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Pilot Study of Health System/Community Partnership for Enhanced Outreach to Prevent Suicide Attempts

Primary Purpose

Suicide, Suicide, Attempted, Suicidal Ideation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhanced Outreach Intervention (EOI) plus Care as Usual
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide focused on measuring Suicide, Suicidal Thoughts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Currently a patient being treated and evaluated by psychiatry service in an MGB ED 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 Able to read English 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 Willing to provide contact information for collateral contact Willing to share contact information and key clinical information with Samaritans of Boston Consent to unencrypted text or email communications Willing to provide social security number (SSN) or individual taxpayer identification number (ITIN) for study compensation Exclusion Criteria: 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 Presence of extremely agitated or violent behavior at the time of consent or enrollment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Enhanced Outreach Intervention plus Care as Usual

    Arm Description

    Participants will receive the Enhanced Outreach Intervention (EOI) plus care as usual for 12 weeks after ED discharge.

    Outcomes

    Primary Outcome Measures

    Self-Report Ratings of Intervention Acceptability
    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.
    Self-Report Ratings of Intervention Feasibility
    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.

    Secondary Outcome Measures

    Suicide Attempts
    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).
    Treatment Attendance
    Treatment attendance during the 12-week intervention period will be captured by manual review of electronic health records and a participant-reported outcome survey.
    Depressive Symptoms
    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.
    Intensity of Suicidal Ideation
    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.

    Full Information

    First Posted
    April 11, 2023
    Last Updated
    April 11, 2023
    Sponsor
    Massachusetts General Hospital
    Collaborators
    National Institutes of Health (NIH), Samaritans of Boston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05825820
    Brief Title
    Pilot Study of Health System/Community Partnership for Enhanced Outreach to Prevent Suicide Attempts
    Official Title
    Pilot Study Health System/Community Partnership for Enhanced Outreach to Prevent Suicide Attempts
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2026 (Anticipated)
    Primary Completion Date
    August 2026 (Anticipated)
    Study Completion Date
    August 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital
    Collaborators
    National Institutes of Health (NIH), Samaritans of Boston

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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: Is the EOI feasible and acceptable? Can the EOI be delivered with fidelity by Samaritans staff? Participants will: 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. Receive caring messages from Samaritans staff at least once per week. Be asked to complete monthly self-report questionnaires, and participate in a phone interview with study staff at the end of the study.
    Detailed Description
    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. The 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. Samaritans 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicide, Suicide, Attempted, Suicidal Ideation
    Keywords
    Suicide, Suicidal Thoughts

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Open, non-randomized single-arm design
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Enhanced Outreach Intervention plus Care as Usual
    Arm Type
    Experimental
    Arm Description
    Participants will receive the Enhanced Outreach Intervention (EOI) plus care as usual for 12 weeks after ED discharge.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Enhanced Outreach Intervention (EOI) plus Care as Usual
    Intervention Description
    The EOI will contain four main components: safety planning, caring contacts, care engagement, and risk assessment. A 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. Participants will also receive standard care that hospitals give for individuals who present to the ED with suicidal thoughts.
    Primary Outcome Measure Information:
    Title
    Self-Report Ratings of Intervention Acceptability
    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.
    Time Frame
    Week 12 of the intervention
    Title
    Self-Report Ratings of Intervention Feasibility
    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.
    Time Frame
    Week 12 of the intervention
    Secondary Outcome Measure Information:
    Title
    Suicide Attempts
    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).
    Time Frame
    4 weeks, 8 weeks, and 12 weeks
    Title
    Treatment Attendance
    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.
    Time Frame
    4 weeks, 8 weeks, and 12 weeks
    Title
    Depressive Symptoms
    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.
    Time Frame
    Baseline, 4 weeks, 8 weeks, and 12 weeks
    Title
    Intensity of Suicidal Ideation
    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.
    Time Frame
    Baseline, 4 weeks, 8 weeks, and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Currently a patient being treated and evaluated by psychiatry service in an MGB ED 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 Able to read English 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 Willing to provide contact information for collateral contact Willing to share contact information and key clinical information with Samaritans of Boston Consent to unencrypted text or email communications Willing to provide social security number (SSN) or individual taxpayer identification number (ITIN) for study compensation Exclusion Criteria: 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 Presence of extremely agitated or violent behavior at the time of consent or enrollment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kate Bentley, PhD
    Phone
    617-724-7741
    Email
    kbentley@mgh.harvard.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rebecca Fortgang, PhD
    Email
    RFORTGANG@mgh.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jordan Smoller, MD, ScD
    Organizational Affiliation
    Massachusetts General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32584936
    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.
    Results Reference
    background
    PubMed Identifier
    25733570
    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.
    Results Reference
    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.
    Results Reference
    background
    PubMed Identifier
    37347878
    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/
    Results Reference
    background

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    Pilot Study of Health System/Community Partnership for Enhanced Outreach to Prevent Suicide Attempts

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