How effective are volunteers at supporting people in their last year of life? A pragmatic randomised wait-list trial in palliative care (ELSA)

Walshe et al. BMC Medicine (2016) 14:203 DOI 10.1186/s12916-016-0746-8 RESEARCH ARTICLE Open Access How effective are volunteers at supporting people in their last year of life? A pragmatic randomised wait-list trial in palliative care (ELSA) Catherine Walshe1* , Steven Dodd1, Matt Hill3, Nick Ockenden3, Sheila Payne1, Nancy Preston1 and Guillermo Perez Algorta2 Abstract Background: Clinical care alone at the end of life is unlikely to meet all needs. Volunteers are a key resource, acceptable to patients, but there is no evidence on care outcomes. This study aimed to determine whether support from a social action volunteer service is better than usual care at improving quality of life for adults in the last year of life. Methods: A pragmatic, multi-centre wait-list controlled trial, with participants randomly allocated to receive the volunteer support intervention either immediately or after a 4 week wait. Trained volunteers provided tailored face-to-face support including befriending, practical support and signposting to services, primarily provided within the home, typically for 2–3 hours per week. The primary outcome was rate of change of quality of life at 4 weeks (WHO QOL BREF, a general, culturally sensitive measure). Secondary outcomes included rate of change of quality of life at 8 weeks and Loneliness (De Jong Gierveld Loneliness Scale), social support (mMOS-SS), and reported use of health and social care services at 4 and 8 weeks. Results: In total, 196 adults (61% (n = 109) female; mean age 72 years) were included in the study. No significant difference was found in main or secondary outcomes at 4 weeks. Rate of change of quality of life showed trends in favour of the intervention (physical quality of life domain: b = 3.98, CI, –0.38 to 8.34; psychological domain: b = 2.59, CI, –2.24 to 7.43; environmental domain: b = 3, CI, –4.13 to 4.91). Adjusted analyses to control for hours of volunteer input found significantly less decrease in physical quality of life in the intervention group (slope (b) 4. 43, CI, 0.10 to 8.76). While the intervention also favoured the rate of change of emotional (b = –0.08; CI, –0.52 to 0. 35) and social loneliness (b = –0.20; CI, –0.58 to 0.18), social support (b = 0.13; CI, –0.13 to 0.39), and reported use of health and social care professionals (b = 0.16; CI, –0.22 to 0.55), these were not statistically significant. No adverse events were reported. Conclusions: Clinicians can confidently refer to volunteer services at the end of life. Future research should focus on ‘dose’ to maximise likely impact. Trial registration: The trial was prospectively registered. ISRCTN Registry: ISRCTN12929812, registered 20 May 2015. Keywords: Pragmatic clinical trial, Randomised controlled trial, Volunteers, Palliative care * Correspondence: 1 International Observatory on End of Life Care, Division of Health Research, Lancaster University, Bailrigg, Lancaster LA1 4YW, UK Full list of author information is available at the end of the article © The Author(s). 2016 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Walshe et al. BMC Medicine (2016) 14:203 Background In 2013, over half a million people died in England and Wales, mostly from long-term conditions such as cancer (29%) and circulatory (28%) and respiratory (15%) diseases that are known to be life limiting [1]. For deaths that can be anticipated, providing excellent care at the end-of-life that is responsive to need is critically important. Compassionate support in the last year of life cannot be the responsibility of health and social care professionals alone and requires a public health response involving the wider community [2, 3], recognising the importance of social networks and social capital [4]. Proponents of these approaches argue that a primary focus on biomedical and physical aspects of end-of-life care ignores the social context within which dying takes place. Social relationships and networks can buffer the effects of crisis associated with dying, provide a framework that may prevent family carer burn out, and demonstrate the importance of supporting social contexts [5–7]. Effective personal network support can substitute for formal care and reduce health service utilisation costs [8]. Individual and community networks and relations of support can, however, be inadequate to meet care needs [5]. Demographic changes such as increased female employment, delayed childbearing, geographical mobility, divorce rates, and longer working lives all potentially impact on the availability of traditional family support. Social isolation on itself also has a major influence on health, comparable with well-established risk factors for mortality [9]. To supplement both clinical and community care many services are using volunteers as a critical part of the multi-disciplinary care offered at the end of life [10, 11]. Volunteers are important to care, and indeed 42% of the adult population volunteer formally [12], with an estimated 3 million in health and social care [13] and 125,000 within hospices [14]. The Department of Health commitment to end-of-life care specifically recognises that such care is not simply ‘medical issues with medical solutions’, and pledges to developing the work of end-of-life care volunteer networks [15]. It is known that people are happy with volunteer support at the end of life [16–20], but there is little evidence of their effect on care outcomes. Evaluation in well-designed comparative studies is therefore recommended [11]. This is particularly apt in palliative and end-of-life care, where the effectiveness of many interventions are not evaluated using robust designs; this is potentially wasteful of resources and could lead to poorer or unintended outcomes. This is the first randomised trial of volunteer delivered support services at the end of life to evaluate the effectiveness of such interventions. Page 2 of 12 Methods Design This study was a pragmatic, randomised, prospective open wait-list trial. The protocol for the study is published [21]. The trial used a wait-list design to randomly allocate participants on a 1:1 basis to receive the intervention either immediately or after a 4 week wait [22–24]. A wait-list approach, where consented participants are allocated to either receive an intervention immediately or after a defined period on a waiting list during which they receive usual care is regarded as more ethically defen (...truncated)