Viewing Study NCT05877118



Ignite Creation Date: 2024-05-06 @ 7:02 PM
Last Modification Date: 2024-10-26 @ 2:59 PM
Study NCT ID: NCT05877118
Status: RECRUITING
Last Update Posted: 2024-06-07
First Post: 2023-05-17

Brief Title: Improving Availability of Intranasal Naloxone
Sponsor: Hartford Hospital
Organization: Hartford Hospital

Study Overview

Official Title: Improving Availability of Intranasal Naloxone Rescue for Opioid Overdose
Status: 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: None
Brief Summary: While there is a lifesaving medication called naloxone that can reverse the deadly effects of opioid overdose patients often fail to fill the prescription at the pharmacy when it is prescribed This is particularly concerning and true in those at the highest risk of death-those who end up in the emergency department for opioid overdose The goal of this study is to compare the impact of different overdose education on naloxone prescription fill rates in opioid users being discharged from our hospital emergency department You will receive either a written education about naloxone through their MyChart account or b a concise one-page handout and 4-minute video clip reviewed with the participant and a support individual familyfriend prior to discharge
Detailed Description: The rates of opioid overdose and overdose deaths in Connecticut have increased dramatically in the past decade While there is a lifesaving medication called naloxone that can reverse the deadly effects of opioid overdose patients often fail to fill the prescription at the pharmacy when it is prescribed This is particularly concerning and true in those at the highest risk of death-those who end up in the emergency department for opioid overdose Indeed a recent national study by the University of Michigan found that from 2001 to 2016 less than 1 of patients filled their prescription for naloxone following ED discharge To address this problem The investigators propose a prospective randomized clinical trial comparing an experimental education intervention that may improve prescription fill rate against the current standard of care at the Hartford Hospital ED HH-ED Our primary aim is to provide preliminary data on the impact of an enhanced overdose education EOE delivered at the HH-ED on intranasal naloxone rescue kit prescription fill rates in opioid users The investigators hypothesize that compared to those who receive standard education written instructions current standard of care opioid users who receive EOE while being discharged from the emergency department will be more likely to fill the prescription for an intranasal naloxone rescue kit within one month of hospital discharge Our secondary aim is to obtain preliminary data on the impact of EOE delivered at the HH-ED on naloxone rescue kit knowledge The investigators hypothesize that compared to the current standard education opioid users and their support network who receive EOE while being discharged from the emergency department will retain more educational content about naloxone rescue kits at one-month post ED visit In exploratory fashion the investigators will also qualitatively examine reasons the kit was or was not filled The long-term overarching goal of this line of research is to reduce mortality in opioid users starting with increasing the likelihood that rescue kit prescriptions will be filled

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None