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Randomized Controlled Trial
. 2023 Jun 23;120(25):425-431.
doi: 10.3238/arztebl.m2023.0123.

A Complex Intervention to Prevent Medication-Related Hospital Admissions

Antje Neubert  1 , Irmgard Toni  1 , Jochem König  2 , Dorothée Malonga Makosi  2 , Philipp Mildenberger  2 , Marcel Romanos  3 , Astrid Bertsche  4   5 , Thilo Bertsche  4   6 , Peter Dahlem  7 , Karin Egberts  3 , Bernhard Erdlenbruch  8 , Stefanie Fekete  3 , Ulrike Haug  9 , Gerd Horneff  10 , Axel Hübler  11 , Wieland Kiess  12 , Martina P Neininger  4 , Tim Niehues  13 , Bernhardt Sachs  14 , Karl-Florian Schettler  15 , Filippa Schreeck  16 , Tim Steimle  17 , Tobias Wenzl  18 , Stefan Wirth  19 , Fred Zepp  20 , Matthias Schwab  16   21   22 , Michael S Urschitz  2 , Wolfgang Rascher  1 ; KiDSafe Consortium
Collaborators, Affiliations
Randomized Controlled Trial

A Complex Intervention to Prevent Medication-Related Hospital Admissions

Antje Neubert et al. Dtsch Arztebl Int. .

Abstract

Background: Children 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.

Methods: PaedPharm 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.

Results: 41 829 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.

Conclusion: The 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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Figures

Figure 1
Figure 1
Study design – time-based allocation of the various intervention phases in the sequences I, intervention phase (intervention effect 1); C, control phase; T, training phase (intervention effect 0,5)
Figure 2
Figure 2
Flow diagram of data acquisition process conducted in the clinics * Suspected medication-related hospitalization AkdÄ, Drug Commission of the German Medical Association; ADE, adverse drug events; ADE-C, ADE coordination unit
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See this image and copyright information in PMC

Comment in

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