Feedback to Reduce Antibiotic Use for Respiratory Infections

Overseen By Daniel J Livorsi, Other, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Daniel Livorsi

Disqualifiers: Non-clinicians, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 18 months

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if providing doctors with feedback can reduce the unnecessary use of antibiotics for viral respiratory infections. Antibiotics are often prescribed when they are ineffective, and this study seeks to change that by comparing doctors' prescribing habits to those of their peers. The trial will occur in Urgent Care and QuickCare clinics, with some doctors receiving feedback on the Real-Time Data (RTD) metric and others not. Clinicians in these settings are eligible to participate. As an unphased trial, this study offers a unique opportunity to improve healthcare practices and reduce antibiotic misuse.

Do I need to stop my current medications to join the trial?

The trial does not specify whether participants need to stop taking their current medications.

What prior data suggests that this feedback method is safe for clinicians?

Research has shown that giving feedback to doctors about their antibiotic prescribing practices is safe. Studies have found that using the RTD (Respiratory Tract Diagnosis) measure for feedback does not harm doctors or patients. This method involves sending emails to doctors to help them compare their antibiotic prescribing frequency with that of their peers.

Previous studies reported no problems linked to this feedback method. The feedback aims to improve antibiotic prescribing, which is crucial for treating respiratory infections without unnecessary medication. Overall, this feedback approach is well-received and promotes better prescribing practices without safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for respiratory infections involve prescribing antibiotics, which can sometimes be overused and contribute to antibiotic resistance. However, the new approach being tested focuses on providing feedback to clinicians about their antibiotic prescribing habits through the RTD metric. Researchers are excited about this trial because it aims to reduce unnecessary antibiotic use by increasing awareness and encouraging more thoughtful prescribing practices. This feedback mechanism is unique as it not only compares a clinician's performance with their peers but also provides a detailed dashboard for deeper practice insights, promoting more responsible and informed decision-making in treating respiratory infections.

What evidence suggests that this feedback method is effective for reducing unnecessary antibiotic use for respiratory infections?

This trial will compare the effects of providing feedback on antibiotic prescribing patterns to clinicians with not providing such feedback. Research has shown that giving feedback to doctors can help reduce unnecessary antibiotic prescriptions for respiratory infections. In this trial, participants in the experimental arm will receive regular updates comparing their antibiotic prescribing rates to those of their peers. Studies have found that when doctors receive such feedback, they tend to prescribe fewer antibiotics. Specifically, one study found that feedback on prescribing habits led to a noticeable decrease in antibiotic use over time, while another showed that personalized feedback reduced antibiotic prescriptions in primary care settings. These findings suggest that informing doctors about their prescribing patterns can effectively reduce unnecessary antibiotics, which is crucial because antibiotics don't work on viral infections. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for clinicians working in Urgent Care or QuickCare clinics within a specific healthcare system. It aims to evaluate their antibiotic prescribing habits for acute respiratory infections.

Inclusion Criteria

Clinician who works in Urgent Care or QuickCare clinics within the healthcare system

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Clinicians receive feedback on their antibiotic-prescribing practices for RTD visits

18 months

Feedback every 2 months via email

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Feedback on RTD metric

Trial Overview The study tests whether giving clinicians feedback on their antibiotic prescription rates, compared to their peers, can reduce unnecessary prescriptions for viral respiratory infections.

How Is the Trial Designed?

Group I: Feedback on RTD metric Experimental Treatment 1 Intervention

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.

Group II: No feedback on RTD metric Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Daniel Livorsi

Lead Sponsor

Trials

1

Recruited

90+

Published Research Related to This Trial

A randomized controlled trial involving 299 GPs in Denmark found that providing feedback on antibiotic prescribing patterns alongside clinical guidelines did not change GPs' prescribing behaviors for respiratory tract infections over a 2-year period.

The study suggests that simply giving GPs feedback on their performance is insufficient to improve antibiotic prescribing practices, indicating a need for more comprehensive interventions to enhance adherence to treatment guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mailed prescriber feedback in addition to a clinical guideline has no impact: a randomised, controlled trial. Søndergaard, J., Andersen, M., Støvring, H., et al.[2019]

In a study involving 40 internal medicine teams, intensive audit and feedback methods, including daily data dashboards and weekly performance reviews, significantly improved the completion of discharge metrics (79.3% vs. 63.2% in the control group, P<0.0001).

The effectiveness of the intensive feedback diminished after the intervention ended, indicating that continuous and timely feedback is crucial for maintaining improved performance in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Next-generation audit and feedback for inpatient quality improvement using electronic health record data: a cluster randomised controlled trial. Patel, S., Rajkomar, A., Harrison, JD., et al.[2019]

A Web-based system was successfully designed to track adverse and near-miss events in surgical patients, identifying 957 adverse events from 15,524 reported cases, which highlights the need for better reporting practices among physicians.

The study revealed significant underreporting, with only 25% of complications and 42% of inpatient deaths reported, indicating a cultural issue in recognizing and documenting adverse events in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an online morbidity, mortality, and near-miss reporting system to identify patterns of adverse events in surgical patients. Bilimoria, KY., Kmiecik, TE., DaRosa, DA., et al.[2022]

The safety profile of medications can change after they are approved for public use, as new safety issues may arise that were not identified during clinical trials.

Regulatory agencies, like the FDA, actively monitor medication safety through various methods, including analyzing adverse experience reports and using large electronic databases to detect potential safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. Sharrar, RG., Dieck, GS.[2021]

The development of an audit and feedback intervention aimed at improving antibiotic prescribing in the NICU faced challenges in providing real-time feedback due to the complexity of data collection and analysis.

