Table 4 Secondary endpoints based on part 1 and part 3
Outcome | Assessment procedure | Assessment timepoints | Corresponding study objectives |
|---|---|---|---|
Part 1 — testing cognitive screening pathway | |||
Feasibility of the cognitive screening pathway procedures | Number of patients who complete the screening in different settings (at home, in-clinic) | Throughout part 1 data collection period | Part 1 Objectives 1, 2, and 3 |
Number of different devices patients use to complete the screening (e.g. tablet, mobile phone, laptop) | |||
Time taken to complete the screening (in minutes) | |||
Number of patients who require reminders and extra support (telephone/in-clinic) to complete the screening | |||
Number and content of contacts between service providers and patient-participants | |||
Patient scores from the cognitive screening measures | Symbol substitution task and/or word colour test and three measures from the Multiple Sclerosis Quality of Life Inventory for self-reported cognitive problems, fatigue, and mental health | Measured during screening as part of usual care | Part 1 Objectives 3 and 4 |
Part 3 — Exploring stakeholder views and experiences | |||
Feasibility and acceptability of trial procedures through qualitative data | Interviews will explore patients’ willingness to be randomised; patients’ views on trial recruitment and retention strategies, preferences, barriers, and facilitators to trial recruitment and retention; importance and acceptability of outcome measures | 3-month and 6-month interviews with patients and interviews with intervention providers | Part 3 Objective 1 |
Operational issues in the delivery of cognitive screening and management pathway | Contextual factors which influence intervention and pathway delivery, including mechanisms which influence its affect and outcomes; behavioural elements of the intervention, essential resources needed, and barriers to screening and intervention delivery Reviewing notes from monthly teleconferences/videoconferences with clinicians and supervision sessions with intervention providers and the part 3 interviews | Throughout data collection (notes) 3-month and 6-month interviews with patients and interviews with intervention providers and clinicians | Part 3 Objectives 2, 3, 4, and 6 |
Patient, intervention provider and clinician experiences of cognitive screening and management pathway | Engagement with the pathway; mechanisms considered important in determining key outcomes: Reviewing notes from monthly teleconferences/videoconferences with clinicians and supervision sessions with intervention providers and the part 3 interviews | Throughout data collection (notes) 3-month and 6-month interviews with patients and interviews with intervention providers and clinicians | Part 3 Objectives 2, 3, 4, and 6 |
Intervention provider experiences of training | Interviews to explore intervention providers’ readiness to deliver NEuRoMS intervention following training; potential contamination issues; potential improvements to training: reviewing training feedback forms, supervision sessions with intervention providers, and part 3 interviews with intervention providers | Throughout data collection (notes) Interviews with intervention providers | Part 3 Objectives 5 and 6 |