Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT05671133

Conditions

Suicide

Suicide, Attempted

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Clinician Decision Support Tool

Study Details

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. The first aim is to evaluate the effects of providing information about risk of patient suicidal behavior to ED clinicians. The investigators 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

Study ID

NCT05671133

Start date

Feb 25, 2025

Status verified date

Jun, 2026

Completion date

Sep 28, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adult status (≥18 years-old);
  • Willing to provide an email address;
  • Presentation at the APS

Exclusion Criteria:

  • Inability to understand the study procedures and provide informed consent such as those with gross cognitive impairment (including florid psychosis), intellectual disability, dementia, acute intoxication, or the presence of extremely agitated or violent behavior
  • Decisions about inclusion/exclusion criteria will be made by the emergency department providers on duty at the time. These broad inclusion criteria maximize the clinical applicability of obtained results while the exclusion criteria ensure the ethical principle of respect for persons.

Study Design

Enrollment

4000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Experimental

Investigators will use previously developed EHR-derived machine- learning-based model to generate predicted probability risk scores of 1-month suicide attempt for each patient. The EHR-derived risk score will be combined with the patient self-report data (initially from the 20-question screener) to generate composite predicted risk scores (based on the most updated ML model developed by investigators via the ensemble ML Super Learner \[SL\] method) for the patient within minutes of the patient completing the self-report survey. Risk scores will be provided to the clinician while the patient is in the ED. This feedback includes information about the patient's relative risk compared to other psychiatric patients seen in the ED and the risk factors contributing to this level of risk.

no intervention: Control

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

Interventions

Clinician Decision Support Tool

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

Primary outcome measure

  • Suicide attempt [ Time Frame: 6-months ]

Central Contacts and Locations

Central contacts

Matthew Nock, PhD

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

Amy Ahn, PhD

yahn@fas.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Matthew Nock

6174964484nock@wjh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-06-22.