Efficacy of a computer based discontinuation strategy to reduce PPI prescriptions: a multicenter cluster-randomized controlled trial.

Deprescribing of inappropriate long-term proton pump inhibitors (PPI) is challenging and there is a lack of useful methods for general practitioners to tackle this. The objective of this randomized controlled trial was to evaluate the effectiveness of the electronic decision aid tool arriba-PPI on reduction of long-term PPI intake. Participants (64.5 ± 12.9 years; 54.4% women) with a PPI intake of at least 6 months were randomized to receive either consultation with arriba-PPI from their general practitioner (n = 1256) or treatment as usual (n = 1131). PPI prescriptions were monitored 6 months before, 6 and 12 months after study initiation. In 49.2% of the consultations with arriba-PPI, the general practitioners and their patients made the decision to reduce or discontinue PPI intake. At 6 months, there was a significant reduction by 22.3% (95% CI 18.55 to 25.98; p < 0.0001) of defined daily doses (DDD) of PPI. A reduction of 3.3% (95% CI - 7.18 to + 0.62) was observed in the control group. At 12 months, the reduction of DDD-PPI remained stable in intervention patients (+ 3.5%, 95% CI - 0.99 to + 8.03), whereas control patients showed a reduction of DDD-PPI (- 10.2%, 95% CI - 6.01 to - 14.33). Consultation with arriba-PPI led to reduced prescription rates of PPI in primary care practices. Arriba-PPI can be a helpful tool for general practitioners to start a conversation with their patients about risks of long-term PPI intake, reduction or deprescribing unnecessary PPI medication.

Experiences of participants of a volunteer-supported walking intervention to improve physical function of nursing home residents - a mixed methods sub-study of the POWER-project.

BACKGROUND: Regular physical activity improves physical health and mental well-being and reduces the risk of falling in older adults. The randomized controlled "Prevention by lay-assisted Outdoor-Walking in the Elderly at Risk" POWER-study investigates whether volunteer-supported outdoor-walking improves physical function and quality of life in older people living independently or in nursing homes. This sub-study explores the experiences of older participants and volunteers in relation to their physical and psychosocial well-being as well as the challenges faced by both groups. A further aim was to explore volunteers' experience with people living in nursing homes during the first pandemic lockdown (spring 2020). METHODS: The sub-study was designed as mixed-methods approach consisting of 11 individual semi-structured guide-based interviews (nursing home residents), two focus group interviews (volunteers), and a cross-sectional questionnaire survey (volunteers). The interviews were audiotaped, transcribed verbatim, and analyzed by content analysis as described by Kuckartz. Topics addressed in the interviews were triangulated by means of a questionnaire. The quantitative data were analyzed using descriptive statistics. RESULTS: Participants' evaluation of the intervention was generally positive. Nursing home residents appreciated the social interaction associated with the assisted walking, which motivated them to take part regularly, provided a sense of safety, and caused pleasure on both sides. The impact on physical health status of the nursing home residents of this sub-study varied to a large degree as reported in interviews: in some cases, an improvement in physical performance, a decrease in physical complaints, and an improvement in gait or independence was reported. If not, reference was made to previous or sudden illnesses and the advanced age of the participants. Despite the COVID-19-lockdown and the associated restrictions, about 60% of contacts were still possible and participants planned to continue the assisted walks after the lockdown. CONCLUSION: Volunteers have a positive effect on the quality of life, mobility, and general health of nursing home residents. Even more than the improvement of physical performance, social interaction was seen as helpful. Despite their advanced age, the nursing home residents were curious and open to new contacts. When removing the identified barriers, it might be possible to integrate this program into the long-term everyday life of nursing homes. TRIAL REGISTRATION: DRKS-ID: DRKS00015188, date of registration: 31.08.2018.

How can we build and maintain the resilience of our health care professionals during COVID-19? Recommendations based on a scoping review.

OBJECTIVE: To explore how to build and maintain the resilience of frontline healthcare professionals exposed to COVID-19 outbreak working conditions. DESIGN: Scoping review supplemented with expert interviews to validate the findings. SETTING: Hospitals. METHODS: We searched PubMed, Embase, PsycINFO, CINAHL, bioRxiv and medRxiv systematically and grey literature for articles focusing on the impact of COVID-19-like working conditions on the physical and/or mental health of healthcare professionals in a hospital setting. Articles using an empirical design about determinants or causes of physical and/or mental health and about interventions, measures and policies to preserve physical and/or mental health were included. Four experts were interviewed to reflect on the results from the scoping review. RESULTS: In total, 4471 records were screened leading to an inclusion of 73 articles. Recommendations prior to the outbreak fostering resilience included optimal provision of education and training, resilience training and interventions to create a feeling of being prepared. Recommendations during the outbreak consisted of (1) enhancing resilience by proper provision of information, psychosocial support and treatment (eg, create enabling conditions such as forming a psychosocial support team), monitoring the health status of professionals and using various forms and content of psychosocial support (eg, encouraging peer support, sharing and celebrating successes), (2) tasks and responsibilities, in which attention should be paid to kind of tasks, task mix and responsibilities as well as the intensity and weight of these tasks and (3) work patterns and working conditions. Findings of the review were validated by experts. CONCLUSIONS: Recommendations were developed on how to build and maintain resilience of frontline healthcare professionals exposed to COVID-19 outbreak working conditions. These practical and easy to implement recommendations can be used by hospitals and other healthcare organisations to foster and preserve short-term and long-term physical and mental health and employability of their professionals.

A volunteer-supported walking programme to improve physical function in older people (the POWER Study): study protocol for a randomised controlled trial.

BACKGROUND: Currently 21% of the German population is older than 65 years. Above this age, the risk of suffering from chronic disease and mental disorders increases rapidly. Therefore, physical inactivity is one of the most important public health concerns among older people. To address this issue, we have conceptualised and evaluated a simple and low-threshold intervention, which requires only minimal demand on the participants, targeting older people with inadequate activity levels. The aim of the POWER Study is to investigate whether volunteer-supported outdoor-walking improves physical function and quality of life in older people. METHODS/DESIGN: In a randomised, controlled interventional superiority-trial, individuals older than 65 years of age living in the community or nursing homes will be randomised into two groups. The study will be conducted in two study centres with assessments at baseline, 6 and 12 months. The intervention group will participate in a supported physical activity intervention for 6 months. An assigned volunteer will visit them three times a week for an outdoor walk between 30 and 50 min, or equivalent indoor activity. Persons in the control group will be invited to two lectures covering topics related to health. Primary endpoint is the physical function measured by the Short Physical Performance Battery (SPPB) at baseline, after 6 and 12 months. Secondary and safety endpoints will be quality of life (EQ. 5D), fear of falling (Falls Efficacy Scale), physical activity (activity diary), cognitive executive function (clock drawing test), falls requiring medical attention, hospitalisation and death. Primary analysis will be carried out by intention to treat. DISCUSSION: We expect the intervention to improve the overall health status of the participants in a wide range of health-related outcomes. If effectiveness can be shown, the intervention will close an important gap in current services for older people. We will disseminate our experiences and results in the form of informational documents (training manual) to allow municipalities and health care organisations to implement a similar intervention. TRIAL REGISTRATION: The trial was registered on 31 Aug 2018; German Clinical Trials Register (www.germanctr.de), Deutsches Register Klinischer Studien: DRKS00015188 .

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

OBJECTIVE: To evaluate the effects of a computerised decision support tool for comprehensive drug review in elderly people with polypharmacy. DESIGN: Pragmatic, multicentre, cluster randomised controlled trial. SETTING: 359 general practices in Austria, Germany, Italy, and the United Kingdom. PARTICIPANTS: 3904 adults aged 75 years and older using eight or more drugs on a regular basis, recruited by their general practitioner. INTERVENTION: A newly developed electronic decision support tool comprising a comprehensive drug review to support general practitioners in deprescribing potentially inappropriate and non-evidence based drugs. Doctors were randomly allocated to either the electronic decision support tool or to provide treatment as usual. MAIN OUTCOME MEASURES: The primary outcome was the composite of unplanned hospital admission or death by 24 months. The key secondary outcome was reduction in the number of drugs. RESULTS: 3904 adults were enrolled between January and October 2015. 181 practices and 1953 participants were assigned to electronic decision support (intervention group) and 178 practices and 1951 participants to treatment as usual (control group). The primary outcome (composite of unplanned hospital admission or death by 24 months) occurred in 871 (44.6%) participants in the intervention group and 944 (48.4%) in the control group. In an intention-to-treat analysis the odds ratio of the composite outcome was 0.88 (95% confidence interval 0.73 to 1.07; P=0.19, 997 of 1953 v 1055 of 1951). In an analysis restricted to participants attending practice according to protocol, a difference was found favouring the intervention (odds ratio 0.82, 95% confidence interval 0.68 to 0.98; 774 of 1682 v 873 of 1712, P=0.03). By 24 months the number of prescribed drugs had decreased in the intervention group compared with control group (uncontrolled mean change -0.42 v 0.06: adjusted mean difference -0.45, 95% confidence interval -0.63 to -0.26; P<0.001). CONCLUSIONS: In intention-to-treat analysis, a computerised decision support tool for comprehensive drug review of elderly people with polypharmacy showed no conclusive effects on the composite of unplanned hospital admission or death by 24 months. Nonetheless, a reduction in drugs was achieved without detriment to patient outcomes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10137559.

Reduction of the long-term use of proton pump inhibitors by a patient-oriented electronic decision support tool (arriba-PPI): study protocol for a randomized controlled trial.

BACKGROUND: Proton 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. METHODS: The 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. DISCUSSION: Our 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 REGISTRATION: German Clinical Trials Register, DRKS00016364. Registered on 31 January 2019.

Reduction of inappropriate medication in older populations by electronic decision support (the PRIMA-eDS project): a survey of general practitioners' experiences.

OBJECTIVE: We sought to investigate the experiences of general practitioners (GPs) with an electronic decision support tool to reduce inappropriate polypharmacy in older patients (the PRIMA-eDS [Polypharmacy in chronic diseases: Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support] tool) in a multinational sample of GPs and to quantify the findings from a prior qualitative study on the PRIMA-eDS-tool. MATERIALS AND METHODS: Alongside the cluster randomized controlled PRIMA-eDS trial, a survey was conducted in all 5 participating study centers (Bolzano, Italy; Manchester, United Kingdom; Salzburg, Austria; Rostock, Germany; and Witten, Germany) between October 2016 and July 2017. Data were analyzed using descriptive statistics and chi-square tests. RESULTS: Ninety-one (n = 160) percent of the 176 questionnaires were returned. Thirty-two percent of the respondents reported that they did not cease drugs because of the medication check. The 68% who had discontinued drugs comprise 57% who had stopped on average 1 drug and 11% who had stopped 2 drugs or more per patient. The PRIMA-eDS tool was found to be useful (69%) and the recommendations were found to help to increase awareness (86%). The greatest barrier to implementing deprescribing recommendations was the perceived necessity of the medication (69%). The majority of respondents (65%) would use the electronic medication check in routine practice if it was part of the electronic health record. CONCLUSIONS: GPs generally viewed the PRIMA-eDS medication check as useful and as informative. Recommendations were not always followed due to various reasons. Many GPs would use the medication check if integrated into the electronic health record.

Polypharmacy in older patients with chronic diseases: a cross-sectional analysis of factors associated with excessive polypharmacy.

BACKGROUND: Polypharmacy is common in older people and associated with potential harms. The aim of this study was to analyse the characteristics of an older multimorbid population with polypharmacy and to identify factors contributing to excessive polypharmacy in these patients. METHODS: This cross-sectional analysis is based on the PRIMA-eDS trial, a large randomised controlled multicentre study of polypharmacy in primary care. Patients' baseline data were used for analysis. A number of socioeconomic and medical data as well as SF-12-scores were entered into a generalized linear mixed model to identify variables associated with excessive polypharmacy (taking ≥10 substances daily). RESULTS: Three thousand nine hundred four participants were recruited. Risk factors significantly associated with excessive polypharmacy were frailty (OR 1.45; 95% CI 1.22-1.71), > 8 diagnoses (OR 2.64; 95% CI 2.24-3.11), BMI ≥30 (OR 1.18; 95% CI 1.02-1.38), a lower SF-12 physical health composite score (OR 1.47; 95% CI 1.26-1.72), and a lower SF-12 mental health composite score (OR 1.33; 95% CI 1.17-1.59) than the median of the study population (≤36.6 and ≤ 48.7, respectively). Age ≥ 85 years (OR 0.83; 95% CI 0.70-0.99) led to a significantly lower risk for excessive polypharmacy. No association with excessive polypharmacy could be found for female sex, low educational level, and smoking. Regarding the study centres, being recruited in the UK led to a significantly higher risk for excessive polypharmacy compared to being recruited in Germany 1/Rostock (OR 1.71; 95% CI 1.27-2.30). Being recruited in Germany 2/Witten led to a slightly significant lower risk for excessive polypharmacy compared to Germany 1/Rostock (OR 0.74; 95% CI 0.56-0.97). CONCLUSIONS: Frailty, multimorbidity, obesity, and decreased physical as well as mental health status are risk factors for excessive polypharmacy. Sex, educational level, and smoking apparently do not seem to be related to excessive polypharmacy. Physicians should especially pay attention to their frail, obese patients who have multiple diagnoses and a decreased health-related quality of life, to check carefully whether all the drugs prescribed are evidence-based, safe, and do not interact in an unfavourable way. TRIAL REGISTRATION: This trial has been registered with Current Controlled Trials Ltd. on 31 July 2014 (ISRCTN10137559).

