Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT05823220
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-28
First Post:
2023-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pragmatic Trial Integrating Homelessness Diversion Services Into an Emergency Department Discharge System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2023-04-08', 'studyFirstSubmitQcDate': '2023-04-08', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of ED visits', 'timeFrame': 'end of study (6 months after start of study)'}], 'secondaryOutcomes': [{'measure': 'Number of participants who experience homelessness', 'timeFrame': 'end of study (6 months after start of study)'}, {'measure': 'Change in health related quality of life as assessed by the Short Form-12 version 2.0 (SF12v2) health Survey', 'timeFrame': 'baseline, month 1, month 2, month 3, month 4, month 5 and month 6', 'description': 'This is a 12 item questionnaire and scores range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Homelessness']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a homelessness diversion program integrated into a hospital emergency department (ED) will lower ED use, to identify characteristics of individuals most likely to benefit from homelessness diversion and to discover opportunities to tailor Homelessness Diversion (HD) services to better meet the needs of diverse communities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English or Spanish speaking\n* discharged from a Harris Health Hospital ED (Ben Taub or LBJ)\n* at imminent risk of homelessness\n* patients with Medicaid, Medicare or who are uninsured\n\nExclusion Criteria:\n\n* having a conservator (legal guardian)\n* plans to move away from Texas in 6 months'}, 'identificationModule': {'nctId': 'NCT05823220', 'briefTitle': 'A Pragmatic Trial Integrating Homelessness Diversion Services Into an Emergency Department Discharge System', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'A Pragmatic Randomized Trial Integrating Homelessness Diversion Services Into an Emergency Department Discharge System', 'orgStudyIdInfo': {'id': 'HSC-SPH-22-0762'}, 'secondaryIdInfos': [{'id': 'R01MD018213', 'link': 'https://reporter.nih.gov/quickSearch/R01MD018213', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Homeless diversion (HD) group', 'interventionNames': ['Behavioral: Homeless diversion (HD)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment-as-usual (TAU) group', 'interventionNames': ['Behavioral: Treatment-as-usual (TAU)']}], 'interventions': [{'name': 'Homeless diversion (HD)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive services from specialty-trained community health workers and will be invited to complete monthly assessments via text and phone to assess their health and housing for 6 months and to share feedback on their experience with the intervention after completion by a text message to a link for the survey', 'armGroupLabels': ['Homeless diversion (HD) group']}, {'name': 'Treatment-as-usual (TAU)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a list of community resources they can contact to receive services and will be invited to complete monthly assessments via text and phone to assess their health and housing for 6 months and to share feedback on their experience with the intervention after completion by a text message to a link for the survey', 'armGroupLabels': ['Treatment-as-usual (TAU) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jack Tsai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jack Tsai', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}