Abstract
BackgroundThe 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.MethodsThis 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.ResultsIn 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.ConclusionsA 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 registrationInternational Standard Randomised Controlled Trial Number (ISRCTN) Register, ISRCTN36040085.
Highlights
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
We report on the feasibility of conducting a pragmatic multi-centre cluster randomised controlled trial (RCT) of a hospital-based complex intervention that aims to better serve patients whose situations are clinically uncertain and where there is a risk that they will die during their hospital stay, versus standard care
All patients on the study wards were screened by research nurses for potential eligibility against the inclusion criteria, which corresponded with the AMBER care bundle eligibility criteria
Summary
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. Evidence suggests that in the last 30 days of life, the combination of deteriorating health and clinical uncertainty is highly distressing for patients in hospital and their families [2, 3] This is amplified when discussions about their situation and preferences for care and location of death do not occur. Research has identified that discussions about prognosis rarely occur [5] This increases the likelihood of hospital deaths and leads to poor care satisfaction, mistrust and loss of confidence in health professionals [6,7,8,9] and may lead to complaints [10]. Health professionals frequently struggle with uncertainty, which can result in overtreatment or over-investigation [11], lack of communication with patients about their future [12, 13], and increased care costs [14]
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