REVIEW URRENT C OPINION
End-of-life care: pathways and evidence Massimo Costantini, Sara Alquati, and Silvia Di Leo
Purpose of review Studies in different countries and settings of care have reported the quality of care for the dying patients as suboptimal. Care pathways have been developed with the aim of ensuring that dying patients and their family members received by health professionals the most appropriate care. This review presents and discusses the evidence supporting the effectiveness of the end-of-life care pathways. Recent findings Two Cochrane systematic reviews updated at June 2013 did not identify studies that met minimal criteria for inclusion. One randomized cluster trial aimed at assessing the effectiveness of the Liverpool Care Pathway in hospitalized cancer patients was subsequently published. The trial did not find a significant difference in the overall quality of care, the primary end-point, but two out of nine secondary outcomes – respect, dignity, and kindness, and control of breathlessness showed significant improvements. Afterwards, we did not find any other potentially eligible published study. Summary The overall amount of evidence supporting the dissemination of end-of-life care pathways is rather poor. One negative randomized trial suggests the pathways have the potential to reduce the gap between hospital and hospices. Further research is needed to understand the potential benefit of end-of-life care pathways. Keywords care of the dying, care pathway, effectiveness, end-of-life, review
INTRODUCTION Care pathways, also known as critical pathways, integrated care pathways, care maps, clinical care pathways, are widely used to systematically plan and follow-up a patient-focused care programme [1]. An international agreed definition of the care pathway does not exist. The most recent definition proposed by the European Pathway Association defines the care pathway ‘a complex intervention for the mutual decision making and organization of care for a well defined group of patients during a well defined period’ [1]. The implemented care pathway documentation becomes an integral part of the clinical documentation, and can support clinical audit [2]. The expected goals from the implementation of a care pathway should include one or more dimensions: improvement of quality of care and/or patient safety, increased patient satisfaction, and a more cost-effective use of resources. Many studies have assessed the effectiveness of the care pathways for different diseases or conditions. The quality of the studies is often poor, with only few controlled study designs [3]. Some systematic reviews have shown that the care pathways have the potentiality to be effective in standardizing low complexity and
uncertainty care processes, [4] in reducing clinical variations and improving quality of care, [5–7] and in promoting teamwork on a multidisciplinary team [8]. A care pathway is a typical complex intervention. A complex intervention was described as an intervention containing several interacting components [9]. Complexity can include different dimensions, for example, the range of possible outcomes, the variability in the target population, the number of elements in the intervention itself. Any end-of-life care pathway includes many interacting components that can enhance or reduce their potential effects. The process of assessment of complex interventions, including care pathways, implies specific problems for evaluators, in addition to practical Palliative Care Unit, IRCCS Arcispedale S. Maria Nuova, Reggio Emilia, Italy Correspondence to Massimo Costantini, Palliative Care Unit, IRCCS Arcispedale S. Maria Nuova, Viale Umberto 1, 50, 42123 Reggio Emilia, Italy. Tel: +39 0522 295369; fax: +39 0522 295622; e-mail: costantini. [email protected] Curr Opin Support Palliat Care 2014, 8:399–404 DOI:10.1097/SPC.0000000000000099
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End of life management
KEY POINTS Poor quality of end-of-life care is widely documented in many studies performed in all settings of care and in different countries. The WHO recognises the importance of providing the best palliative care for dying patients and their families. Since the second half of the 1990s, palliative care research groups developed and started to evaluate the effect of the introduction of ‘Care Pathways’ for patients dying in hospitals. A Cochrane systematic review updated at June 2013, aimed at assessing the effectiveness of end-of-life care pathways, searched for all published randomized controlled trials, quasi-experimental trials, including high-quality controlled before and after studies, but no studies met the inclusion criteria for the review. The first randomized trial assessing the effectiveness of an end-of-life care pathway, published in 2014, did not find a significant difference in the primary endpoint. A significant difference was observed for two secondary outcomes, the ‘Respect, dignity, and kindness’ scale and the ‘breathlessness’ scale. After this trial no other studies potentially eligible for a Cochrane review have been published. The results from the only randomized trial appear promising, but we need more studies appropriately designed, conducted, implemented, and analysed to better understand the effect of end-of-life care pathways and which of their components work better, for whom and what circumstances.
