PMID- 29530091 OWN - NLM STAT- MEDLINE DCOM- 20180927 LR - 20181114 IS - 1472-684X (Electronic) IS - 1472-684X (Linking) VI - 17 IP - 1 DP - 2018 Mar 12 TI - 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. PG - 47 LID - 10.1186/s12904-018-0297-1 [doi] LID - 47 AB - BACKGROUND: Several 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. METHODS: We 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. DISCUSSION: The 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 REGISTRATION: The study is registered at www.isrctn.com - ISRCTN14741671 (FP7-HEALTH-2013-INNOVATION-1 603111) Registration date: July 30, 2015. FAU - Smets, Tinne AU - Smets T AD - Department of Family Medicine and Chronic Care, End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) and Ghent University, Brussels, Belgium. Tinne.smets@vub.be. FAU - Onwuteaka-Philipsen, Bregje B D AU - Onwuteaka-Philipsen BBD AD - EMGO Institute for Health and Care research, Expertise Center for Palliative Care, VU University Medical Center, Amsterdam, the Netherlands. FAU - Miranda, Rose AU - Miranda R AD - Department of Family Medicine and Chronic Care, End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) and Ghent University, Brussels, Belgium. FAU - Pivodic, Lara AU - Pivodic L AD - Department of Family Medicine and Chronic Care, End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) and Ghent University, Brussels, Belgium. FAU - Tanghe, Marc AU - Tanghe M AD - Department of Geriatric Medicine, Ghent University Hospital, Ghent, Belgium. FAU - van Hout, Hein AU - van Hout H AD - Department of General Practice and Elderly Care Medicine, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands. FAU - Pasman, Roeline H R W AU - Pasman RHRW AD - EMGO Institute for Health and Care research, Expertise Center for Palliative Care, VU University Medical Center, Amsterdam, the Netherlands. FAU - Oosterveld-Vlug, Mariska AU - Oosterveld-Vlug M AD - EMGO Institute for Health and Care research, Expertise Center for Palliative Care, VU University Medical Center, Amsterdam, the Netherlands. FAU - Piers, Ruth AU - Piers R AD - Department of Geriatric Medicine, Ghent University Hospital, Ghent, Belgium. FAU - Van Den Noortgate, Nele AU - Van Den Noortgate N AD - Department of Geriatric Medicine, Ghent University Hospital, Ghent, Belgium. FAU - Wichmann, Anne B AU - Wichmann AB AD - IQ healthcare, Radboud University Medical Center, Nijmegen, the Netherlands. FAU - Engels, Yvonne AU - Engels Y AD - IQ healthcare, Radboud University Medical Center, Nijmegen, the Netherlands. FAU - Vernooij-Dassen, Myrra AU - Vernooij-Dassen M AD - IQ healthcare, Radboud University Medical Center, Nijmegen, the Netherlands. FAU - Hockley, Jo AU - Hockley J AD - International Observatory on End-of-Life Care, Lancaster University, Lancaster, UK. FAU - Froggatt, Katherine AU - Froggatt K AD - International Observatory on End-of-Life Care, Lancaster University, Lancaster, UK. FAU - Payne, Sheila AU - Payne S AD - International Observatory on End-of-Life Care, Lancaster University, Lancaster, UK. FAU - Szczerbinska, Katarzyna AU - Szczerbinska K AD - Unit for Research on Aging Society, Department of Sociology of Medicine, Epidemiology and Preventive Medicine Chair, Faculty of Medicine, Jagiellonian University Medical College, Krakow, Poland. FAU - Kylanen, Marika AU - Kylanen M AD - National Institute for Health and Welfare, Helsinki, Finland. FAU - Leppaaho, Suvi AU - Leppaaho S AD - National Institute for Health and Welfare, Helsinki, Finland. FAU - Baranska, Ilona AU - Baranska I AD - Unit for Research on Aging Society, Department of Sociology of Medicine, Epidemiology and Preventive Medicine Chair, Faculty of Medicine, Jagiellonian University Medical College, Krakow, Poland. AD - Faculty of Health Sciences, Jagiellonian University Medical