Clinical trial NCT06311591: Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part B
Official title: Evaluation of Efficacy, Effectiveness, and Implementation of Jaspr Health's Digital Platform in Emergency Department for Patients With Suicidal Risk - Part B: Real-World Study (RWS)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
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: National Institute of Mental Health (NIMH)
name: Worcester Polytechnic Institute
name: University of Colorado, Denver
First posted: 2024-03-15
Enrollment: 27908
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This Study will evaluate the implementation of 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 comprises of evidence-based CAMS certified suicide prevention tools such as a suicide risk assessment, Stanley Brown- inspired safety plan, 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 engage 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 health record to help guide the treatment plan.

Part A of the study will be a Randomized Controlled Trial (RCT) to evaluate the efficacy and mechanism of action of Jaspr's app intervention in EDs. It is reported in a separate CTG protocol (Unique Protocol ID: STUDY00000716 Part A)

This CTG protocol describes Part B of the study, which will be a Real-World Study (RWS) to evaluate the effectiveness and implementation processes in EDs and outcomes. Two health systems affiliated with Ohio State University and the University of Colorado will implement Jaspr as part of routine clinical care. Each health system will implement Jaspr in two diverse EDs: one major academic site, and one community site. Each system will collect data on eligible patients across two Phases: (1) a retrospective enhanced treatment as usual (ETAU) phase comprising 12 months of index ED visits with a 12 month follow-up window, and (2) an Implementation/Intervention phase comprising 18 months of index ED visits with a 12 month follow-up window. Eligible patients will be defined as individuals 18 years or older who present to the ED in the designated date ranges and who screen positive for suicide risk on an evidence based screener administered clinically.

Data for all eligible patients across both phases will be collected. Data sources will be electronic health records (EHR) and state death registries. Data related to the index ED visit and all acute care visits within a 12 month follow-up window of the index visit will be collected. A limited dataset with personal identifiers removed will be shared with UMass Chan Medical School for harmonization and analyses.

Eligibility criteria: Inclusion Criteria:

* \>= 18 years old
* Positive for suicide risk on screener
* Reads English, or has proxy available to read and enter questions

Exclusion Criteria:

* Cognitively or emotionally incapable of engaging with Jaspr

Primary outcomes:
measure: Suicide composite, binary
timeFrame: 12 months post enrollment
Secondary outcomes:
Other outcomes:
measure: Evidence-Based Practice (EBP) delivery
timeFrame: During index visit = Day 1
measure: Patient reach
timeFrame: Duration of implementation = 36 months
measure: Fidelity
timeFrame: Duration of implementation= 36 months
measure: Exposure, Time
timeFrame: Duration of implementation= 36 months
measure: Costs
timeFrame: Duration of implementation= 36 months
measure: Clinician acceptability
timeFrame: Duration of implementation= 36 months
measure: Patient acceptability
timeFrame: Duration of implementation= 36 months
measure: Feasibility of Jaspr in ED
timeFrame: Duration of implementation= 36 months
measure: Usability (clinician)
timeFrame: Duration of implementation= 36 months
measure: System workflow impact, door to behavioral health evaluation
timeFrame: Duration of implementation= 36 months
measure: System workflow impact, total length of stay
timeFrame: Duration of implementation= 36 months
measure: System workflow impact, 28 day revisit
timeFrame: Duration of implementation= 36 months
measure: System workflow impact, clinician perception
timeFrame: Duration of implementation= 36 months
Locations:
city: Aurora
country: United States
facility: UCHealth University of Colorado Hospital
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Memorial Hospital Central
state: Colorado
city: Columbus
country: United States
facility: Ohio State East Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: UMass Chan Medical School
name: Edwin D Boudreaux, PhD
role: PRINCIPAL_INVESTIGATOR
References: