Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT05671133
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2022-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness and Implementation of a Clinician Decision Support System to Prevent Suicidal Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D013406', 'term': 'Suicide, Attempted'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2022-12-16', 'studyFirstSubmitQcDate': '2023-01-03', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Suicide attempt', 'timeFrame': '6-months', 'description': "Suicide attempts will be measured using two methods: (a) self-report surveys and (b) documentation in the Electronic Health Record during the follow-up period. Self-report questions about suicide attempts will be those from the Self-Injurious Thoughts and Behaviors Interview (SITBI), a widely-used measure of suicidal thoughts and behaviors with strong reliability and validity and one of the measures recommended in the PhenX toolkit. We also will examine all new medical records during the 6-months following each participant's index ED visit to determine if the participant revisited the hospital due to suicide ideation or suicide attempt during the follow-up period. This approach has been used in prior studies to measure such outcomes. In our own prior work in the ED we have found high agreement between self-reports on the SITBI and the documentation of suicide attempts in electronic medical records (K=.84)."}], 'secondaryOutcomes': [{'measure': 'Suicide attempt', 'timeFrame': '1-month', 'description': 'Secondary endpoints are suicide attempt (using the same assessment methods as the primary endpoint) within 1-month post-randomization and will also be assessed using two sample tests of proportions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Suicide', 'Suicide, Attempted']}, 'descriptionModule': {'briefSummary': 'The primary aim of this project are to evaluate a comprehensive, practice-ready, and deployment-focused strategy for improving the prediction and prevention of suicide attempts among a sample of 4,000 patients presenting to an ED with a psychiatric concern. Our first aim is to evaluate the effects of providing information about risk of patient suicidal behavior to ED clinicians. We hypothesize that patients randomly assigned to have their clinician receive their risk score will have a lower rate of suicide attempts during 6-month follow-up and that this effect will be mediated by changes in clinician decision-making.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Presentation to emergency psychiatry service\n\nExclusion Criteria:\n\n* Inability to understand study procedures and provide informed consent, such as those with gross cognitive impairment (including florid psychosis), intellectual disability, dementia, acute intoxication\n* Presence of violent or extremely agitated behavior'}, 'identificationModule': {'nctId': 'NCT05671133', 'briefTitle': 'Effectiveness and Implementation of a Clinician Decision Support System to Prevent Suicidal Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Effectiveness and Implementation of a Clinician Decision Support System to Prevent Suicidal Behaviors', 'orgStudyIdInfo': {'id': '2022P002689'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': "Patient's clinician is given Clinician Decision Support Tool", 'interventionNames': ['Diagnostic Test: Clinician Decision Support Tool']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': "Patient's clinician is not given Clinician Decision Support Tool (care as usual)"}], 'interventions': [{'name': 'Clinician Decision Support Tool', 'type': 'DIAGNOSTIC_TEST', 'description': "Clinician Decision Support Tool that provides information about patient's statistical probability of suicide attempt in next 1 month", 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Nock', 'role': 'CONTACT', 'email': 'nock@wjh.harvard.edu', 'phone': '6174964484'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Matthew Nock, PhD', 'role': 'CONTACT', 'email': 'nock@wjh.harvard.edu', 'phone': '617-496-4484'}, {'name': 'Amy Ahn, PhD', 'role': 'CONTACT', 'email': 'yahn@fas.harvard.edu'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'By study end', 'ipdSharing': 'YES', 'description': 'All data will be shared via the National Institute of Mental Health National Data Archive'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Matthew K. Nock, PhD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}