The clinical, social and cost effectiveness of a decision support tool to optimise community-based tailored management of sleep (TIMES) for people living with dementia or mild cognitive impairment and sleep disturbanceTIMES –TaIlored ManagEment of Sleep

Research Questions: What are the key factors influencing interpretation of sleep disturbance and so clinical decision making by clinicians, patients and carers in dementia or MCI? What are in-practice enablers/barriers to tailored sleep management? What should be included in the intervention, who should deliver it and how? Is a randomised controlled trial (RCT) of this intervention feasible? Is a system-embedded tailored sleep management tool to improve outcomes of PLWD/MCI and sleep disturbance clinically and economically effective to implement from a health and personal social service perspective? Which intervention components provide benefit for which groups in dementia and MCI? Background: In the UK, there are 850,000 PLWD and 2.4 million people with MCI. Sleep problems are common in PLWD (20-90%) and MCI (18.3–45.5%).57,58 There are no licensed medications for this and medicines used have harms. Sleep management in PLWD and MCI is a wicked design problem because the problem is complex, the knowledge required to understand and address it includes multiple disciplines and subject expertise, and because interventions do not fix but support best management in context. 6,8,59 Aims: We will develop and test a tool (TIMES) to help primary-care clinicians working with patients/carers to implement tailored decisions on sleep management for PLWD/MCI. Objectives: To develop a tailoring sleep management tool that enables community-based clinicians to optimise the tailored care of PLWD or MCI and sleep disorders, and their carers. Co-design structure and implementation of TIMES Test the feasibility of TIMES Test TIMES in a cluster RCT with internal pilot Evaluate TIMES costs and benefits from an NHS & Personal Social Services (PSS) perspective Methods: WP 1 refines the conceptual framework for a new complex intervention. WP 2 uses co-production methods to translate known components of tailored care (from literature and professional practice) for the tailored management of sleep in the UK context. WP3 2-arm cluster randomised feasibility trial, in 8 general practice sites, recruiting 64 participants (patients and carers) (32 intervention 32 control) over 5 months. Participants, seen in primary care, will receive the TIMES intervention or receive treatment as usual. We will test recruitment, retention and outcomes (patients: sleep duration/quality, behaviour, quality of life and medication usage, carers; sleep, mood and anxiety, burden, quality of life). WP4 2-arm cluster randomised controlled trial of clinical and cost effectiveness, in 110 general practices recruiting an estimated sample size of 495 over 13 months, designed with information from WP3 feasibility study. Timelines for delivery: The programme is over 60 months, development, co-design and refinement take place up to month 22, the implementation study months 1-54, CRCTs months 19–54. Dissemination activities take place throughout as work-packages report with final trial results and final report months 54-60. Anticipated impact and dissemination: Potential is for widespread impact due to the fundamental health importance of sleep, the particular management problems for people with dementia/MCI their families and limited options in primary care. We will approach dissemination proactively, engaging with academic, policy, professional/practitioner and lay audiences.