Abstract
BackgroundMultiple sclerosis is a chronic neurological condition usually starting in early adulthood and regularly leading to severe disability. Immunotherapy options are growing in number and complexity, while costs of treatments are high and adherence rates remain low. Therefore, treatment decision-making has become more complex for patients. Structured decision coaching, based on the principles of evidence-based patient information and shared decision-making, has the potential to facilitate participation of individuals in the decision-making process.This cluster randomised controlled trial follows the assumption that decision coaching by trained nurses, using evidence-based patient information and preference elicitation, will facilitate informed choices and induce higher decision quality, as well as better decisional adherence.Methods/DesignThe decision coaching programme will be evaluated through an evaluator-blinded superiority cluster randomised controlled trial, including 300 patients with suspected or definite relapsing-remitting multiple sclerosis, facing an immunotherapy decision. The clusters are 12 multiple sclerosis outpatient clinics in Germany. Further, the trial will be accompanied by a mixed-methods process evaluation and a cost-effectiveness study.Nurses in the intervention group will be trained in shared decision-making, coaching, and evidence-based patient information principles. Patients who meet the inclusion criteria will receive decision coaching (intervention group) with up to three face-to-face coaching sessions with a trained nurse (decision coach) or counselling as usual (control group). Patients in both groups will be given access to an evidence-based online information tool.The primary outcome is ‘informed choice’ after six months, assessed with the multi-dimensional measure of informed choice including the sub-dimensions risk knowledge (questionnaire), attitude concerning immunotherapy (questionnaire), and immunotherapy uptake (telephone survey). Secondary outcomes include decisional conflict, adherence to immunotherapy decisions, autonomy preference, planned behaviour, coping self-efficacy, and perceived involvement in coaching and decisional encounters. Safety outcomes are comprised of anxiety and depression and disease-specific quality of life.DiscussionThis trial will assess the effectiveness of a new model of patient decision support concerning MS-immunotherapy options. The delegation of treatment information provision from physicians to trained nurses bears the potential to change current doctor-focused practice in Germany.Trial registrationCurrent Controlled Trials (identifier: ISRCTN37929939), May 27, 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0611-7) contains supplementary material, which is available to authorized users.
Highlights
Multiple sclerosis is a chronic neurological condition usually starting in early adulthood and regularly leading to severe disability
The analysis focuses the assessment of coaching quality on respective shared decision-making (SDM) content Here, patient information about benefits and harms of therapy options, using the DECIMS-Wiki, are of particular relevance
The process evaluation offers the opportunity to capture the way in which the complex intervention causes effects, and to determine factors that have a supporting or hindering influence
Summary
Multiple sclerosis is a chronic neurological condition usually starting in early adulthood and regularly leading to severe disability. Structured decision coaching, based on the principles of evidence-based patient information and shared decision-making, has the potential to facilitate participation of individuals in the decision-making process. This cluster randomised controlled trial follows the assumption that decision coaching by trained nurses, using evidence-based patient information and preference elicitation, will facilitate informed choices and induce higher decision quality, as well as better decisional adherence. Recent insurance company based numbers have estimated there to be around 180,000 affected people in Germany [4]. Annual costs per patient in Europe are estimated at €18,000 for mild MS (Expanded Disability Status Scale (EDSS) 7.0) [6]. Total societal costs in Germany have been estimated at around €4,000,000,000 in 2001 [3]
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