Development and testing of an intervention to improve Recovery after an Episode of Delirium (RecoverED study)

Research questions i. What are the therapeutically active components of an intervention to improve recovery after delirium? ii. Is it feasible to deliver a randomised controlled trial and cost-effectiveness analysis of such an intervention? iii. Is the intervention effective and cost-effective in improving outcomes compared with usual care and if so how should it be implemented? Background Delirium is a neurocognitive disorder common in older people. Delirium is associated with poor outcomes. Notably, cognitive, mood and functional deficits can persist for months after an episode of delirium. Previous research has addressed prevention of delirium, and there are guidelines on short-term treatment of delirium. However, no studies have addressed the problem of longer-term recovery after delirium. Aims To develop an intervention to improve recovery from delirium and test its effectiveness, cost-effectiveness and implementability. Objectives i. To develop an intervention to improve recovery after delirium ii. To conduct a feasibility study of the intervention in people who have had delirium compared with usual care iii. To conduct a definitive randomised controlled trial (RCT) and cost-effectiveness analysis of the intervention in people who have had delirium compared with usual care, with parallel process evaluation and an embedded implementation study. Methods Work package (WP) 1: Intervention design Design of a new complex intervention. An expert panel will review evidence from previous research to select appropriate components for the intervention. WP2: Feasibility study and intervention refinement Design: Feasibility multi-centre single arm trial, assess economic evaluation framework, process evaluation. Setting: Intervention in the home after discharge from acute admissions wards, 6 sites Population: 60 People aged over 65 with delirium according to DSM-5 criteria (either with or without dementia), their carers and professionals caring for them. Intervention: Complex intervention designed and manualised during WP1, covering the following domains: 1) support for physical recovery through structured exercise programmes; 2) support for cognitive recovery through cognitively stimulating activities; 3) support for emotional recovery through talking with skilled helpers. Outcomes: Feasibility outcomes and proposed primary outcome: ADL assessed with Disability Assessment for Dementia (DAD) at 6 months after discharge from hospital. Secondary outcomes: Delirium, attention, arousal, cognition, mood, wellbeing, residence, carer burden, carer quality of life, resource use. WP3: Definitive randomised controlled trial with internal pilot Design: Multi-centre definitive RCT, cost-effectiveness analysis, process evaluation. Settings: As WP2, 12 sites Population: 492 People with delirium, carers and professionals caring for them. Intervention: Complex intervention refined following WP2 Comparison: Usual care Randomisation: Participants randomised (1:1) to receive either the intervention or usual care. Primary Outcome: DAD at 6 months Secondary outcomes: as proposed in WP2 WP4: Implementation study: Implementation of intervention in two sites using existing resources: interviews with professionals delivering the intervention. Timelines for delivery Month(M)1-8: Intervention design. M1-26: Feasibility trial M27-60: Definitive trial M41-60: Implementation study Anticipated impact Improved recovery from delirium promotes independence, improves quality of life, reduces care needs, reduces carer burden. Dissemination Dissemination meetings for participants. Conferences and peer-reviewed journals. Presentations and education for commissioners, professional associations and charities. Summary findings shared via social media networks.