RCT to Improve Antibiotic Use for ARIs

Sponsor
Daniel Livorsi (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06144242
Collaborator
(none)
90
2
28.9

Study Details

Study Description

Brief 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, we will assess whether it is helpful to give clinicians feedback on how often they prescribe antibiotics for respiratory infections in comparison to their peers. We will perform this study across Urgent Care and QuickCare clinics within a single healthcare system.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Feedback on RTD metric
N/A

Detailed Description

We 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), we estimate that most clinicians in this setting are frequently prescribing unnecessary antibiotics.

We 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

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Randomized-controlled Trial to Assess Whether Feedback on a New Stewardship Metric Can Improve Antibiotic-prescribing for Acute Respiratory Tract Infections
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
May 31, 2026

Arms and Interventions

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.

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.

No Intervention: No feedback on RTD metric

Any clinician assigned to the control arm will not receive the above-mentioned e-mails.

Outcome Measures

Primary Outcome Measures

  1. Frequency of antibiotic-prescribing for RTD visits [24 hours of visit]

    Percentage of all qualifying respiratory tract diagnosis (RTD) visits prescribed an antibiotic

Secondary Outcome Measures

  1. Frequency of antibiotic-prescribing for all visits [24 hours of visit]

    Percentage of all visits prescribed an antibiotic, regardless of the diagnosis

  2. Follow-up visit to Urgent Care or QuickCare [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.

  3. Follow-up Emergency Department visit and/or acute-care hospitalization [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Any clinician who works in Urgent Care or QuickCare clinics within our healthcare system.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Daniel Livorsi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daniel Livorsi, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier:
NCT06144242
Other Study ID Numbers:
  • 202308456
First Posted:
Nov 22, 2023
Last Update Posted:
Nov 22, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2023