Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-09 @ 4:49 AM
Study NCT ID:
NCT01150994
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2010-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1440}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-12', 'studyFirstSubmitDate': '2010-06-24', 'studyFirstSubmitQcDate': '2010-06-24', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of ER patients screened for self harm', 'timeFrame': 'July 2010 - November 2013'}, {'measure': 'Quality of care', 'timeFrame': 'July 2010 - November 2014', 'description': '* Process outcomes (e.g. receipt of safety plan)\n* Involvement in behavioral health treatment'}, {'measure': 'Suicide-related outcomes', 'timeFrame': 'July 2010 - November 2014', 'description': '* Preparatory acts\n* Suicide attempts\n* Completed suicides'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Suicide screening among ED patients'], 'conditions': ['Suicide']}, 'referencesModule': {'references': [{'pmid': '24588679', 'type': 'RESULT', 'citation': 'Arias SA, Zhang Z, Hillerns C, Sullivan AF, Boudreaux ED, Miller I, Camargo CA. Using structured telephone follow-up assessments to improve suicide-related adverse event detection. Suicide Life Threat Behav. 2014 Oct;44(5):537-47. doi: 10.1111/sltb.12088. Epub 2014 Mar 3.'}, {'pmid': '23426881', 'type': 'RESULT', 'citation': 'Betz ME, Sullivan AF, Manton AP, Espinola JA, Miller I, Camargo CA Jr, Boudreaux ED; ED-SAFE Investigators. Knowledge, attitudes, and practices of emergency department providers in the care of suicidal patients. Depress Anxiety. 2013 Oct;30(10):1005-12. doi: 10.1002/da.22071. Epub 2013 Feb 20.'}, {'pmid': '23495002', 'type': 'RESULT', 'citation': 'Betz ME, Miller M, Barber C, Miller I, Sullivan AF, Camargo CA Jr, Boudreaux ED; ED-SAFE Investigators. Lethal means restriction for suicide prevention: beliefs and behaviors of emergency department providers. Depress Anxiety. 2013 Oct;30(10):1013-20. doi: 10.1002/da.22075. Epub 2013 Mar 14.'}, {'pmid': '25726978', 'type': 'RESULT', 'citation': "Betz ME, Arias SA, Miller M, Barber C, Espinola JA, Sullivan AF, Manton AP, Miller I, Camargo CA Jr, Boudreaux ED. Change in emergency department providers' beliefs and practices after use of new protocols for suicidal patients. Psychiatr Serv. 2015 Jun;66(6):625-31. doi: 10.1176/appi.ps.201400244. Epub 2015 Mar 1."}, {'pmid': '23707435', 'type': 'RESULT', 'citation': 'Boudreaux ED, Miller I, Goldstein AB, Sullivan AF, Allen MH, Manton AP, Arias SA, Camargo CA Jr. The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations. Contemp Clin Trials. 2013 Sep;36(1):14-24. doi: 10.1016/j.cct.2013.05.008. Epub 2013 May 22.'}, {'pmid': '24033624', 'type': 'RESULT', 'citation': 'Caterino JM, Sullivan AF, Betz ME, Espinola JA, Miller I, Camargo CA Jr, Boudreaux ED; Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) Investigators. Evaluating current patterns of assessment for self-harm in emergency departments: a multicenter study. Acad Emerg Med. 2013 Aug;20(8):807-15. doi: 10.1111/acem.12188.'}, {'pmid': '22554432', 'type': 'RESULT', 'citation': 'Ting SA, Sullivan AF, Boudreaux ED, Miller I, Camargo CA Jr. Trends in US emergency department visits for attempted suicide and self-inflicted injury, 1993-2008. Gen Hosp Psychiatry. 2012 Sep-Oct;34(5):557-65. doi: 10.1016/j.genhosppsych.2012.03.020. Epub 2012 May 2.'}, {'pmid': '22288721', 'type': 'RESULT', 'citation': 'Ting SA, Sullivan AF, Miller I, Espinola JA, Allen MH, Camargo CA Jr, Boudreaux ED; Emergency Department Safety and Follow-up Evaluation (ED-SAFE) Investigators. Multicenter study of predictors of suicide screening in emergency departments. Acad Emerg Med. 2012 Feb;19(2):239-43. doi: 10.1111/j.1553-2712.2011.01272.x. Epub 2012 Jan 30.'}, {'pmid': '32706437', 'type': 'DERIVED', 'citation': 'Brown LA, Boudreaux ED, Arias SA, Miller IW, May AM, Camargo CA Jr, Bryan CJ, Armey MF. C-SSRS performance in emergency department patients at high risk for suicide. Suicide Life Threat Behav. 2020 Dec;50(6):1097-1104. doi: 10.1111/sltb.12657. Epub 2020 Jul 24.'}, {'pmid': '26654691', 'type': 'DERIVED', 'citation': 'Boudreaux ED, Camargo CA Jr, Arias SA, Sullivan AF, Allen MH, Goldstein AB, Manton AP, Espinola JA, Miller IW. Improving Suicide Risk Screening and Detection in the Emergency Department. Am J Prev Med. 2016 Apr;50(4):445-453. doi: 10.1016/j.amepre.2015.09.029. Epub 2015 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'The NIMH s RFA-Suicide Prevention in Emergency Medicine Departments recognizes the emergency department (ED) as an important setting to increase suicide detection and prevention efforts but observes that evidence-based practice guidelines do not exist. In response, we have designed the Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) trial. The ED-SAFE study will be conducted using a quasi-experimental design appropriate for studying systems-based change. The study consists of two components (Screening Outcome \\& Intervention Evaluation) and three phases of data collection: Treatment as Usual, Screening Alone, and Intervention. During each phase, 480 suicidal patients (1,440 total) will be enrolled and followed using multiple methods for 12 months.