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 noncancer 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 4 Background Clinical uncertainty in hospital settingsClinical uncertainty has been defined as the inability to determine the meaning and significance of illness-related events (1). It occurs in situations where health professionals are unable to accurately predict outcomes due to insufficient information. Evidence suggests that in the last 30 days of life, a combination of deteriorating health and clinical uncertainty are highly distressing for patients in hospital, and their families (2, 3). This is amplified when discussions about t...

Understanding usual care in randomised controlled trials of complex interventions: A multi-method approach

“…Within the context of this trial, 20 where the complex intervention was designed to serve patients with a terminal diagnosis, and their families, quality of care and treatments can be highly variable. 4 Complex interventions tend to be subtlety modified during local adaptation, adding on to the heterogeneity of the usual care in clinical practice.…”

“…Our study is a prospective, longitudinal, multi-method study within a parallel, feasibility cluster RCT of a complex intervention (ISRCTN36040085). 5,20,24,25 Data were collected between June 2017 and August 2018.…”

“…The selection process of study wards at each study site is detailed elsewhere. 20 As the usual care questionnaires and case notes reviews were conducted at baseline, prior to the implementation of the intervention, the baseline data from the two intervention study wards were also included for the description of usual care.…”

“…The usual care provided prior to the implementation of the complex intervention for the chosen intervention sites and the care provided in the control arms throughout the trial are described within the feasibility cluster RCT of the AMBER care bundle. 20 This is a complex intervention aimed at providing better care to patients whose situations are 'clinically uncertain', with an irreversible, deteriorating condition, and at risk of dying during their hospital admission. [20][21][22][23]…”

“…20 This is a complex intervention aimed at providing better care to patients whose situations are 'clinically uncertain', with an irreversible, deteriorating condition, and at risk of dying during their hospital admission. [20][21][22][23]…”