Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT05825820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-02
First Post:
2023-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study of Health System/Community Partnership for Enhanced Outreach to Prevent Suicide Attempts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D013406', 'term': 'Suicide, Attempted'}, {'id': 'D059020', 'term': 'Suicidal Ideation'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open, non-randomized single-arm design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2023-04-11', 'studyFirstSubmitQcDate': '2023-04-11', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-Report Ratings of Intervention Acceptability', 'timeFrame': 'Week 12 of the intervention', 'description': 'The acceptability of the EOI will be measured by the Acceptability of Intervention Measure (AIM). The scale values range from 1 to 5. Higher scores mean higher acceptability.'}, {'measure': 'Self-Report Ratings of Intervention Feasibility', 'timeFrame': 'Week 12 of the intervention', 'description': 'The feasibility of the EOI will be measured by the Feasibility of Intervention Measure (FIM). The scale values range from 1 to 5. Higher scores mean higher feasibility.'}], 'secondaryOutcomes': [{'measure': 'Suicide Attempts', 'timeFrame': '4 weeks, 8 weeks, and 12 weeks', 'description': 'Whether or not a suicide attempt occurs during the 12-week intervention period will be captured by manual review of electronic health records and through the Self-Injurious Thoughts \\& Behaviors Interview (SITBI).'}, {'measure': 'Treatment Attendance', 'timeFrame': '4 weeks, 8 weeks, and 12 weeks', 'description': 'Treatment attendance during the 12-week intervention period will be captured by manual review of electronic health records and a participant-reported outcome survey.'}, {'measure': 'Depressive Symptoms', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, and 12 weeks', 'description': 'Depressive symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9). The scale values ranges from 0 to 3. Higher total scores mean more severe symptoms.'}, {'measure': 'Intensity of Suicidal Ideation', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, and 12 weeks', 'description': 'The intensity of suicidal ideation will be measured using the Beck Scale for Suicide Ideation (BSS). The scale values ranges from 0 to 2. Higher total scores mean more intense suicidal ideation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Suicide', 'Suicidal Thoughts'], 'conditions': ['Suicide', 'Suicide, Attempted', 'Suicidal Ideation']}, 'referencesModule': {'references': [{'pmid': '32584936', 'type': 'BACKGROUND', 'citation': 'Doupnik SK, Rudd B, Schmutte T, Worsley D, Bowden CF, McCarthy E, Eggan E, Bridge JA, Marcus SC. Association of Suicide Prevention Interventions With Subsequent Suicide Attempts, Linkage to Follow-up Care, and Depression Symptoms for Acute Care Settings: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2020 Oct 1;77(10):1021-1030. doi: 10.1001/jamapsychiatry.2020.1586.'}, {'pmid': '25733570', 'type': 'BACKGROUND', 'citation': 'Milner AJ, Carter G, Pirkis J, Robinson J, Spittal MJ. Letters, green cards, telephone calls and postcards: systematic and meta-analytic review of brief contact interventions for reducing self-harm, suicide attempts and suicide. Br J Psychiatry. 2015 Mar;206(3):184-90. doi: 10.1192/bjp.bp.114.147819.'}, {'type': 'BACKGROUND', 'citation': 'National Action Alliance for Suicide Prevention: Transforming Health Systems Initiative Work Group. Recommended standard care for people with suicide risk: Making health care suicide safe. Education Development Center, Inc. Published online 2018.'}, {'pmid': '37347878', 'type': 'BACKGROUND', 'citation': "Office of the Surgeon General (OSG). The Surgeon General's Call to Action to Implement the National Strategy for Suicide Prevention [Internet]. Washington (DC): US Department of Health and Human Services; 2021-. Available from http://www.ncbi.nlm.nih.gov/books/NBK592704/"}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test an enhanced outreach intervention (EOI) delivered by Samaritans of Boston (a community organization that provides support during mental health crises) for people after they leave an emergency department (ED) visit for suicidal thoughts. The main questions the trial aims to answer are:\n\n* Is the EOI feasible and acceptable?\n* Can the EOI be delivered with fidelity by Samaritans staff?\n\nParticipants will:\n\n* Receive outreach (by call or text) once per week for 12 weeks after ED visit. During these conversations, Samaritans staff will ask participants questions about their suicidal thoughts and behaviors, develop and review a list of coping skills to use if they have suicidal thoughts, and discuss plans for receiving mental health care.\n* Receive caring messages from Samaritans staff at least once per week.