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Optimizing Antibiotics Prescription

The Pennsylvania State University (PENNSTATE) logo

The Pennsylvania State University (PENNSTATE)

Status

Active, not recruiting

Conditions

Antimicrobial Resistance

Treatments

Behavioral: Individualized Feedback
Behavioral: Diagnosis Mandate

Study type

Interventional

Funder types

Other

Identifiers

NCT06436690
STUDY00025143

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Exclusion criteria:

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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Crossover Assignment

Masking

Double Blind

56 participants in 3 patient groups

Control
No Intervention group
Description:
During this phase, physicians do not receive any intervention.
Diagnosis Mandate
Experimental group
Description:
In this phase, physicians receive a refresher training on AMR and a letter requiring the physicians to specify the diagnosis in their prescription note.
Treatment:
Behavioral: Diagnosis Mandate
Feedback
Experimental group
Description:
In this phase, physicians receive a customized feedback letter on their prescription behavior, including antibiotics prescription rate.
Treatment:
Behavioral: Individualized Feedback

Trial contacts and locations

2

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Central trial contact

Yubraj Acharya, Ph.D.

Data sourced from clinicaltrials.gov

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