Improving end-of-life care in acute geriatric hospital wards using the Care Programme for the Last Days of Life: study protocol for a phase 3 cluster randomized controlled trial

BMC Geriatrics

Luc Deliens²  Nele Van Den Noortgate¹  Massimo Costantini³  Joachim Cohen⁴  Tinne Smets⁴  Rebecca Verhofstede⁴ 

[1] Department of Geriatrics, Ghent University Hospital, Ghent, Belgium;Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium;Palliative Care Unit, IRCCS Arcispedale S. Maria Nuova, Reggio Emilia, Italy;End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium

关键词: Older people;    Hospital;    Terminal care;    Cluster randomized controlled trial;   

Others  :  1130583
DOI  :  10.1186/s12877-015-0010-7

 received in 2014-12-19, accepted in 2015-02-03,  发布年份 2015

【 摘 要 】

Background

The Care Programme for the Last Days of Life has been developed to improve the quality of end-of-life care in acute geriatric hospital wards. The programme is based on existing end-of-life care programmes but modeled to the acute geriatric care setting. There is a lack of evidence of the effectiveness of end-of-life care programmes and the effects that may be achieved in patients dying in an acute geriatric hospital setting are unknown. The aim of this paper is to describe the research protocol of a cluster randomized controlled trial to evaluate the effects of the Care Programme for the Last Days of Life.

Methods and design

A cluster randomized controlled trial will be conducted. Ten hospitals with one or more acute geriatric wards will conduct a one-year baseline assessment during which care will be provided as usual. For each patient dying in the ward, a questionnaire will be filled in by a nurse, a physician and a family carer. At the end of the baseline assessment hospitals will be randomized to receive intervention (implementation of the Care Programme) or no intervention. Subsequently, the Care Programme will be implemented in the intervention hospitals over a six-month period. A one-year post-intervention assessment will be performed immediately after the baseline assessment in the control hospitals and after the implementation period in the intervention hospitals. Primary outcomes are symptom frequency and symptom burden of patients in the last 48 hours of life.

Discussion

This will be the first cluster randomized controlled trial to evaluate the effect of the Care Programme for the Last Days of Life for the acute geriatric hospital setting. The results will enable us to evaluate whether implementation of the Care Programme has positive effects on end-of-life care during the last days of life in this patient population and which components of the Care Programme contribute to improving the quality of end-of-life care.

Trial registration

ClinicalTrials.gov Identifier: NCT01890239 webcite. Registered June 24th, 2013.

