Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intervention Study to Improve Antibiotic Prescription in Outpatient Care (SAPI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01358916
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : March 29, 2013
Sponsor:
Collaborators:
Bundesamt für Gesundheit
Sentinella Netzwerk
Schweizerische Gesellschaft für Infektiologie
Pädiatrische Infektiologie Gruppe Schweiz
Information provided by (Responsible Party):
University of Bern

Tracking Information
First Submitted Date  ICMJE May 19, 2011
First Posted Date  ICMJE May 24, 2011
Last Update Posted Date March 29, 2013
Study Start Date  ICMJE November 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2013)
  • Percentage of prescriptions of penicillin for respiratory tract infections [ Time Frame: Two years ]
  • Percentage of prescriptions of TMP/SMX for lower urinary tract infections in adults [ Time Frame: Two years ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2011)
Percentage of prescriptions of penicillin for respiratory tract infections [ Time Frame: one year ]
Change History Complete list of historical versions of study NCT01358916 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2013)
  • Percentage of prescriptions of quinolone for COPD exacerbations in adults [ Time Frame: Two years ]
  • Percentage of antibiotic prescriptions for the indications "sinusitis" and "other upper respiratory tract infections" [ Time Frame: Two years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2011)
  • Percentage of prescriptions of chinolon for COPD [ Time Frame: one year ]
  • Number of antibiotic prescriptions for the indications "sinusitis" and "other upper respiratory tract infections" [ Time Frame: one year ]
  • Percentage of prescriptions of TMP/SMX for acute uncomplicated urinary tract infections [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intervention Study to Improve Antibiotic Prescription in Outpatient Care
Official Title  ICMJE Improvement of Antibiotic Prescription in Outpatient Care: a Cluster-randomised Intervention Study Using a Sentinel Surveillance Network of Physicians
Brief Summary

Antimicrobial resistance has become a world-wide problem and antibiotic consumption is a major driving force for the development of resistance. Thus optimization of antibiotic prescription and reduction of unnecessary antimicrobial treatment are essential in the prevention and reduction of antimicrobial resistance rates.

The goal of this study is the improvement of antibiotic prescription in outpatient care. The study will take place within a Swiss-wide sentinel surveillance network of physicians. The participating physicians will be randomised in a control and intervention group. The intervention group will receive therapeutic guidelines for the treatment of upper and lower respiratory tract infections and lower urinary tract infection as well as regular feed-backs on the prescription pattern of the sentinel physicians during the past months. Sentinel physicians will collect information about each antibiotic prescription, its indication and characteristics of the patient.

Our hypothesis is that the prescription pattern in the intervention group will be optimised and unnecessary antibiotic therapy will be reduced compared to the control group.

Detailed Description

Background

Antimicrobial resistance has become a world-wide problem and antibiotic consumption is a major driving force for the development of resistance. Thus optimization of antibiotic prescription and reduction of unnecessary antimicrobial treatment are essential in the prevention and reduction of antimicrobial resistance rates.

The goal of this study is the qualitative and quantitative improvement of antibiotic prescription in outpatient care. The study will take place within a Swiss-wide sentinel surveillance network consisting of general practitioners, pediatricians and physicians specialized in internal medicine. The participating physicians will be randomised in a control and intervention group. The intervention group will receive therapeutic guidelines for the treatment of upper and lower respiratory tract infections and lower urinary tract infections. Furthermore, regular feed-backs on the prescription pattern of the sentinel physicians in the last months will be provided.

Information about each antibiotic prescription, its indication and the characteristics of the patients will be collected by the sentinel physicians. The standardized reporting of antibiotic prescription by sentinel physicians has been carried out in Switzerland since 2006.

Our hypothesis is that the intervention will affect the antibiotic prescription pattern and that the investigators will observe an optimization of antibiotic prescription and a decrease in the number of antibiotic prescriptions.

Objective

Primary goals:

  • Increase of the percentage of penicillin prescriptions for upper and lower respiratory tract infections
  • Increase of the percentage of TMP/SMX prescriptions for lower urinary tract infections in adults

Secondary goal:

  • Decrease of the percentage of quinolone prescriptions for COPD exacerbations in adults
  • Decrease of the number of antibiotic prescriptions for sinusitis and other upper respiratory tract infections

Methods

Prospective cluster-randomised intervention study. The intervention is the mailing of treatment guidelines for upper and lower respiratory tract infections and lower urinary tract infections as well as regular feed-backs on the antibiotic prescription patterns of the sentinel physicians during the past months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Respiratory Tract Infections
  • Urinary Tract Infections
Intervention  ICMJE Other: Mailing of antibiotic therapy guidelines to the sentinel physicians
Mailing of antibiotic therapy guidelines to the sentinel physicians and regular feedback on antibiotic prescription
Study Arms  ICMJE
  • No Intervention: Usual information policy
    No specific intervention
  • Antibiotic therapy guidelines
    Intervention: Other: Mailing of antibiotic therapy guidelines to the sentinel physicians
Publications * Hürlimann D, Limacher A, Schabel M, Zanetti G, Berger C, Mühlemann K, Kronenberg A; Swiss Sentinel Working Group. Improvement of antibiotic prescription in outpatient care: a cluster-randomized intervention study using a sentinel surveillance network of physicians. J Antimicrob Chemother. 2015 Feb;70(2):602-8. doi: 10.1093/jac/dku394. Epub 2014 Oct 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2013)
140
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2011)
130
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with respiratory tract infections or urinary tract infections

Exclusion Criteria

  • Patients with chronic disease requiring regular antibiotic treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01358916
Other Study ID Numbers  ICMJE Swiss Federal Office of Health
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Bern
Study Sponsor  ICMJE University of Bern
Collaborators  ICMJE
  • Bundesamt für Gesundheit
  • Sentinella Netzwerk
  • Schweizerische Gesellschaft für Infektiologie
  • Pädiatrische Infektiologie Gruppe Schweiz
Investigators  ICMJE
Principal Investigator: Andreas Kronenberg, Dr. med. University of Bern
PRS Account University of Bern
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP