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

NCT ID: NCT05451836

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-04
• Study Completion Date: 2024-01-31

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. 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.

Detailed Description

Antibiotics, along with improved sanitation and vaccination, 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.

To date, antimicrobial stewardship programs attempting to optimize antibiotic therapy and clinical outcomes 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 multi-factorial nature of inappropriate antibiotic prescribing, it is unlikely that a single approach will work for all physicians in 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.

Using the stepped wedge design, the study will include an initial control period of 18 months where none of the 4 hospitals will be exposed to the interventions. During the intervention period, the 4 hospitals will be randomly assigned to one of the 2 tailored interventions. 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 the persistence of the effects of the interventions.

Patient educational materials: Education materials (patient leaflets) will be made available at the Emergency Departments of the participating sites. Patients will be exposed to these materials while visiting the Emergency Department prior to their consultation with the physician.

Feedback to individual physicians by senior doctors: Messages containing the individual antibiotic prescribing rate of each physician in the past month will be sent every two months to the respective physician by their department head (or senior doctor) via Tiger Text. The bite-sized information on tips to reduce antibiotic prescribing for URTI will be sent together with the personalised message.

Conditions

Antimicrobial Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1

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.

Group Type: EXPERIMENTAL

Patient education leaflets

Intervention Type: 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.

Physician feedback

Intervention Type: 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 2

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.

Group Type: EXPERIMENTAL

Patient education leaflets

Intervention Type: 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.

Physician feedback

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Nil

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Changi General Hospital

OTHER

Sponsor Role: collaborator

Khoo Teck Puat Hospital

OTHER

Sponsor Role: collaborator

National University Hospital, Singapore

OTHER

Sponsor Role: collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chow Li Ping Angela

Head and Senior Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela Chow, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Tan Tock Seng Hospital

Locations

Tan Tock Seng Hospital

Singapore, , Singapore

Changi General Hospital

Singapore, , Singapore

Khoo Teck Puat Hospital

Singapore, , Singapore

National University Hospital

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: DERIVED

PMID: 38381495 (View on PubMed)

Other Identifiers

NMRC/CSAINV18MAY0007/2019

Identifier Type: -

Identifier Source: org_study_id