A Usability Assessment of Naloxone Administration by Untrained Community Members

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 distractors.Once 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% (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 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.

Conditions

• Harm Reduction
• Opioid-use Disorder
• Naloxone

Interventions

DEVICE

Nasal Spray Naloxone

Nasal spray naloxone device.

DEVICE

Intramuscular Naloxone

A vial of simulated naloxone and syringe with attached needle.

DEVICE

Improvised Nasal Atomizer

A naloxone bristoject dose and nasal atomizer device.

Sponsors & Collaborators

• Binghamton University

  collaborator OTHER

• State University of New York - Upstate Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-08-23

Primary Completion

2017-09-03

Completion

2017-09-03

FDA Device

Yes

Countries

• United States

Study Locations