Title: ImproveCare: The management of clinical uncertainty in end of life care - a feasibility cluster RCT
Funder: Department of Health and Social Care

Abstract: DESIGN: Feasibility cluster RCT with concurrent qualitative component following MRC & MORCare guidance to develop/evaluate complex interventions in end of life care to inform definitive cluster RCT. SETTING: General medical wards in 4 district general hospitals. TATGET POPULATION: Patients (pts) identified as deteriorating, clinically unstable, with limited/uncertain reversibility of illness, at risk of dying in 1-2 months, and their families. Health technologies assessed: AMBER care bundle (ACB) provides systematic approach to care of hospital pts whose recovery is clinically uncertain and at risk of dying in 1–2 months. It fits any diagnostic group. For those in this position staff are required to i) develop medical plan of management documenting disease interventions & current key issues (usual practice), and anticipated outcomes, pt/carer priorities, and resuscitation status; ii) identify if an escalation plan for future care has been documented (ward only/high dependency/intensive care); iii) ensure pt’s current and future medical plan has been discussed and agreed with nursing staff; iv) ensure discussion has taken place with pt/carer about situation and that priorities are documented. Pt’s status/plan reviewed daily. MEASURMENT, OUTCOMES & COSTS: The primary outcomes we wish to test are changes in ‘Patient/family anxiety and communication subscale’ of the Integrated Palliative care Outcome Scale (I-POS) and the ‘howRwe’, a patient-reported measure to examine changes in patients’ reported experiences of health care. We will also examine secondary outcomes (satisfaction with care inclusion quality of communication), realisation of preferred location of care and location of death, post-bereavement outcomes) using the QUALYCARE postal survey. Health costs will examine health resources, hospital stay, ITU/HDU use & hospital admissions and costs to families. Qualitative interviews/focus groups with pts, families and staffs views on ways to enhance recruitment, improve documentation, and refine components of the ACB and how it is introduced to pts/families. Study recruitment, progression and feasibility parameters will be examined. SAMPLE SIZE: As this is a feasibility trial, we are interested in recruitment, retention and the feasibility and acceptability of the trial to inform a larger trial. Therefore no formal sample size calculations have been performed; the key outcomes are concerned. ANALYSIS: Centres and pts characteristics will be reported as mean and standard deviation or frequency and percentage for continuous and categorical variables. The assessment of the primary end-point will consider the clustered design of the trial through mixed effects regression model adjusted for the average level of quality of care provided to the baseline assessment. Results will be expressed as relative risk or marginal means, and 95% confidence intervals. P-value<0.05 will be considered significant. Qualitative data are analysed using framework approach.

Lay abstract: Background to research: In this country approx 500,000 people die each year. Over half of these deaths take place in hospital. However, research tells us that most people would prefer to die at home. This does not happen because there is often little discussion between patients, families, and health care professionals about what they want. It is made worse when it is difficult for health care staff to identify patients whose situation is clinically uncertain. Uncertainty is not a simple concept; it usually results from several inter-related factors that include unpredictability and complexity. We know that many health care professionals do not possess enough knowledge or skills on how to best care for them in their last few weeks of life, particularly for those where uncertainty is present. Recent reports have highlighted what can go wrong in the presence of clinical uncertainty and at the end of life; it has devastating effects for patients and families at a profoundly emotional level. This is undoable. We must do better. We have conducted some initial research to better understand the effects of the ACB. We observed some important benefits; more patients were aware of how severe their illness was and more discussions took place between clinicians, patients and carers when there was clinical uncertainty. However, it did not improve how the patients or families felt about the methods or content of these discussions and those who were supported by it highlighted that it made them more concerned about care at home. Before more hospitals use the ACB it is very important that we study whether the ACB really does improve care for patients and families or not, whether there are any adverse effects, and whether it works across different hospitals. What we will do: We will compare care delivered on wards using the ACB with the usual care patients receive of the comparison wards to understand if care delivered in this way leads to better outcomes for patients and their families and produces savings for health services and society. However, before this research is possible, we need to do preparatory work (a feasibility study) to ensure we can recruit enough people, that the outcomes we use in the final study really reflect what patients and families feel are important to them, and that the study procedures are clear and workable. We will collect information about hospital admissions and services used from clinical records. We will collect information from patients and their families at different time points. Open interviews with patients, caregivers and staff will help us better understand what they value about the ACB and how it works. All necessary ethical and NHS approvals will be gained before starting the study and all who take part may withdraw at any time without their care being affected. This feasibility study will take place over 15 months. Who we are: We are highly skilled researchers (social scientists, doctors and nurses). We have a track record of delivering high quality value for money research on time, leading to change in clinical practice and health policy. We have actively involved patient and public involvement (PPI) in the design of this study. Our PPI members will continue to be involved up to and including the dissemination of our findings.

Research activity codes: 7.2 END OF LIFE CARE
Health categories: GENERIC HEALTH RELEVANCE