Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-02 @ 7:35 AM
Study NCT ID:
NCT05807568
Status:
RECRUITING
Last Update Posted:
2024-12-05
First Post:
2023-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MIStreatment Screening in Elders Before Discharge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-04-08', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of units using this NCAEM EM-SART Pre-Screen tool', 'timeFrame': '12 months after study', 'description': 'How many times the NCAEM EM-SART Pre-Screen tool is attempted with consented patients'}, {'measure': 'Number of participants who have identified elder mistreatment', 'timeFrame': '15 minute evaluation of each participant, no follow-up', 'description': 'Study participants screening positive based on NCAEM EM-SART Pre-Screen tool'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elder Mistreatment', 'Abuse', 'Neglect', 'Exploitation', 'Screening', 'Geriatric', 'Questionnaire'], 'conditions': ['Elder Abuse', 'Surveys and Questionnaires', 'Self Neglect', 'Geriatrics', 'Geriatric Assessment', 'Health Services for the Aged', 'Aged']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to demonstrate the feasibility of introducing, implementing, and integrating a brief, existent elder mistreatment screening tool (the National Collaboratory to Address Elder Mistreatment (NCAEM)'s Elder Mistreatment - Screening And Response Tool (EM-SART) Pre-Screen) in the Memorial Herman Hospital (MHH)-Texas Medical Center (TMC)Acute Care of Elders(ACE) (MHH-TMC ACE) unit and to identify older adults who may already be suffering from abuse, neglect, and/or financial exploitation, as well as connecting the study participants to the primary Geriatric Medicine team on the ACE unit such that additional care, evaluation (including additional in-depth mistreatment screening), and intervention can be taken to prevent and minimize further harm prior to discharge. The investigators hope to reduce missed opportunities for mistreatment detection to lead to safer health outcomes and hospital discharges."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* current admission to the MHH-TMC ACE unit\n* ability to independently hear, understand, and verbally answer the 3 participant questions on the NCAEM's EM-SART Pre-Screen screening tool when it is read to them\n\nExclusion Criteria:\n\n* unwillingness to participate in the research study."}, 'identificationModule': {'nctId': 'NCT05807568', 'acronym': 'MISSED', 'briefTitle': 'MIStreatment Screening in Elders Before Discharge', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'MIStreatment Screening in Elders Before Discharge (MISSED) Study', 'orgStudyIdInfo': {'id': 'HSC-MS-22-1009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NCAEM EM-SART Pre-Screen', 'interventionNames': ['Other: NCAEM EM-SART Pre-Screen']}], 'interventions': [{'name': 'NCAEM EM-SART Pre-Screen', 'type': 'OTHER', 'description': 'Participants will be verbally asked the 3 participant questions on the NCAEM EM-SART Pre-Screen either directly or with support of hospital approved telephonic interpreters. Answers will be documented by the investigator digitally. Participants will be interviewed one time for a duration of approximately 15 minutes. No further action will be taken on study participants with negative elder mistreatment screens, unless findings concerning for emotional distress are identified by the investigator. If emotional distress is identified, these observations will be communicated to Geriatric Medicine team in person or via secure/encrypted email, with recommendations to follow-up with the participant about the results and take appropriate care actions. Study participants with positive elder mistreatment will have results shared with the study participant directly and with the Geriatric Medicine primary team via secure/encrypted email.', 'armGroupLabels': ['NCAEM EM-SART Pre-Screen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julia A Hiner, MD', 'role': 'CONTACT', 'email': 'Julia.A.Hiner@uth.tmc.edu', 'phone': '713-500-6295'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Julia A Hiner, MD', 'role': 'CONTACT', 'email': 'Julia.A.Hiner@uth.tmc.edu', 'phone': '713-500-6295'}], 'overallOfficials': [{'name': 'Julia A Hiner, MD', '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'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Julia A Hiner', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}