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Trials. 2019 Aug 16;20(1):506. doi: 10.1186/s13063-019-3612-0.

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.

Author information

1
King's College London, Cicely Saunders Institute, London, UK. jonathan.koffman@kcl.ac.uk.
2
King's College London, Cicely Saunders Institute, London, UK.
3
Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, UK.
4
King's College London, Clinical Trials Unit, London, UK.
5
Primary Care Unit, Department of Public Health and Primary Care Organisation, University of Cambridge, Cambridge, UK.
6
Marie Curie Palliative Care Research Department, University College London, London, UK.
7
The Royal Marsden NHS Foundation Trust, London, UK.
8
School of Health Sciences, Faculty of Medicine and Health, University of East Anglia, Norwich, UK.
9
Imperial College London, Imperial Clinical Trials Unit, School of Public Health, London, UK.
10
Sussex Community NHS Foundation Trust, Brighton General Hospital, Brighton, UK.

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 .

KEYWORDS:

AMBER care bundle; Feasibility study; clinical trial; clinical uncertainty; complex intervention; end-of-life care; mixed methods; palliative care

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