\n\nThe Screening Outcome Component\n\nThe Screening Outcome component will use data collected during the Treatment as Usual and Screening Alone phases. Consistent with systems-change principles, when universal screening is incorporated during the Screening Alone phase, it will be completed by the primary nurse as part of routine care. Primarily, it will focus on testing a practical approach to screen ED patients for suicidal ideation and behavior and will assess its impact on suicide detection, process outcomes, and suicide behaviors.\n\nIntervention Evaluation Component\n\nThe Intervention Evaluation component will use data from the Treatment as Usual, Screening Alone, and Intervention Phases. During the Intervention phase, each ED will implement a multi-component, systems-based Intervention called the Safety Assessment and Follow-up Telephone Intervention (SAFTI). The SAFTI will combine elements of: (a) safety planning administered by nursing staff in the ED, and (b) Coping Long Term with Active Suicide Program (CLASP)-ED, a series of up to 7 semi-structured telephone advising calls to the patient and 4 to the significant other over the 12 months after the ED visit. Safety planning will be implemented universally to all suicidal patients, regardless of whether they are ultimately enrolled into the trial, as part of a comprehensive suicide management protocol (e.g., it is a systems-based change). However, for practical and budgetary considerations, the CLASP-ED telephone advising calls will be administered only to participants enrolled into the study.\n\nOur overarching hypotheses will be tested using a combination of the Screening Outcome component and the Intervention Evaluation Component. We predict that screening will improve detection of suicidal ideation, and the intervention will enhance the quality of care and reduce suicide outcomes.', 'detailedDescription': 'see summary above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18,\n* Entering care at a hospital ED,\n* Documented thoughts or behaviors related to self-harm.\n\nExclusion Criteria:\n\n* No phone or permanent address,\n* Does not speak English or Spanish.'}, 'identificationModule': {'nctId': 'NCT01150994', 'acronym': 'ED-SAFE', 'briefTitle': 'Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE)', 'orgStudyIdInfo': {'id': '13420'}, 'secondaryIdInfos': [{'id': '1U01MH088278-01', 'link': 'https://reporter.nih.gov/quickSearch/1U01MH088278-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual'}, {'type': 'NO_INTERVENTION', 'label': 'Screening Alone', 'description': 'Enhanced screening among ED patients'}, {'type': 'EXPERIMENTAL', 'label': 'Safety Assessment and Follow-up Telephone Intervention', 'description': 'SAFTI: Safety Assessment in the ED combine with a Follow-up Telephone Intervention.', 'interventionNames': ['Behavioral: Safety Assessment and Follow-up Telephone Intervention (SAFTI).']}], 'interventions': [{'name': 'Safety Assessment and Follow-up Telephone Intervention (SAFTI).', 'type': 'BEHAVIORAL', 'description': 'Mental health evaluation in ED, followed by Post-ED counseling', 'armGroupLabels': ['Safety Assessment and Follow-up Telephone Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85008', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Maricopa Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas Medical Center', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMass Medical School, Marlborough Hospital', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '68195', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '02860', 'city': 'Pawtucket', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Memorial Hospital of Rhode Island', 'geoPoint': {'lat': 41.87871, 'lon': -71.38256}}], 'overallOfficials': [{'name': 'Edwin Boudreaux, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMass Medical School'}, {'name': 'Carlos Camargo, MD, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Ivan Miller III, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Butler Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Principal Investigator', 'investigatorFullName': 'Edwin Boudreaux', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}