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. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Suicide, Attempted; Suicide
• Intervention / Treatment: Diagnostic test: Clinician Decision Support Tool

• Study Type: Interventional
• Enrollment (Anticipated): 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: Rebecca Fortgang, PhD; Email: Fortgang@fas.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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
Experimental: Experimental; Patient's clinician is given Clinician Decision Support Tool	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
No Intervention: Control; Patient's clinician is not given Clinician Decision Support Tool (care as usual)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 and 1-week post-randomization and will also be assessed using two sample tests of proportions.	1-month and 1-week

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): June 1, 2027
• Study Completion (Anticipated): June 1, 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): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious 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; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No