and methodological difficulties that any successful evaluation must overcome. The United Kingdom Medical Research Council (MRC) has developed a conceptual and methodological framework for developing and assessing complex interventions [9,10]. The MRC framework is more and more used for assessing a wide range of treatments and public health interventions, including educational and quality improvement programmes [11–13]. The first version of the MRC Framework [9] has taken on a ‘stepwise approach’, from phase 0 (preclinical) to phase 4 of clinical trials: (1) Phase 0: establishing the theoretical basis for the intervention. The methodology includes literature reviews and the assessment of theories of individual and organization behaviours. (2) Phase 1: improving the modelling of the intervention by identifying active components and mechanisms by which the outcomes can be influenced. The methodology is mainly qualitative. (3) Phase 2: defining the intervention, testing the procedures of assessment, evaluating the 400
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feasibility and acceptability of the intervention. The methodology is mixed, qualitative, and quantitative. (4) Phase 3: assessing the effectiveness of the intervention. The methodology is mixed, but mainly quantitative. It is the main trial requiring an appropriate control group, when possible randomization, adequate power and blinding (where feasible), appropriate procedures of assessment. (5) Phase 4: to establish the long-term applicability and effectiveness of the intervention when implemented outside of a research. In 2008, in a revised version of the MRC Framework, the process of developing and evaluating complex interventions was described according to cyclical phases [10]. In the area of palliative care research, the new MORECARE statement provides guidance on the evaluation of complex interventions in end-of-life care [14 ]. &&
THE REVIEW For the purpose of this review, ‘end-of-life’ will be used as synonymous of ‘dying phase’. Following the model proposed by OPCARE9, [15] it refers to the last hours–days of life, and includes the hours immediately after the patient’s death.
CARE PATHWAYS IN END-OF-LIFE CARE Poor quality of end-of-life care is widely documented in many studies performed in all settings of care and in different countries [16–22]. Inappropriate end-of-life care may result in the continuation of invasive clinical examinations and treatments, negatively affecting quality of life of both patients and relatives [17,22]. The WHO recognises the importance of providing the best palliative care for dying patients and their families in all care settings [23]. Improving the quality of care at the end-of-life is becoming a global concern. [24] For improving the quality of care of patients dying in different settings, major initiatives and national strategies were developed, implemented, and partially assessed worldwide [25,26]. Since the second half of the 1990s, palliative care research groups in the United Kingdom and the USA developed, implemented, and started to evaluate the effect of the introduction of specific ‘Care Pathways’ for patients dying in hospitals [27–29]. The general objective of these pathways was to transfer the model of excellence for care of the dying from hospices into hospitals and other healthcare settings, with the aim of improving the quality of Volume 8 Number 4 December 2014
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End-of-life care: pathways and evidence Costantini et al.
care delivered to the dying patients and their family members.
EFFECTIVENESS OF CARE PATHWAYS IN END-OF-LIFE CARE A Cochrane systematic review published in 2010, aimed at assessing the effectiveness of end-of-life care pathways, searched for all published randomized controlled trials, quasi-experimental trials, including high-quality controlled before and after studies [30]. The authors identified 920 relevant titles, but no studies met the inclusion criteria for the review. Three years later, a new version of the Cochrane review, updated at June 2013, identified other 1122 potentially relevant articles, but no additional studies met the minimal methodological standards to be included in the review [31 ]. The authors concluded that without further evidence, definitive recommendations for the use of end-of-life pathways in caring for the dying could not be made. Both reviews called for urgent further research [30,31 ]. The studies identified and excluded by the systematic reviews were mainly qualitative, [32–34], often just reporting the description of experience in using the care pathway, or simple noncontrolled before and after [28,29,35,36 ,37]. Two major drawbacks are evident in the analysis of the quantitative studies performed on care pathways. The first one is the poor internal validity of the study designs. Uncontrolled before and after studies are intrinsically weak designs for assessing the effectiveness of an intervention. Secular trends or sudden changes occurred during the study independently by the intervention can produce an improvement. Moreover, the existence of Hawthorne effect