N-of-1 Trials of Interventions to Improve Decision-making for Antibiotic Use
NCT05451836 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15157
Last updated 2024-04-10
Summary
Antibiotics have brought about a substantial reduction in infectious mortality. However, inappropriate antibiotic use has driven the rapid increase in antibiotic resistance. The Centers for Disease Control and Prevention estimates that at least 2 million people in the United States (US) become infected with antibiotic-resistant bacteria each year, and at least 23,000 people die each year as a direct result of these infections.
Antimicrobial stewardship programs have largely focused on inpatient settings and have excluded emergency departments (ED). The ED is a unique healthcare setting which is distinct from inpatient and other ambulatory settings. Given the many factors that could influence inappropriate antibiotic prescribing, a one-size-fits-all approach is unlikely to work for all physicians and all regions. Hence, the design and implementation of tailored interventions based on the understanding of the local patient, physician, and ED organizational factors are pertinent for the interventions. The team has conducted a mixed-methods study to understand the patient, physician, and organisational factors that influence antibiotic prescribing in the local EDs. The findings of the study were used to design two interventions which will be implemented in four EDs in Singapore to reduce the inappropriate antibiotic prescribing in the ED.
This study aims to evaluate the effectiveness of 2 tailored antimicrobial stewardship interventions in reducing antibiotic prescribing rates for uncomplicated URTI patients attending four adult EDs in Singapore:
1. Patient education via information leaflets addressing knowledge-, perception-, and belief-gaps of the local patient population on antibiotic use for URTI
2. Two-monthly physician feedback on their antibiotic prescribing rates by senior ED doctors coupled with bite-sized information on good antibiotic prescribing practices.
The study will include an initial control period of 18 months where none of the 4 hospitals will be exposed to the interventions. At the beginning of the intervention period, the 4 hospitals will be randomly assigned to one of the 2 interventions (Patient education or physician feedback). At the end of 6 months, all hospitals will receive the other intervention and be exposed to both interventions concurrently. Data will be collected for another 6 months to assess if the effects of the interventions are persistent.
Conditions
Interventions
- OTHER
-
Patient education leaflets
Patients who attend the emergency department with upper respiratory tract infections will be provided with patient education leaflets on appropriate antibiotic use and antimicrobial resistance. The leaflets are available in the four national languages in Singapore.
- OTHER
-
Physician feedback
All physicians working in the emergency department will receive a text message from their department head on their antibiotic prescribing rates every two months.
Sponsors & Collaborators
-
Changi General Hospital
collaborator OTHER -
Khoo Teck Puat Hospital
collaborator OTHER -
National University Hospital, Singapore
collaborator OTHER -
Tan Tock Seng Hospital
lead OTHER
Principal Investigators
-
Angela Chow, Ph.D · Tan Tock Seng Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 21 Years
- Max Age
- 110 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-07-04
- Primary Completion
- 2023-06-30
- Completion
- 2024-01-31
Countries
- Singapore
Study Locations
More Related Trials
-
Improving Safe Antibiotic Prescribing in Telehealth
NCT05138874 ·Status: COMPLETED ·Phase: NA
-
Israeli Judicious Antibiotic Prescription Study
NCT01187758 ·Status: COMPLETED ·Phase: NA
-
A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications
NCT00645125 ·Status: COMPLETED ·Phase: PHASE4
-
Comparative Effectiveness of Antibiotics for Respiratory Infections
NCT02297815 ·Status: COMPLETED
-
Trial of Faropenem and Cefadroxil (in Combination With Amoxicillin/Clavulanic Acid and Standard TB Drugs) in Patients With Pulmonary Tuberculosis: Measurement of Early Bactericidal Activity and Effects on Novel Biomarkers
NCT02381470 ·Status: COMPLETED ·Phase: PHASE2
-
Reducing Antibiotic Use by Implementation of Stewardship in Primary and Urgent Care
NCT07217002 ·Status: ACTIVE_NOT_RECRUITING
-
Opinion of the Infectious Disease Specialist Referent for the Good Use of AnTiBiotics
NCT04603313 ·Status: COMPLETED
-
Microbial, Immune, and Metabolic Perturbations by Antibiotics (MIME Study)
NCT02707042 ·Status: COMPLETED ·Phase: PHASE1
-
An Open Label Trial of Azithromycin in Chronic Productive Cough
NCT02196493 ·Status: UNKNOWN ·Phase: PHASE3
-
Effect of Minocycline & Amoxicillin on Antibiotic Resistant Bacteria and Indigenous Microbiotas
NCT02030912 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
NCT03818815 ·Status: COMPLETED ·Phase: PHASE2
-
Do Fair Comparisons or Harms Data Increase Responsiveness to Feedback About Antibiotic Prescribing: 2x2 Factorial Trial
NCT04594200 ·Status: COMPLETED ·Phase: NA
-
Delayed Antibiotic Therapy in General Practice
NCT05361239 ·Status: COMPLETED
-
Digital Otoscope Versus Education and Feedback for Otitis Media in Young Children
NCT06731660 ·Status: COMPLETED ·Phase: NA
-
Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection
NCT01930955 ·Status: WITHDRAWN ·Phase: NA
-
Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
NCT00939185 ·Status: COMPLETED
-
Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia
NCT00818610 ·Status: COMPLETED ·Phase: PHASE4
-
Dose Ranging Study of OTO-201 in AOMT
NCT02719158 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate
NCT02340000 ·Status: COMPLETED ·Phase: PHASE4
-
Multiple Oral Dose Safety, Tolerability And Pharmacokinetic Study Of PF-04287881 In Healthy Adult Subjects
NCT01026545 ·Status: COMPLETED ·Phase: PHASE1
-
Selection of Antibiotic Resistance by Azithromycin and Clarithromycin in the Oral Flora
NCT00354952 ·Status: COMPLETED ·Phase: NA
-
A Three-part Study to Determine the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Volunteers and Healthy Male Japanese Subjects
NCT01818011 ·Status: TERMINATED ·Phase: PHASE1
-
Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination Therapy vs. Oseltamivir Alone for Hospitalised Paediatric Influenza Patients
NCT04315194 ·Status: COMPLETED
-
Study Comparing the Clinical Efficacy and Health Outcomes of Outpatients With Mild to Moderate Community-Acquired Pneumonia (CAP) Treated With Either Telithromycin Once Daily for 7 Days, or Azithromycin Once Daily for 5 Days
NCT00237445 ·Status: TERMINATED ·Phase: PHASE4
-
A Trial to Evaluate Faropenem Medoxomil in the Treatment of Acute Otitis Media
NCT00276042 ·Status: COMPLETED ·Phase: PHASE2