Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-02-26 @ 12:45 AM
Study NCT ID:
NCT06350266
Status:
COMPLETED
Last Update Posted:
2025-01-09
First Post:
2024-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Informing Low-acuity Emergency Department Patients of Non-emergent Resources
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-25', 'size': 41049, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-29T12:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Patients will be aware of their own messages but not of messages sent to other patients or in other arms.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2024-04-01', 'studyFirstSubmitQcDate': '2024-04-01', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'PCP appointment made', 'timeFrame': 'within 60 days following day of discharge', 'description': 'PCP appointment made (yes/no)'}, {'measure': 'PCP visit', 'timeFrame': 'within 60 days following day of discharge', 'description': 'PCP appointment attended (yes/no)'}, {'measure': 'Telehealth appointment made', 'timeFrame': 'within 60 days following day of discharge', 'description': 'Telehealth appointment made (yes/no)'}, {'measure': 'Telehealth appointment attended', 'timeFrame': 'within 60 days following day of discharge', 'description': 'Telehealth appointment attended (yes/no)'}, {'measure': 'Call made to PCP', 'timeFrame': 'within 60 days following day of discharge', 'description': 'Record of patient call to PCP (yes/no)'}, {'measure': 'Any of the suggested actions taken', 'timeFrame': 'within 60 days following day of discharge', 'description': 'PCP called or visited, telehealth appointment attended, or PCP or telehealth appointment made (yes/no)'}, {'measure': 'Urgent care visit', 'timeFrame': 'within 60 days following day of discharge', 'description': 'Urgent care appointment attended (yes/no)'}], 'primaryOutcomes': [{'measure': 'Return to Geisinger ED', 'timeFrame': 'within 120 days following day of discharge', 'description': 'ED visit (yes/no)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emergency Service, Hospital']}, 'descriptionModule': {'briefSummary': "The goal of this campaign is to reduce unnecessary visits to a Geisinger emergency department (ED)/encourage patients with high acuity visits to follow up with an appropriate Geisinger provider. In this campaign, patients will be assigned to receive or not receive outreach following ED discharge that is aligned with the goal. Outreach will occur via a text message, as well as information added to the patient's after visit summary, and will includecalls to action to see their Geisinger CMSL PCP either in person or virtually. The study will assess whether ED use differs across patients in different outreach conditions. It will also examine whether patients follow through on the message-specific calls to action in the messages differently across conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>= 18 years of age\n* Geisinger ED visit rated as low acuity (L4 or L5)\n* Discharged from Geisinger ED in past 24 hours\n\nExclusion Criteria:\n\n* Cannot be contacted via the communication modality being used in the study (i.e., SMS), due to insufficient/missing contact information in the EHR or because the patient opted out\n* Admitted to hospital\n* Already included in intervention in past 365 days'}, 'identificationModule': {'nctId': 'NCT06350266', 'briefTitle': 'Informing Low-acuity Emergency Department Patients of Non-emergent Resources', 'organization': {'class': 'OTHER', 'fullName': 'Geisinger Clinic'}, 'officialTitle': 'Informing Low-acuity Emergency Department Patients of Non-emergent Healthcare Resources Following Discharge to Decrease Emergency Department Utilization', 'orgStudyIdInfo': {'id': '2024-0183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This arm will receive no intervention outside of usual care.'}, {'type': 'EXPERIMENTAL', 'label': 'Other Healthcare Resources', 'description': 'This arm will receive text messages suggesting alternatives to seeking care at a Geisinger emergency department such as seeing their Geisinger CMSL primary care provider in person or virtually (telehealth). Text suggesting these alternatives may also be included in a modified discharge paperwork packet.', 'interventionNames': ['Behavioral: Information about healthcare resources']}], 'interventions': [{'name': 'Information about healthcare resources', 'type': 'BEHAVIORAL', 'otherNames': ['Text messages', 'Discharge summary text', 'Information'], 'description': 'Text messages will be sent following discharge from the emergency department; text may also be modified in the (online and/or printed) discharge summary packet.', 'armGroupLabels': ['Other Healthcare Resources']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Health System', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}], 'overallOfficials': [{'name': 'Amir Goren, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geisinger Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Geisinger Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Program Director, Behavioral Insights Team', 'investigatorFullName': 'Amir Goren', 'investigatorAffiliation': 'Geisinger Clinic'}}}}