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Improving Availability of Intranasal Naloxone

Improving Availability of Intranasal Naloxone Rescue for Opioid Overdose

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05877118
Enrollment
84
Registered
2023-05-26
Start date
2024-03-01
Completion date
2025-12-31
Last updated
2024-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Overdose

Keywords

Naloxone, Overdose education

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 (family/friend) 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.

Interventions

BEHAVIORALEnhanced Overdose Education (EOE)

EOE was adapted by Co-I Dr. Monique Miley at HHC's premier addiction hospital-The Rushford Center. It follows the guidelines set by Co-PI Jonathan Craig Allen when working with opioid patients reluctant to obtain naloxone: * Express confidence in naloxone * Provide a clear statement about suitability (You are an excellent candidate for naloxone) * Begin discussion using presumptive language (You must be ready for an overdose)

BEHAVIORALStandard education

Written instructions that accompany a kit prescription in many EDs throughout the country.

Sponsors

Hartford HealthCare
CollaboratorOTHER
Hartford Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

-Patients will be in the process of being discharged from Hartford Hospital ED with a naloxone kit prescription following opiate or opioid intoxication/poisoning, use of illicit opioids or prescription opioids, or opioid injection use-related conditions

Exclusion criteria

* Patient has previously received the standard naloxone kit education or has a known allergy to naloxone and/or kit constituents * Patient or support network does not speak English * Patient is in police custody * Patient is not being discharged home from the ED.

Design outcomes

Primary

MeasureTime frameDescription
Prescription fill rate1 monthPharmacy records/survey to determine if naloxone kit prescription was filled

Secondary

MeasureTime frameDescription
Education content survey1 monthQuestionnaire measuring how much of education was retained and reasons for filling or not filling prescription

Countries

United States

Contacts

Primary ContactJimmy Choi, PsyD
jimmy.choi@hhchealth.org860-545-7128

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026