Viewing Study NCT04025671



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Last Modification Date: 2024-10-26 @ 1:14 PM
Study NCT ID: NCT04025671
Status: COMPLETED
Last Update Posted: 2019-07-19
First Post: 2019-07-11

Brief Title: A Usability Assessment of Naloxone Administration by Untrained Community Members
Sponsor: State University of New York - Upstate Medical University
Organization: State University of New York - Upstate Medical University

Study Overview

Official Title: A Usability Assessment of Intramuscular Atomized Intranasal and Nasal Spray Administration of Naloxone by Untrained Community Members
Status: COMPLETED
Status Verified Date: 2019-07
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: This will be a randomized open-label usability assessment of intramuscular intranasal and nasal spray administration of naloxone using two different instruction sets by laypersons

Design Single site open-label randomized usability assessment of intramuscular intranasal and nasal spray administration of simulated naloxone A convenience sample of participants will consent to volunteer in the study at a public venue Participants will provide verbal consent and will be randomly assigned a simulated naloxone kit containing either intramuscular intranasal or nasal spray administration materials with either standard or study team designed instructions for use Participants will enter a use scenario station and be asked to assemble and administer the simulated naloxone kit to a mannequin intranasal and nasal spray or simulated flesh pad intramuscular The participant will be instructed to start and will be timed until the simulated naloxone has been successfully administered or 7 minutes has elapsed The participant will be observed by one trained investigator who will assess for successful administration of the simulated naloxone and critical errors The environment will contain distractorsOnce the participant has successfully administered simulated naloxone or 7 minutes elapses the timer will be stopped Successful administration of simulated naloxone will be defined as administration of the agent without any critical errors occurring defined below Data collected will include demographics defined below successful administration of simulated naloxone time to successful administration of simulated naloxone and Likert-item data assessing the ease of use of the device and instructions
Participants adults 18 years of age and older at a public venue will be asked to volunteer Participants with severe visual or hearing impairment defined as legally deaf legally blind unable to read print size provided on instructional handout or unable to hear video audio that have previous naloxone administration training that are not English proficient that are pregnant or that have previously participated in the trial will be excluded
Kits

1 Intranasal simulated naloxone vial bristoject administration instructions standard or study team designed
2 Intramuscular sterile single use needle sterile single use 3 mL syringe simulated naloxone vial administration instructions standard or study team designed
3 Nasal spray simulated naloxone spray administration instructions standard or study team designed
Objectives

1 Primary successful administration of simulated naloxone in the time allowed A successful administration will be defined as administration of the simulated naloxone to the mannequin head of simulated flesh pad within 7 minutes and without any critical errors defined below
2 Secondary time required to successfully administer the simulated naloxone and Likert-item assessment of ease of use of both the device and instructions
Data and Analysis

1 The usability trial will be conducted using a convenience sample so no power analysis will be conducted or minimum sample size defined
2 Demographics age gender handedness level of education and presence or absence of opioid at risk contacts
3 Data successful administration time to administration and Likert-item assessment of both the device and instructions Failure to administer the medication due to a critical use error will be recorded and the specific error reported for all participants
Critical Errors

1 Intranasal failure to remove both yellow caps from bristoject failure to remove cap from simulated naloxone failure to attach atomizer failure to attach simulated naloxone drug leak prior to administration administration in only one nostril and failure to administer within 7 minutes
2 Intramuscular failure to attach the needle to the syringe failure to remove cap from simulated naloxone failure to draw up 90 09 mL of the simulated naloxone failure to puncture simulated flesh pad with needle failure to push entire volume of fluid in the syringe into the simulated flesh pad and failure to administer within 7 minutes
3 Intranasal failure to place the tip of the device into one nostril failure to depress the device and release the simulated naloxone failure to administer within 7 minutes
Detailed Description: Background Opioid abuse and addiction is a growing epidemic both in the United States and globally It impacts the health social welfare and economic stability of those directly affected and society as a whole According to the National Institute on Drug Abuse there are approximately 21 million people in the United States with substance use disorders related to prescription opioid medications and another 467000 addicted to heroin Data from the Center for Disease Control National Vital Statistics System demonstrated that the number of drug poisonings involving opioid analgesics tripled from 2000 to 2014 and in 2010 opioid pain relievers were responsible for 828 of all unintentional deaths in the United States1 In an attempt to combat this epidemic many states have implemented community-based opioid overdose prevention programs aimed at increasing resources to combat addiction and distributing naloxone to community members These programs increase knowledge of overdose prevention and the factors that increase a persons risk for overdose Evaluations of these programs have also demonstrated that nonmedical bystanders are able to administer naloxone effectively after completing training2 Naloxone can be administered intravenously intramuscularly or via inhalation Opioid overdose prevention programs are typically initiated by local and state governments which allows for interprogram variability regarding the route of naloxone administration used by community members Pre-hospital data has demonstrated that intranasal naloxone is a safe and effective alternative to intravenous naloxone3 A usability assessment comparing a naloxone auto-injector Evzio to the use of a nasal atomizer suggested that the route of administration did impact the rate of successful naloxone administration by nonmedical community members4 Opioid overdose prevention programs typically utilize intranasal atomizers nasal inhalers or intramuscular administration routes In 2016 the investigators conducted a usability assessment of naloxone administered by community members who received training on how to use the naloxone device that was assigned Our data supported that intranasal administration with an atomizer or spray resulted in a higher administration success rate when compared to intramuscular injection Recently New York along with many other states passed legislation allowing individuals to purchase naloxone over-the-counter without a prescription This legislation has drastically expanded access to naloxone but has reduced the opportunity to train community members purchasing the medication The investigators plan to conduct a usability assessment of simulated naloxone in community members in the absence of training to assess the rate of successful administration and time to successful administration

