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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…

Overview of attention for article published in Trials, March 2015
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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
Published in
Trials, March 2015
DOI 10.1186/s13063-015-0611-7
Pubmed ID
Authors

Anne Christin Rahn, Sascha Köpke, Jürgen Kasper, Eik Vettorazzi, Ingrid Mühlhauser, Christoph Heesen

Abstract

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. 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. 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. Current Controlled Trials (identifier: ISRCTN37929939 ), May 27, 2014.

Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 211 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Spain 1 <1%
Germany 1 <1%
Canada 1 <1%
Unknown 208 99%

Demographic breakdown

Readers by professional status Count As %
Student > Master 36 17%
Student > Ph. D. Student 30 14%
Researcher 25 12%
Student > Doctoral Student 20 9%
Student > Bachelor 15 7%
Other 38 18%
Unknown 47 22%
Readers by discipline Count As %
Medicine and Dentistry 53 25%
Nursing and Health Professions 34 16%
Psychology 33 16%
Social Sciences 11 5%
Business, Management and Accounting 4 2%
Other 21 10%
Unknown 55 26%