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Completed

NCT Number: NCT03379194

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

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.

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Key information

Conditions

Acute Respiratory Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, CH-4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria

Treatment and study plan

Antibiotic stewardship program

Behavioral

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

Primary outcomes

  1. Overall antibiotic use

    Time frame: from month 13 to month 24 post randomization (longer term intervention effect).

    Change in prescribed antibiotics per 100 consultations

Secondary outcomes

  1. Overall antibiotic use

    Time frame: from month 1 to 12 post randomization (short-term intervention effect)

    Change in prescribed antibiotics per 100 patient consultations

  2. Overall antibiotic use

    Time frame: from month 1 to month 24 post randomization, with two repeated measurements, over the first and the second 12 month period

    Change in prescribed antibiotics per 100 patient consultations

  3. Use of broad spectrum antibiotics

    Time frame: from month 1 to month 12, and from month 13 to month 24).

    Change in broad spectrum antibiotics use per 100 consultations

    • quinolones
    • oral cephalosporines

  4. Hospitalizations rates

    Time frame: from month 1 to month 12, and from month 13 to month 24

    Hospitalizations rates

    • all-cause
    • related to infections (DRG-based definition)

  5. Antibiotic use in four specific age groups

    Time frame: from month 1 to month 12, and from month 13 to month 24.

    Antibiotic use per 100 consultations in four specific age groups, in patients

    • <6 years
    • 6 to <18 years
    • 18 to <65 years
    • ≥ 65 years

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • University Children's Hospital Basel
  • University of Bern

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2017
Registry last updated
Nov 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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