Nurse-led immunotherapy decision coaching in persons with relapsing-re

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Background and study aims Due to the growing number of available immunotherapy drugs for patients with Multiple Sclerosis (MS), decisions on drug treatment have become more complex. Moreover, the costs of treatments are high with many patients stopping treatment after a while. This study aims to find out whether patients with MS benefit from detailed information about immunotherapy treatment options, provided by trained MS nurses (called decision coaches). These coaches will support patients in the decision-making process. Patients will receive high-quality information and coaches will discuss this information with patients using a shared communication approach. This shared decision-making approach aims to present and discuss the available evidence on immunotherapy equally between patient and Coach. We expect that more active participation of patients in immunotherapy decision making will increase patients’ knowledge, improve adherence to decisions and lead to a higher decision quality. Who can participate? We will include 300 patients with suspected or the relapsing form of MS (‘relapsing-remitting MS’) who are facing a decision on starting, stopping, or changing MS immunotherapy. What does the study involve? Interested nurses from five of 10 randomly chosen major MS centres in Germany will be trained to achieve the relevant skills in order to perform the decision coaching. In the remaining five centres, no coaches will be trained. About 30 patients per centre will take part in the study. All patients will get access to an internet-based information platform. In five centres (intervention centres), participating patients will receive the decision coaching. The decision coaching consists of up to three face-to-face coaching sessions with the decision coach, before the final consultation with the doctor takes place. Patients in the other five centres (control centres) will, apart from access to the information platform, receive regular care. Participating patients have to fill in a number of online questionnaires at different time points during the study; they will also be interviewed via telephone. After the study, results from both groups will be compared to find out whether decision coaching is helpful for patients and if it enables patients to make better and more sustainable decisions. What are the possible benefits and risks of participating? We expect that in the intervention centres decision coaching leads to more active participation in decision making on immunotherapy. Patients’ relevant knowledge will increase and lead to more informed decisions and therefore to improved adherence. We think that patients will benefit from the opportunity to reflect longer on the different options and from the personal and individually adapted contact with the decision coach. We do not foresee any serious risks concerning our intervention. However, it is possible that patients are disappointed about the scientific uncertainties of the immunotherapy options. Where is the study run from? The study will be conducted in 10 MS centres in Germany: Hamburg, Bochum, Heidelberg, Bad-Mergentheim, Berlin, Osnabrück, Gießen, Düsseldorf, Rostock and Münster). When is the study starting and how long is it expected to run for? June 2014 to November 2015 Who is funding the study? Federal Ministry of Education and Research within the Competence Network Multiple Sclerosis (Kompetenznetz Multiple Sklerose – KKNMS) (Germany) Who is the main contact? Prof. Christoph Heesen heesen@uke.de