Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06436690
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-24
Brief Title:
Optimizing Antibiotics Prescription
Sponsor:
Penn State University
Organization:
Penn State University
Study Overview
Official Title:
Optimizing Antibiotics Prescription A Stepped-Wedge Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 interventions 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 interventions 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 n3600 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 studys site and strategies for their mitigation After preliminary analysis of the quantitative data key informant interviews with national- and provincial- level health policy makers n5 and in-depth interviews with physicians n5 and hospital managers n5 will be conducted
Objective 3 Assess the extent to which physicians prescribe antibiotics correctly From a subset of patients n120 ie 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
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 n3600 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 studys site and strategies for their mitigation After preliminary analysis of the quantitative data key informant interviews with national- and provincial- level health policy makers n5 and in-depth interviews with physicians n5 and hospital managers n5 will be conducted
Objective 3 Assess the extent to which physicians prescribe antibiotics correctly From a subset of patients n120 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None