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Virtual Training Role-Plays to Improve Patient Suicide Outcomes in Primary Care Settings

Primary Purpose

Suicidal Ideation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Web-based training Product
Sponsored by
SIMmersion, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal Ideation focused on measuring Safety Planning, Access to Lethal Means, Zero Suicide

Eligibility Criteria

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

Inclusion Criteria:

(1) Hold an active license issued by the State of New York for their profession and be in good standing; (2) actively see patients at an IFH site; and (3) have completed IFH's mandated suicide prevention training.

Exclusion Criteria:

(1) have not completed their IFH Suicide Prevention Training as outlined in the IFH's Suicide Prevention Training Policy; or (2) have uncorrected vision or hearing problems that prevent the person from using the software. Specific to Phase II an additional criteria is (3)participated in the Phase 1 feasibility testing.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Phase I Knowledge Assessment

    Phase II Efficacy

    Phase II Acceptability

    Arm Description

    Outcomes

    Primary Outcome Measures

    C-SSRS Screening
    Higher rates of same-day C-SSRS Screening
    Suicide addition to Problem List
    Higher rates of suicide being added to the problem list
    Same-day Safety Planning, if a positive screen
    Higher rates of same-day Safety Planning, if a positive screen
    C-SSRS Lifeline/Recent Completion
    Higher rates of same-day C-SSRS Lifeline/Recent Completion, if a positive screen;
    Risk Assessment
    Higher rates of same-day Risk Assessment, if a positive screen
    Within-Institute referrals
    Higher rates of acceptance and attendance to within-Institute referrals for post intervention patients who are offered the referral at the first visit
    Documented suicide attempts
    Have lower rates of documented suicide attempts

    Secondary Outcome Measures

    Full Information

    First Posted
    June 29, 2017
    Last Updated
    June 29, 2017
    Sponsor
    SIMmersion, LLC
    Collaborators
    The Institute for Family Health, Education Development Center, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03207217
    Brief Title
    Virtual Training Role-Plays to Improve Patient Suicide Outcomes in Primary Care Settings
    Official Title
    Virtual Training Role-Plays to Improve Patient Suicide Outcomes in Primary Care Settings
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2017 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    March 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SIMmersion, LLC
    Collaborators
    The Institute for Family Health, Education Development Center, Inc.

    4. Oversight

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

    5. Study Description

    Brief Summary
    SIMmersion, in collaboration with the Institute for Family Health (IFH) and the Educational Development Center (EDC) propose to develop a web-based training product, Suicide Prevention Role-plays for Interactive Training (SPiRIT), a series of 4 modules to train providers to more effectively manage patients who screen positive for risk of suicide in this Phase I/Phase II fast-track application. If funded, the team will develop the Risk Assessment module in Phase I and utilize a within group pre-post design to evaluate its feasibility. Twenty practicing clinicians will be recruited to utilize the module and complete a pre-post knowledge test. In Phase II, the team will develop Safety Planning, Access to Lethal Means, and Willingness to Accept a Referral modules. The efficacy of the product to positively influence patient outcomes will be tested with a Historically Controlled Trial (HCT) enlisting 65 practicing clinicians across five IFH sites. All providers will be trained and patient outcomes will be tracked for 6 months post training. This data set will be compared to 6 months of historical data for the same provider group. Primary outcomes of this study will measure the participants' ability in obtain improved patient outcomes related to: 1) rate of same-day C-SSRS Screening; 2) rate of suicide being added to the problem list; 3) rate of same-day safety planning; 4) rate of same day C-SSRS Lifeline/Recent Completion; 5) rate of same-day Risk Assessment; 6) rate of acceptance and attendance to within-Institute referrals for post intervention patients who are offered the referral at the first visit; 7) and lower rates of documented suicide attempts. Ultimately, the development and successful testing of this product would provide the US health care system a novel technology to scale up a clinician's confidence and skill to better manage patients who identify as at-risk for suicide. Additionally, if effective, this product will have a direct impact on patient outcomes, a vital component to any training product that attempts to train health care professionals. The utility and scalability of the proposed product will move health care systems toward the goal of zero deaths from suicide consistent with the Zero suicide approach.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicidal Ideation
    Keywords
    Safety Planning, Access to Lethal Means, Zero Suicide

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    91 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Phase I Knowledge Assessment
    Arm Type
    Experimental
    Arm Title
    Phase II Efficacy
    Arm Type
    Experimental
    Arm Title
    Phase II Acceptability
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Web-based training Product
    Intervention Description
    A series of 4 modules to train providers to more effectively manage patients who screen positive for risk of suicide. The modules are: Risk Assessment, Safety Planning, Access to Lethal Means, and Willingness to accept referral.
    Primary Outcome Measure Information:
    Title
    C-SSRS Screening
    Description
    Higher rates of same-day C-SSRS Screening
    Time Frame
    Assessment will occur after a 6 month period of tracking patient records for each provider
    Title
    Suicide addition to Problem List
    Description
    Higher rates of suicide being added to the problem list
    Time Frame
    Assessment will occur after a 6 month period of tracking patient records for each provider
    Title
    Same-day Safety Planning, if a positive screen
    Description
    Higher rates of same-day Safety Planning, if a positive screen
    Time Frame
    Assessment will occur after a 6 month period of tracking patient records for each provider
    Title
    C-SSRS Lifeline/Recent Completion
    Description
    Higher rates of same-day C-SSRS Lifeline/Recent Completion, if a positive screen;
    Time Frame
    Assessment will occur after a 6 month period of tracking patient records for each provider
    Title
    Risk Assessment
    Description
    Higher rates of same-day Risk Assessment, if a positive screen
    Time Frame
    Assessment will occur after a 6 month period of tracking patient records for each provider
    Title
    Within-Institute referrals
    Description
    Higher rates of acceptance and attendance to within-Institute referrals for post intervention patients who are offered the referral at the first visit
    Time Frame
    Assessment will occur after a 6 month period of tracking patient records for each provider
    Title
    Documented suicide attempts
    Description
    Have lower rates of documented suicide attempts
    Time Frame
    Assessment will occur after a 6 month period of tracking patient records for each provider

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: (1) Hold an active license issued by the State of New York for their profession and be in good standing; (2) actively see patients at an IFH site; and (3) have completed IFH's mandated suicide prevention training. Exclusion Criteria: (1) have not completed their IFH Suicide Prevention Training as outlined in the IFH's Suicide Prevention Training Policy; or (2) have uncorrected vision or hearing problems that prevent the person from using the software. Specific to Phase II an additional criteria is (3)participated in the Phase 1 feasibility testing.

    12. IPD Sharing Statement

    Learn more about this trial

    Virtual Training Role-Plays to Improve Patient Suicide Outcomes in Primary Care Settings

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