and, in some circumstances, of regression to the mean, can make the results impossible to interpret. There is also consolidating evidence that the results of uncontrolled before and after studies overestimate the effects of interventions [38]. These studies could be reconsidered within the framework for the assessment of end-of-life care pathways. According to the results of the before and after studies, the care pathways showed the potential to improve quality of care, [36 ] symptom management, [28,37] clinical documentation, [29,37] appropriateness of medications’ prescription, [28,39] and bereavement levels of relatives. [40] These types of study designs can give important information in the process of evaluation of a complex intervention. [9,10,14 ] They can be useful for planning future phase III studies, but do not allow establishing an unbiased relationship between the introduction of the care pathway and the expected outcomes. Not surprisingly, they do not get to the minimum &&
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standard of quality for being included in the Cochrane systematic reviews [30,31 ]. Unfortunately, this is the second major drawback, these studies were not part of a process of assessment of the pathway. In most cases, the research group did not plan or perform any other studies. The MRC framework for the assessment of complex interventions recommends the development of a global strategy of evaluation, starting from the initial phases focused on the standardization of the intervention and the procedures for its evaluation, and getting to the assessment of its effectiveness. An example of a comprehensive strategy of assessment of a care pathway is the pool of studies performed in Italy between 2006 and 2013 for developing and assessing the Italian version of the Liverpool Care Pathways (LCPs) for the dying patient (Table 1). The LCP was developed during the late 1990s in United Kingdom at the Royal Liverpool University Hospital, Marie Curie Hospice Liverpool. The LCP is an example of care pathway focused on the care of dying patients. [27] It was developed to transfer hospice practices of care in the last days of life into hospitals and other care settings. When the Italian research group started the process of assessment of the LCP, over 15 countries were using the pathway, mainly in hospital, although the evidence supporting its use was only from qualitative studies. [32,33] The Italian version of the LCP (LCP-I) was developed by the Regional Palliative Care Network of the National Cancer Research Institute of Genoa (Italy) in compliance with the original format. The Central LCP Team of Liverpool approved the final Italian LCP version. In 2007, a multidisciplinary palliative care team successfully piloted the LCP-I programme in three medical wards of ‘Villa Scassi Hospital’ in Genoa. The research team evaluated the process of LCP-I implementation using a mixed approach, qualitative and quantitative. Focus group, performed on sample of doctors and nurses before and after the implementation of the LCP-I, showed a perception of effectiveness of the Programme, particularly in pain management and in communication with patients and their families. Conversely, the qualitative approach highlighted some limits of the programme, and this allowed the research team to introduce some changes in the strategy of implementation [34]. A quantitative phase II study was performed on consecutive series of cancer deaths before and after the introduction of the LCP-I Programme in four hospital wards [35]. The results of this study allowed testing the feasibility of the procedures of assessment and the validity of process and outcomes indicators for assessing the quality of end-of-life
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End of life management Table 1. The Italian programme for assessing the Liverpool Care Pathways for the dying patient Aims
Methodology
Setting
Main results
Phase 0–1 Di Leo S et al. [34]
Exploring the expectations Literature review. Focus Three General Medicine Professionals recognized that about and the impact groups before and hospital wards LCP might improve symptom on staff of the LCP-I after LCP-I management and professional implementation implementation awareness of the problems related to emotional and informative support in end-of-life care.
Phase 2 Costantini M et al. [35] & Costantini M et al. [36 ] Raijmakers N et al. [39]
Standardization of the Before and after intervention and of the uncontrolled study procedures of assessment. Preliminary assessment of the effectiveness of the LCP
Three General Medicine Validity of the procedures of and one Respiratory assessment of all indicators. Disease hospital Good psychometric properties wards of the scales. Significant improvement in four out of 10 outcomes.
Phase 3 Costantini M et al. [41] Effectiveness && Costantini M et al. [42 ]
Randomized cluster trial
16 General Medicine hospital wards
Smaller effects of the LCP-I than those observed in the phase II study. Nonsignificant the primary end-point, but two out of the nine secondary outcomes, showed significant improvements.