College, ul. Michalowskiego 12, 31-126, Krakow, Poland. FAU - Gambassi, Giovanni AU - Gambassi G AD - Universita Cattolica del Sacro Cuoro, Rome, Italy. FAU - Pautex, Sophie AU - Pautex S AD - Hopitaux Universitaires de Geneve, University of Geneva, Geneva, Switzerland. FAU - Bassal, Catherine AU - Bassal C AD - Center for the Interdisciplinary Study of Gerontology and Vulnerability (CIGEV), University of Geneva, Geneva, Switzerland. FAU - Deliens, Luc AU - Deliens L AD - Department of Family Medicine and Chronic Care, End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) and Ghent University, Brussels, Belgium. FAU - Van den Block, Lieve AU - Van den Block L AD - Department of Family Medicine and Chronic Care, End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) and Ghent University, Brussels, Belgium. CN - PACE trial group LA - eng GR - 603111/European Union's Seventh Framework Programme/ PT - Journal Article PT - Randomized Controlled Trial DEP - 20180312 PL - England TA - BMC Palliat Care JT - BMC palliative care JID - 101088685 SB - IM MH - Belgium MH - Delivery of Health Care/standards MH - England MH - Finland MH - Humans MH - Italy MH - Netherlands MH - Palliative Care/*methods MH - Poland MH - Quality Improvement/standards MH - Skilled Nursing Facilities/*standards/*trends MH - Surveys and Questionnaires MH - Switzerland PMC - PMC5848517 OTO - NOTNLM OT - Care home OT - End-of-life care OT - Nursing home OT - Palliative care OT - Quality improvement COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: Ethics approval from the relevant ethics committees were obtained in all participating countries. Belgium: Commissie Medische Ethiek UZBrussel, 27/05/2015; England: NHS - NRES Committee North West-Haydock, 10/09/2015; Finland: Terveyden jahyvinvoinnin laitos, Institutet for halsa och valfard, 30/6/2015; Italy: Comitato Etico, Universita Cattolica del Sacro Cuore, 6/11/2017; Netherlands: Medisch Ethische Toetsingscommissie VUMedisch Centrum, 2/7/2015; Poland: Komisja Bioetycza, Uniwersytetu Jagiellonskiego, 25/6/2015; Switzerland: Commission cantonale d'ethique de la recherche scientifique de Geneve (CCER), 6/8/2015. All persons participating in the study (facility managers, care staff, GPs, relatives, and the concerned residents and relatives in the interviews for the process evaluation) have to give their prior informed consent in writing. If residents are unable to give informed consent, they will not be involved in the study. In some countries, such as Poland and the Netherlands, a separate informed consent is not required if questionnaires are filled in anonymously. CONSENT FOR PUBLICATION: Not applicable COMPETING INTERESTS: The authors declare that they have no competing interests. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. FIR - Mammarella, Federica IR - Mammarella F FIR - Mercuri, Martina IR - Mercuri M FIR - Rossi, Paola IR - Rossi P FIR - Segat, Ivan IR - Segat I FIR - Stodolska, Agata IR - Stodolska A FIR - Adang, Eddy IR - Adang E FIR - Andreasen, Paula IR - Andreasen P FIR - Kuitunen-Kaija, Outi IR - Kuitunen-Kaija O FIR - Moore, Danni Collingridge IR - Moore DC FIR - Pac, Agnieszka IR - Pac A FIR - Kijowska, Violetta IR - Kijowska V FIR - Ten Koppel, Maud IR - Ten Koppel M FIR - van der Steen, Jenny T IR - van der Steen JT FIR - de Paula, Emilie Morgan IR - de Paula EM EDAT- 2018/03/14 06:00 MHDA- 2018/09/28 06:00 PMCR- 2018/03/12 CRDT- 2018/03/14 06:00 PHST- 2018/02/20 00:00 [received] PHST- 2018/02/27 00:00 [accepted] PHST- 2018/03/14 06:00 [entrez] PHST- 2018/03/14 06:00 [pubmed] PHST- 2018/09/28 06:00 [medline] PHST- 2018/03/12 00:00 [pmc-release] AID - 10.1186/s12904-018-0297-1 [pii] AID - 297 [pii] AID - 10.1186/s12904-018-0297-1 [doi] PST - epublish SO - BMC Palliat Care. 2018 Mar 12;17(1):47. doi: 10.1186/s12904-018-0297-1.