A Usability Assessment of Intramuscular, Atomized Intranasal, and Nasal Spray Administration of Naloxone by Community Members
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 主要终点
- Successful Administration of Naloxone
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adults at least 18 years of age
排除标准
- •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
结局指标
主要结局
Successful Administration of Naloxone
时间窗: 10 minutes
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. Critical errors include: Failure to attach the needle to the syringe, failure to place the device tip into a nostril, failure to remove both caps from the device, failure to remove the cap from the naloxone, failure to depress the device and release the naloxone into the nostril, failure to remove cap from the naloxone, failure to draw up \> 90% (0.9 ml) of the naloxone, failure to attach atomizer to the device, failure to puncture the simulated flesh pad with the needle, failure to attach the naloxone to the device, failure to push the naloxone into the simulated flesh pad, drug leakage before administration, and administration of the total volume in a single nostril.
次要结局
- Time to Successful Administration of Naloxone(10 minutes)