Optimizing Antibiotics Prescription

Antimicrobial Resistance Clinical Trial

Official title:

Optimizing Antibiotics Prescription: A Stepped-Wedge Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06436690
• Other study ID #: STUDY00025143
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Penn State University
• Contact: Yubraj Acharya, Ph.D.
• Phone: 7347573571
• Email: yua36[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Antimicrobial Resistance

Intervention

Behavioral:
• Diagnosis Mandate and Feedback
The intervention consists of: a) a Refresher Training on AMR, (b) a Diagnosis Mandate, and (c) an Individualized Feedback.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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	1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.