NCT05451836

N-of-1 Trials of Interventions to Improve Decision-making for Antibiotic Use

Completed NA Last updated 10 April 2024

What this trial tests

NA trial testing Patient education leaflets in Antimicrobial Resistance in 15,157 participants. Completed in 31 January 2024.

Timeline

4 July 2022

Primary endpoint
30 June 2023

31 January 2024

Quick facts

Lead sponsor	Tan Tock Seng Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	15,157
Start date	4 July 2022
Primary completion	30 June 2023
Estimated completion	31 January 2024
Sites	4 locations across Singapore

Drugs / interventions tested

• Patient education leaflets
• Physician feedback

Conditions studied

• Antimicrobial Resistance — all drugs for Antimicrobial Resistance →

Sponsor

Tan Tock Seng Hospital

Who can join

Adults 21 to 110, any sex, with Antimicrobial Resistance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. N-of-1 Trials of Antimicrobial Stewardship Interventions to Optimize Antibiotic Prescribing for Upper Respiratory Tract Infection in Emergency Departments: Protocol for a Quasi-Experimental Study.
   Attal H, Huang Z, Kuan WS, Weng Y, et al · · 2024 · cited 1× · PMID 38381495 · DOI 10.2196/50417
2. Physician Feedback Reduces Antibiotic Prescribing for Uncomplicated Upper Respiratory Tract Infection in the Emergency Department.
   Guo H, Aithal S, Phua HP, Kuan WS, et al · · 2025 · PMID 41463699 · DOI 10.3390/antibiotics14121196