LCP, Liverpool Care Pathway.
care. The results were promising and supported the design of a phase III study [36 ,39]. It is interesting to note that the study group designed and performed the trial, contrarily to other similar before and after studies, with the primary aim to collect information to perform a subsequent phase III trial [41]. The study was just an intermediate step in the process of assessment of the LCP-I. According to the results of all the previous studies, the Italian research group designed a clusterrandomized trial with the aim of assessing the effectiveness of the LCP-I Programme in improving quality of end-of-life care [41,42 ]. In this phase III trial, pairs of General Medicine hospital medical wards from five Italian regions were randomized to implement the Italian version of the LCP Programme (LCP-I) or to follow standard healthcare practice. The procedures of assessment were the same the group used for the phase II study. According to what reported by family members, there was no difference between groups in the ‘Overall quality of care’ scale (P ¼ 0.186; effect size ¼ 0.33), the primary end-point of the trial [42 ]. A significant difference was observed for two secondary outcomes: the ‘Respect, dignity, and kindness’ scale (P ¼ 0.043; effect size ¼ 0.28), and the ‘breathlessness’ scale (P ¼ 0.026). The ‘Informing and making decisions’ scale showed a trend which did not reach significance, but of a level that may be clinically important (P ¼ 0.076; effect size ¼ 0.31). All &
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the other outcomes showed smaller improvements, but wide confidence intervals do not permit inference on the relevance of their potential clinical impact. The results of the trial suggested that, when carefully implemented, the LCP-I has the potential to reduce the gap between hospices and hospitals. In agreement with the literature [38], the magnitude of the observed effects was smaller than those observed in the earlier phase 2 study [36 ]. The results of this negative trial are not conclusive and other trials are needed to understand the role of end-of-life care pathways. This was the first (and unique until now) randomized trial assessing the effectiveness of an end-oflife care pathway. After the update of Cochrane review, at July 2014, no other studies potentially eligible for a Cochrane review have been published. By reviewing clinicaltrials.gov, we identified two unpublished trials potentially eligible for a Cochrane review. A randomized phase 3 cluster trial is recruiting in Belgium [43]. The trial is aimed at assessing the effectiveness of the Dutch version of the LCP in improving the quality of care of patients dying in acute geriatric hospital wards in Flanders. A second study was registered and completed in Sweden. This is a controlled before and after trial. The aim is assessing the effectiveness of the LCP in Swedish nursing homes [44]. The authors have not published the results of this trial yet. &
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End-of-life care: pathways and evidence Costantini et al.
THE NEUBERGER REPORT Notably, none of the published studies on care pathways reported any adverse effects or complaints from one of the involved subjects (patients, family members and professionals). Concerns about the LCP emerged during the last years in United Kingdom, especially for noncancer patients. As a result, the United Kingdom government set up an Independent Review [45]. The report gives details of repeated instances of poor practice, with the LCP used as a tick box exercise, usually joined to a poor discussion regarding appropriate treatment and respect for patients and families. The report recommends to phase out the LCP, raising concerns especially with the term ‘pathway’ and proposing more individual end-of-life care plans.
CONCLUSION After more than 20 years from the first implementation, the evidence supporting the use of end-of-life care pathways remains poor. The results from the only randomized trial appear promising, but we need more studies appropriately designed, conducted, implemented, and analysed. We need to understand the effects of care pathways in improving the quality of end-of-life care, but also which components of the care pathways work better, for whom and what circumstances. Finally, any future strategy of assessment of end-of-life care pathways should take into account what we have learned from the LCP debate, including what emerged from the Neuberger report. Acknowledgements All the studies of the Italian programme for assessing the Liverpool Care Pathways for the dying patient were funded by the Italian Ministry of Health (Progetto diRicerca Finalizzata, RFPS-2006–6-341619) and Maruzza Lefebvre D’Ovidio Foundation-Onlus, Rome, Italy. We want to thank all professionals involved in these studies. Conflicts of interest We declare that we have no conflicts of interest.
