Viewing Study NCT05837026



Ignite Creation Date: 2024-05-06 @ 6:56 PM
Last Modification Date: 2024-10-26 @ 2:57 PM
Study NCT ID: NCT05837026
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-05-01
First Post: 2023-04-11

Brief Title: A Health SystemCommunity Partnership for Enhanced Outreach to Prevent Suicide Attempts
Sponsor: Massachusetts General Hospital
Organization: Massachusetts General Hospital

Study Overview

Official Title: Randomized Controlled Trial of Health SystemCommunity Partnership for Enhanced Outreach to Prevent Suicide Attempts
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 eg 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 N300 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 raceethnicity and predicted risk of suicide attempt at baseline

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None