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

NCT06311591 | Enrolling By Invitation DMC FDA Device

• 2 other identifiers: STUDY00000716 Part B1P50MH129701
• Study Type: interventional
• Target: 27,908
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Suicidal Ideation; Suicide Attempt; Self Harm

Keywords

Suicide; Self-Harm; Attempt; Ideation; Suicidal thought; Suicidal plan; Crisis intervention; Suicide prevention; Emotional support; Mental Health; Behavioral Health; Psychiatry; Emergency Department; Technology; Mobile Application; Implementation; Safety Plan; Lethal Means

Outcome Measures

Primary Outcomes (1)

• Suicide composite, binary

  Death by suicide OR suicide-related acute care utilization within 12 months after enrollment

  12 months post enrollment

Other Outcomes (13)

• Evidence-Based Practice (EBP) delivery

  During index visit = Day 1

• Patient reach

  Duration of implementation = 36 months

• Fidelity

  Duration of implementation= 36 months

Study Arms (2)

Enhanced Treatment as Usual (ETAU) Historical Control Group

NO INTERVENTION

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.

Jaspr Implementation Group

EXPERIMENTAL

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

Interventions

Jaspr App DEVICE

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.

Jaspr Implementation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cognitively or emotionally incapable of engaging with Jaspr

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Ohio State University: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Evidence-Based Practice Institute, Seattle, WA: collaborator
• Worcester Polytechnic Institute: collaborator
• University of Colorado, Denver: collaborator

Study Sites (4)

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States

Location

Ohio State East Hospital

Columbus, Ohio, 43210, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

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

MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted; Self-Injurious Behavior; Suicide; Suicide Prevention; Psychological Well-Being; Emergencies

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Edwin D Boudreaux, PhD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: March 15, 2024
• Study Start: November 7, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Based on NIMH NDA expectations, investigators will begin sharing data and share data with as long as is expected by NIMH
• Access Criteria: See NDA application for details.

Locations

US (4)