Managing uncertain recovery for patients nearing the end of life in hospital: a mixed-methods feasibility cluster randomised controlled trial of the AMBER care bundle

Abstract

Background: The AMBER (Assessment, Management, Best Practice, Engagement, Recovery Uncertain) care bundle is a complex intervention used in UK hospitals to support patients with uncertain recovery. However, it has yet to be evaluated in a randomised controlled trial (RCT) to identify potential benefits or harms. The aim of this trial was to investigate the feasibility of a cluster RCT of the AMBER care bundle. Methods: This is a prospective mixed-methods feasibility cluster RCT. Quantitative data collected from patients (or proxies if patients lack capacity) were used (i) to examine recruitment, retention and follow-up rates; (ii) to test data collection tools for the trial and determine their optimum timing; (iii) to test methods to identify the use of financial resources; and (iv) to explore the acceptability of study procedures for health professionals and patients. Descriptive statistical analyses and thematic analysis used the framework approach. Results: In total, 894 patients were screened, of whom 220 were eligible and 19 of those eligible (8.6%) declined to participate. Recruitment to the control arm was challenging. Of the 728 patients screened for that arm, 647 (88.9%) were excluded. Overall, 65 patients were recruited (81.3% of the recruitment target of 80). Overall, many were elderly (≥80 years, 46.2%, n = 30, mean = 77.8 years, standard deviation [SD] = 12.3 years). Over half (53.8%) had a non-cancer diagnosis, with a mean of 2.3 co-morbidities; 24.6% patients (n = 16) died during their hospital stay and 35.4% (n = 23) within 100 days of discharge. In both trial arms, baseline IPOS subscale scores identified moderate patient anxiety (control: mean 13.3, SD 4.8; intervention: mean 13.3, SD 5.1), and howRwe identified a good care experience (control: mean 13.1, SD 2.5; intervention: mean 11.5, SD 2.1). Collecting quantitative service use and quality of life data was feasible. No patient participants regarded study involvement negatively. Focus groups with health professionals identified concerns regarding (i) the subjectivity of the intervention's eligibility criteria, (ii) the need to prognosticate to identify potential patients and (iii) consent procedures and the length of the questionnaire. Conclusions: A full trial of the AMBER care bundle is technically feasible but impractical due to fundamental issues in operationalising the intervention's eligibility criteria, which prevents optimal recruitment. Since this complex intervention continues to be used in clinical care and advocated in policy, alternative research approaches must be considered and tested. Trial registration: International Standard Randomised Controlled Trial Number (ISRCTN) Register, ISRCTN36040085.

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

“…We made use of a multi-method design [ 38 ] within the wider mixed-method feasibility cRCT trial [ 22 ]. Data were collected in parallel and then analysed and integrated using NPT.…”

“…It aims to improve care for patients who are deteriorating, clinically unstable with limited reversibility, and at risk of dying in the next one to two months [ 3 ]. The latter criterion was subsequently amended to be at risk of dying during a patient’s episode of hospital care, despite treatment [ 22 ]. The AMBER care bundle is designed to make clinical decision-making explicit in situations of uncertainty by encouraging health professionals to work in concert with patients, who possess sufficient mental capacity, and their families, to develop and document a clear medical plan, including consideration of anticipated outcomes, cardiopulmonary resuscitation and escalation plans, while continuing to acknowledge their situation of uncertainty [ 12 ].…”

“…Interviews with health professionals in a qualitative study identified that the AMBER care bundle was often utilised as a tool to categorise patients, to change the focus of care delivery and indirectly served a symbolic purpose in influencing behaviours of individuals and teams [ 24 ]. More recently, a feasibility cluster randomised controlled trial (cRCT) of the AMBER care bundle across four UK hospital sites revealed a highly varied experience of care and communication for patients supported by the intervention and their relatives [ 22 , 25 ].…”

“…There is now increasing evidence that the successful development and implementation of complex interventions benefit from the contribution of theoretical frameworks [ 31 – 33 ]. As part of the feasibility cRCT of the AMBER care bundle [ 22 ], we conducted a process evaluation to understand how the intervention was operationalised, and what modifications and refinements were needed to optimise its use in acute hospital settings. To achieve this, we made use of Normalisation Process Theory (NPT) [ 34 ], a socio-behavioural theory.…”

“…The theory identifies four essential determinants of embedding or ‘normalising’ complex interventions into common practice. These are (i) ‘coherence’ –the extent to which an intervention is understood as being meaningful, achievable and valuable; (ii) ‘cognitive participation’ –the engagement of individuals (in this case, health professionals) necessary to deliver the intervention; (iii) ‘collective action’– the work that brings the intervention into use; and (iv) ‘reflexive monitoring’ –the on-going process of adjusting the intervention to keep it in place [ 22 ]. These components are considered to be dynamic and interact within the wider context of the intervention, such as existing organisational structures and procedures [ 36 ].…”