• Dtsch Arztebl Int · Jun 2023

    Randomized Controlled Trial Multicenter Study

    A Complex Intervention to Prevent Medication-Related Hospital Admissions—Results of the Stepped-Wedge Cluster Randomized Trial KiDSafe in Pediatrics.

    • Antje Neubert, Irmgard Toni, Jochem König, Malonga MakosiDorothéeDInstitute for Medical Biometry, Epidemiology and Information Technology, University Medicine of the Johannes Gutenberg University of Mainz., Philipp Mildenberger, Marcel Romanos, Astrid Bertsche, Thilo Bertsche, Peter Dahlem, Karin Egberts, Bernhard Erdlenbruch, Stefanie Fekete, Ulrike Haug, Gerd Horneff, Axel Hübler, Wieland Kiess, Martina P Neininger, Tim Niehues, Bernhardt Sachs, Karl-Florian Schettler, Filippa Schreeck, Tim Steimle, Tobias Wenzl, Stefan Wirth, Fred Zepp, Matthias Schwab, Michael S Urschitz, Wolfgang Rascher, and KiDSafe Consortium.
    • Department of Pediatric and Adolescent Medicine, University Hospital Erlangen
    • Dtsch Arztebl Int. 2023 Jun 23; 120 (25): 425431425-431.

    BackgroundChildren are often treated off-label and are at a disadvantage in pharmacotherapy. The aim of this study was to implement and evaluate a quality assurance measure (PaedPharm) for pediatric pharmacotherapy whose purpose is to reduce medication-related hospitalizations among children and adolescents.MethodsPaedPharm consisted of the digital pediatric drug information system PaedAMIS, pediatric pharmaceutical quality circles (PaedZirk), and an adverse drug event (ADE) reporting system (PaedReport). The intervention was implemented in a cluster-randomized trial (DRKS 00013924) in 12 regions, with a pediatric and adolescent medicine clinic in each and a total of 152 surrounding private practitioners, in 6 sequences over 8 quarters. In addition to the proportion of ADE-related hospital admissions (primary endpoint), comprehensive process evaluation included other endpoints such as coverage, user acceptance, and relevance to practice.Results41 829 inpatient admissions were recorded, of which 5101 were patients of physicians who participated in our study. 4.1% of admissions were ADE-related under control conditions, and 3.1% under intervention conditions (95% CI: [2.3; 5.9] and [1.8; 4.5], respectively). A model-based comparison yielded an intervention effect of 0.73 (population-based odds ratio; [0.39; 1.37]; p = 0.33). PaedAMIS achieved moderate user acceptance and PaedZirk achieved high user acceptance.ConclusionThe introduction of PaedPharm was associated with a decrease in medication-related hospitalizations that did not reach statistical significance. The process evaluation revealed broad acceptance of the intervention in outpatient pediatrics and adolescent medicine.

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