Objectives

Primary The successful administration of simulated naloxone without training A successful administration will be defined as administration of the simulated naloxone to the mannequin head or simulated flesh pad within 7 minutes and without any critical errors defined below

Secondary

Total time required to successfully administer the simulated naloxone without training
Comparison of successful administration with standard and simplified instructions
Comparison of total time required for successful administration with standard and simplified instructions
Likert-item assessment of the usability of the simulated naloxone product
Likert-item assessment of usability of the naloxone administration instructions

Design Single site open-label randomized usability assessment of intramuscular intranasal and nasal spray administration of simulated naloxone using standard package-insert or simplified developed by study team instructions A convenience sample of participants will consent to volunteer in the study at a public venue Participants will provide verbal consent and will be randomly assigned a simulated naloxone kit containing either intramuscular standard intramuscular simplified intranasal standard intranasal simplified nasal spray standard or nasal spray simplified administration materials The participant will enter a use scenario station and will be asked to assemble and administer the simulated naloxone kit to a mannequin intranasal and nasal spray or simulated flesh pad intramuscular The participant will be instructed to start and will be timed until the simulated naloxone has been successfully administered or 7 minutes has elapsed The participant will be observed by one trained investigator who will assess for successful administration of the simulated naloxone and critical errors The environment will contain distracters to mimic a community based setting Once the participant has successfully administered the simulated naloxone or 7 minutes has elapsed the timer will be stopped Successful administration of simulated naloxone will be defined as administration of the agent without any critical errors occurring defined below Data collected will include demographics defined below successful administration of simulated naloxone product assessment information instruction assessment information and time to successful administration of simulated naloxone

Eligibility healthy adults 18 years of age and older at a public venue will be asked to participate in the study Participants with severe visual or hearing impairment defined as legally deaf legally blind unable to read print size provided on instructional handout or unable to hear instructions from a research staff member that have previous naloxone administration training that are not English proficient that are pregnant or that have previously participated in the trial will be excluded

Statistical Methods All data will be analyzed using IBM SPSS Statistics software Demographics data will be analyzed using descriptive statistics for continuous measures and percentages for categorical measures The successful administration of naloxone will be compared between groups using the Chi-square test and a significant difference will be defined as a p-value of less than 005 for the result The time to administration between groups will be assessed using a one-way ANOVA and a significant difference will be defined as a p-value of less than 005 for the result The Likert-item data will be reported as percentage of response level and analyzed using a one-way ANOVA with a significant difference defined as a p-value of less than 005 for comparison between administration methods and instruction methods

Data AnalysisInterpretation As stated above data will be collected to assess both the successful administration of and time to administration of naloxone The rate of successful administration will be reported as a percentage for each of the three groups and analyzed using the Chi-square test Successful administration is defined as administration of the simulated naloxone within 7 minutes without committing any critical errors Critical errors are as follows

Intranasal atomizer failure to remove both yellow caps from bristoject failure to remove cap from simulated naloxone failure to attach atomizer failure to attach simulated naloxone drug leak prior to administration administration in only one nostril and failure to administer within 7 minutes
Intramuscular failure to attach the needle to the syringe failure to remove cap from simulated naloxone failure to draw up 90 09 mL of the simulated naloxone failure to puncture simulated flesh pad with needle failure to push entire volume of fluid in the syringe into the simulated flesh pad and failure to administer within 7 minutes
Intranasal spray failure to place the tip of the device into one nostril failure to depress the device and release the simulated naloxone failure to administer within 7 minutes

Time to successful administration will be reported using descriptive statistics mean time to administration and analyzed using a one-way ANOVA Times for participants who commit a critical error or who do no administer the simulated naloxone within 7 minutes will not be included in the analysis The Likert-item data will be reported as a median with an inter-quartile range and analyzed using a one-way ANOVA

A route of administration will be considered to be more user-friendly if it demonstrates a statistically significantly higher rate of successful administration compared to another route of administration Additionally a route or instruction type will be considered user preferred if the Likert-item data demonstrates a significantly better score on usability

Study Procedures No study procedures will be performed on study participants

Study Oversight

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