Trial document




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  DRKS00003387

Trial Description

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Title

Rational antibiotic therapy in ambulatory care (RAT) - Evaluation of an internet-based training program for the rational prescription of antibiotics in ambulatory medical care

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Trial Acronym

RAT-EVAL

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URL of the Trial

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Brief Summary in Lay Language

Antibiotics are used for the treatment of diseases that are caused by bacteria. Increasingly, these bacteria are resistant (immune) to the antibiotics used. The resistance of the bacteria occurs e.g. because of the inappropriate use of antibiotics. In Germany, up to half of all antibiotic therapies are inadequate in terms of indication, dosage, or effect spectrum.

Since the vast majority, about 85% of all antibiotics in Germany, are prescribed in outpatient care, it is important to focus attention on outpatient antibiotic therapy.

The study wants to examine the relevant factors influencing the prescription of antibiotics in outpatient care. Additionally, it is checked whether an Internet-based training for practicing physicians has a significant effect on the frequency of prescribing antibiotics, as well as on the knowledge and the attitudes of doctors. The study is conducted with practicing physicians in the state of Brandenburg (Germany).

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Brief Summary in Scientific Language

The present study analyses the prescription of antibiotics in the outpatient medical care in Brandenburg and aims to reduce the inappropriate use of antibiotics through the development and evaluation of an internet-based training program on prescribing antibiotics.

Objectives:
Analysis of antibiotic theapies in regular ambulatory care in Brandenburg regarding indication, quantity of prescriptions and class of antibiotics.

Evaluation of the effectiveness and acceptability of an Internet-based training program about antibiotic treatment and antibiotic multi-resistant pathogens, and the investigation of the factors that influence the frequency of prescription of antibiotics.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003387
  •   2012/01/16
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  •   yes
  •   Approved
  •   EA4/118/11, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   Evaluation of the effectiveness of an Internet-based training program for physicians on rational prescription of antibiotics
  •   Analysis of antibiotic prescriptions in ambulatory care in Brandenburg in terms of indication, quantity of prescriptions and prescribed class of antibiotics
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Interventions/Observational Groups

  •   The intervention group receives access to an Internet-based training program of approximately 45 minutes.
  •   The control group received access to a Web page with brief information about antibiotics
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Health care system
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Prescription behavior of the participants 3, 6 and 12 months after entry into the study / participation in the program. Measured by prescription data codes (ATC) and diagnostic codes (ICD codes) provided by a health insurance company.

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Secondary Outcome

Attitude, intention, (self-assessed) knowledge and communicative skills of the participants in the context of antibiotic therapy. Data is collected 3, 6 and 12 months after entry into the study / participation in the program, using web-based questionnaires.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2012/05/16
  •   216
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

All general practitioners, internists, urologists and ENT doctors in Brandenburg, treating at least 50 patients of the AOK health insurance company in each quarter.

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Exclusion Criteria

In addition to the inclusion criteria, no other exclusion criteria are defined.

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Addresses

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    • Institut für Hygiene und Umweltmedizin Charité - Universitätsmedizin Berlin. Campus Benjamin Franklin
    • Ms.  Prof. Dr. Med.  Petra  Gastmeier 
    • Hindenburgdamm 27
    • 12203  Berlin
    • Germany
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    • delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH
    • Mr.  Dr.  Peter  Tossmann 
    • Kaiserdamm 8
    • 14057  Berlin
    • Germany
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    • delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH
    • Mr.  Dr.  Peter  Tossmann 
    • Kaiserdamm 8
    • 14057  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit (BMG)
    • Rochusstr. 1
    • 53123  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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