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

Study Overview
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Brief Summary
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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.

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

Conditions
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Suicide, Suicide, Attempted

Intervention / Treatment
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* Diagnostic Test: Clinician Decision Support Tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Patient's clinician is given Clinician Decision Support Tool | Diagnostic Test: Clinician Decision Support Tool<br>* Clinician Decision Support Tool that provides information about patient's statistical probability of suicide attempt in next 1 month<br>|
| No Intervention: Control<br>Patient's clinician is not given Clinician Decision Support Tool (care as usual) | |

What is the study measuring?
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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 |