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Improving Availability of Intranasal Naloxone

Primary Purpose

Opioid Overdose

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Overdose Education (EOE)
Standard education
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid Overdose focused on measuring Naloxone, Overdose education

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hartford Hospital Emergency Department
  • Olin Neuropsychiatry Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard education

Enhanced Overdose Education (EOE)

Arm Description

Written 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.

A 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.

Outcomes

Primary Outcome Measures

Prescription fill rate
Pharmacy records/survey to determine if naloxone kit prescription was filled

Secondary Outcome Measures

Education content survey
Questionnaire measuring how much of education was retained and reasons for filling or not filling prescription

Full Information

First Posted
May 17, 2023
Last Updated
May 17, 2023
Sponsor
Hartford Hospital
Collaborators
Hartford HealthCare
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1. Study Identification

Unique Protocol Identification Number
NCT05877118
Brief Title
Improving Availability of Intranasal Naloxone
Official Title
Improving Availability of Intranasal Naloxone Rescue for Opioid Overdose
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 3, 2023 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital
Collaborators
Hartford HealthCare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. Participants 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, we 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. We 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. We 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, we 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Overdose
Keywords
Naloxone, Overdose education

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard education
Arm Type
Active Comparator
Arm Description
Written 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.
Arm Title
Enhanced Overdose Education (EOE)
Arm Type
Experimental
Arm Description
A 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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Overdose Education (EOE)
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Standard education
Intervention Description
Written instructions that accompany a kit prescription in many EDs throughout the country.
Primary Outcome Measure Information:
Title
Prescription fill rate
Description
Pharmacy records/survey to determine if naloxone kit prescription was filled
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Education content survey
Description
Questionnaire measuring how much of education was retained and reasons for filling or not filling prescription
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jimmy Choi, PsyD
Phone
860-545-7128
Email
jimmy.choi@hhchealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Weidner, MD, MBA
Organizational Affiliation
Hartford HealthCare
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan C Allen, MD
Organizational Affiliation
Hartford HealthCare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital Emergency Department
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Pepper, MD
Facility Name
Olin Neuropsychiatry Research Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Availability of Intranasal Naloxone

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