title: Evaluator-blinded trial evaluating nurse-led immunotherapy DEcision Coaching In persons with relapsing-remitting Multiple Sclerosis (DECIMS) and accompanying process evaluation: study protocol for a cluster randomised controlled trial.
abstract: BACKGROUND
  Multiple 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
  The 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.
  
  
  CONCLUSIONS
  This 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.
  
  
  BACKGROUND
  Current Controlled Trials (identifier: ISRCTN37929939 ), May 27, 2014.
authors: Institute for Neuroimmunology and Clinical MS Research, University Medical Center Hamburg-Eppendorf, Martinistraße 52, D-20246, Hamburg, Germany. Anne.Rahn@uni-hamburg.de.|Unit of Health Sciences and Education, MIN Faculty, University of Hamburg, Martin-Luther-King-Platz 6, D-20146, Hamburg, Germany. Anne.Rahn@uni-hamburg.de.
authors: Anne Christin
authors: AC
authors: Rahn
authors: Nursing Research Unit, Institute of Social Medicine and Epidemiology, University of Lübeck, Ratzeburger Allee 160, D-23538, Lübeck, Germany. sascha.koepke@uksh.de.
authors: Sascha
authors: S
authors: Köpke
authors: Faculty of Health Sciences, Department of Health and Care Sciences, University of Tromsø, MH Building, N-9037, Tromsø, Norway. juergen.kasper@uit.no.
authors: Jürgen
authors: J
authors: Kasper
authors: Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, D-20246, Hamburg, Germany. E.Vettorazzi@uke.de.
authors: Eik
authors: E
authors: Vettorazzi
authors: Unit of Health Sciences and Education, MIN Faculty, University of Hamburg, Martin-Luther-King-Platz 6, D-20146, Hamburg, Germany. Ingrid_Muehlhauser@uni-hamburg.de.
authors: Ingrid
authors: I
authors: Mühlhauser
authors: Institute for Neuroimmunology and Clinical MS Research, University Medical Center Hamburg-Eppendorf, Martinistraße 52, D-20246, Hamburg, Germany. heesen@uke.de.|MS Day Hospital and Outpatient Unit, Department of Neurology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, D-20246, Hamburg, Germany. heesen@uke.de.
authors: Christoph
authors: C
authors: Heesen
mesh_terms: D002985:Clinical Protocols; D006801:Humans; D007167:Immunotherapy; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000628:therapy*; D009726:Nurses; D018579:Patient Selection; D018401:Sample Size