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Routine Antibiotic Prescription Monitoring in Primary Care Physicians: A Nationwide Trial

Routine Antibiotic Prescription and Resistance Monitoring in Primary Care Physicians: A Nationwide Pragmatic Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03379194
Enrollment
3426
Registered
2017-12-20
Start date
2018-01-02
Completion date
2019-12-31
Last updated
2022-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Tract Infection, Urinary Tract Infections

Keywords

antibiotic prescriptions, resistance, feedback, primary care

Brief summary

Antibiotic resistance is an increasingly serious problem in Switzerland which is associated with the exposure and overall uptake of antibiotics in a population. Reduced antibiotic prescribing for outpatients is paralleled by a decrease in antibiotic resistance rates. In a recent pragmatic trial, the investigators found only promising yet not very conclusive results as those were present only in some groups. This nationwide antibiotic stewardship program with routine feedback on antibiotic prescribing was not associated with an overall change in antibiotic use. In older children, adolescents, and younger adults fewer antibiotics were prescribed, but not consistently over the entire intervention period. Hence, the investigators now aim to evaluate a better-tailored program to obtain a better understanding of the effects on patient-relevant outcomes, antibiotic resistance, and the underlying mechanisms leading to different effects in certain subgroups of patients. The investigators plan to evaluate a nationwide antibiotic stewardship program combining routine prescription feedback with the provision of physician and patient education material for primary care physicians in Switzerland. The project is conducted within the framework of the National Program on antimicrobial resistance by the Swiss National Science Foundation. Also, additional subprojects will be done where we will assess the impact of COVID-19 on AB prescription by comparing the years 2017,2018, and 2019 with the year 2020 data.

Detailed description

This is a randomized pragmatic controlled trial in all primary care physicians in Switzerland e.g. the top 75% antibiotic prescribers. The trial is based on routinely collected individual reimbursement claims data of the three largest Swiss health insurers covering an estimated number of 3.8 million Swiss residents, and on routinely collected surveillance data on antibiotic resistance. A pragmatic trial design is used. Physicians in the intervention group will not have to provide informed consent but they may opt out and decline receiving any interventional information. Physicians in the control group will not be notified. This approach is justifiable and has previously been approved by all Swiss ethical committees. Investigators will take any measures to guarantee the confidentiality of all collected data. Data provided by health insurers on physicians and patients will be completely anonymized. This is a nationwide study enrolling all registered primary care physicians (general internal medicine and pediatrics) with more than 100 patient contacts in the year prior to the start of the trial. All primary care providers with shared ZSR (Zahlstellenregister) numbers (e.g. ambulatory settings in hospitals where individual physicians cannot be identified) and with less than 100 patient contacts per year will be excluded.

Interventions

Routine feedback on antibiotic prescriptions in addition to evidence based guidelines for the management of acute respiratory and urinary tract infection and patient leaflets for using antibiotics wisely

Sponsors

University of Bern
CollaboratorOTHER
University Children's Hospital Basel
CollaboratorOTHER
University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

For final data analysis the biostatistician will be blinded for treatment allocation of physicians.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Primary care physicians in Switzerland board certified with FMH (Foederatio Medicorum Helveticorum) title in general internal medicine or paediatrics & adolescent medicine, above the 25th percentile of antibiotic prescribing, consulting with at least 100 patients per year and with individual Zahlstellenregister number.

Exclusion criteria

* There are no

Design outcomes

Primary

MeasureTime frameDescription
Overall antibiotic usefrom month 13 to month 24 post randomization (longer term intervention effect).Change in prescribed antibiotics per 100 consultations

Secondary

MeasureTime frameDescription
Overall antibiotic usefrom month 1 to 12 post randomization (short-term intervention effect)Change in prescribed antibiotics per 100 patient consultations
Use of broad spectrum antibioticsfrom month 1 to month 12, and from month 13 to month 24).Change in broad spectrum antibiotics use per 100 consultations 1. quinolones 2. oral cephalosporines
Hospitalizations ratesfrom month 1 to month 12, and from month 13 to month 24Hospitalizations rates 1. all-cause 2. related to infections (DRG-based definition)
Antibiotic use in four specific age groupsfrom month 1 to month 12, and from month 13 to month 24.Antibiotic use per 100 consultations in four specific age groups, in patients 1. \<6 years 2. 6 to \<18 years 3. 18 to \<65 years 4. ≥ 65 years

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026