Reduction of inappropriate medication in older populations by electronic decision support (the PRIMA-eDS study): a qualitative study of practical implementation in primary care.

BACKGROUND: Within the EU-funded project PRIMA-eDS (Polypharmacy in chronic diseases: Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support) an electronic decision support tool (the "PRIMA-eDS-tool") was developed for general practitioners (GPs) to reduce inappropriate medication in their older polypharmacy patients. After entering patient data relevant to prescribing in an electronic case report form the physician received a comprehensive medication review (CMR) on his/her screen displaying recommendations regarding missing indications, necessary laboratory tests, evidence-base of current medication, dose adjustments for renal malfunction, potentially harmful drug-drug interactions, contra-indications, and possible adverse drug events. We set out to explore the usage of the PRIMA-eDS tool and the adoption of the recommendations provided by the CMR to optimise the tool and prepare it for its future implementation. METHODS: In a qualitative study carried out in North Rhine-Westphalia, Germany, 21 GPs using the PRIMA-eDS tool within the PRIMA-eDS study were interviewed. Interviews encompassed the GPs' attitudes regarding use of the electronic case report form and the CMR, their response to the recommendations, and the implementation of the tool into daily practice routine. The collected data were analysed applying thematic qualitative text analysis. RESULTS: GPs found the patient data entry into the electronic case report form to be inconvenient and time-consuming. The CMR was conducted often outside practice hours and without the patient present. GPs found that the PRIMA-eDS CMR provided relevant information for and had several positive effects on the caring process. However, they encountered several barriers when wanting to change medication. CONCLUSIONS: It is unlikely that the PRIMA-eDS CMR will be used in the future as it is now as patient data entry is too time-consuming. Several barriers towards deprescribing medications were found which are common in deprescribing studies. Given the positive attitude towards the CMR, a new way of entering patient data into the PRIMA-eDS tool to create the CMR needs to be developed.

Correction to: Effectiveness and safety of vitamin K antagonists and new anticoagulants in the prevention of thromboembolism in atrial fibrillation in older adults - a systematic review of reviews and the development of recommendations to reduce inappropriate prescribing.

CORRECTION: After publication of the original article [1] it was found that author Marc Krause's name had been spelt incorrectly. In the original article it is presented as Mark Krause, rather than Marc Krause. The revised spelling has been included in the author list for this Correction.

A set of systematic reviews to help reduce inappropriate prescribing to older people: study protocol.

BACKGROUND: Multimorbidity and polypharmacy are common in older people. Assessment tools or lists of criteria aimed at supporting prescription decisions for older people exist, but have often been based on expert opinion with insufficient consideration of the evidence available. The present paper describes the methods we are using to systematically review the existing evidence on the efficacy and safety of the most commonly prescribed drugs for older people in the management of their chronic medical conditions and to develop recommendations to reduce inappropriate prescriptions for incorporation into the Comprehensive Medication Review (CMR) tool developed by the PRIMA-eDS European project. METHODS: We selected the 20 most relevant drugs/drug classes in terms of prescription volumes and risk of hospitalisation for older people and the most relevant indications for the most common chronic conditions among older people and a total of 35 distinct drug-indication pairs were chosen. Based on clinical considerations we collapsed some indications together, reducing the 35 pairs to a final total of 22 separate systematic reviews (SR). A common methodology will be used for each individual SR, based on the methodological manuals of the Cochrane collaboration and the PRISMA statement for reporting systematic reviews. Our search strategy will have a staged approach where we initially search for systematic reviews and meta-analyses, but if relevant reviews are not found, then search for individual studies (controlled intervention and observational studies). Our pilot work and initial scoping of the literature suggested that very few, relevant individual trials or existing systematic reviews have researched or reported exclusively on older people. Therefore, sufficient data might not be available to perform meta-analysis but we will provide a narrative synthesis describing characteristics and findings of included studies. The collected evidence will be used to construct recommendations on when not to use or to discontinue a drug, or when to reduce its dose. Recommendations will be developed in team meetings using the GRADE methodology to reflect the strength of the recommendation and the quality of the evidence. Recommendations will be built into the CMR tool. DISCUSSION: This protocol has been prepared for a series of systematic reviews which will provide research-based evidence to develop recommendations to reduce inappropriate polypharmacy in older people as part of the CMR tool of the PRIMA-eDS project.

