Optimizing Antibiotics Prescription: A Stepped-Wedge Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Antibiotics prescription rate
研究概览
简要总结
Interventions that are low-cost, do not add substantially to the physician workload, are consistent with good physician practices and WHO guidelines, and serve as a reminder on the risks of overprescribing antibiotics are critically needed. The overall goal of the proposed project is to test the effect of two behavioral interventions targeted to junior physicians-specifically, requiring them to specify the diagnosis in the prescription note and providing feedback-on their antibiotics prescription rate; examine the intervention's effects across gender and caste; and draw lessons for scaling up the intervention.
详细描述
Antimicrobial resistance (AMR) is one of the top ten threats to global health. Limited existing evidence from Nepal, the site for the proposed study, suggests that physicians "err on the side of caution" by prescribing antibiotics even for viral conditions, which contributes to AMR. Interventions that are low-cost, do not add substantially to the physician workload, are consistent with good physician practices and WHO guidelines, and serve as a reminder on the risks of overprescribing antibiotics are critically needed. The overall goal of the proposed project is to test the effect of a behavioral intervention targeted to junior physicians-specifically, requiring them to specify the diagnosis in the prescription note and providing feedback-on their antibiotics prescription rate; examine the intervention's effects across gender and caste; and draw lessons for scaling up the intervention.
The specific objectives are the following:
Objective 1. Assess the effect of a behavioral intervention targeted to junior physicians on antibiotics prescription rate, including by caste and gender of the patient. A stepped-wedge randomized control trial (RCT) will be conducted among 60 junior physicians in five hospitals (1 government, 2 private teaching, and 2 community) in Nepal. The intervention will be rolled out sequentially across the hospitals and data will be collected from patients (n=3,600) both before and after the intervention. The intervention will consist of three components: (a) a Refresher Training on AMR, (b) a Diagnosis Mandate, and (c) an Individualized Feedback.
Objective 2. Identify barriers to scaling up the intervention beyond the study's site and strategies for their mitigation. After preliminary analysis of the quantitative data, key informant interviews with national- and provincial- level health policy makers (n=5), and in-depth interviews with physicians (n=5) and hospital managers (n=5) will be conducted.
Objective 3. Assess the extent to which physicians prescribe antibiotics correctly. From a subset of patients (n=120, i.e., 2 per physician), more detailed medical information will be collected and analyzed from their outpatient booklet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
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
- •For physicians:
- •Inclusion criteria:
- •working at an outpatient clinic in one of the participating hospitals.
排除标准
- •<18 years of age
- •working at more than one of the participating hospitals
- •For patients:
- •Inclusion criteria:
- •sought care at one of the outpatient clinics in the participating hospitals.
- •Exclusion criteria:
- •<18 years of age
- •one of the vulnerable populations (pregnant women, cognitively impaired adults)
研究组 & 干预措施
Control
During this phase, physicians do not receive any intervention.
Diagnosis Mandate
In this phase, physicians receive a refresher training on AMR and a letter requiring the physicians to specify the diagnosis in their prescription note.
干预措施: Diagnosis Mandate (Behavioral)
Feedback
In this phase, physicians receive a customized feedback letter on their prescription behavior, including antibiotics prescription rate.
干预措施: Individualized Feedback (Behavioral)
结局指标
主要结局
Antibiotics prescription rate
时间窗: 1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.
The number of patient visits in which antibiotics are prescribed by the total number of visits
次要结局
- Differences in prescription rates by patient's gender(1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.)
- Differences in prescription rates by patient's ethnicity (advantaged versus disadvantaged)(1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.)
研究者
Yubraj Acharya, Ph.D.
Associate Professor
Penn State University