Improving Availability of Intranasal Naloxone
1 other identifier
interventional
84
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2024
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2023
CompletedFirst Posted
Study publicly available on registry
May 26, 2023
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJune 7, 2024
June 1, 2024
1.5 years
May 17, 2023
June 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prescription fill rate
Pharmacy records/survey to determine if naloxone kit prescription was filled
1 month
Secondary Outcomes (1)
Education content survey
1 month
Study Arms (2)
Standard education
ACTIVE COMPARATORWritten instructions and information communicated to the patient through MyChart. The following four key points are covered: (1) When someone overdoses on opiates, their breathing will get very slow and may stop (2) Naloxone is a safe life-saving medication that can reverse an opioid overdose (3) You give someone naloxone by injecting it through the nostril, (4) If a first dose of naloxone does not work after about 3 minutes, give a second dose.
Enhanced Overdose Education (EOE)
EXPERIMENTALA one-page education pamphlet handed to participants and their identified support individual and a 4-minute video clip that will be viewed in the hospital and emailed or texted to both. EOE is purposefully brief and intended to increase uptake by participants and their support network who may not be motivated or willing to engage in face-to-face or extensive education. The pamphlet and video both emphasize the Why and How. That is, the significance of naloxone in decreasing the likelihood of death following an overdose while providing simple instructions on how to use the nasal kit. They also emphasize an important point missing in standard education: to tell others in the support network where it is and how to use it.
Interventions
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)
Written instructions that accompany a kit prescription in many EDs throughout the country.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hartford Hospitallead
- Hartford HealthCarecollaborator
Study Sites (2)
Hartford Hospital Emergency Department
Hartford, Connecticut, 06106, United States
Olin Neuropsychiatry Research Center
Hartford, Connecticut, 06106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan C Allen, MD
Hartford HealthCare
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2023
First Posted
May 26, 2023
Study Start
March 1, 2024
Primary Completion
August 31, 2025
Study Completion
December 31, 2025
Last Updated
June 7, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share