Title: Randomised controlled trial of hospital at home compared to standard inpatient management of patients with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD), triaged for hospital admission by Accident and Emergency and with low mortality risk according to the novel DECAF score.
Funder: Department of Health (England)

Abstract: Background In acute exacerbations of COPD (AECOPD), the Cochrane group concluded that there is insufficient evidence of clinical or financial benefit of Hospital at Home (HAH) compared to standard inpatient care.[4, 10] HAH may reduce readmissions,[5] but this analysis was influenced by one study[11] on selected patients (aged 75 years or older), with intensive input in the HAH arm and high readmission rates in the standard care arm. The evidence for other outcomes, including cost, is of low or very low quality.[5] Previous RCTs of HAH for AECOPD show considerable heterogeneity in selection criteria and level of support at home, limiting the generalisability of their results. NICE advise patient selection for HAH be based on prognosis, but acknowledge the (previous) lack of a prognostic tool.[6] In the recently developed DECAF score for AECOPD, 53% of unselected patients had a low risk of mortality (1.4%),[8] and therefore were potentially suitable for HAH. This is double the proportion of patients identified in earlier trials, which lacked a robust prognostic tool to inform patient selection. Aims We intend to conduct an RCT of HAH compared to standard inpatient care for patients with AECOPD and low risk DECAF score. We will assess clinical outcomes, patient preference, and health and social costs. An embedded qualitative study will explore patients’, carers’, and healthcare professionals’ views of HAH. Plan of investigation Consecutive admissions with AECOPD to either of two hospitals will be assessed for eligibility. To ensure balanced groups and avoid selection bias, participating patients will be randomised to HAH or standard inpatient care by minimisation[12] or computer generated random sequence, in equal proportion.[13] The researcher will be blinded to the method used. Once randomised, any future admissions will be treated according to the allocated protocol, provided their DECAF risk remains low. Patients in the HAH arm will be transferred home within 48 hours, often on the same day. A potential criticism of previous HAH is increased carer burden: To address this, same day temporary social care will be available, including 24-hour care. Patients will have 1 to 2 daily respiratory nurse visits with support from consultant physicians, physiotherapists and occupational therapists. Physiological observations charts will be maintained, and controlled oxygen and nebulisers will be available. Patients will have access to the HAH team 24 hours a day, by telephone or by tablet (face time). The primary outcome is hospital bed days over 90 days. Secondary outcomes include survival, readmission rates, patient and carer preference and quality of life (QoL). A full cost analysis will be performed including direct and indirect costs, and social care and care-giver costs. In an embedded qualitative study, patients, carers and healthcare professionals will be interviewed to explore perceptions of HAH. Potential benefits of study HAH may help patients to maintain their usual activities and foster independence and confidence in self-management. Compared to inpatient care, HAH may be associated with better QoL and fewer readmissions, total hospital bed days and complications, including hospital acquired infections, deconditioning and poor nutrition. Patients and carers may prefer HAH. AECOPD are one of the most common reasons for hospital admission and, compared to earlier trials, the DECAF score identifies a much higher proportion of patients as potentially suitable for HAH. Should this model of HAH prove clinically and cost effective, the potential benefits to patients and the NHS are considerable. The planned interviews with patients, carers and healthcare professionals will identify potential barriers to wider implementation, whilst the economic analysis will inform appropriate resource allocation and ensure that costs are not simply redistributed from secondary care to the community, patient and family carer.


Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: RESPIRATORY