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

Primary Purpose

Suicide, Suicide, Attempted

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinician Decision Support Tool
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental

    Control

    Arm Description

    Patient's clinician is given Clinician Decision Support Tool

    Patient's clinician is not given Clinician Decision Support Tool (care as usual)

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    December 16, 2022
    Last Updated
    January 3, 2023
    Sponsor
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05671133
    Brief Title
    Effectiveness and Implementation of a Clinician Decision Support System to Prevent Suicidal Behaviors
    Official Title
    Effectiveness and Implementation of a Clinician Decision Support System to Prevent Suicidal Behaviors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    June 2027 (Anticipated)
    Study Completion Date
    June 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicide, Suicide, Attempted

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    4000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Patient's clinician is given Clinician Decision Support Tool
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patient's clinician is not given Clinician Decision Support Tool (care as usual)
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Clinician Decision Support Tool
    Intervention Description
    Clinician Decision Support Tool that provides information about patient's statistical probability of suicide attempt in next 1 month
    Primary Outcome Measure Information:
    Title
    Suicide attempt
    Description
    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).
    Time Frame
    6-months
    Secondary Outcome Measure Information:
    Title
    Suicide attempt
    Description
    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.
    Time Frame
    1-month and 1-week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Matthew Nock, PhD
    Phone
    617-496-4484
    Email
    nock@wjh.harvard.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rebecca Fortgang, PhD
    Email
    Fortgang@fas.harvard.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    All data will be shared via the National Institute of Mental Health National Data Archive
    IPD Sharing Time Frame
    By study end

    Learn more about this trial

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

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