Routine Prescription Feedback and Peer Comparison to Lower Antibiotic Prescriptions in Primary Care

Routine Prescription Feedback and Peer Comparison to Lower Antibiotic Prescriptions in Primary Care - a Pragmatic Randomised Controlled Trial

To evaluate the effect of a continuous postal and web-based feedback and peer comparison system of individual antibiotic prescription rates on the prescription behaviour of primary care physicians in Switzerland.

Study Overview

Detailed Description

Background: Excessive use of antibiotics may lead to unnecessary adverse events and raise the emergence of bacterial resistance, an increasingly serious problem in Europe. In absolute terms most antibiotics are prescribed in primary care with considerable unexplained variation of antibiotic use indicating the need for further important improvement of prescription practice in Switzerland.

Aim: To evaluate the effect of a continuous postal and web-based feedback and peer comparison system of individual antibiotic prescription rates on the prescription behaviour of primary care physicians in Switzerland.

Design: Randomized, controlled, pragmatic intervention trial. Setting: Primary care providers of Switzerland above the median of antibiotic prescription rates.

Population: Primary care physicians caring for patients enlisted with social health insurance companies that provide invoice data to the SANTÉSUISSE DATENPOOL AND TARIFPOOL.

Endpoints: Primary endpoint: Prescription rate of antibiotics as defined daily doses (DDD) per 100 consultations at 12 and 24 months. Secondary endpoints: Costs-savings from the intervention, acceptability of the program, percentage of prescriptions fulfilling disease-specific quality indicators for outpatient antibiotic criteria by the European Surveillance of Antimicrobial Consumption (ESAC).

Intervention: Quarterly postal and electronic feedback for 24 months on the crude number of antibiotics prescribed, a population adjusted benchmark-profile in comparison to other primary care physicians, and evidence-based guidelines for the use of antibiotics in primary care. Physicians in the control group receive no information.

Variables and measurement: Rates of antibiotic prescriptions overall and per drug class (DDD), cost of prescribed drugs and the intervention program; number of web-application logins and participation cancellations, and - in a sub-sample - number of prescriptions fulfilling disease-specific quality indicators for outpatient antibiotic criteria (ESAC).

Expected results: We expect a 5% reduction of antibiotic prescription rates between the intervention and control groups after 12 months with an assumed participation rate (at least one web-access) and return of acceptance questionnaire of 30%. We expect that the intervention program will be cost-saving. ESAC quality indicators will be a useful tool for monitoring the quality of antibiotic prescription in ambulatory care in Switzerland.

Analyses: Analysis will be done by intention to treat principles. We will use linear regression analysis to determine the difference in antibiotic prescriptions between the intervention and the control group with appropriate adjustment for the case mix of patient populations and self-dispensation. Based on outpatient data of 2009 from the Helsana insurance and conservative effect estimates a sample-size of 1427 physicians each for the intervention and control group is planned.

Significance: This trial will investigate if a repeated feedback system results in a long-term reduction of antibiotic prescription practices. In addition, the feasibility of a web-based interface as communication tool to primary care physicians will be assessed. If effective, the system could be easily employed for other interventions as well.

Study Type

Interventional

Enrollment (Actual)

2900

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

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:

  • Board certified physicians with a certificate from the Swiss Medical Association (Facharzttitel' General Internal Medicine, Subspecialities in Internal Medicine, Paediatrics) with an own ZAHLSTELLENREGISTER NUMBER (Konkordatsnummer).
  • At least 100 patients enlisted with the specified social health insurance providers (SANTÉSUISSE DATENPOOL AND TARIFPOOL). (to avoid classifying physicians as high prescribers who only see a small number of patients and describe antibiotics to many of them)
  • Prescription-rates of antibiotics (DDD per 100 consultations) - that are prescribed to patients enlisted with the specified social health insurance providers (SANTÉSUISSE TARIFPOOL)
  • are in the upper median of the prescription number distribution in the year prior to the start of the trial.

Exclusion Criteria:

  • Physicians with no own "Zentralstellenregister" (ZSR) number (practice fellows or substitutes, medical trainees in general practices).
  • Physicians working in institutions without own but with institutional ZSR NUMBER (ambulatory care facilities of University Hospitals, permanence, practices or Health Maintenance Organisation (HMO) with group ZSR number).

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

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: No feedback
Physicians in the control group will only be monitored for their antibiotic prescription rates (Physicians are unaware of the trial).
Physicians in the control group will only be monitored for their antibiotic prescription rates (Physicians are unaware of the trial)
Other Names:
  • Controls
EXPERIMENTAL: Antibiotic prescription feedback
Physicians receive quarterly electronic feedback on their antibiotic prescriptions
Monthly postal and electronic feedback on antibiotic prescription rates
Other Names:
  • Active physician benchmarking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prescription rate of antibiotics as defined daily doses (DDD) per 100 consultations
Time Frame: at 12 and 24 months
at 12 and 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Costs-savings from the intervention
Time Frame: at 24 months
at 24 months
Rate of physicians rating that the continuous update on antibiotic prescription data is useful
Time Frame: at 24 months
at 24 months
Percentage of prescriptions fulfilling disease-specific quality indicators for outpatient antibiotic criteria by the European Surveillance of Antimicrobial Consumption (ESAC).
Time Frame: at 24 months
at 24 months
Number of logins into the web-application
Time Frame: at 24 months
at 24 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Heiner C Bucher, Prof Dr med, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel
  • Principal Investigator: Andreas Widmer, Prof Dr med, Klinik für Infektiologie und Spitalhygiene, University Hospital Basel
  • Principal Investigator: Andreas Zeller, PD Dr med, Institut für Hausarztmedizin, University of Basel

Publications and helpful links

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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

October 1, 2013

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

August 24, 2012

First Submitted That Met QC Criteria

January 18, 2013

First Posted (ESTIMATE)

January 23, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

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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