Clinical trial NCT05877118: Improving Availability of Intranasal Naloxone
Official title: Improving Availability of Intranasal Naloxone Rescue for Opioid Overdose
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Overdose
Keywords: Naloxone
Overdose education
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: Hartford HealthCare
First posted: 2023-05-26
Enrollment: 84
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prescription fill rate
timeFrame: 1 month
Secondary outcomes:
measure: Education content survey
timeFrame: 1 month
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital Emergency Department
state: Connecticut
city: Hartford
country: United States
facility: Olin Neuropsychiatry Research Center
state: Connecticut
Study officials:
affiliation: Hartford HealthCare
name: Jonathan C Allen, MD
role: PRINCIPAL_INVESTIGATOR
References: