Polypharmacy in chronic diseases–Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support (PRIMA-eDS): study protocol for a randomized controlled trial

Abstract

BackgroundMultimorbidity is increasing in aging populations with a corresponding increase in polypharmacy as well as inappropriate prescribing. Depending on definitions, 25-50 % of patients aged 75 years or older are exposed to at least five drugs. Evidence is increasing that polypharmacy, even when guidelines advise the prescribing of each drug individually, can potentially cause more harm than benefit to older patients, due to factors such as drug-drug and drug-disease interactions. Several approaches reducing polypharmacy and inappropriate prescribing have been proposed, but evidence showing a benefit of these measures regarding clinically relevant endpoints is scarce. There is an urgent need to implement more effective strategies. We therefore set out to develop an evidence-based electronic decision support (eDS) tool to aid physicians in reducing inappropriate prescribing and test its effectiveness in a large-scale cluster-randomized controlled trial.MethodsThe “Polypharmacy in chronic diseases–Reduction of Inappropriate Medication and Adverse drug events in older populations” (PRIMA)-eDS tool is a tool comprising an indication check and recommendations for the reduction of polypharmacy and inappropriate prescribing based on systematic reviews and guidelines, the European list of inappropriate medications for older people, the SFINX-database of interactions, the PHARAO-database on adverse effects, and the RENBASE-database on renal dosing. The tool will be evaluated in a cluster-randomized controlled trial involving 325 general practitioners (GPs) and around 3500 patients across five study centres in the United Kingdom, Germany, Austria and Italy. GP practices will be asked to recruit 11 patients aged 75 years or older who are taking at least eight medications and will be cluster-randomized after completion of patient recruitment. Intervention GPs will have access to the PRIMA-eDS tool, while control GPs will treat their patients according to current guidelines (usual care) without access to the PRIMA-eDS tool. After an observation time of 2 years, intervention and control groups will be compared regarding the primary composite endpoint of first non-elective hospitalization or death.DiscussionThe principal hypothesis is that reduction of polypharmacy and inappropriate prescribing can improve the clinical composite outcome of hospitalization or death. A positive result of the trial will contribute substantially to the improvement of care in multimorbidity. The trial is necessary to investigate not only whether the reduction of polypharmacy improves outcome, but also whether GPs and patients are willing to follow the recommendations of the PRIMA-eDS tool.Trial registrationThis trial has been registered with Current Controlled Trials Ltd. on 31 July 2014 (ISRCTN10137559).Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1177-8) contains supplementary material, which is available to authorized users.

Impact of strategies to reduce polypharmacy on clinically relevant endpoints: a systematic review and meta‐analysis

“…Moreover, recommendations regarding the reduction of polypharmacy or the avoidance of inappropriate medication should be based on best available evidence instead of expert opinions, as done in the development of PIM lists, and by consensus or expert medication review, as performed in some of the studies we identified. There appears to be a strong need for new and better described approaches – for example, more direct and upstream interventions (e.g. computerized physician order entry systems and evidence‐based clinical decision support).…”

Use of an electronic decision support tool to reduce polypharmacy in elderly people with chronic diseases: cluster randomised controlled trial

“…Overall, 3904 patients were enrolled between 7 January and 5 October 2015. A more detailed description of the PRIMA-eDS trial protocol is available elsewhere 9. Further details of the trial’s electronic decision support tool and the randomised controlled trial have been presented elsewhere,1011 and baseline data have been published previously 12…”

Consenso brasileiro de medicamentos potencialmente inapropriados para idosos

“…27 Evitar o uso de MPI para idosos é uma importante estratégia de saúde pública, pois, em muitos países, os instrumentos para detecção de MPI para idosos foram fundamentais para otimizar a postura de prescrição apropriada para idosos e reduzir os desfechos negativos relacionados à farmacoterapia nessa população, como RAM preveníveis, hospitalizações, incapacidades e morte. 28 Em contrapartida, a classificação de um fármaco como MPI não configura uma contraindicação absoluta para o uso em idosos. 29 Todavia, a prescrição de um MPI requer a consideração racional da relação risco-benefício, da disponibilidade de agentes alternativos e de recursos não farmacológicos, da escolha da menor dose necessária, das potenciais interações medicamentosas e do monitoramento dos efeitos no paciente.…”