REFERENCES AND RECOMMENDED READING Papers of particular interest, published within the annual period of review, have been highlighted as: & of special interest && of outstanding interest 1. Vanhaecht K, Bollmann M, Bower K, et al. Prevalence and use of clinical pathways in 23 countries - an international survey by the European Pathway Association (www.e-p-a.org). J Integr Care Pathw 2006; 10:28–34. 2. Campbell H, Hotchkiss R, Bradshaw N, Porteous M. Integrated care pathways. BMJ 1998; 316:133–137. 3. Bandolier Forum. Independent evidence-based healthcare. On care pathways 2003. http://www.medicine.ox.ac.uk/bandolier/Extraforbando/Forum2.pdf. [Accessed 5 August 2014]
4. McDonald KM, Sundaram V, Bravata DM, et al. Closing the quality gap: a critical analysis of quality improvement strategies (Vol. 7: Care Coordination). Rockville, (MD, US): Agency for Healthcare Research and Quality; 2007. Report No. 04(07)-0051-7. 5. Panella M, Marchisio S, Di SF. Reducing clinical variations with clinical pathways: do pathways work? Int J Qual Health Care 2003; 15:509– 521. 6. Kim S, Losina E, Solomon DH, et al. Effectiveness of clinical pathways for total knee and total hip arthroplasty: literature review. J Arthroplasty 2003; 18:69– 74. 7. Lemmens L, van Zelm R, Vanhaecht K, Kerkkamp H. Systematic review: indicators to evaluate effectiveness of clinical pathways for gastrointestinal surgery. J Eval Clin Pract 2008; 14:880–887. 8. Deneckerea S, Euwemab M, Van Hercka P, et al. Care pathways lead to better teamwork: Results of a systematic review. Soc Sci Med 2012; 75:264– 268. 9. Campbell M, Fitzpatrick R, Haines A, et al. 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Evaluating complex interventions in && end of life care: the MORE care statement on good practice generated by a synthesis of transparent expert consultations and systematic reviews. BMC Med 2013; 11:111. This is an evidence-based guidance on the best methods for the design and conduct of research on end-of-life care, specifically in the assessment of complex intervention. 15. Costantini M, Lunder U. OPCARE9 – a European perspective on the last days of life. Eur J Palliat Care 2012; 19:175–177. 16. Middlewood S, Gardner G, Gardner A. Dying in hospital: medical failure or natural outcome? J Pain Symptom Manage 2001; 22:1035–1041. 17. Lynn J, Teno J, Phillips R. Perceptions by family members of the dying experience of older and seriously ill patients. SUPPORT Investigators. Study to understand prognoses and preferences for outcomes and risks of treatments. Ann Intern Med 1997; 126:97–106. 18. Eriksson E, Arve S, Lauri S. Informational and emotional support received by relatives before and after the cancer patient’s death. Eur J Oncol Nurs 2006; 10:48–58. 19. Sato K, Miyashita M, Morita T, et al. Quality of end-of-life treatment for cancer patients in general wards and the palliative care unit at a regional cancer centre in Japan: a retrospective chart review. Support Care Cancer 2008; 16:113–122. 20. Toscani F, Di Giulio P, Brunelli C, et al. How people die in hospital general wards: a descriptive study. J Pain Symptom Manage 2005; 30:33–40. 21. Beccaro M, Caraceni A, Costantini M. End-of-life care in Italian hospitals: quality of and satisfaction with care from the caregivers’ point of view– results from the Italian Survey of the Dying of Cancer. J Pain Symptom Manage 2010; 39:1003–1015. 22. Sean STA, Low JA, Chan YH. Symptoms and care of dying elderly patients in an acute hospital. Singapore Med J 2005; 46:210–214. 23. Sepulveda C, Marlin A, Yoshida T, Ullrich A. Palliative care: the World Health Organization’s global perspective. J Pain Symptom Manage 2002; 24:91– 96. 24. Singer PA, Bowman KW. Quality end-of-life care: a global perspective. BMC Palliat Care 2002; 1:4. 25. Department of Health. End of life care strategy: promoting high quality care for all adults at the end of life. London: Department of Health; 2008. 26. Hall S, Petkova H, Tsouros AD, et al. Palliative care for older people: better practices. Copenhagen: World Health Organization; 2011. 27. Ellershaw J, Ward C. Care of the dying: the last hours or days of life. BMJ 2003; 326:30–34. 28. Bailey FA, Burgio KL, Woodby LL, et al. Improving processes of hospital care during the last hours of life. Arch Intern Med 2005; 165:1722–1727. 29. Bookbinder M, Blank A, Arney E, et al. Improving end of life care: development and pilot test of a clinical pathway. J Pain Symptom Manage 2005; 29:529– 543. 30. Chan R, Webster J. End-of-life care pathways for improving outcomes in caring for the dying. Cochrane Database Syst Rev 2010; 20:CD008006. 31. Chan RJ, Webster J. End-of-life care pathways for improving outcomes in && caring for the dying. Cochrane Database Syst Rev 2013; 11:CD008006. This is the Cochrane systematic review updated at Jun 2013 to assess the effects of end-of-life care pathways, compared with usual care. No studies met minimal criteria for inclusion in the review update.
