Neuropsychological Evaluation and Rehabilitation in Multiple Sclerosis - Developing, evaluating and implementing a clinical management pathway (NEuRoMS)

Background: Multiple sclerosis (MS) is the UK s leading cause of non-traumatic neurologic disability in young adults; and for the majority, it is progressive. The healthcare and societal costs associated with MS are high. Up to 70% of people with MS (pwMS) have cognitive problems, which affect their personal, professional and social life. However, in MS clinics, cognitive problems are not routinely identified and cognitive rehabilitation not offered. Cognitive screening batteries exist, but there is no evidence-based pathway to implement these in clinics, owing to systemic barriers. Systematic reviews suggest that cognitive rehabilitation is effective in reducing disability, but is based on evidence from studies evaluating group formats, mostly with pwMS with severe cognitive problems. However, approximately 50% of pwMS have mild-moderate cognitive problems, and their cognitive problems are often unidentified and not treated. Addressing cognitive problems is a 'top 10' research priority for pwMS. Aims and objectives: (1) To develop and evaluate a: (i) cognitive screening pathway for pwMS; and (ii) brief neuropsychological rehabilitation (BNR) for pwMS with mild-moderate cognitive problems, to reduce impact of these problems and improve quality of life. (2) To develop an implementation package to enable swift rollout of the cognitive screening and BNR intervention. Methods The programme develops over five work-packages (WPs). WP1, using qualitative methods, iteratively develops the cognitive screening technology and BNR with pwMS and key health and charity stakeholders; develops and tests the online/tablet screening; resulting in a refined programme theory and logic model, and intervention and staff training protocols. (Months 0-14). WP2 refines the screening and intervention pathway, implements it in three test sites, and assesses frequency of cognitive problems, and potential benefits and harms of screening and the BNR, using case studies and an observational study. (Months 15-20). WP3 is a three-site feasibility randomised controlled trial (RCT; n=60) assessing feasibility outcomes, and intervention fidelity evaluation, with a nested qualitative study to understand barriers and facilitators to progressing to WP4. (Months 21-30). WP4 is the definitive, pragmatic, individually randomised RCT evaluating clinical and cost-effectiveness of the BNR intervention, in six NHS MS clinics, randomising 478 pwMS with mild-moderate cognitive problems. The manualised, nurse/occupational therapist-delivered 1-2-1 intervention comprises psychoeducation, teaching cognitive and coping strategies, and dealing with mood and fatigue, plus usual care. The control arm receives usual care. The primary outcome is participant-reported impact of cognitive problems at 6-months post-randomisation. Secondary outcomes include quality of life, self-efficacy, mood, function, work, cognition, and drug-treatment adherence. A nested economic evaluation assesses cost-effectiveness. (Months 31-69). WP5 uses the qualitative data collected across all WPs (analysed for implementation-relevant content), with additional interviews with stakeholders to understand the process of implementation to real-world contexts. (Months 0-69). Impact and dissemination: We anticipate our intervention will improve quality of life of pwMS, enabling them to remain longer in education/employment; streamline service provision; and reduce NHS and societal costs in the long term. Dissemination will include participants, other pwMS, policy makers, commissioners, clinicians, and patient organisations through workshops, evidence summaries, academic/practitioner journal articles, conferences, study website and social media.