Optimizing Antibiotics Prescription

NCT06436690 | Active Not Recruiting DMC

• 1 other identifier: STUDY00025143
• Study Type: interventional
• Target: 56
• Locations: 2 countries
• Sites: 2

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.

Conditions

Antimicrobial Resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Differences in prescription rates by patient's gender

  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)

  1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.

Study Arms (3)

Control

NO INTERVENTION

During this phase, physicians do not receive any intervention.

Diagnosis Mandate

EXPERIMENTAL

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

Feedback

EXPERIMENTAL

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

Behavioral: Individualized Feedback

Interventions

Diagnosis Mandate BEHAVIORAL

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

Diagnosis Mandate

Individualized Feedback BEHAVIORAL

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

Feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \<18 years of age
• working at more than one of the participating hospitals
• For patients:
• age 18+
• sought care at one of the outpatient clinics in the participating hospitals.
• \<18 years of age
• one of the vulnerable populations (pregnant women, cognitively impaired adults)

Sponsors & Collaborators

• Penn State University: lead

Study Sites (2)

Pennsylvania State University

University Park, Pennsylvania, 16801, United States

Location

Institute for Social and Environmental Research - Nepal

Bharatpur, Bagmati, 44200, Nepal

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a stepped-wedge randomized controlled trial

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: April 15, 2025
• Primary Completion: November 28, 2025
• Study Completion: April 30, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1); US (1)