Trial document





This trial has been registered retrospectively.
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  DRKS00006792

Trial Description

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Title

Optimising patient safety in paediatric prescription

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Drug-related problems in prescription are a common reason for preventable adverse drug events and lack of therapeutic success. Especially children and adolescents are very vulnerable patients due to the need of patient-individualised dosing considering age and weight.
With this quality assurance study we are aiming at analysing and optimising paediatric prescription in routine patient care. In the control group, we assess type and frequency of drug-related problems, especially in prescription of inhaled drugs and analgesics/antipyretics. Based on these findings, a tailored intervention programme will be put into practice to optimise prescription (intervention group). The intervention programme consists of dosage recommendations and individualised pharmaceutical counselling, and addresses the inter-relation of prescription and administration by monitoring and coaching the nurses (Ethical approval by Ethikkommission an der Medizinischen Fakultät der Universität Leipzig, 09/03/2012, No. 074-12-05032012) and structured feedback on the inhalation processes to the physicians. Sustainability of the intervention programme will be analysed in a follow-up. Quality outcomes will be assessed by the frequency of drug-related problems in paediatric prescription. No therapies other than routinely prescribed are used. The therapy decision is the sole responsibility of the prescribing physician.

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Brief Summary in Scientific Language

Drug-related problems in prescription are a common reason for preventable adverse drug events and lack of therapeutic success. Especially children and adolescents are very vulnerable patients due to the need of patient-individualised dosing considering age and weight.
With this quality assurance study we are aiming at analysing and optimising paediatric prescription in routine patient care. In the control group, we assess type and frequency of drug-related problems, especially in prescription of inhaled drugs and analgesics/antipyretics. Based on these findings, a tailored intervention programme will be put into practice to optimise prescription (intervention group). The intervention programme consists of dosage recommendations and individualised pharmaceutical counselling, and addresses the inter-relation of prescription and administration by monitoring and coaching the nurses (Ethical approval by Ethikkommission an der Medizinischen Fakultät der Universität Leipzig, 09/03/2012, No. 074-12-05032012) and structured feedback on the inhalation processes to the physicians. Sustainability of the intervention programme will be analysed in a follow-up. Quality outcomes will be assessed by the frequency of drug-related problems in paediatric prescription. No therapies other than routinely prescribed are used. The therapy decision is the sole responsibility of the prescribing physician.

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Organizational Data

  •   DRKS00006792
  •   2014/10/01
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  •   yes
  •   Approved
  •   212/11-11072011, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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Health Condition or Problem studied

  •   Diseases in children and adolescents
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Interventions/Observational Groups

  •   Dosage recommendations and individualised pharmaceutical counselling on drug-related problems in prescription (especially concerning inhalative drugs and antipyretics/analgesics).
  •   Arm 2 is subsequent to arm 1. Additionally to the pharmaceutical counselling physicians receive structured feedback on the quality of the inhalation processes because the optimal dosage depends on the invividual inhalation technique, the clinical condition of the patient and the dosage regimen. Regarding other drugs, there are no differences between arm 1 and 2.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Number of patients with a least one pre-defined drug-related problem in prescription

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Secondary Outcome

Not specified

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/08/15
  •   625
  •   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 consecutive prescriptions of hospitalised patients at our department for children and adolescents

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Exclusion Criteria

None

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Addresses

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    • Universität Leipzig
    • Ritterstraße 26
    • 04109  Leipzig
    • Germany
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    • Klinische Pharmazie, Institut für Pharmazie, Universität Leipzig
    • Mr.  Prof. Dr.  Thilo  Bertsche 
    • Eilenburger Str. 15a
    • 04317  Leipzig
    • Germany
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    • Klinische PharmazieInstitut für PharmazieUniversität Leipzig
    • Mr.  Prof. Dr.  Thilo  Bertsche 
    • Eilenburger Str. 15a
    • 04317  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Universität Leipzig
    • Ritterstraße 26
    • 04109  Leipzig
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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