Antimicrobial ResistanceNCT05451836
N-of-1 Trials of Interventions to Improve Decision-making for Antibiotic Use
A study testing Patient education leaflets and Physician feedback in people with Antimicrobial Resistance, run by Tan Tock Seng Hospital at 4 sites in Singapore.
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… Read more about this study
- Who is it for?
- Ages 21 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Antimicrobial Resistance
- What is being tested?
- Patient education leaflets and Physician feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,157 participants
- Where
- 4 sitesSingapore
- Study dates
- 4 Jul 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Nil
Trial locations and contacts
4 sites in 1 country.
Singapore4 sites
Tan Tock Seng Hospital
Singapore, 308433
Changi General Hospital
Singapore
Khoo Teck Puat Hospital
Singapore
National University Hospital
Singapore
About this study
Official title: Patient, Physician, and Organizational Factors Influencing Decision-making for Antibiotic Use, and N-of-1 Trials of Interventions to Improve the Decision-making
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.
Read more
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:
- Patient education via information leaflets addressing knowledge-, perception-, and belief-gaps of the local patient population on antibiotic use for URTI
- 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.
Read the 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:
- Patient education via information leaflets addressing knowledge-, perception-, and belief-gaps of the local patient population on antibiotic use for URTI
- 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
- Being tested
- Patient education leaflets, Physician feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education leafletsOther
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 feedbackOther
All physicians working in the emergency department will receive a text message from their department head on their antibiotic prescribing rates every two months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Patient education leaflets; Other: Physician feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured monthly for 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start4 Jul 2022
- Primary completion30 Jun 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antimicrobial ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Interrupted time series quasi-experimental design
- Masking
- None (open label)
- Enrolment
- 15,157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changi General Hospital, Khoo Teck Puat Hospital, National University Hospital, Singapore
- Responsible party
- Principal investigator, Chow Li Ping Angela, Tan Tock Seng Hospital
- Investigators
- Angela Chow, Ph.D, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451836
- Sponsor's protocol ID
- NMRC/CSAINV18MAY0007/2019
- Status last verified
- Apr 2024
- First submitted
- 3 Jul 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the site-PI will receive data on the antibiotic prescribing rates of the ED physicians for them to provide the physician feedback. The data of one site will not be shared with the site-PIs of other sites to preserve participant confidentiality.
Publications
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.
PubMed 38381495
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient, Physician, and Organizational Factors Influencing Decision-making for Antibiotic Use, and N-of-1 Trials of Interventions to Improve the Decision-making
- ClinicalTrials.gov ID
- NCT05451836
- Acronym / sponsor ID
- NMRC/CSAINV18MAY0007/2019
- Conditions
- Antimicrobial Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,157 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Changi General Hospital, Khoo Teck Puat Hospital, National University Hospital, Singapore
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patient education via information leaflets addressing knowledge-, perception-, and belief-gaps of the local patient population on antibiotic use for URTI
- 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:
- Patient education via information leaflets addressing knowledge-, perception-, and belief-gaps of the local patient population on antibiotic use for URTI
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interrupted time series quasi-experimental design
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Patient education leaflets, Other: Physician feedbackGroup 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 2 | Experimental | Other: Patient education leaflets, Other: Physician feedbackGroup 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. |
Who may qualify
- Ages
- 21 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- 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
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient education leafletsPatients 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 | Group 1, Group 2 |
| Physician feedbackAll physicians working in the emergency department will receive a text message from their department head on their antibiotic prescribing rates every two months. | Other | Group 1, Group 2 |
Primary outcome
Antibiotic prescribing rates
Time frame: Measured monthly for 15 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 38381495Attal 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.
- Individual participant dataSharing planned: No. Only the site-PI will receive data on the antibiotic prescribing rates of the ED physicians for them to provide the physician feedback. The data of one site will not be shared with the site-PIs of other sites to preserve participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Chow, Ph.D principal investigator
Tan Tock Seng Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education leaflets and Physician feedback in people with Antimicrobial Resistance, run by Tan Tock Seng Hospital at 4 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic prescribing rates (time frame: Measured monthly for 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05451836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.