Clinical trial NCT06436690: Optimizing Antibiotics Prescription
Official title: Optimizing Antibiotics Prescription: A Stepped-Wedge Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Antimicrobial Resistance
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: This is a stepped-wedge randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.

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.

Eligibility 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)

Primary outcomes:
measure: Antibiotics prescription rate
timeFrame: 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:
measure: Differences in prescription rates by patient's gender
timeFrame: 1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.
measure: Differences in prescription rates by patient's ethnicity (advantaged versus disadvantaged)
timeFrame: 1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.
Other outcomes:
Locations:
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
city: Bharatpur
country: Nepal
facility: Institute for Social and Environmental Research - Nepal
state: Bagmati
Study officials:
References: