Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311591
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-12-18
Brief Title:
Efficacy Effectiveness and Implementation of Jaspr Health in Emergency Department- Part B
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
Evaluation of Efficacy Effectiveness and Implementation of Jaspr Healths Digital Platform in Emergency Department for Patients with Suicidal Risk - Part B Real-World Study RWS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Jaspr-PartB
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
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 Jasprs 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 Jasprs 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 ImplementationIntervention 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
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 Jasprs 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 ImplementationIntervention 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1P50MH129701 | NIH | None | httpsreporternihgovquickSearch1P50MH129701 |