Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-31 @ 9:06 AM
Study NCT ID:
NCT05502861
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2022-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pragmatic Trial of an Active Choice Nudge for Generalist or Specialist Palliative Care for Seriously Ill Inpatients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D058005', 'term': 'General Practitioners'}], 'ancestors': [{'id': 'D010820', 'term': 'Physicians'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'stepped-wedge cluster (at hospital-level) randomized trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16000}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2022-08-12', 'studyFirstSubmitQcDate': '2022-08-12', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital-free days', 'timeFrame': '6 months', 'description': 'Days from enrollment spent alive and not in an acute care hospital through 6 months or death'}], 'secondaryOutcomes': [{'measure': 'Goals of Care (GOC) conversation within a discrete GOC note type', 'timeFrame': 'up to 6 weeks', 'description': 'Presence or absence of documented GOC conversation after enrollment detected by natural language programming algorithm or by a discrete GOC note type'}, {'measure': 'Pain scores', 'timeFrame': 'up to 6 weeks', 'description': 'pain level according to standardized scale across hospitals after enrollment'}, {'measure': 'Palliative care consultation note', 'timeFrame': 'up to 6 weeks', 'description': 'Presence or absence of signed inpatient palliative care note after enrollment'}, {'measure': 'Time to palliative care consult', 'timeFrame': 'up to 6 weeks', 'description': 'starts at time of enrollment until receipt of first documented inpatient palliative care consultation note'}, {'measure': 'Change in code status found in chart documentation', 'timeFrame': 'up to 6 weeks', 'description': 'no change, new limitations on life support (e.g., DNAR, DNI) or discontinued limitations on life support'}, {'measure': 'Intensive care unit admission', 'timeFrame': 'up to 6 weeks', 'description': 'admitted to any ICU during hospital encounter'}, {'measure': 'Hospital length of stay', 'timeFrame': 'up to 6 weeks', 'description': 'number of days in hospital staring at enrollment'}, {'measure': 'Hospital all-cause mortality', 'timeFrame': 'up to 6 weeks', 'description': 'death occurred in the hospital or within 1 day of discharge'}, {'measure': 'Hospice enrollment', 'timeFrame': 'up to 6 weeks', 'description': 'yes if new hospice enrollment'}, {'measure': 'Home or clinic palliative care referral', 'timeFrame': 'up to 6 weeks', 'description': 'yes if new home of clinic palliative care order after enrollment'}, {'measure': 'Hospital discharge disposition written in discharge order', 'timeFrame': 'up to 6 weeks', 'description': 'Discharge to home, other acute facility, skilled nursing facility'}, {'measure': '30-day hospital readmission', 'timeFrame': '30 days', 'description': 'readmission within 30 days of discharge'}, {'measure': '180-day all cause mortality', 'timeFrame': '180 days', 'description': '180 days after enrollment'}, {'measure': 'Hospital total costs', 'timeFrame': 'up to 6 weeks', 'description': 'continuous hospital costs'}, {'measure': 'Future acute care costs', 'timeFrame': 'enrollment to 6 months post hospital discharge', 'description': 'acute care costs over the 6 month follow up period'}, {'measure': 'Goal-concordant care', 'timeFrame': 'enrollment to 6 months post hospital discharge', 'description': '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'}, {'measure': 'McGill Quality of Life-Revised', 'timeFrame': '1 month', 'description': '14-item survey instrument; score 0-10; continuous'}, {'measure': 'McGill Quality of Life-Revised', 'timeFrame': '3 months', 'description': '14-item survey instrument; score 0-10; continuous'}, {'measure': 'McGill Quality of Life-Revised', 'timeFrame': '6 months', 'description': '14-item survey instrument; score 0-10; continuous'}, {'measure': 'CMS-MACRA PC Quality', 'timeFrame': '1 month', 'description': '(1) felt heard and understood (4-items); (2) received desired help for pain (3-items); continuous'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Palliative Care, Pragmatic Trial'], 'conditions': ['Palliative Care']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Inpatient or observation admission status at a study hospital\n* Predicted 6-month mortality risk moderate (e.g., ≥40%) or higher\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Inpatient primary service: hospice, rehabilitation, obstetrics, psychiatry\n* Patients that have died or been discharged before 0800 on hospital day 3 when the mortality risk is generated and enrollment occurs'}, 'identificationModule': {'nctId': 'NCT05502861', 'briefTitle': 'A Pragmatic Trial of an Active Choice Nudge for Generalist or Specialist Palliative Care for Seriously Ill Inpatients', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'A Pragmatic Trial of an Active Choice Nudge for Generalist or Specialist Palliative Care for Seriously Ill Inpatients: The Palliative Connect Trial', 'orgStudyIdInfo': {'id': '848497'}, 'secondaryIdInfos': [{'id': 'R01AG073384', 'link': 'https://reporter.nih.gov/quickSearch/R01AG073384', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': "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.", 'interventionNames': ['Behavioral: Generalist + Specialist palliative care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control/Usual Care', 'description': '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.', 'interventionNames': ['Behavioral: Pre-Intervention phase']}], 'interventions': [{'name': 'Generalist + Specialist palliative care', 'type': 'BEHAVIORAL', 'otherNames': ['Active choice generalist palliative care'], 'description': '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.', 'armGroupLabels': ['Intervention']}, {'name': 'Pre-Intervention phase', 'type': 'BEHAVIORAL', 'otherNames': ['Usual care'], 'description': 'Patients meeting eligibility criteria will be enrolled for study data collection but there will be no attempt to influence delivery of care.', 'armGroupLabels': ['Control/Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Katherine R Courtright, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'url': 'http://www.pair.upenn.edu', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': "Data will be available beginning 9 months after publication and up to 36 months following publication. After 36 months the data will be available in our University's data warehouse but without support, except for deposited metadata.", 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie published results will be made available to other researchers, after deidentification.', 'accessCriteria': 'Proposals for data use will be reviewed by Principal Investigator and independent review boards (such as Institutional Review Board and Data Safety and Monitoring Board). Approved data requestors will need to sign data use agreements to access and use data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Katherine Courtright', 'investigatorAffiliation': 'University of Pennsylvania'}}}}