Abstract
BackgroundProton pump inhibitors (PPIs) are increasingly being prescribed, although long-term use is associated with multiple side effects. Therefore, an electronic decision support tool with the aim of reducing the long-term use of PPIs in a shared decision-making process between general practitioners (GPs) and their patients has been developed. The developed tool is a module that can be added to the so-called arriba decision support tool, which is already used by GPs in Germany in routine care. In this large-scale cluster-randomized controlled trial we evaluate the effectiveness of this arriba-PPI tool.MethodsThe arriba-PPI tool is an electronic decision support system that supports shared decision-making and evidence-based decisions around the long-term use of PPIs at the point of care. The tool will be evaluated in a cluster-randomized controlled trial involving 210 GP practices and 3150 patients in Germany. GP practices will be asked to recruit 20 patients aged ≥ 18 years regularly taking PPIs for ≥ 6 months. After completion of patient recruitment, each GP practice with enrolled patients will be cluster-randomized. Intervention GP practices will get access to the software arriba-PPI, whereas control GPs will treat their patients as usual. After an observation period of six months, GP practices will be compared regarding the reduction of cumulated defined daily doses of PPI prescriptions per patient.DiscussionOur principal hypothesis is that the application of the arriba-PPI tool can reduce PPI prescribing in primary care by at least 15% compared to conventional strategies used by GPs. A positive result implies the implementation of the arriba-PPI tool in routine care.Trial registrationGerman Clinical Trials Register, DRKS00016364. Registered on 31 January 2019.
Highlights
Proton pump inhibitors (PPIs) are increasingly being prescribed, long-term use is associated with multiple side effects
According to the German drug prescription report, a total of 3.7 billion defined daily doses (DDD) of PPIs were prescribed in Germany in 2015
Even though long-term use without indication is considered inappropriate [9], PPIs are frequently overused as lifestyle drugs [10]
Summary
Proton pump inhibitors (PPIs) are increasingly being prescribed, long-term use is associated with multiple side effects. PPIs are increasingly used as a means of protecting the stomach in polypharmacy patients (i.e. the current intake of several drugs [7]) and in combination with non-steroidal antirheumatic drugs or platelet aggregation inhibitors. They are used in patients suffering from nun-ulcer dyspepsia and for stress ulcer prophylaxis during hospital stay [1, 8]. Apart from the potential risks, the frequent use of PPIs contributes to substantial costs for the healthcare system [1]
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