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

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

Trial Summary

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 data supports the effectiveness of the treatment Feedback on RTD metric, Feedback on Real-Time Data metric, RTD Feedback for reducing antibiotic use for respiratory infections?

Research shows that feedback interventions using routinely collected health data can reduce antibiotic use, as seen in a study where personalized feedback helped lower antibiotic prescriptions in primary care. Additionally, audit and feedback methods have been effective in improving clinical care by highlighting gaps between current and ideal practices. ^{1 2 3 4 5}

Is the Feedback to Reduce Antibiotic Use for Respiratory Infections treatment safe for humans?

The research articles provided do not contain specific safety data for the Feedback to Reduce Antibiotic Use for Respiratory Infections treatment or its related names. ^{6 7 8 9 10}

How does the treatment to reduce antibiotic use for respiratory infections differ from other treatments?

This treatment is unique because it uses feedback interventions based on routinely collected health data to reduce antibiotic use, which is different from traditional methods that often require more resources and structural changes. ^{1 2 3 5 11}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Next-generation audit and feedback for inpatient quality improvement using electronic health record data: a cluster randomised controlled trial. [2019]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Mailed prescriber feedback in addition to a clinical guideline has no impact: a randomised, controlled trial. [2019]

4. Egypt pubmed.ncbi.nlm.nih.gov

Development of an antimicrobial stewardship intervention using a model of actionable feedback. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Personalized Prescription Feedback Using Routinely Collected Data to Reduce Antibiotic Use in Primary Care: A Randomized Clinical Trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a computer-assisted antibiotic-dose monitor. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. [2022]

8. United States 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. [2021]

10. Spain pubmed.ncbi.nlm.nih.gov

Safety profile of cefditoren. A pooled analysis of data from clinical trials in community-acquired respiratory tract infections. [2012]

11. England pubmed.ncbi.nlm.nih.gov

Impact of a monthly antimicrobial stewardship quality assurance tool for elevated vancomycin levels. [2023]