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Optimizing Antibiotics Prescription

Optimizing Antibiotics Prescription: A Stepped-Wedge Randomized Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06436690
Enrollment
62
Registered
2024-05-31
Start date
2025-04-15
Completion date
2026-12-30
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antimicrobial Resistance

Brief 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 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.

Detailed 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.

Interventions

BEHAVIORALDiagnosis Mandate

The intervention consists of: a) a Refresher Training on AMR, and (b) a Diagnosis Mandate.

Physicians receive a customized feedback on their prescription behavior, including antibiotics prescription rate.

Sponsors

Penn State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

This is a stepped-wedge randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

For physicians: Inclusion criteria: * age 18+ * working at an outpatient clinic in one of the participating hospitals.

Exclusion criteria

* \<18 years of age * working at more than one of the participating hospitals For patients: Inclusion criteria: * age 18+ * sought care at one of the outpatient clinics in the participating hospitals.

Design outcomes

Primary

MeasureTime frameDescription
Antibiotics prescription rate1-3 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

Secondary

MeasureTime frameDescription
Differences in prescription rates by patient's gender1-3 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, by male and female
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.The number of patient visits in which antibiotics are prescribed by the total number of visits, by advantaged and disadvantaged status

Countries

Nepal, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026