【 授权许可】

   
2015 Verhofstede et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Morrison RS, Meier DE: Palliative care. N Engl J Med 2004, 350(25):2582-2590.
• [2]Ellershaw J, Ward C: Care of the dying patient: the last hours or days of life. BMJ 2003, 326:30-34.
• [3]Bradley E, Cramer L, Bogardus JST, Kasl SV, Johnson-Hurzeler R, Horwitz SM: Physicians’ ratings of their knowledge, attitudes, and End-of-life-care practices. Acad Med 2002, 77(4):305-311.
• [4]Sullivan A, Lakoma MD, Block SD: The status of medical education in End-of-life care. J Gen Intern Med 2003, 18(9):685-695.
• [5]Curtis JR, Patrick DL, Caldwell ES, Collier AC: Why don’t patients and physicians talk about end-of-life care?: Barriers to communication for patients with acquired immunodeficiency syndrome and their primary care clinicians. Arch Intern Med 2000, 160(11):1690-1696.
• [6]Fallowfield L, Jenkins V: Communicating sad, bad, and difficult news in medicine. Lancet 2004, 363:312-319.
• [7]Meraviglia MG, McGuire C, Chesley DA: Nurses’ needs for education on cancer and end-of-life care. J Contin Educ Nurs 2002, 34(3):122-127.
• [8]World Health Organization: Better palliative care for older people. WHO, Copenhagen; 2004.
• [9]Gardiner C, Cobb M, Gott M: Barriers to providing palliative care for older people in acute hospitals. Age Ageing 2011, 40:233-8.
• [10]Lynn J, Teno JM, Philips RS, Wu AW, Desbiens N, Harrold J, et al.: Perceptions by family members of the dying experience of older and seriously ill patients. Ann Intern Med 1997, 126:97-106.
• [11]Seah STA, Low JA, Chan YH: Symptoms and care of dying elderly patients in an acute hospital. Singapore Med J 2005, 46:210-214.
• [12]Seale C: Changing patterns of death and dying. Soc Sci Med 2000, 51:917-930.
• [13]Cohen J, Bilsen J, Addington-Hall J, Löfmark R, Miccinesi G, Kaasa S, et al.: Population-based study of dying in hospital in six European countries. Palliat Med 2008, 22:702-710.
• [14]Houttekier D, Cohen J, Surkyn J, Deliens L: Study of recent and future trends in place of death in Belgium using death certificate data: a shift from hospitals to care homes. BMC Public Health 2011, 11:228. BioMed Central Full Text
• [15]Houttekier D, Cohen J, Pepersack T, Deliens L: Dying in hospital: a study of incidence and factors related to hospital death using death certificate data. Eur J Pub Health 2014, 24(5):751-756.
• [16]Woo J, Lo R, Cheng JOY, Wong F, Mak B: Quality of end-of-life care for non-cancer patients in a non-acute hospital. J Clin Nurs 2011, 20:1834-41.
• [17]Ellershaw J, Wilkinson S: Care of the dying: a pathway to excellence. University Press, Oxford; 2011.
• [18]Chan R, Webster J: End-of-life care pathways for improving outcomes in caring for the dying. Cochrane Database Syst Rev 2010, 1.
• [19]Costantini M, Ottonelli S, Canavacci L, Pellegrini F, Beccaro M: The effectiveness of the Liverpool care pathway in improving end of life care for dying cancer patients in hospital. A cluster randomised trial. BMC Health Serv Res 2011, 11:13. BioMed Central Full Text
• [20]Costantini M, Romoli V, Di Leo S, Beccaro M, Bono L, Pilastri P, et al.: Liverpool Care Pathway for patients with cancer in hospital: a cluster randomised trial. Lancet 2013, 6736:1-12.
• [21]Øvretveit J, Gustafson D: Evaluation of quality improvement programmes. Qual Saf Health Care 2002, 11:270-5.
• [22]Phillips JL, Halcomb EJ, Davidson PM: End-of-life care pathways in acute and hospice care: an integrative review. J Pain Symptom Manage 2011, 41:940-55.
• [23]Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M: Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008, 337.
• [24]Elley C, Kerse N, Chondros P: Randomised trials-cluster versus individual randomisation: Primary Care Alliance for Clinical Trials (PACT) network. Aust Fam Physician 2004, 33(9):759-763.
• [25]Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Med Res Methodol 2001, 1(1):2. BioMed Central Full Text
• [26]Volicer L, Hurley AC, Blasi ZV: Scales for evaluation of End-of-Life Care in Dementia. Alzheimer Dis Assoc Disord 2001, 15:194-200.
• [27]Hearns J, Higginson I: Development and validation of a core outcome measure for palliative care: the palliative care outcome scale. Qual Heal Care 1999, 8(4):219-227.
• [28]Biola H, Sloane PD, Williams CS, Daaleman TP, Williams SW, Zimmerman S: Physician communication with family caregivers of long-term care residents at the end of life. J Am Geriatr Soc 2007, 55(6):846-56.
• [29]Boelen PA: Personal goals and prolonged grief disorder symptoms. Clin Psychol Psychother 2011, 18(6):439-444.
• [30]Gijsberts MJ, van der Steen JT, Muller MT, Deliens L: End-of-life with dementia in Dutch antroposofic and traditional nursing homes. Tijdschr Gerontol Geriatr 2008, 39(6):256-264.
• [31]Ringash J, O’Sullivan B, Bezjak A, Redelmeier D: Interpreting clinically significant changes in patient-reported outcomes. Cancer 2007, 110:196-202.
• [32]Costantini M, Di Leo S, Beccaro M: Methodological issues in a before-after study design to evaluate the Liverpool Care Pathway for the Dying Patient in hospital. Palliat Med 2011, 25:766-73.
• [33]Higgins JP: Cochrane handbook for systematic reviews of interventions. Chichester, Wiley-Blackwell; 2008.
• [34]Klar N, Donner A: Current and future challenges in the design and analysis of cluster randomization trials. Stat Med 2001, 20:3729-3740.
• [35]Veerbeek L, van Zuylen L, Swart SJ, van der Maas PJ, de Vogel-Voogt E, van der Rijt CC, et al.: The effect of the Liverpool Care Pathway for the dying: a multi-centre study. Palliat Med 2008, 22:145-51.
• [36]McGlinchey T, Mason S, Gambles M, Murphy D, Ellershaw J: National care of the dying audit hospitals (NCDAH) round 3 results. BMJ Support Palliative Care 2012, 2(1):A94.
• [37]Ellershaw J, Smith C, Overill S, Walker SE, Aldridge J: Care of the dying: setting standards for symptom control in the last 48 hours of life. J Pain Symptom Manage 2001, 21:12-17.
• [38]Klinkenberg M, Smit JH, Deeg DJH, Willems DL, Onwuteaka-Philipsen BD, Van Der Wal G: Proxy reporting in after-death interviews: the use of proxy respondents in retrospective assessment of chronic diseases and symptom burden in the terminal phase of life. Palliat Med 2003, 17:191-201.
• [39]Addington-Hall JM, Kalra L: Who should measure quality of life? Br Med J 2001, 322:1417-1420.
• [40]McPherson CJ, Addington-Hall JM: Judging the quality of care at the end of life: can proxies provide reliable information? Soc Sci Med 2003, 56:95-109.
• [41]Costantini M, Pellegrini F, Di Leo S, Beccaro M, Rossi C, Flego G, et al.: The Liverpool Care Pathway for cancer patients dying in hospital medical wards: a before-after cluster phase II trial of outcomes reported by family members. Palliat Med 2014, 28:10-7.