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

April 11, 2023 updated by: Jordan W. Smoller, MD, Massachusetts General Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced Outreach Intervention plus Care as Usual
Participants will receive the Enhanced Outreach Intervention (EOI) plus care as usual for 12 weeks after ED discharge.
Behavioral: Enhanced Outreach Intervention (EOI) plus Care as Usual

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Report Ratings of Intervention Acceptability
Time Frame: Week 12 of the intervention
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.
Week 12 of the intervention
Self-Report Ratings of Intervention Feasibility
Time Frame: Week 12 of the intervention
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.
Week 12 of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suicide Attempts
Time Frame: 4 weeks, 8 weeks, and 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 through the Self-Injurious Thoughts & Behaviors Interview (SITBI).
4 weeks, 8 weeks, and 12 weeks
Treatment Attendance
Time Frame: 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 a participant-reported outcome survey.
4 weeks, 8 weeks, and 12 weeks
Depressive Symptoms
Time Frame: 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.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Intensity of Suicidal Ideation
Time Frame: 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 total scores mean more intense suicidal ideation.
Baseline, 4 weeks, 8 weeks, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institutes of Health (NIH)
Samaritans of Boston

Investigators

  • Principal Investigator: Jordan Smoller, MD, ScD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2026

Primary Completion (Anticipated)

August 1, 2026

Study Completion (Anticipated)

August 1, 2026

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023P000611-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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