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A Health System/Community Partnership for Enhanced Outreach to Prevent Suicide Attempts

Randomized Controlled Trial of Health System/Community Partnership for Enhanced Outreach to Prevent Suicide Attempts

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05837026
Enrollment
300
Registered
2023-05-01
Start date
2026-06-01
Completion date
2027-11-01
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicidal Ideation, Suicide, Suicide, Attempted

Keywords

Suicide, Suicidal Thoughts

Brief summary

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: * Does the EOI reduce suicide-related behaviors? * Does the EOI increase outpatient treatment attendance? * Is the EOI acceptable and feasible? * Can the EOI be delivered with fidelity by Samaritans? 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: * Receive outreach (by call or text) at a planned time once per week for the next 12 weeks. 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. * Receive standard care that hospitals give for patients who present with suicidal thoughts. * Be asked to complete monthly self-report questionnaires. For care as usual alone, participants will: * Receive standard care that hospitals give for patients who present with suicidal thoughts. * Be asked to complete monthly self-report questionnaires.

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. 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.

Interventions

BEHAVIORALEnhanced Outreach Intervention (EOI) plus Care as Usual (CAU)

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.

Participants will receive standard care that hospitals provide to patients who present with suicidal thoughts.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
Samaritans of Boston
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Currently a patient being treated and evaluated by psychiatry service in an MGB ED 2. 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 3. Able to read English 4. 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 5. Willing to provide contact information for collateral contact 6. Willing to share contact information and key clinical information with Samaritans of Boston 7. Consent to unencrypted text or email communications 8. Willing to provide social security number (SSN) or individual taxpayer identification number (ITIN) for study compensation

Exclusion criteria

1. 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 2. Presence of extremely agitated or violent behavior at the time of consent or enrollment

Design outcomes

Primary

MeasureTime frameDescription
Number of Suicide Attempts4 weeksWhether 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).

Secondary

MeasureTime frameDescription
Treatment Attendance4 weeks, 8 weeks, and 12 weeksTreatment attendance during the 12-week intervention period will be captured by manual review of electronic health records and participant-reported outcome survey.
Depressive SymptomsBaseline, 4 weeks, 8 weeks, and 12 weeksDepressive 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 IdeationBaseline, 4 weeks, 8 weeks, and 12 weeksThe 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.

Contacts

CONTACTKate Bentley, PhD
kbentley@mgh.harvard.edu617-724-7741
CONTACTRebecca Fortgang, PhD
RFORTGANG@mgh.harvard.edu
PRINCIPAL_INVESTIGATORJordan Smoller, MD, ScD

Massachusetts General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026