Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part B (Jaspr-PartB)

Evaluation of Efficacy, Effectiveness, and Implementation of Jaspr Health's Digital Platform in Emergency Department for Patients With Suicidal Risk - Part B: Real-World Study (RWS)

This Study will evaluate the implementation of a multi-component suicide prevention technology (Jaspr Health) that facilitates delivery of suicided-related evidence-based practices (EBPs) while replacing wasted waiting time with productive time in the Emergency Departments (EDs). The EBPs satisfy several key performance elements for systems adopting Zero Suicide.

A Complementary Randomized Controlled Trial and Real-World Study for Efficacy, Effectiveness, and Implementation Study Design (CREID) will be used

Study Overview

• Status: Enrolling by invitation
• Conditions: Suicidal Ideation; Self Harm; Suicide Attempt
• Intervention / Treatment: Device: Jaspr App

Detailed Description

This study will evaluate Jaspr's patient-facing tablet-based application (app) during suicide-related ED visits. The app guides patients in completing the Suicide Status Interview, which comprises of evidence-based CAMS certified suicide prevention tools such as a suicide risk assessment, Stanley Brown- inspired safety plan, and lethal means safety counseling. It also offers access to a menu of "Comfort and Skills" modules that teaches patients behavioral skills to effectively manage imminent distress, while shared stories offer a library of professionally produced, racially and culturally diverse, inspirational videos of people with suicide-centered lived experience.

Subjects who engage with Jaspr can continue to access their safety plan, comfort and coping skills exercises, and the video library via Jaspr at Home (JAH) mobile application; a summary of the self-administered risk assessment is shared with the clinical team directly through the patient electronic health record to help guide the treatment plan.

Part A of the study will be a Randomized Controlled Trial (RCT) to evaluate the efficacy and mechanism of action of Jaspr's app intervention in EDs. It is reported in a separate CTG protocol (Unique Protocol ID: STUDY00000716 Part A)

This CTG protocol describes Part B of the study, which will be a Real-World Study (RWS) to evaluate the effectiveness and implementation processes in EDs and outcomes. Two health systems affiliated with Ohio State University and the University of Colorado will implement Jaspr as part of routine clinical care. Each health system will implement Jaspr in two diverse EDs: one major academic site, and one community site. Each system will collect data on eligible patients across two Phases: (1) a retrospective enhanced treatment as usual (ETAU) phase comprising 12 months of index ED visits with a 12 month follow-up window, and (2) an Implementation/Intervention phase comprising 18 months of index ED visits with a 12 month follow-up window. Eligible patients will be defined as individuals 18 years or older who present to the ED in the designated date ranges and who screen positive for suicide risk on an evidence based screener administered clinically.

Data for all eligible patients across both phases will be collected. Data sources will be electronic health records (EHR) and state death registries. Data related to the index ED visit and all acute care visits within a 12 month follow-up window of the index visit will be collected. A limited dataset with personal identifiers removed will be shared with UMass Chan Medical School for harmonization and analyses.

• Study Type: Interventional
• Enrollment (Estimated): 27908
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UCHealth University of Colorado Hospital
    • Colorado Springs, Colorado, United States, 80909
      • UCHealth Memorial Hospital Central
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
    • Columbus, Ohio, United States, 43210
      • Ohio State East Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• >= 18 years old
• Positive for suicide risk on screener
• Reads English, or has proxy available to read and enter questions

Exclusion Criteria:

