Antibacterial AgentsNCT06144242
Improving Antibiotic Use for ARIs in Urgent Care Clinics
A study testing Feedback on RTD metric in people with Antibacterial Agents and Ambulatory Care, run by Daniel Livorsi at 1 site in United States.
Trial summary
Many clinicians prescribe antibiotics for patients with acute respiratory infections even when antibiotics will not benefit the patient because the infection is due to a virus. To discourage this type of unnecessary antibiotic use, the investigators will assess whether it is helpful to give clinicians feedback on how… Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibacterial Agents, Ambulatory Care
- What is being tested?
- Feedback on RTD metric
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Any clinician who works in Urgent Care or QuickCare clinics within our healthcare system.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Randomized-controlled Trial to Assess Whether Feedback on a New Stewardship Metric Can Improve Antibiotic-prescribing for Acute Respiratory Tract Infections in Urgent Care Clinics
Many clinicians prescribe antibiotics for patients with acute respiratory infections even when antibiotics will not benefit the patient because the infection is due to a virus. To discourage this type of unnecessary antibiotic use, the investigators will assess whether it is helpful to give clinicians feedback on how often they prescribe antibiotics for respiratory infections in comparison to their peers. The investigators will perform this study across Urgent Care and QuickCare clinics within a single healthcare system.
Read the detailed description
The investigators have used an established HEDIS (Healthcare Effectiveness Data and Information Set) metric to evaluate Urgent Care and QuickCare clinicians on their antibiotic use for respiratory tract diagnoses (RTDs). This RTD metric excludes visits that are more complicated, based on well-defined criteria. Based on our baseline assessment (2018-2022), the investigators estimate that most clinicians in this setting are frequently prescribing unnecessary antibiotics.
The investigators will perform a randomized controlled trial to assess whether providing individualized feedback to clinicians on the RTD metric can safely reduce antibiotic use for qualifying respiratory tract visits across Urgent and QuickCare settings within a single integrated healthcare system. Clinicians who do not opt-out of the trial will be randomized to either receive feedback or not receive feedback on this RTD metric. The trial will last for 18 months. The primary outcome of effectiveness will be the frequency of antibiotic-prescribing for RTD visits. Secondary outcomes include total antibiotic use (regardless of diagnosis), changes in the use of diagnostic codes, 30-day rates of follow-up visits and hospital admissions. The RE-AIM framework will be used to guide additional study evaluation.
- Conditions
- Antibacterial Agents, Ambulatory Care
- Being tested
- Feedback on RTD metric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback on RTD metricBehavioural
Clinicians in the experimental arm will receive feedback on the RTD metric while clinicians in the No intervention arm will not.
| Study group | Role | What they receive |
|---|---|---|
| Feedback on RTD metric | Experimental | An e-mail will be sent to the clinicians in the experimental arm every two months describing their performance on the RTD metric and making a comparison to how their peers have performed. The e-mail will also direct clinicians to visit a dashboard to review their practice in greater depth. Receives: Behavioral: Feedback on RTD metric |
| No feedback on RTD metric | No intervention | Any clinician assigned to the control arm will not receive the above-mentioned e-mails. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of antibiotic-prescribing for RTD visits
Percentage of all qualifying respiratory tract diagnosis (RTD) visits prescribed an antibiotic
Measured: 24 hours of visit
Secondary outcomes (3)
Frequency of antibiotic-prescribing for all visits
Percentage of all visits prescribed an antibiotic, regardless of the diagnosis
Measured: 24 hours of visit
Follow-up visit to Urgent Care or QuickCare
Percentage of patients with a qualifying RTD visit who were seen at least once in Urgent Care or QuickCare within the 30 days after their index visit date.
Measured: 30 days
Follow-up Emergency Department visit and/or acute-care hospitalization
Percentage of patients with a qualifying RTD visit who were seen at least once in the Emergency Department and/or who were hospitalized (any reason) within the 30 days after their index visit date.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Jan 2024
- Primary completion30 Jun 2025
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibacterial AgentsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel Livorsi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Livorsi, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144242
- Sponsor's protocol ID
- 202308456
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized-controlled Trial to Assess Whether Feedback on a New Stewardship Metric Can Improve Antibiotic-prescribing for Acute Respiratory Tract Infections in Urgent Care Clinics
- ClinicalTrials.gov ID
- NCT06144242
- Acronym / sponsor ID
- 202308456
- Conditions
- Antibacterial Agents, Ambulatory Care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Daniel LivorsiUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 22 Nov 2023 (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.
Many clinicians prescribe antibiotics for patients with acute respiratory infections even when antibiotics will not benefit the patient because the infection is due to a virus. To discourage this type of unnecessary antibiotic use, the investigators will assess whether it is helpful to give clinicians feedback on how often they prescribe antibiotics for respiratory infections in comparison to their peers. The investigators will perform this study across Urgent Care and QuickCare clinics within a single healthcare system.
Detailed description
The investigators have used an established HEDIS (Healthcare Effectiveness Data and Information Set) metric to evaluate Urgent Care and QuickCare clinicians on their antibiotic use for respiratory tract diagnoses (RTDs). This RTD metric excludes visits that are more complicated, based on well-defined criteria. Based on our baseline assessment (2018-2022), the investigators estimate that most clinicians in this setting are frequently prescribing unnecessary antibiotics.
The investigators will perform a randomized controlled trial to assess whether providing individualized feedback to clinicians on the RTD metric can safely reduce antibiotic use for qualifying respiratory tract visits across Urgent and QuickCare settings within a single integrated healthcare system. Clinicians who do not opt-out of the trial will be randomized to either receive feedback or not receive feedback on this RTD metric. The trial will last for 18 months. The primary outcome of effectiveness will be the frequency of antibiotic-prescribing for RTD visits. Secondary outcomes include total antibiotic use (regardless of diagnosis), changes in the use of diagnostic codes, 30-day rates of follow-up visits and hospital admissions. The RE-AIM framework will be used to guide additional study evaluation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback on RTD metric | Experimental | Behavioral: Feedback on RTD metricAn e-mail will be sent to the clinicians in the experimental arm every two months describing their performance on the RTD metric and making a comparison to how their peers have performed. The e-mail will also direct clinicians to visit a dashboard to review their practice in greater depth. |
| No feedback on RTD metric | No intervention | –Any clinician assigned to the control arm will not receive the above-mentioned e-mails. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Feedback on RTD metricClinicians in the experimental arm will receive feedback on the RTD metric while clinicians in the No intervention arm will not. | Behavioural | Feedback on RTD metric |
Primary outcome
Frequency of antibiotic-prescribing for RTD visits
Time frame: 24 hours of visit
Percentage of all qualifying respiratory tract diagnosis (RTD) visits prescribed an antibiotic
3 secondary outcomes
Frequency of antibiotic-prescribing for all visits
Time frame: 24 hours of visit
Follow-up visit to Urgent Care or QuickCare
Time frame: 30 days
Follow-up Emergency Department visit and/or acute-care hospitalization
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback on RTD metric in people with Antibacterial Agents and Ambulatory Care, run by Daniel Livorsi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Frequency of antibiotic-prescribing for RTD visits (time frame: 24 hours of visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2025.