Optimizing Antibiotics Prescription: A Stepped-Wedge Randomized Trial

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. This registration is for objective 1. Therefore, only details pertaining to that objective will be provided here. ;

Study Design

Related Conditions & MeSH terms

Antimicrobial Resistance

Clinical Trial Details

NCT number	NCT06436690
Study type	Interventional
Source	Penn State University
Contact	Yubraj Acharya, Ph.D.
Phone	7347573571
Email	yua36@psu.edu
Status	Not yet recruiting
Phase	N/A
Start date	July 15, 2024
Completion date	June 30, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.