Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05451836 |
| Other study ID # |
NMRC/CSAINV18MAY0007/2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 4, 2022 |
| Est. completion date |
January 31, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Tan Tock Seng Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
