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Clinical Trials/NCT05671133
NCT05671133
Recruiting
N/A

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

Massachusetts General Hospital1 site in 1 country4,000 target enrollmentFebruary 25, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Suicide
Sponsor
Massachusetts General Hospital
Enrollment
4000
Locations
1
Primary Endpoint
Suicide attempt
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 25, 2025
End Date
June 2028
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthew K. Nock, PhD

Research Scientist

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Suicide attempt

Time Frame: 6-months

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).

Secondary Outcomes

  • Suicide attempt(1-month)

Study Sites (1)

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