Title: Developing, implementing and testing a new intervention to improve healthy living in older people with frailty. The Holistic Assessment and care Planning in Partnership Intervention (HAPPI) Study.
Funder: Health Education England

Abstract: Background: Frailty is a syndrome associated with ageing that manifests as a loss of biological reserves, due to dysfunction of body systems. It puts an older person at risk when facing even minor stressors, and is associated with poor outcomes including disability, hospitalisation and death. Frailty develops insidiously over a period of 5 15 years and is not routinely diagnosed outside of Geriatric Medicine. Due to lack of agreed diagnostic criteria and definition, it can be difficult to determine numbers of frail people, however, studies estimate that in people aged over 80 years 25% to 50% will be frail. Frailty syndromes such as falls, delirium, immobility and incontinence often lead to admission to hospital and frail people have longer lengths of stay and suffer more hospital acquired complications than those who are fit. A recognised intervention for frailty is Comprehensive Geriatric Assessment (CGA). The CGA is a method of identifying patient need and planning care in partnership with them and their carers. CGA has primarily been Geriatrician-led and carried out in acute hospitals, so not available in primary care. This disadvantages the majority of frail people and prevents a more pro-active approach aimed at preventing deterioration and avoiding acute hospital admission. There have been recent proposals that a holistic intervention developed from CGA principles and delivered by nurses might be beneficial in primary care. This would ensure availability of the intervention to many more frail older people and earlier, proactive management along the frailty trajectory. Aim: This mixed methods feasibility study aims to develop, implement and test a nurse-led Holistic Assessment and care Planning in Partnership Intervention (HAPPI) and to determine important parameters for the design of a definitive randomised controlled trial (RCT). Design and Methods: The study has 3 work packages (WP): WP1: A three-round Delphi study will gain consensus from an expert stakeholder group on the components of the intervention and existing skills and knowledge deficits. Using this data, the components will be mapped to patient needs using the best available evidence to ascertain those which may be feasible in terms of clinical and cost effectiveness. The outcome of this mapping exercise will be translated into a procedure guide for the intervention with an accompanying training package. The procedure guide will be tested for practicability in clinical practice and further refined by a focus group of clinicians who will be delivering the intervention in WP2. WP 2: A feasibility cluster RCT will be conducted to gather process, resource, management and scientific data to inform the design of a future definitive trial. The proposed outcome measures will be related to adverse effects of frailty, which have been confirmed by PPI consultations and the literature. Outcomes will be measured at baseline, 6 and 12 months. WP3: An embedded qualitative study will explore experiences of patients and carers who participated in the study and the nurses carrying out the intervention. This will help to identify methodological issues such as recruitment and retention and any enablers and barriers to the intervention which may impede the future RCT. Expected Outcomes: Findings will inform the definitive RCT protocol, and will include but not limited to; Number of HAPPI interventions completed fully and time taken to complete Percentage completed outcome measures Number of adverse events Sample size estimates Appropriateness of proposed outcome measures and determination of primary outcome Ability to collect cost data that can be used for a future health economic evaluation Recruitment and retention rates Participant and clinician feedback

Lay abstract: Frailty can be a distressing but not inevitable part of getting older. People who are frail may feel more tired and weak than normal, have trouble getting around, lose weight and feel that they are slowing down. Frailty progresses over a period of 5-15 years and may lead to losing independence, hospital admissions and moving to a care home. Previous research has suggested that it may be possible to support older people to manage frailty like any other long term condition. If recognised early, we can provide care and support that may delay or prevent negative effects of frailty so that older people can retain their independence and quality of life. To do this, people need effective support at home from health services such as their GP, community and practice nurses.We know that once people are aged 80 years and over, between a quarter and a half will show some of the signs of frailty. Therefore, it is important that we understand the causes and how best to manage the condition for the future. Like many long term conditions, frailty cannot be cured, so we need to understand how to empower people to live well with it.Our research aims to explore how people can be best supported at home and how community nurses need to work to provide individualised support. We want to explore if we can improve outcomes for patients enabling them to live at home , improve wellbeing, prevent falls and reduce the need for hospital care. In order to ensure the study meets the needs of older people who live with frailty we have involved them in the development of this project. We have consulted via interviews with frail patients, their carers, and a group of older people who are not frail. They have helped us to identify that our proposed research is an important priority for them and that they consider the suggested outcomes to be significant to them. They told us that they would want co-ordinated care led by a GP or a nurse delivered close to home.In order to understand the views of community health teams, we held a focus group of community nurses and carried out a survey of GPs. They agreed with the suggestions of the older people and also suggested to include a study exploring the enablers and barriers to supporting frail older people in primary care and how better care can become routine clinical practice.The first part of our study will include a survey of an expert group of nurses, doctors and older people to explore their views of elements of care for frail older people in the community and to identify the training needs and skills that nurses need to deliver effective care. This will enable us to develop a care plan based on the individual needs of people that can be used by nurses in partnership with patients and their carers. In the second part of our study, we will undertake a small randomised controlled trial to test this new care plan, including frailty assessment and evaluation, to see if it is practical and achievable. In this part of the study, there will be a group of patients who receive the new care plan and a group who will receive care as usual. In the final part of this project we will talk to frail patients, carers and nurses to explore their experiences of participating in the randomised controlled trial. The information gathered during the proposed project will be used to inform a future larger clinical trial to ensure the methods we are using are fit for purpose. To maximise the impact of the study we will ensure that the findings are publicised in a number of ways. Results will be published in journals relevant to the care of older people, through clinical networks and via websites such as Age UK and the British Geriatrics Society. There are plans to develop a website for the study which will keep interested people up to date with progress and findings. We will also create Facebook and Twitter accounts to communicate throughout the study period with the public and health professionals. The investigators will submit abstracts to national and international conferences in order to present the study findings. Local primary care and community groups have been involved from the outset and will continue to be part in the dissemination of findings.

Research activity codes: 3.2 INTERVENTIONS TO ALTER PHYSICAL AND BIOLOGICAL ENVIRONMENTAL RISKS;7.2 END OF LIFE CARE
Health categories: INJURIES AND ACCIDENTS