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End of life management 32. Jack BA, Gambles M, Murphy D, Ellershaw JE. Nurses’ perceptions of the Liverpool Care Pathway for the dying patient in the acute hospital setting. Int J Palliat Nurs 2003; 9:375–381. 33. Gambles M, Stirzaker S, Jack BA, Ellershaw JE. The Liverpool Care Pathway in hospices: an exploratory study of doctor and nurse perceptions. Int J Palliat Nurs 2006; 12:414–421. 34. Di Leo S, Beccaro M, Finelli C, et al. Expectations about and impact of the Liverpool care Pathway for the dying patient in an Italian hospital. Palliat Med 2011; 25:293–303. 35. 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; 25:766–773. 36. Costantini M, Pellegrini F, Di Leo S, 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; 28:10–17. In this article, the results of the phase 2 study on the effect of the LCP on cancer patients in hospital wards are presented and discussed. 37. Veerbeek L, van Zuylen L, Swart SJ, et al. The effect of the Liverpool Care Pathway for the dying: a multicentre study. Palliat Med 2008; 22:145–151. 38. Odgaard-Jensen J, Vist GE, Timmer A, et al. Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst Rev 2011; 13:MR000012. 39. Raijmakers N, van Zuylen L, Furst CJ, et al. Variation in medication use in cancer patients at the end of life: a cross-sectional analysis. Supp Care Cancer 2013; 21:1003–1011.
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40. Veerbeek L, van der Heide A, de Vogel-Voogt E, et al. Using the LCP: bereaved relatives’ assessments of communication and bereavement. Am J Hosp Palliat Care 2008; 25:207–214. 41. Costantini M, Ottonelli S, Canavacci L, et al. 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. 42. Costantini M, Romoli V, Di Leo S, et al. Liverpool Care Pathway for patients && with cancer in hospital: a cluster randomised trial. Lancet 2014; 383:226– 237. This is the first randomized cluster trial aimed at assessing the effectiveness of LCP in the hospital setting. The authors did not find significant difference in the primary end-point, although two out of nine secondary outcomes showed significant improvements. 43. Verhofstede R. The effectiveness of the Liverpool Care Pathway (LCP). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000–2014. Available from: URL of the record NLM Identifier: NCT01890239. 44. Bra¨nnstro¨m M. Liverpool Care Pathway for the dying at Residential Care Homes. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000–2014. Available from: URL of the record NLM Identifier: NCT01428206. (in press). 45. Department of Health. More care, less pathway. A review of the Liverpool Care Pathway. Published 15 July 2013. https://www.gov.uk/government/uploads/ system/uploads/attachment_data/file/212450/Liverpool_Care_Pathway.pdf. [Accessed 21August 2014]
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End-of-life care: pathways and evidence Massimo Costantini, Sara Alquati, and Silvia Di Leo
Purpose of review Studies in different countries and settings of care have reported the quality of care for the dying patients as suboptimal. Care pathways have been developed with the aim of ensuring that dying patients and their family members received by health professionals the most appropriate care. This review presents and discusses the evidence supporting the effectiveness of the end-of-life care pathways. Recent findings Two Cochrane systematic reviews updated at June 2013 did not identify studies that met minimal criteria for inclusion. One randomized cluster trial aimed at assessing the effectiveness of the Liverpool Care Pathway in hospitalized cancer patients was subsequently published. The trial did not find a significant difference in the overall quality of care, the primary end-point, but two out of nine secondary outcomes – respect, dignity, and kindness, and control of breathlessness showed significant improvements. Afterwards, we did not find any other potentially eligible published study. Summary The overall amount of evidence supporting the dissemination of end-of-life care pathways is rather poor. One negative randomized trial suggests the pathways have the potential to reduce the gap between hospital and hospices. Further research is needed to understand the potential benefit of end-of-life care pathways. Keywords care of the dying, care pathway, effectiveness, end-of-life, review
INTRODUCTION Care pathways, also known as critical pathways, integrated care pathways, care maps, clinical care pathways, are widely used to systematically plan and follow-up a patient-focused care programme [1]. An international agreed definition of the care pathway does not exist. The most recent definition proposed by the European Pathway Association defines the care pathway ‘a complex intervention for the mutual decision making and organization of care for a well defined group of patients during a well defined period’ [1]. The implemented care pathway documentation becomes an integral part of the clinical documentation, and can support clinical audit [2]. The expected goals from the implementation of a care pathway should include one or more dimensions: improvement of quality of care and/or patient safety, increased patient satisfaction, and a more cost-effective use of resources. Many studies have assessed the effectiveness of the care pathways for different diseases or conditions. The quality of the studies is often poor, with only few controlled study designs [3]. Some systematic reviews have shown that the care pathways have the potentiality to be effective in standardizing low complexity and
