Suicidal Ideation Clinical Trial
— Jaspr-PartAOfficial 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
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
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 |
Country | Name | City | State |
---|---|---|---|
United States | UMass Memorial Health | Worcester | Massachusetts |
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 |
United States,
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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