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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06223867
Other study ID # STUDY00000716 Part A
Secondary ID 1P50MH129701
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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