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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Samaritans of Boston | UNKNOWN |
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The goal of this study 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 it aims to answer are:
Participants will be randomized to the EOI plus care as usual or care as usual alone. Participants in the EOI plus care as usual group will:
For care as usual alone, participants will:
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. The investigators will conduct a randomized controlled trial (N=300) of the EOI plus care as usual versus care as usual alone after ED discharge to test effectiveness of the EOI and collect data on implementation-related factors. The investigators will also explore potential moderators of intervention effects, including age, sex, race/ethnicity, and predicted risk of suicide attempt at baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Outreach Intervention plus Care as Usual (CAU) | Experimental | Participants will receive the Enhanced Outreach Intervention (EOI) plus care as usual for 12 weeks after ED discharge. |
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| Care as Usual (CAU) | Other | Participants will receive the standard care (i.e., CAU) that the hospital provides to patients who present with suicidal thoughts. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Outreach Intervention (EOI) plus Care as Usual (CAU) | Behavioral | The EOI will contain four main components: safety planning, caring contacts, care engagement, and risk assessment. Outreach (via phone 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 the participant has suicidal thoughts, and (c) discuss 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 provide to patients who present with suicidal thoughts. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of 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 the Self-Injurious Thoughts & Behaviors Interview (SITBI). | 4 weeks |
| Number of 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 the Self-Injurious Thoughts & Behaviors Interview (SITBI). | 8 weeks |
| Number of 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 the Self-Injurious Thoughts & Behaviors Interview (SITBI). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Attendance | Treatment attendance during the 12-week intervention period will be captured by manual review of electronic health records and participant-reported outcome survey. | 4 weeks, 8 weeks, and 12 weeks |
| Depressive Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kate Bentley, PhD | Contact | 617-724-7741 | kbentley@mgh.harvard.edu | |
| Rebecca Fortgang, PhD | Contact | RFORTGANG@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jordan Smoller, MD, ScD | Massachusetts General Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32584936 | Background | 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. | |
| 25733570 |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D013406 | Suicide, Attempted |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Effectiveness-implementation Hybrid Type 1 randomized trial. Participants will be randomized to EOI plus care as usual (CAU) or CAU alone using an equal (1:1) allocation ratio.
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| Care as Usual (CAU) | Other | Participants will receive standard care that hospitals provide to patients who present with suicidal thoughts. |
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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.
| Baseline, 4 weeks, 8 weeks, and 12 weeks |
| 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 scores mean more intense suicidal ideation. | Baseline, 4 weeks, 8 weeks, and 12 weeks |
| Background |
| 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. |
| Background | 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. |
| 37347878 | Background | 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/ |