Effectiveness and patient safety of platelet aggregation inhibitors in the prevention of cardiovascular disease and ischemic stroke in older adults - a systematic review.

BACKGROUND: Platelet aggregation inhibitors (PAI) are among the most frequently prescribed drugs in older people, though evidence about risks and benefits of their use in older adults is scarce. The objectives of this systematic review are firstly to identify the risks and benefits of their use in the prevention and treatment of vascular events in older adults, and secondly to develop recommendations on discontinuing PAI in this population if risks outweigh benefits. METHODS: Staged systematic review consisting of three searches. Searches 1 and 2 identified systematic reviews and meta-analyses. Search 3 included controlled intervention and observational studies from review-articles not included in searches 1 and 2. All articles were assessed by two independent reviewers regarding the type of study, age of participants, type of intervention, and clinically relevant outcomes. After data extraction and quality appraisal we developed recommendations to stop the prescribing of specific drugs in older adults following the Grading of Recommendations Assessment Development and Evaluation (GRADE) methodology. RESULTS: Overall, 2385 records were screened leading to an inclusion of 35 articles reporting on 22 systematic reviews and meta-analyses, 11 randomised controlled trials, and two observational studies. Mean ages ranged from 57.0 to 84.6 years. Ten studies included a subgroup analysis by age. Overall, based on the evaluated evidence, three recommendations were formulated. First, the use of acetylsalicylic acid (ASA) for primary prevention of cardiovascular disease (CVD) in older people cannot be recommended due to an uncertainty in the risk-benefit ratio (weak recommendation; low quality of evidence). Secondly, the combination of ASA and clopidogrel in patients without specific indications should be avoided (strong recommendation; moderate quality of evidence). Lastly, to improve the effectiveness and reduce the risks of stroke prevention therapy in older people with atrial fibrillation (AF) and a CHA2DS2-VASc score of ≥ 2, the use of ASA for the primary prevention of stroke should be discontinued in preference for the use of oral anticoagulants (weak recommendation; low quality of evidence). CONCLUSIONS: The use of ASA for the primary prevention of CVD and the combination therapy of ASA and clopidogrel for the secondary prevention of vascular events in older people may not be justified. The use of oral anticoagulants instead of ASA in older people with atrial fibrillation may be recommended. Further high quality studies with older adults are needed.

Effectiveness and safety of beta blockers in the management of hypertension in older adults: a systematic review to help reduce inappropriate prescribing.

BACKGROUND: The benefit from a blood pressure lowering therapy with beta blockers may not outweigh its risks, especially in older populations. The aim of this study was to look for evidence on risks and benefits of beta blockers in older adults and to use this evidence to develop recommendations for the electronic decision support tool of the PRIMA-eDS project. METHODS: Systematic review of the literature using a stage approach with searches for systematic reviews and meta-analyses first, and individual studies only if the previous searches are inconclusive. The target population were older adults (≥65 years old) with hypertension. We included studies reporting on the effectiveness and/or safety of beta blockers on clinically relevant endpoints (e.g. mortality, cardiovascular events, and stroke) in the management of hypertension. The recommendations were developed according to the GRADE methodology. RESULTS: Fifteen studies were included, comprising one meta-analysis, four randomized controlled trials, six secondary analyses of randomized controlled trials and four observational studies. Seven studies involved only older adults and eight studies reported subgroup analyses by age. With regard to a composite endpoint (death, stroke or myocardial infarction) beta blockers were associated with a higher risk of events then were other antihypertensive agents. Further, beta blockers showed no benefit compared to other antihypertensive agents or placebo regarding mortality. They appear to be less effective than other antihypertensive agents in reducing cardiovascular events. Contradictory results were found regarding the effect of beta blockers on stroke. None of the studies explored the effect on quality of life, hospitalisation, functional impairment/status, safety endpoints or renal failure. CONCLUSION: The quality of current evidence to interpret the benefits of beta blockers in hypertension is rather weak. It cannot be recommended to use beta blockers in older adults as first line agent for hypertension.

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.

BACKGROUND: Multimorbidity 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. METHODS: The "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. DISCUSSION: The 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 REGISTRATION: This trial has been registered with Current Controlled Trials Ltd. on 31 July 2014 (ISRCTN10137559).