Title: Peri-operative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-PERFECTED" project"
Funder: Department of Health and Social Care

Abstract: This programme, which is consistent with the MRC Framework for Complex Interventions (1), aims to improve hospital care for people with dementia (PwD) admitted with a fractured hip. We will develop and examine the feasibility, acceptability and potential clinical and cost effectiveness of an Enhanced Recovery Pathway (ERP). Objectives: 1. Establish current best practice from a systematic review and the perspectives of service users, carers, health care professionals, health service managers and experts in the field (Work Package (WP) 1) 2. Define an optimised care pathway- the ERP (WP 1). 3. Determine the staff training and cultural/organisational changes required to implement and maximise adherence to the ERP in hospital settings (WP 2). 4. Produce a training manual promoting cultural and organisational changes and maximising ERP adherance (WP 2). 5. Undertake a pilot study to assess the clinical and cost effectiveness of the ERP to inform a future large Randomised Controlled Trial (RCT) (WP 3). 6. Disseminate and definitive trial bid development (WP 4). BACKGROUND PwD with a fractured hip often have complications but can achieve comparable outcomes to patients without dementia (3-6). There is a need to optimise inpatient care for PWD and explore models of re-ablement to improve outcomes and reduce costs (6). IMPORTANCE Hospital care for PwD is a high priority as admission often worsens health and increases risks of complications e.g delirium (7, 8). NEED FOR RESEARCH Research is needed to define a system of care for cognitively impaired patients including rehabilitation, which aims to prevent undue decline. PAST AND CURRENT RESEARCH There has been very limited research in PWD and hip fracture particularly in complex interventions. WORK UNDERTAKEN Members of the team have undertaken systematic reviews on the management of delirium and significantly contributed to NICE guidance on hip fracture, delirium and dementia. We have presented PERFECTED to consumer groups, clinicians, hospital managers and commissioners. The project was reviewed by carers and patients from the Alzheimer s Society and Dementia UK and strongly endorsed. RESEARCH PLANS WP 1: We will establish best practice in the care of PwD with hip fracture by systematically reviewing the literature, observing practice, surveying care, and eliciting stakeholders views. Key components will form the Enhanced Recovery Pathway (ERP) and an audit checklist. WP 2: We will produce a training manual reflecting and supporting changes in working culture and organisation to ensure wards put the ERP into practice as faithfully as possible. This will be developed through 3 cycles of action research consisting of audits of practice, feedback to clinical staff and development of practice, which will inform the content and structure of the Manual. WP 3: We will conduct a cluster, randomised, controlled, pilot study in 10 hospitals to test for preliminary evidence of clinical effectiveness and cost-effectiveness. It will gather data to inform recruitment, select appropriate outcome measures and allow a sample size calculation for a definitive RCT. WP 4: Disseminate findings and develop definitive RCT proposal. RESEARCH TEAM The highly interdisciplinary team has recognised experts in all required domains: in dementia, delirium, hip fracture acute care and rehabilitation, development and evaluation of complex interventions, nursing research, occupational therapy, physiotherapy, behaviour change and organisational change theory, health economics, statistics, clinical trials, quantitative and qualitative research methods, workforce planning and NHS management. RESEARCH ENVIRONMENT The University of East Anglia has fifteen years of health services research with high impact outputs (e.g in The Lancet), using multi-methods research, RCTs, systematic reviews, qualitative and health economic studies. We will be supported by a UKCRC registered Clinical Trials Unit and by pioneers of multi-component interventions from Sweden and the USA. OUTPUTS AND IMPACT Our work will improve the care of PwD who have had a hip fracture. The ERP and Audit tool will be prototypes for PwD and acute hospital care and we will build in adaptability to other co-morbidities in PwD. NHS benefits commence in: month 20 with best practice evidence; month 34 a training and delivery manual; and month 60 a definitive trial submission. PUBLIC INVOLVEMENT We have had scrutiny and feedback from: (1) the Norfolk hip fracture PPI group, (2) PPIRes, (3) PwD and their carers facilitated by the Alzheimer s Society, Dementia UK and DeNDRoN. We have a core group of advisors, including PwD and their carers, to assist with programme design and conduct. ETHICAL IMPLICATIONS We will use ethical procedures legally approved for use in patients with cognitive and physical frailty. RESOURCES JUSTIFICATION This is a complex, mixed methods research programme, conducted over multiple sites, requiring an experienced and suitably qualified Programme Manager who will assume overall responsibility for each WP and integrity of the programme. Research Associates with both qualitative and quantitative experience will be required for each work package. Where it is feasible and economical there will some continuity of employment to promote quality and satisfying employment experience.

Lay abstract: One quarter of acute NHS hospital beds are occupied by people with dementia (PwD). They are exceptionally vulnerable and at high risk of serious complications. There is little research on how best to look after these people in hospital. Inconsistent standards of care, poor physical and mental health management and overuse of sedatives have been highlighted in national reports. These provide recommendations for improving care, for example people who break their hip have a high risk of delirium, which is linked to delayed recovery and causes distress for patients and their families. There is good quality evidence that preventing delirium is possible. However, not enough is known about how modification in hospital care can prevent delirium in PwD. Our team of national and international experts from diverse disciplines in the field will use this programme of research to address the Ministerial Advisory Group on Dementia s research priorities by developing and piloting evidence based interventions to improve the hospital care of physical and mental health problems in PwD. Implementation principles will be central considering patients /families and staff. We will: (1) determine what is the current model of optimal care for a PwD who break their hip (Enhanced Recovery Pathway and audit tool); (2) Develop a Training Manual to ensure that the model of care is implemented; (3) Conduct a pilot study in hospitals in the UK to assess the feasibility of procedures and provide information to inform a definitive trial. We will adopt ethical procedures appropriate for PwD and physical frailty. This will be the first dementia-specific study combining the most feasible and effective elements of best care with a formal implementation system. Based on detailed evaluation of this pilot study we will be able to develop a definitive package for testing in a future major clinical trial.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: MENTAL HEALTH;NEUROLOGICAL;INJURIES AND ACCIDENTS