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

Primary Purpose

Acute Respiratory Tract Infection, Urinary Tract Infections

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Antibiotic stewardship program
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Respiratory Tract Infection focused on measuring antibiotic prescriptions, resistance, feedback, primary care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

'Antibiotic stewardship program'

Control

Arm Description

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.

No intervention

Outcomes

Primary Outcome Measures

Overall antibiotic use
Change in prescribed antibiotics per 100 consultations

Secondary Outcome Measures

Overall antibiotic use
Change in prescribed antibiotics per 100 patient consultations
Overall antibiotic use
Change in prescribed antibiotics per 100 patient consultations
Use of broad spectrum antibiotics
Change in broad spectrum antibiotics use per 100 consultations quinolones oral cephalosporines
Hospitalizations rates
Hospitalizations rates all-cause related to infections (DRG-based definition)
Antibiotic use in four specific age groups
Antibiotic use per 100 consultations in four specific age groups, in patients <6 years 6 to <18 years 18 to <65 years ≥ 65 years

Full Information

First Posted
December 7, 2017
Last Updated
November 14, 2022
Sponsor
University Hospital, Basel, Switzerland
Collaborators
University of Bern, University Children's Hospital Basel
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1. Study Identification

Unique Protocol Identification Number
NCT03379194
Brief Title
Routine Antibiotic Prescription Monitoring in Primary Care Physicians: A Nationwide Trial
Official Title
Routine Antibiotic Prescription and Resistance Monitoring in Primary Care Physicians: A Nationwide Pragmatic Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
University of Bern, University Children's Hospital Basel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Tract Infection, Urinary Tract Infections
Keywords
antibiotic prescriptions, resistance, feedback, primary care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
For final data analysis the biostatistician will be blinded for treatment allocation of physicians.
Allocation
Randomized
Enrollment
3426 (Actual)

8. Arms, Groups, and Interventions

Arm Title
'Antibiotic stewardship program'
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Antibiotic stewardship program
Intervention Description
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 Outcome Measure Information:
Title
Overall antibiotic use
Description
Change in prescribed antibiotics per 100 consultations
Time Frame
from month 13 to month 24 post randomization (longer term intervention effect).
Secondary Outcome Measure Information:
Title
Overall antibiotic use
Description
Change in prescribed antibiotics per 100 patient consultations
Time Frame
from month 1 to 12 post randomization (short-term intervention effect)
Title
Overall antibiotic use
Description
Change in prescribed antibiotics per 100 patient consultations
Time Frame
from month 1 to month 24 post randomization, with two repeated measurements, over the first and the second 12 month period
Title
Use of broad spectrum antibiotics
Description
Change in broad spectrum antibiotics use per 100 consultations quinolones oral cephalosporines
Time Frame
from month 1 to month 12, and from month 13 to month 24).
Title
Hospitalizations rates
Description
Hospitalizations rates all-cause related to infections (DRG-based definition)
Time Frame
from month 1 to month 12, and from month 13 to month 24
Title
Antibiotic use in four specific age groups
Description
Antibiotic use per 100 consultations in four specific age groups, in patients <6 years 6 to <18 years 18 to <65 years ≥ 65 years
Time Frame
from month 1 to month 12, and from month 13 to month 24.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heiner C Bucher, Prof. Dr.
Organizational Affiliation
University Hospital Basel CEB
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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