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

March 27, 2013 updated by: University of Bern

Improvement of Antibiotic Prescription in Outpatient Care: a Cluster-randomised Intervention Study Using a Sentinel Surveillance Network of Physicians

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Institute for Infectious Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with respiratory tract infections or urinary tract infections

Exclusion Criteria

  • Patients with chronic disease requiring regular antibiotic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Usual information policy
No specific intervention
OTHER: Antibiotic therapy guidelines
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of prescriptions of penicillin for respiratory tract infections
Time Frame: Two years
Two years
Percentage of prescriptions of TMP/SMX for lower urinary tract infections in adults
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of prescriptions of quinolone for COPD exacerbations in adults
Time Frame: Two years
Two years
Percentage of antibiotic prescriptions for the indications "sinusitis" and "other upper respiratory tract infections"
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Collaborators

Bundesamt für Gesundheit
Sentinella Netzwerk
Schweizerische Gesellschaft für Infektiologie
Pädiatrische Infektiologie Gruppe Schweiz

Investigators

  • Principal Investigator: Andreas Kronenberg, Dr. med., University of Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

May 19, 2011

First Submitted That Met QC Criteria

May 23, 2011

First Posted (ESTIMATE)

May 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 29, 2013

Last Update Submitted That Met QC Criteria

March 27, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Swiss Federal Office of Health

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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