Optimizing Antibiotics Prescription

NCT ID: NCT06436690

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2026-04-30

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.

Conditions

Antimicrobial Resistance

Study Design

• Allocation Method: NA
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Control

During this phase, physicians do not receive any intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Diagnosis Mandate

Intervention Type: BEHAVIORAL

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

Feedback

In this phase, physicians receive a customized feedback letter on their prescription behavior, including antibiotics prescription rate.

Group Type: EXPERIMENTAL

Individualized Feedback

Intervention Type: BEHAVIORAL

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

Interventions

Diagnosis Mandate

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

Intervention Type: BEHAVIORAL

Individualized Feedback

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• age 18+
• working at an outpatient clinic in one of the participating hospitals.

• age 18+
• sought care at one of the outpatient clinics in the participating hospitals.

Exclusion Criteria

• <18 years of age
• working at more than one of the participating hospitals

For patients:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Yubraj Acharya, Ph.D.

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pennsylvania State University

University Park, Pennsylvania, United States

Institute for Social and Environmental Research - Nepal

Bharatpur, Bagmati, Nepal

Countries

United States; Nepal

Other Identifiers

STUDY00025143

Identifier Type: -

Identifier Source: org_study_id