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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03207217
Other study ID # R44MH114710-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 29, 2017
Last updated June 29, 2017
Start date July 2017
Est. completion date March 2020

Study information

Verified date June 2017
Source SIMmersion, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 91
Est. completion date March 2020
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
SIMmersion, LLC Education Development Center, Inc., The Institute for Family Health

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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