Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part B (Jaspr-PartB)

University of Massachusetts, Worcester

Status: Invitation-only

Conditions: Suicide Attempt; Suicidal Ideation; Self Harm

Treatments: Device: Jaspr App

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06311591

1P50MH129701 (U.S. NIH Grant/Contract)

STUDY00000716 Part B

Details and patient eligibility

About

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

Full 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.

Enrollment: 27,908 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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27,908 participants in 2 patient groups

Enhanced Treatment as Usual (ETAU) Historical Control Group

No Intervention group

Description:

Enhanced Treatment As Usual (ETAU) Historical Control is defined as the treatment provided as part of routine clinical care in the participating EDs during a period of time when Jaspr was not being implemented.

Jaspr Implementation Group

Experimental group

Description:

This group will receive the enhanced treatment as usual (ETAU) provided as part of routine clinical care at the participating EDs. They will also be considered by their treating team for administration of Jaspr. Jaspr administers a Suicide Status Interview (SSI), Safety Planning, and Lethal means counseling, and allows open access to the Jaspr resource library. They can sign up to receive Jaspr at Home mobile app. Electronic Health Records (EHR) will be used to assess the outcomes in the 12 months following the index visit.

Treatment:

Device: Jaspr App