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

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.

Study Overview

• Status: Recruiting
• Conditions: Suicide, Attempted; Suicide
• Intervention / Treatment: Diagnostic test: Clinician Decision Support Tool

Detailed Description

This study is designed to test the effects of providing emergency department (ED) clinicians with enhanced information about their patients' risk of a suicide attempt in the 6-months after leaving the ED. The study will be conducted in five EDs. The primary study will be conducted in four EDs within Mass General Brigham (MGB): Massachusetts General Hospital (MGH), MGB-Salem, Brigham and Women's Hospital (BWH), and Brigham and Women's Faulkner Hospital (BWFH). The investigators propose to enroll 4,000 participants over the study period and to provide the treating clinician with a risk score for a randomly selected half of those 4,000 participants. The primary outcome will be rate of suicide attempts over the next 6-months. It is anticipated that provision of this risk score will change clinician decision-making, leading clinicians to be more likely to hospitalize high-risk patients and less likely to hospitalize low-risk patients. A smaller (N=250) pilot implementation study has been added in a new non-MGB ED at Cambridge Health Alliance (CHA).

The primary study will enroll 4,000 patients presenting to the ED at MGH MGB-Salem, BWH, and BWFH. Study inclusion criteria include presentation to the ED, adult status (≥18 years-old), and ability to provide an email address.

Exclusion criteria include the presence of any factor that impairs an individual's ability to comprehend and effectively participate in the study, including an inability to speak or write English fluently, the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, or the presence of extremely agitated or violent behavior. These broad inclusion criteria maximize the clinical applicability of results while the exclusion criteria ensure the ethical principle of respect for persons.

According to prior studies in the MGB system, investigators anticipate the MGB sample will be about 73% White/European American, 9% African-American, 4% Asian American, and the remainder of other or mixed ethnicity. The implementation study will enroll 250 patients presenting to the ED at CHA and will have the same inclusion/exclusion criteria as the primary study. Based on recent numbers reported in the CHA 2021 Annual Report, it is anticipated that the CHA sample will be about 37% White/European American, 16% African- American, 9% Asian American, and the remainder of other or mixed ethnicity.

Study Research Assistants (RAs) will use well-established protocols of reviewing patients presenting to the ED, where investigators have been conducting IRB approved research on the prediction of suicidal behavior for >15 years. RAs will first consult potentially eligible patients' assigned clinician to obtain their permission to approach the patient to briefly describe the study and ask if they are interested in learning more about it. Only those patients determined to meet the inclusion/exclusion criteria will be approached. To further ensure communication between the research and clinical team, investigators will give a presentation about the study to the ED clinical teams before starting recruitment and at regular intervals throughout the award period. RAs will obtain written informed consent from participants (using REDCap, described below) while in the ED, and administer a baseline self-report assessment battery (on an iPad). Contact information (including the full name, phone number, and if available, email address for both the participant and a collateral contact for emergency situations) will be collected via secure REDCap data collection surveys at baseline, and with participants' permission, select health data (e.g., readmission for a suicide attempt over the next 6 months) will be extracted from the EHR (and stored in a de-identified database). Participants will receive an email-based survey to assess the receipt of treatment and the presence of a suicide attempt at 1-month and 6-months after their ED visit. Participants will receive financial incentives for each survey completed.

In the primary study, after completing a brief baseline assessment, participants will be randomly assigned (1:1) to have their clinician receive a predicted probability that this patient will make a suicide attempt after leaving the ED. There is no intervention with the patient themselves. Investigators hypothesize that clinicians receiving this evidence-based prediction score will be more likely to hospitalize high-risk patients and less likely to hospitalize low-risk patients and that this will lead to a decrease in the rate of suicide attempts in the experimental condition relative to the control condition. The primary endpoint in this study is suicide attempt during the six months post-randomization. Suicide attempts will be measured using two methods: (a) self-report surveys and (b) documentation in the EHR 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. Investigators 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 prior work in the APS we have found high agreement between self-reports on the SITBI and the documentation of suicide attempts in electronic medical records (K=.84). Secondary endpoints are suicide attempt within 1-month post-randomization. Additional exploratory hypotheses are: (1) among patients estimated by the model to be high-risk, clinicians of patients in the experimental condition will be more likely to recommend hospitalization than clinicians of patients in the control condition; (2) among patients estimated to be at intermediate risk, clinicians of patients in the experimental condition are (a) less likely to recommend hospitalization and (b) more likely to recommend partial hospitalization compared to clinicians of patients in the control condition, and (3) among patients estimated to be at low risk, clinicians of patients in the experimental condition are more likely to discharge to home than clinicians of patients in the control condition. Investigators will additionally investigate the mediating role of clinician choice on the association between the intervention and patient outcomes using mediation analysis.

• Study Type: Interventional
• Enrollment (Estimated): 4000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Nock, PhD; Phone Number: 617-496-4484; Email: nock@wjh.harvard.edu
• Study Contact Backup: Name: Amy Ahn, PhD; Email: yahn@fas.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Matthew Nock; Phone Number: 6174964484; Email: nock@wjh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patient's clinician is not given Clinician Decision Support Tool (care as usual)
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.	Diagnostic test: Clinician Decision Support Tool; Clinician Decision Support Tool that provides information about patient's statistical probability of suicide attempt in next 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicide attempt	The primary endpoint is the occurrence (0,1) of a suicide attempt during the 6 months following randomization. The outcome will be measured as a single binary variable, indicating whether a participant experienced at least one suicide attempt during the follow-up period. This outcome will be ascertained using participant self-report and EHR documentation. Self-reported suicide attempts will be assessed using questions 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. EHR review will further identify documented suicide attempts during follow-up. Information from both sources will be used to determine a single outcome value for each participant. The singular outcome measure is the occurrence of at least one suicide attempt during follow-up (Yes/No; 0,1) as identified by either source (self-report or EHR).	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicide attempt	Secondary endpoints are suicide attempt (using the same assessment methods as the primary endpoint) within 1-month post-randomization and will also be assessed using two sample tests of proportions.	1-month

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): September 28, 2028

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Behavior; Suicide; Suicide, Attempted
• Other Study ID Numbers: 2022P002689

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be shared via the National Institute of Mental Health National Data Archive
• IPD Sharing Time Frame: By study end
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No