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

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ClinicalTrials.gov Identifier: NCT03207217
Recruitment Status : Not yet recruiting
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborators:
The Institute for Family Health
Education Development Center, Inc.
Information provided by (Responsible Party):
SIMmersion, LLC

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.

Condition or disease Intervention/treatment Phase
Suicidal Ideation Other: Web-based training Product Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 91 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Virtual Training Role-Plays to Improve Patient Suicide Outcomes in Primary Care Settings
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Phase I Knowledge Assessment Other: Web-based training Product
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.

Experimental: Phase II Efficacy Other: Web-based training Product
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.

Experimental: Phase II Acceptability Other: Web-based training Product
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 Measures :
  1. C-SSRS Screening [ Time Frame: Assessment will occur after a 6 month period of tracking patient records for each provider ]
    Higher rates of same-day C-SSRS Screening

  2. Suicide addition to Problem List [ Time Frame: Assessment will occur after a 6 month period of tracking patient records for each provider ]
    Higher rates of suicide being added to the problem list

  3. 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 ]
    Higher rates of same-day Safety Planning, if a positive screen

  4. C-SSRS Lifeline/Recent Completion [ Time Frame: Assessment will occur after a 6 month period of tracking patient records for each provider ]
    Higher rates of same-day C-SSRS Lifeline/Recent Completion, if a positive screen;

  5. Risk Assessment [ Time Frame: Assessment will occur after a 6 month period of tracking patient records for each provider ]
    Higher rates of same-day Risk Assessment, if a positive screen

  6. Within-Institute referrals [ Time Frame: Assessment will occur after a 6 month period of tracking patient records for each provider ]
    Higher rates of acceptance and attendance to within-Institute referrals for post intervention patients who are offered the referral at the first visit

  7. Documented suicide attempts [ Time Frame: Assessment will occur after a 6 month period of tracking patient records for each provider ]
    Have lower rates of documented suicide attempts



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Responsible Party: SIMmersion, LLC
ClinicalTrials.gov Identifier: NCT03207217     History of Changes
Other Study ID Numbers: R44MH114710-01 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by SIMmersion, LLC:
Safety Planning
Access to Lethal Means
Zero Suicide

Additional relevant MeSH terms:
Suicide
Suicidal Ideation
Self-Injurious Behavior
Behavioral Symptoms