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

Suicidal Ideation Clinical Trial

— Jaspr-PartA  

Official title:

Evaluation of Efficacy, Effectiveness, and Implementation of Jaspr Health's Digital Platform in Emergency Department for Patients With Suicidal Risk- Part A: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06223867
• Other study ID #: STUDY00000716 Part A
• Secondary ID: 1P50MH129701
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2024
• Est. completion date: April 1, 2027

Study information

• Verified date: March 2024
• Source: University of Massachusetts, Worcester
• Contact: Edwin D Boudreaux, PhD
• Phone: 508-334-3817
• Email: Edwin.Boudreaux[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Study will comprehensively evaluate 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 comprise of an evidence-based Collaborative Assessment & Management of Suicidality (CAMS) certified suicide prevention tools such as a suicide risk assessment, Stanley Brown- inspired safety planning, 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 interact 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 medical record to help guide the treatment plan. Part A of the study will be an individual, patient-level Randomized Controlled Trial (RCT) to evaluate the efficacy and mechanism of action of Jaspr's app intervention in EDs. All subjects will complete a baseline assessment prior to random assignment to one of the the two study conditions. All subjects will receive follow-up phone calls for 12 months after enrollment at weeks 6, 12, 24, 36, and 52. These calls will assess suicide related outcomes and healthcare utilization. In addition, the Massachusetts Department of Public Health (MA DPH) death registry will be reviewed, and each subject's electronic health record will be reviewed. Part B of the study will be a Real-World Study (RWS) to evaluate the effectiveness and implementation processes in EDs and outcomes. This ClinicalTrials.gov record will cover only Part A. Part B is summarized in a separate entry.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 670
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Positive for suicide risk on the Patient Safety Screener in the ED (active suicidal ideation int the past 2 weeks, or suicidal attempt in the past 6 months)
• Cognitively and emotionally capable of consent and engaging in Jaspr app.
• Reads English at 6th grade level.
• Reliable telephone access.
• Owns a smart phone
• Lives in Massachusetts

Exclusion Criteria:

• Prisoners or in state custody
• Adults unable to consent
• Patient <18 yeas
• Enrolled subjects during the 12 month follow-up period

Related Conditions & MeSH terms

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

Intervention

Device:
• Jaspr App + JAH
With assistance form a research coordinator, the subject will complete self-administered suicide risk assessment on the tablet via Jaspr app, then the subject will engage with suicide-related coping skills and resources that the app provides. Subject will continue to have access to the coping skills and videos via a mobile app after discharge.

Behavioral:
• ETAU
Usual care for suicidal patients at UMass Memorial ED that may include Behavioral health evaluation by a trained clinician. Environmental safety precautions. Personalized safety upon discharge

Locations

Country	Name	City	State
United States	UMass Memorial Health	Worcester	Massachusetts

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 target engagement, perceived social support	Perceived social support (attachment/affiliation) measured by Interpersonal Needs Questionnaire (INQ-15), Likert-type scale, higher scores = stronger social support	12 months after enrollment
Other	Patient target engagement, suicide-related coping	Suicide-related coping (behavioral inhibition) measured by Suicide-Related Coping Scale (SRCS), Likert-type scale, higher scores = better ability to cope with suicidal thoughts	12 months after enrollment
Other	Patient target engagement, behavioral activation	Behavioral activation (effort) measured by Behavioral Activation Scale (BAS) - Drive sub scale, Likert-type scale, higher scores = greater behavioral activation	12 months after enrollment
Other	In situ self-injury	Intentional Self-Harm behavior during the index ED visit and inpatient stay related to the index visit, binary, In situ self-injury Yes/No	Index visit= Day 1
Other	In situ distress	Pre-post distress measure that will use 0 to 10 distress scale at start of enrollment and at 1, 2, 3 hours later. It will assess patient's distress during the index ED	Index visit= Day 1
Other	In situ suicide related coping	Pre-post suicide coping measure that will use 0 to 10 coping scale at start of enrollment and at 1, 2, 3 hours later. It will assess patient's suicide-related coping during the index ED	Index visit= Day 1
Other	ED visit satisfaction	0 to 10 visit satisfaction scale at start of enrollment and at 1, 2, 3 hours later to assess patient's satisfaction with the ED care during index visit	Index visit= Day 1
Other	Psychiatric symptoms	Psychiatric symptoms on the diagnostic and statistical manual of mental disorders (DSM-5) Crosscutting measure, Likert-type scale, higher scores = more severe psychiatric symptoms	Index visit and 12 months after enrollment
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 enrollment = 30 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 (fidelity)	Duration of enrollment = 30 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 enrollment = 30 months
Other	Exposure, modules	Within patients who started the Suicide Status Interview (SSI) in Jaspr app, total number of modules completed	Duration of enrollment = 30 months
Other	Costs	Costs associated with Jaspr preparation, training, deployment, use, workflow changes	Duration of enrollment = 30 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 enrollment = 30 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 enrollment = 30 months
Other	Patient appropriateness	Structured measure viewing Jaspr as appropriate using the Intervention Appropriateness Measure (IAM), Likert type scale, higher scores = stronger patient ratings of appropriateness	Duration of enrollment = 30 months
Other	Feasibility of Jaspr in ED	Structured clinician measure; qualitative review of barriers to implementation using Feasibility of Intervention Measure (FIM)	Duration of enrollment = 30 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 enrollment = 30 months
Other	Usability, patient	Structured measure of clinicians' perception of the usability of Jaspr using the System Usability Scale (SUS), Likert type scale, higher scores = stronger patient ratings of usability	Duration of enrollment = 30 months
Other	System workflow impact, admissions to psychiatric units	Of patients who meet eligibility criteria for Jaspr, how many (what percentage) get admitted to a psychiatric unit from the index ED visit, binary, psychiatric hospitalization = yes/No	During index ED visit= Day 1
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	During index ED visit= Day 1
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	During index ED visit= Day 1
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	Within 28 days of index ED visit
Other	System workflow impact, clinician perception	Clinician perception of workflow impact after Jaspr is implemented, assessed by a structured interview, qualitative descriptions	Assessed within 3 months of Jaspr implementation
Primary	Suicide composite, binary	Death by suicide OR suicide-related acute care utilization within 12 months after enrollment	12 months after enrollment
Secondary	Suicidal attempt	Suicidal attempt measured by the Columbia-Suicide Severity Rating Scale (CSSRS), Suicide attempt present Y/N	12 months after enrollment
Secondary	Suicidal behavior	Suicidal behavior measured by the Columbia-Suicide Severity Rating Scale (CSSRS), including any preparatory, aborted, interrupted, and actual suicidal attempts. Suicidal Behavior present Y/N	12 months after enrollment
Secondary	Suicidal ideation severity	Suicidal ideation severity measured by the Columbia-Suicide Severity Rating Scale (CSSRS). Suicidal Ideation (Highest Level Endorsed 1-5. 1= least severe and 5= highest severity)	12 months after enrollment

External Links

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