Effectiveness and Implementation of a Clinician Decision Support System to Prevent Suicidal Behaviors

NCT05671133 | Recruiting DMC FDA Device

• 1 other identifier: 2022P002689
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this project are to evaluate a comprehensive, practice-ready, and deployment-focused strategy for improving the prediction and prevention of suicide attempts among a sample of 4,000 patients presenting to an ED with a psychiatric concern. Our first aim is to evaluate the effects of providing information about risk of patient suicidal behavior to ED clinicians. We hypothesize that patients randomly assigned to have their clinician receive their risk score will have a lower rate of suicide attempts during 6-month follow-up and that this effect will be mediated by changes in clinician decision-making.

Conditions

Suicide; Suicide, Attempted

Outcome Measures

Primary Outcomes (1)

• Suicide attempt

  Suicide attempts will be measured using two methods: (a) self-report surveys and (b) documentation in the Electronic Health Record during the follow-up period. Self-report questions about suicide attempts will be those from the Self-Injurious Thoughts and Behaviors Interview (SITBI), a widely-used measure of suicidal thoughts and behaviors with strong reliability and validity and one of the measures recommended in the PhenX toolkit. We also will examine all new medical records during the 6-months following each participant's index ED visit to determine if the participant revisited the hospital due to suicide ideation or suicide attempt during the follow-up period. This approach has been used in prior studies to measure such outcomes. In our own prior work in the ED we have found high agreement between self-reports on the SITBI and the documentation of suicide attempts in electronic medical records (K=.84).

  6-months

Secondary Outcomes (1)

• Suicide attempt

  1-month

Study Arms (2)

Experimental

EXPERIMENTAL

Patient's clinician is given Clinician Decision Support Tool

Diagnostic Test: Clinician Decision Support Tool

Control

NO INTERVENTION

Patient's clinician is not given Clinician Decision Support Tool (care as usual)

Interventions

Clinician Decision Support Tool DIAGNOSTIC_TEST

Clinician Decision Support Tool that provides information about patient's statistical probability of suicide attempt in next 1 month

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Presentation to emergency psychiatry service

You may not qualify if:

• Inability to understand study procedures and provide informed consent, such as those with gross cognitive impairment (including florid psychosis), intellectual disability, dementia, acute intoxication
• Presence of violent or extremely agitated behavior

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Suicide; Suicide, Attempted

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Matthew Nock, PhD

CONTACT

617-496-4484; nock@wjh.harvard.edu

Amy Ahn, PhD

CONTACT

yahn@fas.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 4, 2023
• Study Start: February 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: By study end

Locations

US (1)