\n* Be asked to complete monthly self-report questionnaires, and participate in a phone interview with study staff at the end of the study.', 'detailedDescription': 'The period after discharge from an emergency department (ED) is a critical time of increased risk for suicide and related behavior (SRB). Brief "caring contact" interventions that provide follow-up and support after a healthcare visit have been shown to reduce SRB and are now recommended best practices for suicide prevention in healthcare systems. However, system- and individual-level barriers to widespread implementation exist. For example, deployment of brief contact interventions requires dedicated resources and staffing within already overburdened healthcare settings, and even single-session interventions require robust provider training and ongoing oversight for successful implementation.\n\nThe purpose of this study is to evaluate a recently developed Enhanced Outreach Intervention (EOI) for post-ED discharge that combines multiple evidence-based suicide prevention components (e.g., safety planning, risk assessment, caring contacts, and care engagement) and is delivered through a partnership between a healthcare system (Mass General Brigham \\[MGB\\]) and a local crisis line organization (Samaritans of Boston). Combining multiple evidence-based interventions has the potential to increase effectiveness over usual practices, and partnering with a community organization vastly increases scalability.\n\nSamaritans staff will undergo robust, multifaceted training on the EOI, and use standardized decision trees to guide EOI delivery. In this trial, the investigators will develop operational workflows for using a suicide risk algorithm to identify patients to receive the EOI, conduct a small open pilot of the EOI (N = 20), and assess the barriers and facilitators, and feasibility, acceptability, and fidelity of implementing the EOI in an academic medical setting to inform intervention refinement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Currently a patient being treated and evaluated by psychiatry service in an MGB ED\n2. Participants enrolled in another study (NCT05671133; PI Nock) conducted by the research team who fall into the top 50% of risk based on the suicide risk prediction algorithm used in that study\n3. Able to read English\n4. Ownership of a smartphone (iOS or Android) and consistent access to their smartphone following discharge from the current treatment unit or program; ability to be reliably contacted\n5. Willing to provide contact information for collateral contact\n6. Willing to share contact information and key clinical information with Samaritans of Boston\n7. Consent to unencrypted text or email communications\n8. Willing to provide social security number (SSN) or individual taxpayer identification number (ITIN) for study compensation\n\nExclusion Criteria:\n\n1. Any factor that impairs an individual's ability to comprehend and effectively participate in informed consent, including the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, or acute intoxication\n2. Presence of extremely agitated or violent behavior at the time of consent or enrollment"}, 'identificationModule': {'nctId': 'NCT05825820', 'briefTitle': 'Pilot Study of Health System/Community Partnership for Enhanced Outreach to Prevent Suicide Attempts', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Pilot Study Health System/Community Partnership for Enhanced Outreach to Prevent Suicide Attempts', 'orgStudyIdInfo': {'id': '2023P000611-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced Outreach Intervention plus Care as Usual', 'description': 'Participants will receive the Enhanced Outreach Intervention (EOI) plus care as usual for 12 weeks after ED discharge.', 'interventionNames': ['Behavioral: Enhanced Outreach Intervention (EOI) plus Care as Usual']}], 'interventions': [{'name': 'Enhanced Outreach Intervention (EOI) plus Care as Usual', 'type': 'BEHAVIORAL', 'description': "The EOI will contain four main components: safety planning, caring contacts, care engagement, and risk assessment.\n\nA phone call (or text messaging) from Samaritans staff will be conducted every week of the 12 week intervention. Conversations will use a standardized phone script to (a) conduct a risk assessment, (b) develop and review a list of coping skills to use if you have suicidal thoughts, and (c) discuss participants' plans for receiving mental health care. Samaritans staff will also send a caring text message or email at least once per week.\n\nParticipants will also receive standard care that hospitals give for individuals who present to the ED with suicidal thoughts.", 'armGroupLabels': ['Enhanced Outreach Intervention plus Care as Usual']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kate Bentley, PhD', 'role': 'CONTACT', 'email': 'kbentley@mgh.harvard.edu', 'phone': '617-724-7741'}, {'name': 'Rebecca Fortgang, PhD', 'role': 'CONTACT', 'email': 'RFORTGANG@mgh.harvard.edu'}], 'overallOfficials': [{'name': 'Jordan Smoller, MD, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Samaritans of Boston', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Chief for Research, Department of Psychiatry', 'investigatorFullName': 'Jordan W. Smoller, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}