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

NCT05451836 | Completed

• 1 other identifier: NMRC/CSAINV18MAY0007/2019
• Study Type: interventional
• Target: 15,157
• Locations: 1 country
• Sites: 4

Brief 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. 1.Patient education via information leaflets addressing knowledge-, perception-, and belief-gaps of the local patient population on antibiotic use for URTI
2. 2.Two-monthly physician feedback on their antibiotic prescribing rates by senior ED doctors coupled with bite-sized information on good antibiotic prescribing practices.

Conditions

Antimicrobial Resistance

Outcome Measures

Primary Outcomes (1)

• Antibiotic prescribing rates

  The antibiotic prescribing rates are computed by dividing the number of URTI patients prescribed with antibiotics with the total number of URTI seen by the physician. The data is obtained from the electronic medical records.

  Measured monthly for 15 months

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1 (Two emergency departments) will receive patient education leaflets for 6 months and will receive physician feedback for the next 6 months on top of the patient education.

Other: Patient education leaflets; Other: Physician feedback

Group 2

EXPERIMENTAL

Group 1 (Two emergency departments) will receive physician feedback for 6 months and will receive patient education leaflets for the next 6 months on top of the physician feedback.

Other: Patient education leaflets; Other: Physician feedback

Interventions

Patient education leaflets OTHER

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.

Group 1; Group 2

Physician feedback OTHER

All physicians working in the emergency department will receive a text message from their department head on their antibiotic prescribing rates every two months.

Group 1; Group 2

Eligibility Criteria

• Age: 21 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients:
• Adults aged 21 years and above
• Attendance at any of the study sites' Emergency Department: National University Hospital, Khoo Teck Puat Hospital, Changi General Hospital and Tan Tock Seng Hospital
• Presenting with upper respiratory tract infections
• Physicians:
• Working at any of the study sites' Emergency Department: National University Hospital (NUH), Khoo Teck Puat Hospital (KTPH), Changi General Hospital (CGH), Tan Tock Seng Hospital (TTSH) and Sengkang General Hospital (SKH), during the study period

You may not qualify if:

• Nil

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Changi General Hospital: collaborator
• Khoo Teck Puat Hospital: collaborator
• National University Hospital, Singapore: collaborator

Study Sites (4)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Changi General Hospital

Singapore, Singapore

Location

Khoo Teck Puat Hospital

Singapore, Singapore

Location

National University Hospital

Singapore, Singapore

Location

Related Publications (1)

• Attal H, Huang Z, Kuan WS, Weng Y, Tan HY, Seow E, Peng LL, Lim HC, Chow A. 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. JMIR Res Protoc. 2024 Feb 21;13:e50417. doi: 10.2196/50417.

  PMID: 38381495 DERIVED

Study Officials

• Angela Chow, Ph.D

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head and Senior Consultant

Model Details: Interrupted time series quasi-experimental design

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 11, 2022
• Study Start: July 4, 2022
• Primary Completion: June 30, 2023
• Study Completion: January 31, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (4)