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NCT Number: NCT06223867

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

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

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Key information

Conditions

Suicidal Ideation Behavior Behavioral Symptoms Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Self Harm Self-Injurious Behavior Suicide Suicide Attempt Suicide Prevention Suicide, Attempted

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Memorial Health

Worcester, Massachusetts, 01655, United States

Location status: Recruiting

Location contact

Edwin D Boudreaux, PhD

CONTACT

[email protected]

508-334-3817

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Jaspr App + JAH

Device

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.

ETAU

Behavioral

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

Other names: Enhanced Treatment As Usual

Primary outcomes

  1. Suicide composite, binary

    Time frame: 12 months after enrollment

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

Secondary outcomes

  1. Suicidal attempt

    Time frame: 12 months after enrollment

    Suicidal attempt measured by the Columbia-Suicide Severity Rating Scale (CSSRS), Suicide attempt present Y/N

  2. Suicidal behavior

    Time frame: 12 months after enrollment

    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

  3. Suicidal ideation severity

    Time frame: 12 months after enrollment

    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)

Other outcomes

  1. Evidence-Based Practice (EBP) delivery

    Time frame: During index visit= Day 1

    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

  2. Patient target engagement, perceived social support

    Time frame: 12 months after enrollment

    Perceived social support (attachment/affiliation) measured by Interpersonal Needs Questionnaire (INQ-15), Likert-type scale, higher scores = stronger social support

  3. Patient target engagement, suicide-related coping

    Time frame: 12 months after enrollment

    Suicide-related coping (behavioral inhibition) measured by Suicide-Related Coping Scale (SRCS), Likert-type scale, higher scores = better ability to cope with suicidal thoughts

  4. Patient target engagement, behavioral activation

    Time frame: 12 months after enrollment

    Behavioral activation (effort) measured by Behavioral Activation Scale (BAS) - Drive sub scale, Likert-type scale, higher scores = greater behavioral activation

  5. In situ self-injury

    Time frame: Index visit= Day 1

    Intentional Self-Harm behavior during the index ED visit and inpatient stay related to the index visit, binary, In situ self-injury Yes/No

  6. In situ distress

    Time frame: Index visit= Day 1

    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

  7. In situ suicide related coping

    Time frame: Index visit= Day 1

    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

  8. ED visit satisfaction

    Time frame: Index visit= Day 1

    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

  9. Psychiatric symptoms

    Time frame: Index visit and 12 months after enrollment

    Psychiatric symptoms on the diagnostic and statistical manual of mental disorders (DSM-5) Crosscutting measure, Likert-type scale, higher scores = more severe psychiatric symptoms

  10. Patient reach

    Time frame: Duration of enrollment = 30 months

    Percentage of eligible patients who initiated Jaspr by answering at least one question on the Suicide Status Interview (SSI) in Jaspr app

  11. Fidelity

    Time frame: Duration of enrollment = 30 months

    Percentage of patients who started the Suicide Status Interview (SSI) in Jaspr app and who completed the SSI and a safety plan (fidelity)

  12. Exposure, time

    Time frame: Duration of enrollment = 30 months

    Within patients who started the Suicide Status Interview (SSI) in Jaspr app, total time spent on all components. Measured in minutes

  13. Exposure, modules

    Time frame: Duration of enrollment = 30 months

    Within patients who started the Suicide Status Interview (SSI) in Jaspr app, total number of modules completed

  14. Costs

    Time frame: Duration of enrollment = 30 months

    Costs associated with Jaspr preparation, training, deployment, use, workflow changes

  15. Clinician acceptability

    Time frame: Duration of enrollment = 30 months

    Structured measure viewing Jaspr as agreeable, palatable, satisfactory using the Acceptability of Intervention Measure (AIM), Likert type scale, higher scores = stronger clinician acceptability

  16. Patient acceptability

    Time frame: Duration of enrollment = 30 months

    Structured measure viewing Jaspr as agreeable, palatable, satisfactory using the Acceptability of Intervention Measure (AIM), Likert type scale, higher scores = stronger patient acceptability

  17. Patient appropriateness

    Time frame: Duration of enrollment = 30 months

    Structured measure viewing Jaspr as appropriate using the Intervention Appropriateness Measure (IAM), Likert type scale, higher scores = stronger patient ratings of appropriateness

  18. Feasibility of Jaspr in ED

    Time frame: Duration of enrollment = 30 months

    Structured clinician measure; qualitative review of barriers to implementation using Feasibility of Intervention Measure (FIM)

  19. Usability, clinician

    Time frame: Duration of enrollment = 30 months

    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

  20. Usability, patient

    Time frame: Duration of enrollment = 30 months

    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

  21. System workflow impact, admissions to psychiatric units

    Time frame: During index ED visit= Day 1

    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

  22. System workflow impact, door to behavioral health evaluation

    Time frame: During index ED visit= Day 1

    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

  23. System workflow impact, total length of stay

    Time frame: During index ED visit= Day 1

    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

  24. System workflow impact, 28 day revisit

    Time frame: Within 28 days of index ED visit

    Of patients who meet eligibility criteria for Jaspr, how many return to the ED within 28 days, binary, Yes/No

  25. System workflow impact, clinician perception

    Time frame: Assessed within 3 months of Jaspr implementation

    Clinician perception of workflow impact after Jaspr is implemented, assessed by a structured interview, qualitative descriptions

Study contacts

Contact information is provided by the study sponsor or research team.

Edwin D Boudreaux, PhD

CONTACT

[email protected]

508-334-3817

Mhd B Rahmoun, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

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

Registry information

Official study 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

Acronym: Jaspr-PartA

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 25, 2024
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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