Clinical trial NCT03207217: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Suicidal Ideation
Keywords: Safety Planning
Access to Lethal Means
Zero Suicide
Lead sponsor: SIMmersion, LLC
Sponsor class: INDUSTRY
Collaborators: name: The Institute for Family Health
name: Education Development Center, Inc.
First posted: 2017-07-02
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: C-SSRS Screening
timeFrame: Assessment will occur after a 6 month period of tracking patient records for each provider
measure: Suicide addition to Problem List
timeFrame: Assessment will occur after a 6 month period of tracking patient records for each provider
measure: Same-day Safety Planning, if a positive screen
timeFrame: Assessment will occur after a 6 month period of tracking patient records for each provider
measure: C-SSRS Lifeline/Recent Completion
timeFrame: Assessment will occur after a 6 month period of tracking patient records for each provider
measure: Risk Assessment
timeFrame: Assessment will occur after a 6 month period of tracking patient records for each provider
measure: Within-Institute referrals
timeFrame: Assessment will occur after a 6 month period of tracking patient records for each provider
measure: Documented suicide attempts
timeFrame: Assessment will occur after a 6 month period of tracking patient records for each provider
Secondary outcomes:
Other outcomes:
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