[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07224594":3,"trial-entities:NCT07224594":143,"trial-summary:NCT07224594":148},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":44,"secondary_outcomes":49,"sex":102,"minimum_age":103,"maximum_age":16,"healthy_volunteers":104,"eligibility_criteria":105,"std_ages":113,"locations":116,"central_contacts":134,"overall_officials":135,"references":141,"see_also_links":142},"NCT07224594","855378","Comparing Optimized Models of Primary And Specialist Services for Palliative Care","ENROLLING_BY_INVITATION","2030-07-31","2026-01","2026-03-12","2026-02-16","University of Pennsylvania","OTHER",true,"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.",null,[18],"Seriously Ill Hospitalized Patients",[20],"Palliative","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[24],"NA",{"count":26,"type":27},78302,"ESTIMATED",[29,36,40],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Default Order","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.",[34,35],"Specialist Palliative Care","Trained Generalist Palliative Care",{"type":30,"name":37,"description":38,"armGroupLabels":39},"Accountable Justification","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.",[35],{"type":30,"name":41,"description":42,"armGroupLabels":43},"Standardized Usual Care","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.",[41],[45],{"measure":46,"description":47,"timeFrame":48},"Hospital free days","Count of days from enrollment spent alive outside of an acute care hospital through 182 days.","Enrollment- 182 days.",[50,54,58,61,64,67,70,74,77,81,85,89,92,95,99],{"measure":51,"description":52,"timeFrame":53},"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.","1-month, 3-months, and 6-months post-enrollment",{"measure":55,"description":56,"timeFrame":57},"Clinician communication","Patient or caregiver report of how much patients feel heard and understood, using the 4-item CMS-MACRA survey instrument","1-month post-enrollment",{"measure":59,"description":60,"timeFrame":57},"Pain management","Patient or caregiver report of whether patients receive desired help for pain, using the 3-item CMS-MACRA survey instrument.",{"measure":62,"description":63,"timeFrame":57},"Goal concordant care","Patient or caregiver report of the patient's perception of whether their treatment matched what they wanted.",{"measure":65,"description":66,"timeFrame":57},"Social interaction","Patient or caregiver report of patient's social support using the 4-item Duke Social Support Index's Social Interaction Sub-scale",{"measure":68,"description":69,"timeFrame":57},"Loneliness","Patient or caregiver report of patient's loneliness using the 3-item Duke UCLA loneliness scale.",{"measure":71,"description":72,"timeFrame":73},"Hospital free days at 3 months","Count of days from enrollment spent alive and not in an acute care hospital through 3 months.","Enrollment - 3-months post-enrollment",{"measure":75,"description":76,"timeFrame":73},"Institution free days at 3 months","Count of days from enrollment spent alive and not in any care facility through 3 months.",{"measure":78,"description":79,"timeFrame":80},"Institution free days at 6 months","Count of days from enrollment spent alive and not in any care facility through 6 months.","Enrollment - 6-months post-enrollment",{"measure":82,"description":83,"timeFrame":84},"30-day hospital readmissions","Count of readmissions","Enrollment - 30 days post-enrollment",{"measure":86,"description":87,"timeFrame":88},"90-day hospital readmissions","Count of readmissions.","Enrollment - 90 days post-enrollment",{"measure":90,"description":91,"timeFrame":80},"Community-based palliative care use","Binary variable indicating any use (use\u002Fno use) captured through EHR and claims data and count of days of PC visits.",{"measure":93,"description":94,"timeFrame":80},"Hospice use","Binary variable indicating any use (use\u002Fno use) captured through EHR and claims data and count of days of hospice.",{"measure":96,"description":97,"timeFrame":98},"Change in code status","Binary indicator of whether code status changed from enrollment.","Enrollment- Discharge from hospital (an average of 7 days)",{"measure":100,"description":101,"timeFrame":98},"Time to palliative care consult","Time from enrollment until receipt of the first documented inpatient palliative care consultation note.","ALL","18 Years",false,{"inclusion":106,"exclusion":108,"raw_text":112},[107],"Age 18 years of age or older; AND Predicted 1-year mortality risk of 70% or greater; AND Admitted to a study hospital.",[109,110,111],"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","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",[114,115],"ADULT","OLDER_ADULT",[117,126],{"facility":118,"city":119,"state":120,"zip":121,"country":122,"geoPoint":123},"Kaiser Permanente Southern California","Pasadena","California","91101","United States",{"lat":124,"lon":125},34.14778,-118.14452,{"facility":127,"city":128,"state":129,"zip":130,"country":122,"geoPoint":131},"Trinity Health","Livonia","Michigan","48152",{"lat":132,"lon":133},42.36837,-83.35271,[],[136,139],{"name":137,"affiliation":12,"role":138},"Scott Halpern, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":140,"affiliation":12,"role":138},"Katherine Courtright, MD, MS",[],[],{"nct_id":4,"conditions":144,"biomarkers":147},[145,146],"Palliative Care Patients","Seriously Ill Patients",[],{"nct_id":4,"found":104,"summary":16,"prompt_version":16}]