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

Not Applicable

Not yet recruiting

• Conditions: Suicidal Ideation; Suicide; Suicide, Attempted
• Interventions: Other: Care as Usual (CAU); Behavioral: Enhanced Outreach Intervention (EOI) plus Care as Usual (CAU)

• Registration Number: NCT05837026
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-27
• Study First Posted: 2023-05-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Study Start: 2026-06
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care as Usual (CAU)	Care as Usual (CAU)	Participants will receive the standard care (i.e., CAU) that the hospital provides to patients who present with suicidal thoughts.
Enhanced Outreach Intervention plus Care as Usual (CAU)	Enhanced Outreach Intervention (EOI) plus Care as Usual (CAU)	Participants will receive the Enhanced Outreach Intervention (EOI) plus care as usual for 12 weeks after ED discharge.

Primary Outcome Measures

Name	Time	Method
Number of Suicide Attempts	12 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Treatment Attendance	4 weeks, 8 weeks, and 12 weeks	Treatment attendance during the 12-week intervention period will be captured by manual review of electronic health records and participant-reported outcome survey.
Depressive Symptoms	Baseline, 4 weeks, 8 weeks, and 12 weeks	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	Baseline, 4 weeks, 8 weeks, and 12 weeks	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.