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

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ClinicalTrials.gov Identifier: NCT03379194
Recruitment Status : Enrolling by invitation
First Posted : December 20, 2017
Last Update Posted : January 9, 2019
Sponsor:
Collaborators:
University of Bern
University Children's Hospital Basel
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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 of antibiotic use. In older children, adolescents, and younger adults less 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, on antibiotic resistance, and of 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 in primary care physician in Switzerland. The project is conducted within the framework of the National Program on antimicrobial resistance by the Swiss National Science Foundation.


Condition or disease Intervention/treatment Phase
Acute Respiratory Tract Infection Urinary Tract Infections Behavioral: Antibiotic stewardship program Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: For final data analysis the biostatistician will be blinded for treatment allocation of physicians.
Primary Purpose: Health Services Research
Official Title: Routine Antibiotic Prescription and Resistance Monitoring in Primary Care Physicians: A Nationwide Pragmatic Randomized Controlled Trial
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: 'Antibiotic stewardship program'
Physicians receive quarterly over 24 months, first in January 2018 postal mail a feedback on their antibiotic prescriptions and updated antibiotic resistance information from the community. With the first letter, educational material, evidence-based guidelines for conditions leading to most outpatient prescriptions in primary care and leaflets for on using antibiotics wisely are provided. Additional material is made available on a study website that can be accessed by each physician in the intervention group by an unique access code.
Behavioral: Antibiotic stewardship program
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

No Intervention: Control
No intervention



Primary Outcome Measures :
  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 Outcome Measures :
  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

    1. quinolones
    2. oral cephalosporines

  4. Hospitalizations rates [ Time Frame: from month 1 to month 12, and from month 13 to month 24 ]

    Hospitalizations rates

    1. all-cause
    2. 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

    1. <6 years
    2. 6 to <18 years
    3. 18 to <65 years
    4. ≥ 65 years



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379194


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, CH-4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University of Bern
University Children's Hospital Basel
Investigators
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Principal Investigator: Heiner C Bucher, Prof. Dr. University Hospital Basel CEB

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03379194     History of Changes
Other Study ID Numbers: CEB-NFP72
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Basel, Switzerland:
antibiotic prescriptions
resistance
feedback
primary care

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Respiratory Tract Infections
Urologic Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents