Clinical trial NCT03309449: A Usability Assessment of Naloxone by Community Members
Official title: A Usability Assessment of Intramuscular, Atomized Intranasal, and Nasal Spray Administration of Naloxone by Community Members
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Overdose
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This will be a usability trial to assess administration of naloxone via intramuscular, atomized intranasal, and nasal spray routes by nonmedical community members. Participants will undergo blocked randomization to naloxone kits containing supplies for one of the aforementioned routes and view an instructional video on how to appropriately administer the kit they were assigned. Participants will then have the opportunity to administer the simulated drug to a mannequin designated to simulate the route of administration assigned to the participant. The rate of successful administration will be determined for each route.

Detailed description: Objectives:

* Primary: The successful administration of simulated naloxone. A successful administration will be defined as administration of the simulated naloxone to the mannequin head or simulated flesh pad within 10 minutes and without any critical errors (defined below).
* Secondary: Total time required to successfully administer the simulated naloxone.

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. Participants will be shown an instructional video demonstrating how to appropriately assemble and administer the simulated naloxone kit they were randomly assigned. Once the video is complete the individual will enter a use scenario station where they 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 10 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 distractors (radio playing) and items that will simulate a community based dwelling (table, chairs, and an inflatable mattress). The mannequin and simulated flesh pad will be located on the mattress. Once the participant has successfully administered simulated naloxone or 10 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, and time to successful administration of simulated naloxone.

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 0.05 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 0.05 for the result.

Data Analysis/Interpretation: 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 10 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 10 minutes.
* Intramuscular: failure to attach the needle to the syringe, failure to remove cap from simulated naloxone, failure to draw up \>90% (0.9 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 10 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 10 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 10 minutes will not be included in the analysis.

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.

Study Procedures: No study procedures will be performed on study participants.

Eligibility criteria: Inclusion Criteria:

* healthy adults at least 18 years of age

Exclusion Criteria:

* severely visually or hearing impaired (defined as: legally deaf, legally blind, unable to read print size provided on instructional handout, or unable to hear video audio), previous naloxone administration training, not English proficient, previously participated in the trial, or pregnant

Primary outcomes:
measure: Successful Administration of Naloxone
timeFrame: 10 minutes
Secondary outcomes:
measure: Time to Successful Administration of Naloxone
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
affiliation: State University of New York - Upstate Medical University
name: William Eggleston, PharmD
role: PRINCIPAL_INVESTIGATOR
References: