Integrating palliative care in long-term care facilities across Europe (PACE): protocol of a cluster randomized controlled trial of the ‘PACE Steps to Success’ intervention in seven countries

Abstract

BackgroundSeveral studies have highlighted the need for improvement in palliative care delivered to older people long-term care facilities. However, the available evidence on how to improve palliative care in these settings is weak, especially in Europe. We describe the protocol of the PACE trial aimed to 1) evaluate the effectiveness and cost-effectiveness of the ‘PACE Steps to Success’ palliative care intervention for older people in long-term care facilities, and 2) assess the implementation process and identify facilitators and barriers for implementation in different countries.MethodsWe will conduct a multi-facility cluster randomised controlled trial in Belgium, Finland, Italy, the Netherlands, Poland, Switzerland and England. In total, 72 facilities will be randomized to receive the ‘Pace Steps to Success intervention’ or to ‘care as usual’. Primary outcome at resident level: quality of dying (CAD-EOLD); and at staff level: staff knowledge of palliative care (Palliative Care Survey). Secondary outcomes: resident’s quality of end-of-life care, staff self-efficacy, self-perceived educational needs, and opinions on palliative care. Economic outcomes: direct costs and quality-adjusted life years (QALYs).Measurements are performed at baseline and after the intervention. For the resident-level outcomes, facilities report all deaths of residents in and outside the facilities over a previous four-month period and structured questionnaires are sent to (1) the administrator, (2) staff member most involved in care (3) treating general practitioner, and (4) a relative. For the staff-level outcomes, all staff who are working in the facilities are asked to complete a structured questionnaire. A process evaluation will run alongside the effectiveness evaluation in the intervention group using the RE-AIM framework.DiscussionThe lack of high quality trials in palliative care has been recognized throughout the field of palliative care research. This cross-national cluster RCT designed to evaluate the impact of the palliative care intervention for long-term care facilities ‘PACE Steps to Success’ in seven countries, will provide important evidence concerning the effectiveness as well as the preconditions for optimal implementation of palliative care in nursing homes, and this within different health care systems.Trial registrationThe study is registered at www.isrctn.com – ISRCTN14741671 (FP7-HEALTH-2013-INNOVATION-1 603111) Registration date: July 30, 2015.

Implementing the theory-based advance care planning ACP+ programme for nursing homes: study protocol for a cluster randomised controlled trial and process evaluation

“…Firstly, while there are very few high-quality studies that evaluate the effects of ACP in nursing homes, and in particular very few cluster RCTs [3], we contribute to filling this gap by planning and designing this proposed study according to recent recommendations in the conduct of high-quality RCTs [35,36]. The study design follows that of a previous trial conducted by members of the research team [32]. Therefore, the study protocol has been proved feasible and successful in this study population.…”

“…They will put the questionnaire in sealed envelopes and deposit it in a locked letter box (only accessible to the researchers) in a central spot in the nursing home. As was done in a previous Flemish and EU study, two reminders will be sent [19,32]. Using the anonymous codes, the researchers will register response.…”

“…This based on the judgement of the two researchers (JG and AWvD), using a list of 12 predefined criteria that define extensive policy and practice. This list is based on a list (of yes/no questions) which is used in a previous Flemish study [32]. Questions range from "The nursing home has a clear and written ACP policy"; "There is oral/written information made available to residents and family regarding ACP, ADs and the assignment of legal representatives" to "Wishes regarding the end-of-life for all nursing home residents (and/or their loved ones) are regularly discussed in team meetings, especially when there are changes".…”

Agreement of Nursing Home Staff With Palliative Care Principles: A PACE Cross-sectional Study Among Nurses and Care Assistants in Five European Countries

“…Initiatives such as the PACE Steps to Success Programme can contribute to making such a shift by integrating palliative care into mainstream care and can raise awareness of palliative care in nursing home staff. 47…”

Quantity over Quality? Perception of Designating Long-Term Care Hospitals as Providers of Hospice and Palliative Care

“…We how to deliver a service more effectively (18,19). It should be noted that these 2 trials aimed not only to train care staff but also to reform the organization as a whole and thereby improve end-of-life care by influencing the facilities' end-of-life culture, decision-making processes, and practices overall (19).…”