Addressing the Opioid Epidemic Through Community Pharmacy Engagement: Randomized Controlled Trial (Aim 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in Naloxone Dispensing Rate Over a 6-month Period
研究概览
简要总结
This is a pilot Randomized Controlled Trial (RCT) in which 120 pharmacists will be randomized to an experimental or control group and data on naloxone dispensing and secondary outcomes will be collected over the course of the RCT.
详细描述
This is a prospective pilot RCT that will evaluate the impact of naloxone communication training (Nalox-Comm) on 120 pharmacists' naloxone dispensing behaviors (primary outcome). Data will be collected at baseline, immediately after training is completed, and at 3-month follow up. Data sources include pharmacy records (for naloxone dispensing), simulated patient observations (to rate quality of communication), and survey data (for self-reports of knowledge and self-efficacy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •currently work at a pharmacy that stocks naloxone;
- •currently work at a rural community pharmacy;
- •are at least 18 years of age; and
- •speak English.
排除标准
- •Non-staff pharmacists such as pharmacy "floaters" or fill-in pharmacists will not be eligible to participate.
结局指标
主要结局
Change in Naloxone Dispensing Rate Over a 6-month Period
时间窗: 3-month period before intervention and 3-month follow-up dispensing data
Pharmacy records indicated the number of times each pharmacy dispensed naloxone and opioid prescriptions over the RCT period. These data were aggregated into the total number of naloxone and opioid prescriptions dispensed in the 3 months pre-intervention and the 3 months post-intervention. The change in naloxone dispensing rates was measured by comparing pharmacy records of the number of naloxone products dispensed in the three months prior to study participation to the number of naloxone products dispensed in the three months after study completion. The rate was defined as the number of naloxone products dispensed divided by the number of opioid prescriptions dispensed in each 3-month period.
次要结局
- Mean Willingness to Dispense Naloxone Score(up to 3-month Follow-up Survey)
- Mean Naloxone Counselling Self-Efficacy Score(up to 3-month Follow-up Survey)
- Mean Pharmacist Quality of Non-verbal Communication Score(up to 1-month post-training)