- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06144242
Improving Antibiotic Use for ARIs in Urgent Care Clinics
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Feedback on RTD metric
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.
|
Clinicians in the experimental arm will receive feedback on the RTD metric while clinicians in the No intervention arm will not.
|
|
No Intervention: No feedback on RTD metric
Any clinician assigned to the control arm will not receive the above-mentioned e-mails.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
24 hours of visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of antibiotic-prescribing for all visits
Time Frame: 24 hours of visit
|
Percentage of all visits prescribed an antibiotic, regardless of the diagnosis
|
24 hours of visit
|
|
Follow-up visit to Urgent Care or QuickCare
Time Frame: 30 days
|
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.
|
30 days
|
|
Follow-up Emergency Department visit and/or acute-care hospitalization
Time Frame: 30 days
|
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.
|
30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202308456
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ambulatory Care
-
Harvard Medical School (HMS and HSDM)Completed
-
Centre Hospitalier Universitaire de NīmesRecruitingAnesthesia | Dexmedetomidine | Hemodynamics | Ambulatory CareFrance
-
Maureen T GreeneCompletedAmbulatory Care | Cancer-related Problem/ConditionUnited States
-
Brigham and Women's HospitalUnknownClinical Decision Support Systems | Ambulatory Care Information SystemsUnited States
-
University of CoimbraPortuguese Oncology Institute, CoimbraCompletedCancer | Biomarkers | Complementary Therapies | Ambulatory Care | Well-Being, PsychologicalPortugal
-
Rush University Medical CenterActive, not recruitingMinor Surgical Procedures With Monitored Anesthesia Care | Driving Performance After Minor Ambulatory SurgeryUnited States
-
Catalan Institute of HealthMinistry of Health; Carlos III Health Institute; Jordi Gol i Gurina FoundationUnknownAcute Disease | Ambulatory Care | Nursing Care | Family Practice
-
Montreal Heart InstituteRoche Diagnostic Ltd.CompletedQuality of Life | Anticoagulants | Drug Monitoring | Pharmacy | Ambulatory CareCanada
-
Simon BerthelotRecruitingAmbulatory Care | Costs | Quality of Care | Emergency Services, HospitalCanada
-
Mayo ClinicArizona State UniversityCompletedAnemia | Oncology | Ambulatory Care | Hematology | Red Blood Cell TransfusionsUnited States
Clinical Trials on Feedback on RTD metric
-
Aalborg UniversityCompletedJoint Diseases | Patellofemoral Pain Syndrome | Musculoskeletal DisordersDenmark
-
Wake Forest University Health SciencesNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University... and other collaboratorsRecruitingObesity (Disorder) | Obesity & OverweightUnited States
-
Seong Soo JeonRecruiting
-
Penn State UniversityCompleted
-
University College CorkCompletedSimulation TrainingIreland
-
Boston Children's HospitalNot yet recruiting
-
US Department of Veterans AffairsTerminated
-
Duke UniversityGilead SciencesWithdrawn
-
University of AarhusCompleted
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityNot yet recruitingMyopia | Randomized Controlled Trials | Artificial Intelligence (AI)China