Managing uncertain recovery for patients nearing the end of life in hospital; a mixed-method, 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. Aim: To investigate the feasibility of a cluster RCT of the AMBER care bundle. Methods: Mixed-method, feasibility cluster RCT. Prospective, quantitative data collected from patients (or proxies lacking capacity) to (i) examine recruitment, retention and follow-up rates; (ii) test trial data collection tools and determine their optimum timing; (iii) test methods to identify use of financial resources; (iv) explore the acceptability of study procedures for health professionals and patients. Descriptive statistical analyses and thematic analysis using the Framework approach. Results: 894 patients were screened, of whom, 220 were eligible and 19 (8.6%) declined to participate. Recruitment to the control arm was challenging; of the 728 patients screened, 647 (88.9%) were excluded. 65 (81.3% of the recruitment target) patients were recruited. Many were elderly (≥80 years 46.2%, n=30, mean-77.8 years 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 (mean 13.3 (SD 4.8) control, 13.3 (SD 5.1) intervention), and howRwe identified a ‘good’ care experience (mean 13.1 (SD 2.5) control, 11.5 (SD 2.1) intervention). Collection of quantitative service use/quality of life data was feasible. No patient participants regarded study involvement negatively. Focus groups with health professionals identified concerns regarding (i) subjectivity of the intervention eligibility criteria; (ii) the need to prognosticate to identify potential patients; (iii) consent procedures and questionnaire length. 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 preventing 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