Title: A Multi-Centre Randomised Controlled Trial to Compare the Effectiveness of Admission Avoidance Hospital at Home with Comprehensive Geriatric Assessment vs. Inpatient Comprehensive Geriatric Assessment on the Number of Frail Older People ‘Living at Home’
Funder: Department of Health and Social Care

Abstract: BACKGROUND Evidence is needed on how to provide high quality acute hospital level care to older adults in greater numbers with a fixed or shrinking hospital resource (1). OBJECTIVE We will test the cost-effectiveness of hospital at home (HaH) with comprehensive geriatric assessment (CGA) compared with hospital admission with CGA. DESIGN A multi-centre randomised controlled trial (RCT), a parallel economic evaluation and interview study comparing CGA in an admission avoidance HaH setting with hospital admission with CGA; an update of the Cochrane Review of HaH. SETTING HaH and inpatient hospitals in England, Wales and Scotland. LITERATURE REVIEW We will update the Cochrane Review of admission avoidance HaH. TARGET POPULATION Older people with markers of frailty or prior dependence, this will include patients presenting with delirium, functional decline, dependence, falls, immobility or a background of dementia presenting with physical disease. We will exclude patients with acute coronary syndrome, requiring acute surgical assessment, a suspected stroke, refusing HaH or considered by the clinical staff to be too high risk for home based care. INTERVENTION Admission avoidance HaH with CGA provides active treatment by healthcare professionals for a condition that otherwise would require acute in-patient care. CGA is a specialist led service providing multi-level assessment and management, a tailored management plan and co-ordinated care. Usual care will be hospital-based inpatient CGA. MEASUREMENT OF COSTS AND OUTCOMES Primary outcome: living at home (the inverse of death or living in a residential care setting). Secondary outcomes: incidence of delirium (2), mortality, new long-term residential care, cognitive impairment (3), activities of daily living (4), quality of life and quality adjusted survival (EQ-5D) (5), length of stay, readmission or transfer to hospital, resource use, costs and cost-effectiveness. Follow-up will be at 6 and 12 months. SAMPLE SIZE With 90% power, a two tailed test of significance at the level of 0.05, we will need to recruit 1552 participants to detect a 10% absolute difference in the primary outcome living at 12 months, assuming a control group event rate at 12 months of 50% (1). PROJECT TIMETABLE This will be a two phase trial; in phase one (18 months) we will establish feasibility of recruitment, randomisation and data collection; if successful we will continue in phase 2 (30 months). An update of the Cochrane Review will start in year 2 and be completed in year 4. (1)Shepperd S et al. Hospital at home admission avoidance. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD007491. DOI: 10.1002/14651858. (2)Inouye SK et al et al, Clarifying Confusion: The Confusion Assessment Method. A New Method for Detection of Delirium. Ann Intern Med. 1990; 113:941-8 (3)Nasreddine ZS et al. The Montreal Cognitive Assessment (MoCA): A Brief Screening Tool For Mild Cognitive Impairment. J Amer Ger Soc 53:695-699, 2005 (4)Wade D, et al. The Barthel ADL Index: A standard measure of physical disability. Int Dis Studies 1988;10(2):64-7. (5)EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199-20

Lay abstract: Evidence is needed on how to provide high quality acute hospital level care to older adults in greater numbers with a fixed or shrinking hospital resource. Evidence from a few small studies has suggested that frail older people may be less likely to die if they receive hospital specialist care in their own home. These types of services are commonly called 'admission avoidance hospital at home’. Importantly this approach was preferred by patients and their carers and may be less costly than hospital care. It is important to stress that the evidence for these findings is from a few small studies and we have a moderate level of uncertainty about how robust the findings are. We know from previous research that older adults with multiple health problems and disability, who are admitted to hospital, will do much better when a specialist assesses their health problems and co-ordinates their care. We aim to combine and evaluate the effectiveness of these two models of care (admission avoidance hospital at home and specialist led care) in a study conducted in several centres. We will look at key health outcomes (such as death, living at home, transfer to hospital and admission to residential care) and will also look at the patient and carer experience as well as the cost effectiveness. We will randomise eligible patients to i) the provision of admission avoidance hospital at home setting with specialist led geriatric care vs. ii) specialist hospital care for the frailer older adult. We will recruit older people (>65 years) requiring hospital admission after they have been referred by their GP. A research nurse will discuss the research with patients who are eligible for our research and their carers, provide them with written information describing the research and will invite patients to participate. Patients who agree to participate will be asked to formally agree by reading and signing an informed consent form; the research nurse will then make a phone call to find out which type of care the patient will receive and will let the patient, and their carer, know if they will receive specialist home care or specialist hospital care. Before starting this research we will apply for approval from the relevant research ethics and R&D committees, and we will seek the views of patients and carers about potential concerns with this type of research. One issue might be that patients, and/or their carers, wish to transfer to hospital care if they are receiving care at home. If this is the case then a transfer to hospital will be arranged. The research team has extensive experience in conducting research in this area and includes specialists in the care of older people in a hospital and community based setting. We will set up a committee to monitor the progress of patients who participate in this research and consider safety and ethical issues which may arise during the course of this research. Members of the committee will not be involved in the research. We will also set up a committee of advisors, referred to as a trial steering committee, which will include some of the research team and independent experts who will provide overall supervision of the research and will ensure the research is compliant with national standards for the conduct of high quality research.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE