Impact of a multimedia website with patient experiences of multiple sclerosis (PExMS) on immunotherapy decision-making: study protocol for a pilot randomised controlled trial in a mixed-methods design

Abstract Background A variety of management options (e.g. immunotherapies, lifestyle interventions, and rehabilitation) are available for people with relapsing-remitting multiple sclerosis (RRMS). Besides coping the diagnosis, MS (pwMS) have to make complex decisions such as deciding about immunotherapies. In addition factual information, reports patient experiences (PEx) may support patients in decision-making. The added value PEx decision-making is not clear, controlled studies rare. Therefore, systematic methods necessary develop analyse PEx. As there no evaluated Germany, we currently creating a website presenting structured according topics illustrated by video, audio, text files. We aim determine feasibility an intervention using evaluate whether help pwMS their immunotherapy processes supplement evidence-based information. Methods This project will follow Medical Research Council framework development evaluation interventions. After PEx, randomised pilot trial (pilot RCT) be conducted 2–3 centres, clinics, or rehabilitation centres including 55 accompanied process evaluation. Patients RRMS diagnosis considering eligible. primary outcome decision self-efficacy. Secondary outcomes include preparation decision-making, decisional conflict, risk knowledge, confidence active participation, affective forecasting, social support, self-reported impact eHealth on its users. Participants randomly assigned either (i) group 4 weeks access information resource PExMS-website adjunct (ii) control alone. 6-member advisory panel involving representatives pwMS, researchers, neurologists, who accompany whole project, mentor this RCT. Discussion was developed methods, created involvement critical appraisal expert panel. study innovative it contributes controversial evidence use context Trial registration ClinicalTrials.gov, NCT04236544