SBIR-STTR Award

Evaluating the Comparative Validity and Reliability of SERAS: a Decision Support Tool for Assessing Near Term Risk of Suicide in Emergency Departments
Award last edited on: 5/22/2023

Sponsored Program
SBIR
Awarding Agency
NIH : NIMHD
Total Award Amount
$1,828,107
Award Phase
2
Solicitation Topic Code
104
Principal Investigator
John E Helzer

Company Information

Wiser Systems LLC

819 West Hargett Street
Raleigh, NC 27603
   (919) 551-5566
   N/A
   www.wisersystems.com
Location: Single
Congr. District: 04
County: Wake

Phase I

Contract Number: 1R43MH113408-01
Start Date: 5/1/2017    Completed: 10/31/2018
Phase I year
2017
Phase I Amount
$223,619
The goal of the NIMH Zero Suicide Initiative is prevention of suicide among individuals being served by health care systems The Products to Support Applied Research Towards Zero Suicide Healthcare Systems FOA specifically calls for development of health IT products designed to meet this goal Our Systematic Expert Risk Assessment of Suicide SERAS is a neural network based decision support tool that replicates the critical thinking process of experienced clinicians in weighing risk factors to assess an individualandapos s near term risk of suicide Desjardins et al SERAS triages patients by level of near term risk It takes less than minute to administer and of patients rate the interaction favorably We aim to further establish the scientific merit of SERAS to improve immediate near term suicide prevention in hospitals by comparing the performance of SERAS to the most commonly used suicide risk detection method the Columbia Suicide Severity Rating Scale C SSRS Every year in the United States there are more deaths from suicide than from motor vehicle accidents National Center for Health Statistics Up to of those who die from suicide had received health care services for reasons unrelated to suicide or mental health in the year preceding their death and up to had visited a doctor within the prior month Ahmedani This latter finding helped prompt the Joint Commission JC to mandate screening of suicide potential for all patients in contact with healthcare settings nationwide most recent JC Sentinel Event Alert Feb At present there is a lack of efficient and validated measures of suicide related behaviors necessary for real time clinical decision making Bongiovi Garcia et al Ronquillo et al Randall et al Horowitz et al Doran et al This is especially true for the assessment of near term risk for suicide which is variably defined and poorly assessed by existing screening tools The Columbia Suicide Severity Rating Scale C SSRS Posner et al Youngstrom et al is widely used for the detection of lifetime suicidal ideation behaviors and related non suicidal self injury Posner et al Youngstrom et al Brown et al However it does not address near term risk There remains a critical need for a new tool that can be rapidly administered in the ED allows for prediction of near term risk and provides decision support The current prospective clinical study proposes to collect a sample of patients in an emergency department with aims to compare the predictive ability sensitivity specificity and test retest reliability of SERASTM compared to the C SSRS and to confirm level of patient satisfaction with SERAS Completion of these aims will allow us to establish the technical reliability and scientific merit of SERAS and prepare us for a Phase II proposal in which we will conduct cost benefit analyses obtain a broader sample of patients finalize the technical feasibility optimization data model and interface of SERAS and prepare a detailed commercialization plan PROJECT NARRATIVE Using adult patients presenting to the emergency department we will examine the predictive ability sensitivity specificity and test retest reliability of SERAS compared to the C SSRS for the assessment of near term suicide risk Every day more people commit suicide than die from motor vehicle accidents in the US We expect that improved and standardized screening for suicide risk on all patients in emergency departments will substantially improve public health

Phase II

Contract Number: 2R44MH113408-02
Start Date: 6/18/2017    Completed: 5/31/2023
Phase II year
2020
(last award dollars: 2022)
Phase II Amount
$1,604,488

Every day more people commit suicide than die from motor vehicle accidents in the US. The goal of the NIMH Zero Suicide Initiative is prevention of suicide among those being served by health care systems. The Joint Commission has mandated that hospitals reduce suicide in healthcare settings through the use of evidence- based screening and assessment. An essential element of this process is the development of rapid but effective evidence-based screeners for use in emergency rooms, crisis clinics, and other first responder facilities. Our Systematic Expert Risk Assessment of Suicide (SERAS™) is a neural-network-based decision support tool that replicates the critical thinking of experienced clinicians in weighing risk factors to prospectively assess an individual's near-term risk of suicide. Our Phase I project demonstrated that SERAS™ provides the same concurrent and predictive validity as a full clinician-based Columbia Suicide Severity Rating Scale (CSSRS) when used in an emergency department setting, yet takes a fraction of the time. We have two goals in this Phase II application. Our first goal is to integrate SERASTM into the workflow of a new healthcare system electronic health record and to establish its acceptability and usability when it replaces current standard screeners. We expect that SERASTM will have good-to-excellent usability and will be readily accepted as being easy to use and useful. Our second goal is to move SERAS™ to a large scale, full implementation across a healthcare system and pairing it with in-person or telehealth secondary assessments for those who screen at low to moderate risk. By implementing SERAS™ into the standard clinical workflow of 4 hospitals out of a 20 hospital system in the Omaha, Nebraska region, and screening more than 100,000 adults with SERAS™ we will examine whether there is a reduction in the incidence of suicide and suicide-related events in this system over a two-year period. This project, when complete will enable timely care; it will implement efficient and less costly healthcare delivery; it will enhance surveillance of individuals at risk within the healthcare system; and it will provide immediate decision support to the end user by identifying targeted interventions. We provide evidence for the commercial potential of SERAS™ through a detailed commercialization plan that demonstrates that, even with relatively low levels of market penetration, this tool can become self-sustaining to allow for more evidence-based screens and more lives saved.

Public Health Relevance Statement:
PROJECT NARRATIVE Every day more people commit suicide than die from motor vehicle accidents in the US. Using a newly validated evidence-based screening tool for near-term suicide risk called SERAS™ we demonstrate that we can integrate this system into the workflow of a busy healthcare system and find it to be acceptable and usable. We will then test whether SERASTM, when coupled with evidence-based assessment either in person or via telehealth, will reduce suicide-related events in over 100,000 people screened over a two-year time frame.

Project Terms:
Accident and Emergency department; accomplished suicide; Adult; base; Caring; Chronic; Clinic; Clinical; commercialization; comparative; cost; Coupled; Critical Thinking; Development; Disadvantaged; Electronic Health Record; Elements; emergency settings; Emergency Situation; Evaluation; Event; evidence base; experience; first responder; follow-up; Goals; Gold; handheld mobile device; health assessment; Health Care Costs; health care delivery; Health care facility; health care settings; Healthcare; Healthcare Systems; high risk; Hospitals; Hour; Human Resources; Incidence; Individual; Intervention; Interviewer; Joints; Measures; Medical; Methods; National Institute of Mental Health; Nature; Nebraska; Network-based; neural network; Operative Surgical Procedures; Patient Triage; Patients; Penetration; Persons; Phase; Process; prospective; Provider; Psychiatrist; Psychologist; reducing suicide; response; Risk; Risk Assessment; Risk Factors; Rural; screening; Screening procedure; Self Administration; Severities; Small Business Innovation Research Grant; Structure; suicidal behavior; suicidal morbidity; suicidal risk; Suicide; Suicide prevention; suicide rate; support tools; System; Tablet Computer; telehealth; Telemedicine; Testing; Time; tool; Training; University Hospitals; usability; Validity and Reliability; vehicular accident