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

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.

Study Overview

• Status: Unknown
• Conditions: Suicidal Ideation
• Intervention / Treatment: Other: Web-based training Product

• Study Type: Interventional
• Enrollment (Anticipated): 91
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-SSRS Screening	Higher rates of same-day C-SSRS Screening	Assessment will occur after a 6 month period of tracking patient records for each provider
Suicide addition to Problem List	Higher rates of suicide being added to the problem list	Assessment will occur after a 6 month period of tracking patient records for each provider
Same-day Safety Planning, if a positive screen	Higher rates of same-day Safety Planning, if a positive screen	Assessment will occur after a 6 month period of tracking patient records for each provider
C-SSRS Lifeline/Recent Completion	Higher rates of same-day C-SSRS Lifeline/Recent Completion, if a positive screen;	Assessment will occur after a 6 month period of tracking patient records for each provider
Risk Assessment	Higher rates of same-day Risk Assessment, if a positive screen	Assessment will occur after a 6 month period of tracking patient records for each provider
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	Assessment will occur after a 6 month period of tracking patient records for each provider
Documented suicide attempts	Have lower rates of documented suicide attempts	Assessment will occur after a 6 month period of tracking patient records for each provider

Collaborators and Investigators

• Sponsor: SIMmersion, LLC
• Collaborators: Education Development Center, Inc.; The Institute for Family Health

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 29, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Safety Planning; Access to Lethal Means; Zero Suicide
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: R44MH114710-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No