: Default Order']}], 'interventions': [{'name': 'Default Order', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Specialist Palliative Care', 'Trained Generalist Palliative Care']}, {'name': 'Accountable Justification', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Trained Generalist Palliative Care']}, {'name': 'Standardized Usual Care', 'type': 'BEHAVIORAL', 'description': '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 within 24 hours if they elect to do so.', 'armGroupLabels': ['Standardized Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91101', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Southern California', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '48152', 'city': 'Livonia', 'state': 'Michigan', 'country': 'United States', 'facility': 'Trinity Health', 'geoPoint': {'lat': 42.36837, 'lon': -83.35271}}], 'centralContacts': [{'name': 'Vanessa Madden, B.S.', 'role': 'CONTACT', 'email': 'COMPASS-PC@pennmedicine.upenn.edu', 'phone': '(215) 746-4923'}, {'name': 'Dorothy Sheu, MPH', 'role': 'CONTACT', 'email': 'dorothy.sheu@pennmedicine.upenn.edu', 'phone': '3014613385'}], 'overallOfficials': [{'name': 'Scott Halpern, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Katherine Courtright, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pcori.org/research-related-projects/about-our-research/data-sharing-maximizing-utility-pcori-funded-data', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': "The IPD and supporting information will be available between 3 and 6 months after the study completion date, and will be available on the Patient Centered Outcomes Data Repository in line with PCORI's policies for data retention.", 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'Applicants will follow the guidelines as set out on the Patient Centered Outcomes Data Repository for accessing this data set.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke Clinical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics & Health Policy', 'investigatorFullName': 'Scott Halpern', 'investigatorAffiliation': 'University of Pennsylvania'}}}}