Title: Managing clinical uncertainty for older people in community hospitals to improve communication and palliative care; development, implementation and evaluation of the SPACEtoolkit – Symptom and Psychosocial Assessment and Communication Evaluation
Funder: Health Education England

Abstract: Background and aim Older people that live with frailty and multi-morbidities can experience marked physical decline and poor health outcomes from a seemingly minor health problem16. These episodes of decline are often characterized by uncertainty as to recover or continued deterioration leading to end-of-life. The use of tools (e.g. outcome measures) in clinical practice can support assessment and communication at times of uncertainty and improve patient outcomes.17,18 However, relatively little is known about their usefulness in non-acute settings to support interventions that either promote recovery or palliate the signs and symptoms of deterioration (sometimes referred to as progressive dwindling)19. There is a need for development work grounded in the experiences of frail older people to ensure that the tools are context specific and designed to support assessment of symptoms, address concerns and involve patients and families in decision-making.20 This study aims to improve communication and palliative care for older people in community hospitals during times of clinical uncertainty by developing, implementing and evaluating the feasibility of the new SPACEtoolkit Symptom Psychological Assessment and Communication Evaluation. The toolkit will use existing evidence based tools that have been shown to both address treatment uncertainty and support decision-making and communication from admission and stay to discharge or end-of-life (EoL). Plan of investigation Implementation is considered throughout the study to inform a full evaluation in a definitive cluster RCT and wider utility in community hospitals in England. The study comprises five work packages (WP): WP1: developing the theoretical underpinning for the SPACEtoolkit using systematic review method of Critical Interpretive Synthesis21, 22 to identify tools to improve communication and/or palliative care during clinical uncertainty in inpatient settings. We use the conceptual domains of uncertainty23 as a matrix to map the included tool components (e.g. processes) and work with our PPI group to agree the tools included. Outputs: 1) the SPACEtoolkit tools and guidance and underpinning theory; 2) identification of SPACEtoolkit attributes and choices examined in WP3. WP2: identification of mortality and requirement for palliative and EoL care using a population-based cohort study of all community hospitals in England to examine mortality over 12-months from a given census date and the associations. Outputs: 1) Optimizing palliative and EoL care in community hospitals by identifying mortality over 1 year. WP3: Patients and families refine the SPACEtoolkit using a discrete choice experiment (DCE) in three community hospital wards to identify the components of the SPACEtoolkit, examine the relative importance of the attributes, and test the methods for a full DCE. Outputs 1) Patients' and families' identification of the SPACEtoolkit components, processes of delivery and outcomes; 2) Research methods for a full DCE. WP4: a comparative feasibility evaluation of the SPACEtoolkit using a quasi-experimental design involving 4 wards in 3 community hospitals randomized at ward level, and a participatory approach with two cyclical iterations of SPACEtoolkit - introduction, evaluation, refinement, re-introduction: first exploring the feasibility of implementing SPACE using non-participant observation, qualitative interviews and staff survey; and second testing procedures for a full cluster RCT (e.g. sample size calculation, main outcome). Outputs: 1) Research methods for a cluster RCT and implementing the SPACEtoolkit WP5: Protocols for full DCE and cluster RCT and exploration of SPACE wider utility in community hospitals final synthesis of all the data across the WPs to complete research protocols and grant applications for a full cluster RCT and full underpinning DCE. Synthesis of all implementation data to explore the utility and implementation of the SPACEtoolkit and training programme in community hospitals in England. Outputs: 1) Full protocols and NIHR HTA and SD&HSR grant applications; and 2) Implementation requirements and methods of evaluation for the SPACEtoolkit.

Lay abstract: Background to the research and aim Older people who are frail and experience multiple-illnesses are vulnerable to decline in wellbeing and slow recovery from seemingly minor health problem, like a chest infection. These episodes of decline are often accompanied by clinical uncertainty as to recovery or continued deterioration potentially leading to end-of-life. Community hospitals are important resources to manage episodes of decline both in supporting rehabilitation and recovery and providing end-of-life care. There are over 320 community hospitals in England.7 Older people and families often prefer these settings to acute hospital because they provide inpatient care nearer to home. The main reason for admission is because of a combination of an acute event such as a fall with more diffuse symptoms and concerns.8 During clinical uncertainty communication and support for patients and families is crucial to facilitate decision-making and understanding on expected outcomes of care.9,10, 11 Providing palliative care is important for older people during points of decline and uncertain recovery to support both those who may recover and those who deteriorate leading eventually to end-of-life.12 Palliative care is relevant across all advanced illnesses to enable people and their families to live as well as possible, and plan future care if they choose. 13 A way to improve care of people when there is uncertainty about the likely outcome following admission is to provide a structured, but flexible approach to communication and planning. An approach that must incorporate both recovery and continued deterioration and be used by different health professionals involved in decision making to plan and review care, and communicate care on discharge to e.g. a care home. There are a number of tools used in healthcare to improve communication and palliative care during clinical uncertainty. The majority of these tools were developed in acute hospitals12,14. It is unknown if these tools can be used in settings where there is no onsite medical provision and whether they can inform decision-making with older people with multiple health and social needs. This study aims to develop and evaluate the feasibility the new SPACEtoolkit Symptom Psychosocial and Communication Evaluation - in community hospitals to improve communication and palliative care. Design and methods The design is a mixed method phased design with subsequent phases informing the next that use evidence review, interviews with patients, families and clinicians, and observation and case note review. The SPACEtoolkit will be a resource for staff and families that draws on evidence about how to improve assessment of symptoms and concerns and communicate with patients and families about expectations of care and treatment, and on discharge (e.g. a care home). We plan to develop the SPACEtoolkit by reviewing the existing evidence and asking patients and families what they think are the key components and how best to use these in practice. Based on our findings we will refine the SPACEtoolkit and test the feasibility of using it in four community hospital wards. We will look at the effect of the toolkit on communication between staff, patients and families' decisions that relate to palliative care, and its impact for patients and families. We will also review anonymous national data on hospital use and death registration data to explore how many people in community hospitals died over 12months from a given date. The introduction of the SPACEtoolkit into community hospitals will enable us to design a full study to examine patient and family benefit, the cost and impact on quality of life and what is required to implement the toolkit more widely. Patient and public involvement We work with a group of seven lay members on our research work on improving palliative and end-of-life care for older people in community settings. This group reviewed and commented on the protocol, and will continue to support the study. The group will meet as our Independent Project Advisory group (IPAG) every 3-4 months and assist with specific aspects of the study outside of these meetings. Two members (Guerrier and Talmey) will be members of the project Steering Group overseeing PPI involvement across the study. We reimburse travel and time in accordance with INVOLVE guidance and provide training and support through our PPI group at the Cicely Saunders Institute15. Dissemination:Our PPI group will support the development of our dissemination plan by ensuring the findings are accessible and relevant to older people and families at the local, regional and national level. This plan includes publications in local journals and radio programmes and nationally through for example the Guardian monthly section on ageing.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: GENERIC HEALTH RELEVANCE