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Patients admitted to hospital with a terminal illness and uncertain recovery often receive inconsistent care and do not have the opportunity to die in their preferred place of death. Previous end-of-life care packages, such as the Liverpool Care Pathway for the Dying Patient, have sometimes been badly implemented. The AMBER (Assessment; Management; Best practice; Engagement; Recovery uncertain) care bundle was developed to remedy this. It has not been evaluated in a randomised trial, but a definitive trial would face many hurdles.To optimise the design of and determine the feasibility of a pragmatic, multicentre, cluster randomised controlled trial of the AMBER care bundle compared with best standard care.A feasibility cluster randomised controlled trial including semistructured interviews with patients and relatives, focus groups with health-care professionals, non-participant observations of multidisciplinary team meetings, a standard care survey, heat maps and case note reviews. Retrospective data were collected from the family or close friends of deceased patients via a bereavement survey.Four general medical wards at district general hospitals in England.There were 65 participants (control,The AMBER care bundle is implemented by a nurse facilitator. It includes the development and documentation of a medical plan, consideration of outcomes, resuscitation and escalation status and daily plan revisiting. The AMBER care bundle encourages staff, patients and families to talk openly about their preferences and priorities should the worst happen.Two 'candidate' primary outcomes were selected to be evaluated for a future definitive trial: Integrated Palliative care Outcome Scale patient/family anxiety and communication subscale and 'Data were collected for 65 patients. This trial was not powered to measure clinical effectiveness, but variance and changes observed in the Integrated Palliative care Outcome Scale subscale indicated that this measure would probably detect differences within a definitive trial. It was feasible to collect data on health, social and informal care service use and on quality of life at two time points. The AMBER care bundle was broadly acceptable to all stakeholders and was delivered as planned. The emphasis on 'clinical uncertainty' prompted health-care professional awareness of often-overlooked patients. Reviewing patients' AMBER care bundle status was integrated into routine practice. Refinements included simplifying the inclusion criteria and improving health-care professional communication training. Improvements to trial procedures included extending the time devoted to recruitment and simplifying consent procedures. There was also a recommendation to reduce data collected from patients and relatives to minimise burden.The recruitment rate was lower than anticipated. The inclusion criteria for the trial were difficult to interpret. Information sheets and consent procedures were too detailed and lengthy for the target population. Health-care professionals' enthusiasm and specialty were not considered while picking trial wards. Participant recruitment took place later during hospital admission and the majority of participants were lost to follow-up because they had been discharged. Those who participated may have different characteristics from those who did not.This feasibility trial has demonstrated that an evaluation of the AMBER care bundle among an acutely unwell patient population, although technically possible, is not practical or feasible. The intervention requires optimisation.Current Controlled Trials ISRCTN36040085. National Institute for Health Research (NIHR) Portfolio registration number 32682.This project was funded by the NIHR Health Technology Assessment programme and will be published in full inUnwell hospital patients who are approaching the end of their lives and may die at any moment receive inconsistent care and often do not have opportunities to discuss their future care preferences. The AMBER (Assessment; Management; Best practice; Engagement; Recovery uncertain) care bundle was developed to help identify such patients, train health-care professionals to better communicate their concerns with them and their families and, where possible, to realise their preferences for place of care and death. The Liverpool Care Pathway for the Dying Patient, previously used across England, was designed to provide the best possible quality of care to those at the end of life. However, an independent review identified that it often was not used appropriately, leading to poor patient outcomes. A number of the criticisms of the Liverpool Care Pathway for the Dying Patient, such as reports of quickened deaths from the withdrawal of hydration/nutrition, as well as poor communication with patients and families, may have been identified earlier if it had been thoroughly evaluated. The AMBER care bundle, developed at Guy’s and St Thomas’ Hospital, aims to provide better outcomes for patients with clinically uncertain recovery and their families. It is important that the AMBER care bundle is properly investigated before wider use. A bigger study of the AMBER care bundle would be complex and expensive, so we examined whether or not this would be possible and acceptable to patients cared for in four wards across four hospitals, before deciding whether or not to go ahead with this bigger study. Two wards used the care bundle and two did not. We interviewed participants, their families and staff, and examined participants’ clinical notes. We found that the AMBER care bundle was largely acceptable to patients, relatives and staff, and generally delivered as intended. We successfully collected information from 65 unwell patients at the beginning of the trial and again 3–5 and 10–15 days later. However, a limited number of data were collected at the final time point (10–15 days) due to many participants being discharged from the hospital. Group discussions with staff and interviews with participants and relatives identified important changes required to improve the AMBER care bundle and views on how the trial was conducted. These included simplifying the type of patients who may be appropriate for the AMBER care bundle and improving communication training for staff. Although we identified that a further study was technically possible, it is currently impractical. Future solutions that would require further testing include focusing on clinical need rather than trying to guess how the patient’s condition will develop to identify potential trial participants and using questions completed by the patients as part of their routine care as a source of information. In the meantime, the AMBER care bundle continues to be used in over 40 hospitals in England.

Supplemental material, Usual_Care_Questionnaire for Understanding usual care in randomised controlled trials of complex interventions: A multi-method approach by Emel Yorganci, Catherine J Evans, Halle Johnson, Stephen Barclay, Fliss EM Murtagh, Deokhee Yi, Wei Gao, Andrew Pickles and Jonathan Koffman in Palliative Medicine

Supplemental material, Focus_Group_Topic_Guide for Understanding usual care in randomised controlled trials of complex interventions: A multi-method approach by Emel Yorganci, Catherine J Evans, Halle Johnson, Stephen Barclay, Fliss EM Murtagh, Deokhee Yi, Wei Gao, Andrew Pickles and Jonathan Koffman in Palliative Medicine

Background: Evaluations of complex interventions compared to usual care provided in palliative care are increasing. Not describing usual care may affect the interpretation of an intervention’s effectiveness, yet how it can be described remains unclear. Aim: To demonstrate the feasibility of using multi-methods to describe usual care provided in randomised controlled trials (RCTs) of complex interventions, shown within a feasibility cluster RCT. Design: Multi-method approach comprising usual care questionnaires, baseline case note review and focus groups with ward staff completed at study end. Thematic analysis of qualitative data, descriptive statistics of quantitative data, followed by methodological triangulation to appraise approach in relation to study aim. Setting/participants: Four general medical wards chosen from UK hospitals. Purposive sampling of healthcare professionals for usual care questionnaires, and focus groups. Review of 20 patients’ notes from each ward who died during admission or within 100 days of discharge. Results: Twenty-three usual care questionnaires at baseline, two focus groups comprising 20 healthcare professionals and 80 case note reviews. Triangulation of findings resulted in understanding the usual care provided to the targeted population in terms of context, structures, processes and outcomes for patients, families and healthcare professionals. Usual care was described, highlighting (1) similarities and embedded practices, (2) heterogeneity and (3) subtle changes in care during the trial within and across sites. Conclusions: We provide a feasible approach to defining usual care that can be practically adopted in different settings. Understanding usual care enhances the reliability of tested complex interventions, and informs research and policy priorities.