An interventional study of Diagnosis Mandate and Individualized Feedback in Antimicrobial Resistance, sponsored by Penn State University. Active, not recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Penn State University · Not applicable, Interventional, and Health services research
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.
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.
Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
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For physicians:
Inclusion criteria:
Exclusion criteria:
For patients:
Inclusion criteria:
Exclusion criteria:
During this phase, physicians do not receive any intervention.
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
In this phase, physicians receive a customized feedback letter on their prescription behavior, including antibiotics prescription rate.
Behavioral: Individualized Feedback
The intervention consists of: a) a Refresher Training on AMR, and (b) a Diagnosis Mandate.
Physicians receive a customized feedback on their prescription behavior, including antibiotics prescription rate.
Antibiotics prescription rate
The number of patient visits in which antibiotics are prescribed by the total number of visits
Time frame: 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 gender
The number of patient visits in which antibiotics are prescribed by the total number of visits, by male and female
Time frame: 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
Time frame: 1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.
Plan to share: No — There are potential risks about confidentiality, as the number of physicians is small.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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