Optimizing Antibiotics Prescription

Optimizing Antibiotics Prescription: A Stepped-Wedge Randomized Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Antimicrobial Resistance
• Intervention / Treatment: Behavioral: Diagnosis Mandate; Behavioral: Individualized Feedback

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Bagmati
    • Bharatpur, Bagmati, Nepal, 44200
      • Institute for Social and Environmental Research - Nepal
• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16801
      • Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; During this phase, physicians do not receive any intervention.
Experimental: 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.	Behavioral: Diagnosis Mandate; The intervention consists of: a) a Refresher Training on AMR, and (b) a Diagnosis Mandate.
Experimental: Feedback; In this phase, physicians receive a customized feedback letter on their prescription behavior, including antibiotics prescription rate.	Behavioral: Individualized Feedback; Physicians receive a customized feedback on their prescription behavior, including antibiotics prescription rate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotics prescription rate	The number of patient visits in which antibiotics are prescribed by the total number of visits	1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in prescription rates by patient's gender	The number of patient visits in which antibiotics are prescribed by the total number of visits, by male and female	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)	The number of patient visits in which antibiotics are prescribed by the total number of visits, by advantaged and disadvantaged status	1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.

Collaborators and Investigators

• Sponsor: Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Actual): November 28, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00025143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are potential risks about confidentiality, as the number of physicians is small.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No