跳至主要内容
临床试验/NCT06521892
NCT06521892Enrolling By Invitation不适用

The Effect of Social Surveillance and Health Education Interventions Non-prescription Dispensing of Antibiotics in Community Pharmacies: a Randomized Controlled Trial

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
400
试验地点
1
主要终点
Proportion of antibiotics dispensing without a prescription

研究概览

简要总结

This study was a randomized controlled trial conducted in community pharmacies. Empirical data were collected primarily using standardized patient methods. In Hubei Province, 400 community pharmacies were randomly selected and assigned to the intervention group and the control group according to the ratio of 1:1. A one-month intervention was conducted in community pharmacies in the intervention group, which included both social surveillance and health education. First, on-site training was provided to community pharmacy staff. Respiratory physicians and pediatricians were invited to give health education lectures on disease diagnosis and treatment, medication use, etc. Second, signs were posted or hung in the community pharmacies of the intervention group, saying that "antibiotics need to be purchased with a prescription, and you are welcome to call the 12315 hotline to report if you find any sales without a prescription", in order to open up the channels of social supervision and to form a social surveillance intervention. The control group only received the regular drug supervision and management measures in Hubei Province. The primary outcome is to observe the proportion of community pharmacies selling antibiotics without a prescription.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

Pharmacies participating in the study did not know which group they were assigned to. Standardized patient surveyors also did not know which group of pharmacies they surveyed.

入排标准

性别
All
接受健康志愿者

入选标准

  • The qualification of retail pharmacies to sell antimicrobial drugs complies with relevant regulations and requirements, ensuring that the study participants operate legally within the regulatory framework.
  • Pharmacies located in Hubei Province.

排除标准

  • The retail pharmacy plans to undergo major changes during the study period, such as relocation, renovation, shutdown, or closure;
  • Retail pharmacies that refused to respond to the call for training from the Hubei Provincial Drug Administration;
  • Participants had poor compliance and do not participate in the intervention as required by the trial on multiple occasions;
  • Subjects withdrew from the study on their own or were lost to follow-up.

结局指标

主要结局

Proportion of antibiotics dispensing without a prescription

时间窗: baseline, First month after intervention, 3, 6, and 12 months after intervention

Proportion of antibiotics dispensing without a prescription measured by standardized patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaoxv Yin, PhD

Professor and Head of Social Medicne and Health Management Department

Huazhong University of Science and Technology

研究点 (1)

Loading locations...

相似试验