Effectiveness and Implementation of a Clinician Decision Support System to Prevent Suicidal Behaviors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult status (≥18 years-old);
Willing to provide an email address;
Presentation at the APS
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Clinician Decision Support Tool
Diagnostic testClinician Decision Support Tool that provides information about patient's statistical probability of suicide attempt in next 1 month
Treatment groups
4,000 Participants
are divided into 2 treatment groupsGroup A: ExperimentalExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
6-monthsSecondary outcomes
1
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.
Time frame
1-monthSponsors and contacts
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Source ClinicalTrials.gov