The AMBER care bundle for hospital inpatients with uncertain recovery nearing the end of life: the ImproveCare feasibility cluster RCT

Abstract

Background 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. Objective 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. Design 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. Setting Four general medical wards at district general hospitals in England. Participants There were 65 participants (control, n = 36; intervention, n = 29). There were 24 interviews, four focus groups, 15 non-participant meeting observations, six case note reviews and three heat maps, and 15 of out 23 bereavement, standard care surveys were completed. Intervention 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. Main outcome measures 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 ‘howRwe’. The secondary outcome measures were Integrated Palliative care Outcome Scale symptoms, Australian-modified Karnofsky Performance Status scale, EuroQol-5 Dimensions, five-level version, Client Service Receipt Inventory, recruitment rate, intervention fidelity and intervention acceptability. Results 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. Limitations 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. Conclusions 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. Trial registration Current Controlled Trials ISRCTN36040085. National Institute for Health Research (NIHR) Portfolio registration number 32682. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 55. See the NIHR Journals Library website for further project information.

Processes of consent in research for adults with impaired mental capacity nearing the end of life: systematic review and transparent expert consultation (MORECare_Capacity statement)

“…Further process evaluation of multimedia techniques is needed to determine the content and duration as the active ingredients of the techniques which leads to enhanced decisional capacity in studies for specific populations. Toolkits are useful resources to inform consent processes that encompass the heterogeneity of for example palliative care populations and the legislative framework for the respective jurisdiction and context [138] (See page 96 in for example [139]).…”

Implementation of a complex intervention to improve care for patients whose situations are clinically uncertain in hospital settings: A multi-method study using normalisation process theory

“…Selection of study wards at each site was informed by heat maps that provided contextual information at a ward level on the number of deaths during and up to 100 days after admission. Wards with the highest number of deaths per year were considered to be suitable for the study [ 22 , 29 ]. In this paper, we focus on the two intervention sites, where the AMBER care bundle was implemented and delivered and who provided data for the process evaluation reported in this paper Table 1 .…”

“…This involved: familiarisation with the ward, introducing the intervention to health professionals and training them on its use, supporting them in the practice of using the intervention, and observing how they used it in practice. Full details of the implementation of the intervention across study sites is reported in detail elsewhere [ 22 , 29 ].…”

“…Concerns are amplified as this intervention has been identified by National Health Service (NHS) England as one of five key enablers to Transform End of Life Care in Acute Hospitals [ 26 ], highlighted as representing ‘good practice’ by both the Royal College of Physicians [ 27 ] and the National Institute for Health and Care Excellence [ 28 ]. Additionally, it has been widely adopted across a network of approximately 40 UK District General Hospitals [ 29 ] and a growing number of hospitals in New South Wales, Australia [ 30 ].…”

Guidelines for Evaluating the Feasibility of Recruitment in Pilot Studies of Diverse Populations: An Overlooked but Important Component

“…More often than not, studies fall short of their recruitment goals in a specific time frame. [25][26][27][28][29] Occasionally, studies achieve their goal 30 or even surpass the goal 31 suggesting that the recruitment methods were successful.…”