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NCT Number: NCT06436690

Optimizing Antibiotics Prescription

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Social and Environmental Research - Nepal, Bharatpur, Bagmati, Nepal

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • <18 years of age
  • one of the vulnerable populations (pregnant women, cognitively impaired adults)

Treatment and study plan

Diagnosis Mandate

Behavioral

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

Individualized Feedback

Behavioral

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

Primary outcomes

  1. Antibiotics prescription rate

    Time frame: 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

Secondary outcomes

  1. Differences in prescription rates by patient's gender

    Time frame: 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 male and female

  2. Differences in prescription rates by patient's ethnicity (advantaged versus disadvantaged)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

Optimizing Antibiotics Prescription: A Stepped-Wedge Randomized Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 31, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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