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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06144242
Other study ID # 202308456
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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