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

Suicidal Ideation Clinical Trial

— Jaspr-PartB  

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06311591
• Other study ID #: STUDY00000716 Part B
• Secondary ID: 1P50MH129701
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: June 1, 2027

Study information

• Verified date: June 2024
• Source: University of Massachusetts, Worcester
• Contact: Edwin D Boudreaux, PhD
• Phone: 5083343817
• Email: edwin.boudreaux[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 27908
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Self Harm
• Self-Injurious Behavior
• Suicidal Ideation
• Suicide
• Suicide Attempt
• Suicide, Attempted

Intervention

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.

Locations

Country	Name	City	State
United States	UCHealth University of Colorado Hospital	Aurora	Colorado
United States	UCHealth Memorial Hospital Central	Colorado Springs	Colorado
United States	Ohio State East Hospital	Columbus	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (6)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Evidence-Based Practice Institute, Seattle, WA, National Institute of Mental Health (NIMH), Ohio State University, University of Colorado, Denver, Worcester Polytechnic Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Costs	Costs associated with Jaspr deployment and use. Measured by: U.S. dollar (US$)	Duration of implementation= 36 months
Other	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
Other	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
Other	Feasibility of Jaspr in ED	Clinicians' qualitative review of barriers to implementation	Duration of implementation= 36 months
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Suicide composite, binary	Death by suicide OR suicide-related acute care utilization within 12 months after enrollment	12 months post enrollment

External Links

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