Improving Antibiotic Use for ARIs in Urgent Care Clinics

Ambulatory Care Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06144242
• Other study ID #: 202308456
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: March 2024
• Source: University of Iowa
• Contact: Daniel J Livorsi, Other, MS
• Phone: 319-688-3871
• Email: daniel-livorsi[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 31, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 99 Years
• Eligibility: Any clinician who works in Urgent Care or QuickCare clinics within our healthcare system.

Related Conditions & MeSH terms

• Ambulatory Care
• Antibacterial Agents

Intervention

Behavioral:
• Feedback on RTD metric
Clinicians in the experimental arm will receive feedback on the RTD metric while clinicians in the No intervention arm will not.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Daniel Livorsi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of antibiotic-prescribing for RTD visits	Percentage of all qualifying respiratory tract diagnosis (RTD) visits prescribed an antibiotic	24 hours of visit
Secondary	Frequency of antibiotic-prescribing for all visits	Percentage of all visits prescribed an antibiotic, regardless of the diagnosis	24 hours of visit
Secondary	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.	30 days
Secondary	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.	30 days