• Cognitively or emotionally incapable of engaging with Jaspr

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Enhanced Treatment as Usual (ETAU) Historical Control Group; Enhanced Treatment As Usual (ETAU) Historical Control is defined as the treatment provided as part of routine clinical care in the participating EDs during a period of time when Jaspr was not being implemented.
Experimental: Jaspr Implementation Group; This group will receive the enhanced treatment as usual (ETAU) provided as part of routine clinical care at the participating EDs. They will also be considered by their treating team for administration of Jaspr. Jaspr administers a Suicide Status Interview (SSI), Safety Planning, and Lethal means counseling, and allows open access to the Jaspr resource library. They can sign up to receive Jaspr at Home mobile app. Electronic Health Records (EHR) will be used to assess the outcomes in the 12 months following the index visit.	Device: Jaspr App; Jaspr was designed to improve delivery of evidence-based, personalized suicide care in the ED. Jaspr (Dimeff, R44MH108222) is rooted in EBPs, including Collaborative Assessment and Management of Suicide (CAMS) and Dialectical Behavior Therapy (DBT). Briefly, Jaspr provides a patient interface, optimized for a tablet computer provided to the patient, which uses an avatar to administer: (1) the CAMS Suicide Status Form (SSF), an evidence-based suicide risk assessment; (2) crisis stabilization planning (CAMS' version of safety planning) or Stanley-Brown Safety Planning Intervention, depending on site choice; (3) lethal means safety counseling. Further, Jaspr teaches behavioral skills from DBT to manage imminent distress and has a library of over 40 racially and culturally diverse, inspirational videos of people with lived experience. Finally, Jaspr@home provides access to these resources after the visit during the high-risk transition to outpatient care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicide composite, binary	Death by suicide OR suicide-related acute care utilization within 12 months after enrollment	12 months post enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence-Based Practice (EBP) delivery	Number of patients receiving evidence based care, including evidence based suicide risk assessment, safety planning, lethal means safety counseling, Cognitive Behavioral Therapy (CBT) coping skills training, suicide education materials, and behavioral health referral resources. Higher count = more EBPs delivered	During index visit = Day 1
Patient reach	Percentage of eligible patients who initiated Jaspr by answering at least one question on the Suicide Status Interview (SSI) in Jaspr app	Duration of implementation = 36 months
Fidelity	Percentage of patients who started the Suicide Status Interview (SSI) in Jaspr app and who completed the SSI and a safety plan	Duration of implementation= 36 months
Exposure, Time	Within patients who started the Suicide Status Interview (SSI) in Jaspr app, total time spent on all components. Measured in minutes	Duration of implementation= 36 months
Clinician acceptability	Structured measure viewing Jaspr as agreeable, palatable, satisfactory using the Acceptability of Intervention Measure (AIM), Likert type scale, higher scores = stronger clinician acceptability	Duration of implementation= 36 months
Patient acceptability	Structured measure viewing Jaspr as agreeable, palatable, satisfactory using the Acceptability of Intervention Measure (AIM), Likert type scale, higher scores = stronger patient acceptability	Duration of implementation= 36 months
Feasibility of Jaspr in ED	Clinicians' qualitative review of barriers to implementation	Duration of implementation= 36 months
Usability (clinician)	Structured measure of clinicians' perception of the usability of Jaspr using the System Usability Scale (SUS) , Likert type scale, higher scores = stronger clinician ratings of usability	Duration of implementation= 36 months
System workflow impact, door to behavioral health evaluation	Of patients who meet eligibility criteria for Jaspr, how long in minutes does it take to get a behavioral health evaluation from when they are registered in the ED, continuous, measured in minutes, higher minutes = longer evaluation wait	Duration of implementation= 36 months
System workflow impact, total length of stay	Of patients who meet eligibility criteria for Jaspr, how long in minutes does it take for their entire visit from registration to discharge, continuous, measured in minutes, higher minutes = longer total length of stay	Duration of implementation= 36 months
System workflow impact, 28 day revisit	Of patients who meet eligibility criteria for Jaspr, how many return to the ED within 28 days, binary, Yes/No	Duration of implementation= 36 months
System workflow impact, clinician perception	Clinician perception of workflow impact after Jaspr is implemented, assessed by a structured interview, qualitative descriptions	Duration of implementation= 36 months
Costs	Costs associated with Jaspr deployment and use. Measured by: U.S. dollar (US$)	Duration of implementation= 36 months

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: University of Colorado, Denver; National Institute of Mental Health (NIMH); Ohio State University; Worcester Polytechnic Institute; Evidence-Based Practice Institute, Seattle, WA
• Investigators: Principal Investigator: Edwin D Boudreaux, PhD, Umass Chan Medical School

Publications and helpful links

Helpful Links

• The Center for Accelerating Practices to End Suicide through Technology Translation (CAPES)- Signature Project

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Mental Health; Implementation; Emergency Department; Suicide prevention; Psychiatry; Suicide; Behavioral Health; Mobile Application; Technology; Crisis intervention; Safety Plan; Emotional support; Self-Harm; Attempt; Ideation; Suicidal thought; Suicidal plan; Lethal Means
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Behavioral Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Personal Satisfaction; Suicide Prevention; Emergencies; Suicide; Suicidal Ideation; Self-Injurious Behavior; Suicide, Attempted; Psychological Well-Being
• Other Study ID Numbers: STUDY00000716 Part B; 1P50MH129701 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Investigators will comply with the expectations of the NIMH Data Archive (NDA) regarding data components and support documents, including the recommended timeline
• IPD Sharing Time Frame: Based on NIMH NDA expectations, investigators will begin sharing data and share data with as long as is expected by NIMH
• IPD Sharing Access Criteria: See NDA application for details.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No