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

Suicide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05671133
• Other study ID #: 2022P002689
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: June 2028

Study information

• Verified date: January 2023
• Source: Massachusetts General Hospital
• Contact: Matthew Nock, PhD
• Phone: 617-496-4484
• Email: nock[@]wjh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: June 2028
• Est. primary completion date: June 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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