## Protocol Section
### Identification Module
**NCT ID:** NCT06436690

**Brief Title:** Optimizing Antibiotics Prescription: A Stepped-Wedge Randomized Trial

**Official Title:** Optimizing Antibiotics Prescription: A Stepped-Wedge Randomized Trial

#### Organization Study ID Info
**ID:** STUDY00025143
#### Organization
**Class:** OTHER
**Full Name:** Penn State University
### Status Module
#### Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-04-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Penn State University

#### Responsible Party

**Investigator Affiliation:** Penn State University

**Investigator Full Name:** Yubraj Acharya, Ph.D.

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Antimicrobial Resistance

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SEQUENTIAL

**Intervention Model Description:** This is a stepped-wedge randomized controlled trial

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The intervention will consist of three components: (a) a Refresher Training on antimicrobial resistance, (b) a Diagnosis Mandate, and (c) an Individualized Feedback.

**Intervention Names:**

- Behavioral: Diagnosis Mandate and Feedback

**Label:** Diagnosis Mandate and Feedback

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Diagnosis Mandate and Feedback

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

**Name:** Diagnosis Mandate and Feedback

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The number of patient visits in which antibiotics are prescribed by the total number of visits

**Measure:** Antibiotics prescription rate

**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.

#### Secondary Outcomes

**Description:** The number of patient visits in which antibiotics are prescribed by the total number of visits, by male and female

**Measure:** Differences in prescription rates by patient's gender

**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.

**Description:** The number of patient visits in which antibiotics are prescribed by the total number of visits, by advantaged and disadvantaged status

**Measure:** Differences in prescription rates by patient's ethnicity (advantaged versus disadvantaged)

**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.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

For physicians: 1) Age 18+, 2) working at an outpatient clinic in one of the participating hospitals.

For patients: 1) Age 18+, 2) Having sought care at one of the outpatient clinics in the participating hospitals.

Exclusion Criteria:

For physicians: \<18 years of age, For patients: \<18 years of age or falling into one of the vulnerable populations (pregnant women, cognitively impaired adults)

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yua36@psu.edu

**Name:** Yubraj Acharya, Ph.D.

**Phone:** 7347573571

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