NICU clinicians preferred a non-punitive approach to feedback, emphasizing shared responsibility for antibiotic prescribing, which required careful customization of the feedback process to ensure it was meaningful and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an antimicrobial stewardship intervention using a model of actionable feedback. Patel, SJ., Saiman, L., Duchon, JM., et al.[2022]

In a study of 638 patients treated with vancomycin, early monitoring and feedback by Infection Control Team pharmacists did not significantly improve the maintenance of target vancomycin trough concentrations (10-20 μg/ml).

However, early intervention was associated with a reduced duration of vancomycin administration, suggesting that timely audits can help optimize treatment duration even if they don't affect concentration levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the initial timing of infection control pharmacist-driven audit and monitoring of vancomycin therapy in patients with infectious diseases: A retrospective observational study. Sugita, H., Okada, N., Okamoto, M., et al.[2023]

The implementation of an audit-and-feedback monitoring method in 7 hospitals led to a significant reduction in the rate of vancomycin dosing errors associated with acute kidney injury, decreasing from 35.2% in the preimplementation period to 19.6% postimplementation.

Despite the consistent number of serum-level evaluations per patient, the initiative improved patient safety by effectively lowering the occurrence of dangerously high vancomycin serum levels (≥25 µg/mL) and related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a monthly antimicrobial stewardship quality assurance tool for elevated vancomycin levels. Knack, OC., Landayan, AM., Williams, KN., et al.[2023]

The implementation of a computer-assisted antibiotic-dose monitor at LDS Hospital significantly reduced the number of patients receiving excessive dosages of antibiotics from 50% to 44% during the intervention period, along with a decrease in the average duration of excessive dosing from 4.7 days to 2.9 days.

The intervention also led to a reduction in adverse drug events (ADEs) related to antibiotics, with only 14 ADEs (0.3%) reported during the intervention compared to 82 ADEs (0.9%) in the preintervention period, indicating improved safety in antibiotic administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a computer-assisted antibiotic-dose monitor. Evans, RS., Pestotnik, SL., Classen, DC., et al.[2017]

The definition of an adverse drug event (ADE) should be tailored to the specific purpose of the evaluation, with stricter definitions needed for scientific studies and more flexible ones for clinical use.

Postmarketing safety data for drugs is limited at launch, but can be supplemented through systems like the FDA's Spontaneous Reporting System and targeted research projects, emphasizing the importance of robust epidemiological evidence for regulatory actions like drug recalls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. Rogers, AS.[2022]

A nationwide feedback intervention aimed at reducing antibiotic prescriptions among 2900 primary care physicians in Switzerland did not lead to a significant overall reduction in antibiotic use over two years, indicating that such feedback alone may not be sufficient for effective antibiotic stewardship.

However, the feedback did result in a notable decrease in antibiotic prescriptions for children aged 6 to 18 years in the first year and for adults aged 19 to 65 years in the second year, suggesting some targeted effectiveness in specific age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Prescription Feedback Using Routinely Collected Data to Reduce Antibiotic Use in Primary Care: A Randomized Clinical Trial. Hemkens, LG., Saccilotto, R., Reyes, SL., et al.[2022]

Cefditoren, an antibiotic for respiratory infections, showed a higher incidence of diarrhea (9.9%) compared to standard comparators (6.9%), particularly in studies for pharyngotonsillitis, indicating a notable side effect profile.

Overall, the adverse events associated with cefditoren were similar to those of standard antibiotics, suggesting it is a safe option for treating community-acquired respiratory infections, with some specific differences in side effects like lower rates of vaginosis in females.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of cefditoren. A pooled analysis of data from clinical trials in community-acquired respiratory tract infections. Granizo, JJ., Aguilar, L., Gimenez, MJ., et al.[2012]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38271275/

Antibiotic Prescribing Patterns for Respiratory Tract ... Here, we assess the long-term effects of this intervention on antibiotic prescribing following cessation of feedback. Methods: RTD encounters ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/42/NCT06144242/Prot_SAP_000.pdf

Randomized-controlled trial to assess whether feedback ... metric to evaluate clinicians on their antibiotic use for respiratory tract diagnoses (RTDs). This. RTD metric excludes visits that are more complicated ...

3. researchgate.net researchgate.net/publication/352073796_Development_and_validation_of_antibiotic_stewardship_metrics_for_outpatient_respiratory_tract_diagnoses_and_association_of_provider_characteristics_with_inappropriate_prescribing

Development and validation of antibiotic stewardship ... 7, 8 The RTD metric quantifies the percentage of patient visits with a RTD that were prescribed an antibiotic. In primary care practices across one university ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30755451/

Effectiveness and safety of electronically delivered ... Main outcome measures: Primary outcome was the rate of antibiotic prescriptions for respiratory tract infections from electronic health records.

5. researchgate.net researchgate.net/publication/311947889_Personalized_Prescription_Feedback_Using_Routinely_Collected_Data_to_Reduce_Antibiotic_Use_in_Primary_Care_A_Randomized_Clinical_Trial

Personalized Prescription Feedback Using Routinely ... Objective: To determine if quarterly antibiotic prescription feedback over 2 years reduces antibiotic use when implemented in a complex health ...

6. shea-online.org shea-online.org/establishing-a-social-norm-of-antibiotic-prescribing-provider-feedback-reporting-in-the-outpatient-setting/

Establishing a social norm of antibiotic prescribing They classified the RTDs into 3 tiers based on the 2010-11 National Ambulatory Medical Care Survey published by the CDC in 2016.2 Tier 1 included those ...