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

Table 1 Major endpoints CRCT

Instrument		Measurement time points
		Enrolment	Allocation	Post-allocation
		-t₁	t₀	t₁	t₂	t₃	t₄	t₅
Eligibility screen		X
Informed consent		X
Allocation
Sociodemographic data		X	X
EDSS			X
SDMT			X
MS-related data and resource use			X				X	X
MMIC:
	Risk knowledge		X			X	X	X
	Attitude			X	X	X
	Immunotherapy status		X			X	X	X
Dyadic DCS				X (nurse)	X (physician and patient)
Dyadic MAPPIN’SDM				X (nurse and patient)	X (physician and patient)
HCR trust scale (Physician/Nurse trust)				X	X
PBMS			X			X		X
CPS			X			X		X
Decision autonomy						X	X	X
CSES			X			X		X
HAQUAMS			X			X		X
HADS			X			X		X

t₁ = after last decision coaching; t₂ = directly after final physician decision encounter; t₃ = two weeks after final physician encounter; t₄ = three months after final physician encounter; t₅ = six months after final physician encounter. CPS: Control Preference Scale; CSES: Coping self-efficacy scale; DCS: Decisional Conflict Scale; EDSS: Expanded Disability Status Scale; HADS: Hospital Anxiety and Depression Scale; HAQUAMS: Hamburg Quality of Life in MS Scale; HCR trust scale: Health care relationship trust scale; MAPPIN’SDM: Multifocal Approach to Sharing in Shared Decision Making; MMIC: Multi-dimensional measure of informed choice; MS: Multiple Sclerosis; PBMS: Planned Behaviour in MS Scale; SDMT: Symbol Digital Modalities Test.

ISSN: 1745-6215