Trial document




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  DRKS00020389

Trial Description

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Title

Reduction of antibiotic resistance in uncomplicated urinary tract infections by treatment according to national guidelines in the ambulatory care

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Trial Acronym

RedAres

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URL of the Trial

http://www.redares.de

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Brief Summary in Lay Language

138 GP practices (including dropouts) in four federal states will be trained in the treatment of uncomplicated urinary tract infections in women and their past and future prescription behavior will be recorded and analyzed. The aim is to optimize guideline-adherent prescribing behavior by means of feedback mechanisms. The training content for all practices includes information on the local pathogen and resistance situation (provided by the Robert Koch Institute) and specially prepared guideline content for uncomplicated urinary tract infections. The 69 GP practices of the control group will receive all intervention contents after the end of the study.
The accompanying process evaluation provides conclusions on the applicability and acceptance of the training and feedback mechanisms. A handout for a subsequent broad implementation of the intervention in regular medical practice will be developed.

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Brief Summary in Scientific Language

Randomized, controlled trial with multimodal intervention:

three-level-intervention:

1. Information on local resistance data for antibiotic prescription in uncomplicated urinary tract infections (by RKI)
2. Communication of treatment guideline contents for the uncomplicated urinary tract infection to the interventional practices
3. Feedback on the prescribing behaviour of the intervention practices (individual and benchmarking)

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

Yes

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Description IPD sharing plan:

The study protocol is made available starting with the status of registration.
The collected resistance data of the RKI (separate registration of subproject a) by RKI with DRKS) will be made available on the Redares Homepage (open access).
The feedback data of the individual practices will not be freely accessible. After completion of the study, the feedback data of both groups (intervention/control- anonymously) will be accessible.

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Organizational Data

  •   DRKS00020389
  •   2020/01/30
  •   [---]*
  •   yes
  •   Approved
  •   20191106 01, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N30.0 -  Acute cystitis
  •   N30.9 -  Cystitis, unspecified
  •   N39.0 -  Urinary tract infection, site not specified
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Interventions/Observational Groups

  •   To detect a 10% absolute difference in the prescribing rate of second-line antibiotics after one year, with a significance level of 5% and a power of 90%, a sample size of 65 practices per group would be needed.
    Assuming a dropout rate of 5% a total sample size of 138 practices (69 per group) of GPs will be recruited in four regions of Germany: Baden-Wuerttemberg, Bavaria, Berlin-Brandenburg and Thuringia
    Intervention group (69 practices):
    The training content for all practices includes information on the local pathogen and resistance situation (provided by the Robert Koch Institute) and specially prepared guideline content on uncomplicated urinary tract infections. At the beginning of the study, there is a retrospective data extraction (t0) of the preceding quarter (prescription behaviour) prior to active training.
    After that a quarterly analysis of the prescription behaviour is implemented.
  •   Control group (69 practices):
    The 69 GP practices of the control group will receive all contents of the intervention after completion of the study.
    At the end of the last study quarter a retrospective analysis of the prescription behavior in UTIs in women over the last 5 quarters is carried out. The first quarter corresponds to the retrospective t0 data of the intervention group.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Rate of second-line antibiotics prescribed for UTIs at the practice level after 12 months of study, based on aggregated data

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Secondary Outcome

Change in prescription rate of total antibiotics for the treatment of UTI as a result of the acceptance of guideline information by the intervention practices.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2021/04/01
  •   138
  •   Multicenter 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

General practicioners with the willingness to participate in the four Network regions (Baden-Wuerttemberg, Bavaria, Berlin/Brandenburg, Thuringia).

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Exclusion Criteria

Private practices

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Addresses

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    • Universitätsklinikum Würzburg Geschäftsbereich 1 – Forschungsförderung und Drittmittelmanagement
    • Ms.  Anna   Schraut 
    • Josef-Schneider-Straße 2
    • 97080  Würzburg
    • Germany
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    • Institut für klinische Epidemiologie und Biometrie (IKE-B), Universität Würzburg
    • Mr.  Prof. Dr. med.  Peter  Heuschmann 
    • Josef-Schneider-Str. 2/Haus D7
    • 97080  Würzburg
    • Germany
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    • Universität Bremen Institut für Public Health und PflegeforschungAbteilung 1: Versorgungsforschung
    • Mr.  PD Dr. med.  Guido  Schmiemann 
    • Grazer Straße 4
    • 28359  Bremen
    • Germany
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    • Mr.  Dr. med.  Wolfgang  Schneider-Rathert 
    • Parkstrasse 8
    • 38102  Braunschweig
    • Germany
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    • Institut für Allgemeinmedizin, Universitätsklinikum Würzburg
    • Ms.  Alexandra  Greser 
    • Josef-Schneider-Str.2, Haus D7
    • 97080  Würzburg
    • Germany
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    • Institut für Allgemeinmedizin Universitätsklinikum Würzburg
    • Ms.  Christiane  Wagner 
    • Josef-Schneider-Str. 2 // Haus D7
    • 97080  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss/DLR
    • Wegelystraße 8
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

  •   Studienprotokoll
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* This entry means the parameter is not applicable or has not been set.