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

NCT03379194 | Completed

• 1 other identifier: CEB-NFP72
• Study Type: interventional
• Target: 3,426
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Tract Infection; Urinary Tract Infections

Keywords

antibiotic prescriptions; resistance; feedback; primary care

Outcome Measures

Primary Outcomes (1)

• Overall antibiotic use

  Change in prescribed antibiotics per 100 consultations

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

Secondary Outcomes (5)

• Overall antibiotic use

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

• Overall antibiotic use

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

• Use of broad spectrum antibiotics

  from month 1 to month 12, and from month 13 to month 24).

• Hospitalizations rates

  from month 1 to month 12, and from month 13 to month 24

• Antibiotic use in four specific age groups

  from month 1 to month 12, and from month 13 to month 24.

Study Arms (2)

'Antibiotic stewardship program'

EXPERIMENTAL

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

Control

NO INTERVENTION

No intervention

Interventions

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

'Antibiotic stewardship program'

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University of Bern: collaborator
• University Children's Hospital Basel: collaborator

Study Sites (1)

University Hospital Basel

Basel, CH-4031, Switzerland

Location

Related Publications (1)

• Aghlmandi S, Halbeisen FS, Saccilotto R, Godet P, Signorell A, Sigrist S, Glinz D, Moffa G, Zeller A, Widmer AF, Kronenberg A, Bielicki J, Bucher HC. Effect of Antibiotic Prescription Audit and Feedback on Antibiotic Prescribing in Primary Care: A Randomized Clinical Trial. JAMA Intern Med. 2023 Mar 1;183(3):213-220. doi: 10.1001/jamainternmed.2022.6529.

  PMID: 36745412 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Heiner C Bucher, Prof. Dr.

  University Hospital Basel CEB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: For final data analysis the biostatistician will be blinded for treatment allocation of physicians.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 20, 2017
• Study Start: January 2, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)