Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523985
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
The Feasibility of Using the PulsePoint to Facilitate Overdose Education and Naloxone Distribution
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Feasibility of Using the National PulsePoint Cardiopulmonary Resuscitation Responder Network to Facilitate Overdose Education and Naloxone Distribution
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PP-OD
Brief Summary:
This study is a feasibility trial to assess whether in a random sample of 180 agencies where PulsePoint is already active revised procedures hereinafter PulsePoint-OD to facilitate opioid overdose and naloxone distribution OEND can successfully recruit first responder agencies and layperson responders For this study agency refers to a single implementation site where PulsePoint is active and that is bound by the service area or jurisdiction of the first responder agency collaborating with PulsePoint
The study will test the following hypotheses
H1 more first responder agencies will be successfully recruited by arm 2 than by arm 1
H2 more layperson responders will report engaging with OEND programming in arm 2 than in arms 1 or 3 and in arm 1 than in arm 3 only this hypothesis is covered by the IRB hypothesis 1 is not human subjects research
The study will test the following hypotheses
H1 more first responder agencies will be successfully recruited by arm 2 than by arm 1
H2 more layperson responders will report engaging with OEND programming in arm 2 than in arms 1 or 3 and in arm 1 than in arm 3 only this hypothesis is covered by the IRB hypothesis 1 is not human subjects research
Detailed Description:
A full detailed description of the study protocol and preregistered procedures is located in our formal protocol paper httpsdoiorg10219657280 which is also cited at the end of this specific registration
All specific language throughout this document is derived directly verbatim from the protocol paper which is our controlling planned preregistration document for this project
All specific language throughout this document is derived directly verbatim from the protocol paper which is our controlling planned preregistration document for this project
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None