Clinical trial NCT06223867: Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part a
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Suicide Attempt
Self Harm
Keywords: Suicide
Self-Harm
Attempt
Ideation
Suicidal thought
Suicidal plan
Crisis intervention
Suicide prevention
Emotional support
Mental Health
Behavioral Health
Psychiatry
Emergency Department
Technology
Mobile Application
Implementation
Safety Plan
Lethal Means
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Ohio State University
name: Evidence-Based Practice Institute, Seattle, WA
name: Worcester Polytechnic Institute
name: National Institute of Mental Health (NIMH)
name: University of Colorado, Denver
First posted: 2024-01-25
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Suicide composite, binary
timeFrame: 12 months after enrollment
Secondary outcomes:
measure: Suicidal attempt
timeFrame: 12 months after enrollment
measure: Suicidal behavior
timeFrame: 12 months after enrollment
measure: Suicidal ideation severity
timeFrame: 12 months after enrollment
Other outcomes:
measure: Evidence-Based Practice (EBP) delivery
timeFrame: During index visit= Day 1
measure: Patient target engagement, perceived social support
timeFrame: 12 months after enrollment
measure: Patient target engagement, suicide-related coping
timeFrame: 12 months after enrollment
measure: Patient target engagement, behavioral activation
timeFrame: 12 months after enrollment
measure: In situ self-injury
timeFrame: Index visit= Day 1
measure: In situ distress
timeFrame: Index visit= Day 1
measure: In situ suicide related coping
timeFrame: Index visit= Day 1
measure: ED visit satisfaction
timeFrame: Index visit= Day 1
measure: Psychiatric symptoms
timeFrame: Index visit and 12 months after enrollment
measure: Patient reach
timeFrame: Duration of enrollment = 30 months
measure: Fidelity
timeFrame: Duration of enrollment = 30 months
measure: Exposure, time
timeFrame: Duration of enrollment = 30 months
measure: Exposure, modules
timeFrame: Duration of enrollment = 30 months
measure: Costs
timeFrame: Duration of enrollment = 30 months
measure: Clinician acceptability
timeFrame: Duration of enrollment = 30 months
measure: Patient acceptability
timeFrame: Duration of enrollment = 30 months
measure: Patient appropriateness
timeFrame: Duration of enrollment = 30 months
measure: Feasibility of Jaspr in ED
timeFrame: Duration of enrollment = 30 months
measure: Usability, clinician
timeFrame: Duration of enrollment = 30 months
measure: Usability, patient
timeFrame: Duration of enrollment = 30 months
measure: System workflow impact, admissions to psychiatric units
timeFrame: During index ED visit= Day 1
measure: System workflow impact, door to behavioral health evaluation
timeFrame: During index ED visit= Day 1
measure: System workflow impact, total length of stay
timeFrame: During index ED visit= Day 1
measure: System workflow impact, 28 day revisit
timeFrame: Within 28 days of index ED visit
measure: System workflow impact, clinician perception
timeFrame: Assessed within 3 months of Jaspr implementation
Locations:
city: Worcester
country: United States
facility: UMass Memorial Health
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Edwin D Boudreaux, PhD
role: PRINCIPAL_INVESTIGATOR
References: