Title: Development and testing of an intervention to improve Recovery after an Episode of Delirium (RecoverED study)
Funder: Department of Health and Social Care

Abstract: 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.

Lay abstract: Aims This programme aims to develop and test a package of activities (intervention) to help people recover from delirium. What is the problem? The word delirium describes a change in the brain which makes a person become suddenly more confused or more confused than usual. It affects a quarter of older people who come into hospital. Delirium is usually caused by an illness such as an infection. Many people take months to recover their memory and thinking skills, and some never recover completely. Previous research has looked at how to prevent and treat delirium while people are in hospital but there has been little research into how to improve people s recovery after delirium. What do we intend to do? First, we will ask an expert panel with patient and public involvement (PPI) to help us design an evidence-based intervention. The intervention will include physical exercises, activities to improve memory and emotional support. Then we will undertake a small study to test our approach. This is to test whether the intervention works well, and whether people are willing to take part. Sixty people who have had delirium will take part: they will receive the intervention for six-twelve weeks. The intervention will be delivered by therapists. Three and six months after the intervention we will measure how well they are able to look after themselves, memory and thinking skills, quality of life, use of health, social and care services and impact on well-being of carers. We will interview some participants and professionals involved to see how the intervention could be improved. Finally, we will undertake the larger trial and value-for-money assessment of the improved intervention. We will recruit approximately 500 people. Half will be randomly chosen to receive the intervention and half will receive usual care. We will follow them up at three and six months using the same measures as the small study. We will interview participants to help us see how to implement this intervention. At the end of the study, we will be able to say whether the intervention benefits people who have had delirium, whether it s good value-for-money and if successful, how it should be introduced into the NHS. Involving the public A PPI advisory group has helped develop this programme. They will participate in project management meetings, advise on documents for participants and help write newsletters and lay summaries of research. Sharing our findings We will set up a website and social media accounts and produce newsletters. We will hold meetings for participants to share our results. The findings will be shared at scientific meetings and published in scientific journals. We will work with decision-makers, associations for specialists such as therapists and charities to share our results. &emsp;

Research activity codes: 5.7 PHYSICAL;6.6 PSYCHOLOGICAL AND BEHAVIOURAL;6.7 PHYSICAL;5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH