Elsevier

The Lancet

Volume 390, Issue 10090, 8–14 July 2017, Pages 125-134
The Lancet

Articles
Improving comfort around dying in elderly people: a cluster randomised controlled trial

https://doi.org/10.1016/S0140-6736(17)31265-5Get rights and content

Summary

Background

Over 50% of elderly people die in acute hospital settings, where the quality of end-of-life care is often suboptimum. We aimed to assess the effectiveness of the Care Programme for the Last Days of Life (CAREFuL) at improving comfort and quality of care in the dying phase in elderly people.

Methods

We did a cluster randomised controlled trial in acute geriatric wards in ten hospitals in Flemish Region, Belgium, between Oct 1, 2012, and March 31, 2015. Hospitals were randomly assigned to implementation of CAREFuL (CAREFuL group) or to standard care (control group) using a random number generator. Patients and families were masked to interventaion allocation; hospital staff were unmasked. CAREFuL comprised a care guide for the last days of life, training, supportive documentation, and an implementation guide. Primary outcomes were comfort around dying, measured with the End-of-Life in Dementia–Comfort Assessment in Dying (CAD-EOLD), and symptom management, measured with the End-of-Life in Dementia–Symptom Management (SM-EOLD), by nurses and family carers. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01890239.

Findings

451 (11%) of 4241 beds in ten hospitals were included in the analyses. Five hospitals were randomly assigned to standard health care practice and five to the CAREFuL programme; 118 patients in the control group and 164 in the CAREFuL group were eligible for assessment. Assessments were done for 132 (80%) of 164 patients in the CAREFuL group and 109 (92%) of 118 in the control group by nurses, and 48 (29%) in the CAREFuL group and 23 (19%) in the control group by family carers. Implementation of CAREFuL compared with control significantly improved nurse-assessed comfort (CAD-EOLD baseline-adjusted mean difference 4·30, 95% CI 2·07–6·53; p<0·0001). No significant differences were noted for the CAD-EOLD assessed by family carers (baseline-adjusted mean difference −0·62, 95% CI −6·07 to 4·82; p=0·82) or the SM-EOLD assessed by nurses (−0·41, −1·86 to 1·05; p=0·58) or by family carers (−0·59, −3·75 to 2·57; p=0·71).

Interpretation

Although a continuous monitoring of the programme is warranted, these results suggest that implementation of CAREFuL might improve care during the last days of life for patients in acute geriatric hospital wards.

Funding

The Flemish Government Agency for Innovation by Science and Technology and the Belgian Cancer Society “Kom Op Tegen Kanker”.

Introduction

Each year, 58 million people die around the world, 53% of whom are aged 60 years and older.1 In a population-based study in 14 countries, between 25% (Netherlands) and 85% (South Korea) of people potentially benefiting from palliative care died in hospital.2 In another report, over half of all deaths in Britain occurred in the acute hospital setting.3 Findings from previous studies have suggested that end-of-life care for elderly people in acute hospital wards is suboptimum.3, 4 Delivery of optimum end-of-life care is challenging because dying people often have complex and multifaceted needs.5, 6

Various initiatives have been introduced worldwide to improve end-of-life care in acute hospital settings.5, 7, 8, 9 The Liverpool Care Pathway for the Dying Patient (LCP) is one of the most well-known programmes.10 However, a Cochrane review,11, 12 updated in 2016,13 identified only one published cluster randomised trial of the effectiveness of an end-of-life care programme in the acute hospital setting, namely the LCP, for patients with cancer in Italy.14 In this trial, there was no significant difference in overall quality of care between the CAREFuL and control groups, but the trial was statistically underpowered. Findings from several non-randomised studies7, 15 suggest positive effects (eg, improved symptom control) of end-of-life care programmes.

To improve the quality of end-of-life care in acute geriatric hospital wards,5 we developed the Care Programme for the Last Days of Life (CAREFuL).16, 17, 18 This programme is based on three existing LCP programmes (UK, the Netherlands, and Italy). Development took into account critiques of the original LCP in the UK.19, 20 We avoided the suggestion of a care pathway because this was deemed to lead to perceptions of the guide as a protocol and tick box exercise rather than an approach to care; goals within the guide were changed into points of attention for similar reasons. We developed an implementation strategy, which included training and a guide on implementation of the programme, and developed a quantitative process assessment instrument to assess and monitor the quality of implementation. Additionally, the programme was modelled to the acute geriatric care setting.16 We aimed to assess whether comfort and quality of care in the dying phase in elderly people (called patients hereafter) can be improved by implementation of CAREFuL.

Research in context

Evidence before this study

Various initiatives have been introduced worldwide to improve end-of-life care. However, there have been sustained concerns about the safety of implementing such pathways or programmes, particularly about one of the most well known—The Liverpool Care Pathway for the Dying Patient (LCP) in the UK. Therefore, clinicians and policy makers need end-of-life care programmes that are evidence based. In the most recent Cochrane review (updated search in July, 2015, of original search done in 2009), which used the search terms (“randomized controlled trial” or “controlled clinical trial” or “intervention studies/experiments” or “random”) and (”palliative care” or “palliative care” or “end-of-life” or “terminally ill” or “dying” or “hospice” or “end-stage”) and (”critical pathways” or “clinical pathway$ or care pathways” or “integrated care pathways”), only one cluster randomised trial assessing the effectiveness of the LCP was found, for patients with cancer in Italy. This trial showed no significant differences in overall quality of care between the intervention and control groups, but was statistically underpowered. The authors of the Cochrane review judged the study to be at high risk of bias overall, mainly because patients were not masked to treatment allocation and there were high rates of attrition. Thus, little evidence exists regarding the clinical, physical, psychological, or emotional effectiveness of end-of-life care pathways or programmes. No search was done for randomised controlled trials of end-of-life care programmes in intensive care units, because the intensive care unit is a different setting with different approaches to care compared with the acute geriatric hospital wards in which the intervention in our study was used.

Added value of this study

This study is, to our knowledge, the first sufficiently powered randomised controlled trial to test the effectiveness of an end-of-life care programme, the Care Programme for the Last Days of Life (CAREFuL) programme. We found a statistically and clinically significant improvement in comfort around dying assessed by nurses after implementation of the programme. We also found a significant positive effect of the programme on symptoms and care needs, but a negative effect on satisfaction with care.

Implications of all the available evidence

Our findings suggest that CAREFuL can improve the quality of dying and quality of care in acute geriatric hospital wards; however, further qualitative research is needed to gain a better understanding of the effect of CAREFuL on satisfaction with care. Further controlled implementation of the programme in acute geriatric hospital wards is likely to improve care at the end of life. Use and assessment of the programme in other settings where people are cared for at the end of life might also merit consideration.

Section snippets

Study design and participants

We did a multicentre cluster randomised controlled trial, with hospitals as the units of randomisation and patients the units of analysis. By designating hospitals as the units of randomisation, we ensured that all patients within a given ward were assigned to the same trial group, thereby reducing the risk of cross-contamination. The study protocol has been published previously.17 We followed the CONSORT guidelines21 to design and report this study.

To be included in the study, hospitals had to

Results

To recruit at least ten hospitals, we invited 31 eligible hospitals to participate in the study. 13 agreed to participate; however, three dropped out in the first 3 months after inclusion (figure 2). Across the Flemish Region, there are 4241 geriatric beds, of which 451 (11%) in ten hospitals were included in the analyses. All hospitals were non-academic (ie, regional) hospitals varying from 170 to 1083 beds. 925 patients died in acute geriatric hospital wards, 320 (35%) of whom were eligible

Discussion

This is, to our knowledge, the first adequately powered cluster randomised controlled trial to test the effectiveness of an end-of-life care programme in acute geriatric hospital wards.11, 12 We found a statistically and clinically significant improvement in one of the primary outcomes of the trial, comfort around dying assessed by nurses after implementation of the programme; however, this effect was not found by family carers. We also found a significant positive effect on symptoms and care

References (32)

  • SK Inouye et al.

    Geriatric syndromes: clinical, research, and policy implications of a core geriatric concept

    J Am Geriatr Soc

    (2007)
  • FA Bailey et al.

    Improving processes of hospital care during the last hours of life

    Arch Intern Med

    (2005)
  • J Ellershaw et al.

    Care of the dying: a pathway to excellence

    (2011)
  • J Ellershaw et al.

    Care of the dying patient: the last hours or days of life

    BMJ

    (2003)
  • RJ Chan et al.

    End-of-life care pathways for improving outcomes in caring for the dying

    Cochrane Database Syst Rev

    (2013)
  • R Chan et al.

    End-of-life care pathways for improving outcomes in caring for the dying

    Cochrane Database Syst Rev

    (2010)
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