Randomized trial reveals feasibility challenges and low recruitment for home-based post-delirium rehabilitation in older adults, indicating the need to refine delivery pathways.
Background Delirium is a common neurocognitive disorder in older adults and is associated with poor outcomes. Cognitive, mood and functional deficits can persist for months following an episode, impacting long-term well-being. While previous research has focused on delirium prevention and guidelines exist for short-term management, there remains a critical gap in understanding and supporting longer-term recovery. Objectives Objectives were to: (1) develop an intervention to improve recovery after delirium; (2) conduct a feasibility study of the intervention in people who have had delirium; and (3) conduct a definitive randomised controlled trial 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. Design The study consisted of four work packages. In work package 1, we designed a complex, theory-based rehabilitation intervention informed by a realist review, qualitative research and expert panel input. Work package 2, using a single-arm study, assessed the feasibility of the intervention and of undertaking a definitive randomised controlled trial and cost-effectiveness analysis with an embedded process evaluation, while the aim of work package 3 was to test its effectiveness in a definitive randomised controlled trial, and the aim of work package 4 was to focus on implementation in real-world settings. Setting Acute admissions wards and community follow-up after discharge at six National Health Service hospital sites. Participants Patients aged ≥ 65 years experiencing delirium during acute hospital admission. Intervention Home-based rehabilitation programme designed to support recovery after hospital discharge, addressing cognitive, physical, physiological and psychosocial needs. Delivered by a trained team of occupational therapists, physiotherapists and rehabilitation support workers, the intervention included a comprehensive home assessment, collaborative goal setting, up to 10 personalised therapy sessions over 12 weeks, the use of a recovery record to guide progress, education and psychosocial support. Main outcome measures The main objective of work package 1 was the development of a theory-based and person-centred rehabilitation intervention for individuals recovering from delirium. It included structured components targeting physical, cognitive and emotional recovery, along with an intervention manual and training materials for healthcare professionals. In work package 2, we assessed feasibility, including eligibility, recruitment, data collection, attrition, acceptability of the rehabilitation intervention and the cost-effectiveness framework for a subsequent definitive trial. Patient and carer participants and professional delivering the intervention were interviewed in a process evaluation. Results The intervention was developed using insights from a realist review, stakeholder interviews and expert panel discussions, identifying key recovery domains: physical, cognitive and emotional. Key facilitators included carer involvement, tailoring to individual needs, fostering interpersonal connections and promoting positive self-expression. The feasibility study identified 435 patients with delirium across 6 hospitals, of whom 36 (8%) met eligibility criteria, with 19 (53%) of these consenting to participate. Among those enrolled, 13 (68%) started the intervention, and 10 (53%) completed the final follow-up. Participants had a mean (standard deviation) baseline disability assessment for dementia score of 43.7 (27.1), reflecting the functional status of the recruited population. The mean cost of delivering the intervention was £1249 per participant. The process evaluation highlighted the intervention’s flexibility, acceptability and strong continuity of care, although challenges in recruitment and retention were noted. Limitations In work package 2, the study was limited by a lack of ethnic diversity, reliance on clinical teams for delirium diagnosis and potential selection bias due to staff capacity constraints, which may have impacted recruitment and generalisability. Recruitment was insufficient to progress to the definitive randomised controlled trial, preventing further evaluation and the final implementation study. Following a funding review, the programme was discontinued after work package 2. Patient and public involvement and engagement A patient and public involvement and engagement group of people who had experienced delirium and carers was involved throughout the programme. They assisted with participant materials, design of the intervention, interpretation of the results and recruitment strategies. Conclusions A multidisciplinary rehabilitation intervention for delirium recovery was successfully developed and implemented, with high engagement from participants who remained in the study. However, challenges in recruitment and retention to an evaluation study must be addressed. Future work Future research should focus on understanding hospital processes, the natural history of delirium recovery, community pathways and available services. Refining inclusion criteria will be essential to ensure the feasibility of conducting a randomised controlled trial or other evaluation of the intervention. Study registration This study is registered as ISRCTN15676570, registered 13 December 2022. https://doi.org/10.1186/ISRCTN15676570 Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: NIHR202338) and is published in full in Programme Grants for Applied Research ; Vol. 14, No. 7. See the NIHR Funding and Awards website for further award information.
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