Nurse-led immunotreatment DEcision Coaching In people with Multiple Sclerosis (DECIMS) - A cluster- randomised controlled trial and mixed methods process evaluation.

ABSTRACT

OBJECTIVE: To evaluate a nurse-led decision coaching programme aiming to redistribute health professionals' tasks to support immunotherapy decision-making in people with multiple sclerosis (MS). METHODS: Cluster-randomised controlled trial with an accompanying mixed methods process evaluation (2014 - 2018). We planned to recruit 300 people with clinically isolated syndrome or relapsing-remitting MS facing immunotherapy decisions in 15 clusters across Germany. Participants in the intervention clusters received up to three decision coaching sessions by a trained nurse and access to an evidence-based online information platform. In the control clusters, participants also had access to the information platform. The primary outcome was informed choice after six months, defined as good risk knowledge and congruent attitude and uptake. RESULTS: Twelve nurses from eight clusters participated in the decision coaching training. Due to insufficient recruitment, the randomised controlled trial was terminated prematurely with 125 participants (n = 42 intervention clusters, n = 83 control clusters). We found a non-significant difference between groups for informed choice favouring decision coaching odds ratio 1.64 (95% CI 0.49-5.53). CONCLUSIONS: Results indicate that decision coaching might facilitate informed decision-making in MS compared to providing patient information alone. PRACTICE IMPLICATIONS Barriers have to be overcome to achieve structural change and successful implementation.