uncertainty care processes, [4] in reducing clinical variations and improving quality of care, [5–7] and in promoting teamwork on a multidisciplinary team [8]. A care pathway is a typical complex intervention. A complex intervention was described as an intervention containing several interacting components [9]. Complexity can include different dimensions, for example, the range of possible outcomes, the variability in the target population, the number of elements in the intervention itself. Any end-of-life care pathway includes many interacting components that can enhance or reduce their potential effects. The process of assessment of complex interventions, including care pathways, implies specific problems for evaluators, in addition to practical Palliative Care Unit, IRCCS Arcispedale S. Maria Nuova, Reggio Emilia, Italy Correspondence to Massimo Costantini, Palliative Care Unit, IRCCS Arcispedale S. Maria Nuova, Viale Umberto 1, 50, 42123 Reggio Emilia, Italy. Tel: +39 0522 295369; fax: +39 0522 295622; e-mail: costantini. [email protected] Curr Opin Support Palliat Care 2014, 8:399–404 DOI:10.1097/SPC.0000000000000099
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End of life management
KEY POINTS Poor quality of end-of-life care is widely documented in many studies performed in all settings of care and in different countries. The WHO recognises the importance of providing the best palliative care for dying patients and their families. Since the second half of the 1990s, palliative care research groups developed and started to evaluate the effect of the introduction of ‘Care Pathways’ for patients dying in hospitals. A Cochrane systematic review updated at June 2013, aimed at assessing the effectiveness of end-of-life care pathways, searched for all published randomized controlled trials, quasi-experimental trials, including high-quality controlled before and after studies, but no studies met the inclusion criteria for the review. The first randomized trial assessing the effectiveness of an end-of-life care pathway, published in 2014, did not find a significant difference in the primary endpoint. A significant difference was observed for two secondary outcomes, the ‘Respect, dignity, and kindness’ scale and the ‘breathlessness’ scale. After this trial no other studies potentially eligible for a Cochrane review have been published. The results from the only randomized trial appear promising, but we need more studies appropriately designed, conducted, implemented, and analysed to better understand the effect of end-of-life care pathways and which of their components work better, for whom and what circumstances.
and methodological difficulties that any successful evaluation must overcome. The United Kingdom Medical Research Council (MRC) has developed a conceptual and methodological framework for developing and assessing complex interventions [9,10]. The MRC framework is more and more used for assessing a wide range of treatments and public health interventions, including educational and quality improvement programmes [11–13]. The first version of the MRC Framework [9] has taken on a ‘stepwise approach’, from phase 0 (preclinical) to phase 4 of clinical trials: (1) Phase 0: establishing the theoretical basis for the intervention. The methodology includes literature reviews and the assessment of theories of individual and organization behaviours. (2) Phase 1: improving the modelling of the intervention by identifying active components and mechanisms by which the outcomes can be influenced. The methodology is mainly qualitative. (3) Phase 2: defining the intervention, testing the procedures of assessment, evaluating the 400
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feasibility and acceptability of the intervention. The methodology is mixed, qualitative, and quantitative. (4) Phase 3: assessing the effectiveness of the intervention. The methodology is mixed, but mainly quantitative. It is the main trial requiring an appropriate control group, when possible randomization, adequate power and blinding (where feasible), appropriate procedures of assessment. (5) Phase 4: to establish the long-term applicability and effectiveness of the intervention when implemented outside of a research. In 2008, in a revised version of the MRC Framework, the process of developing and evaluating complex interventions was described according to cyclical phases [10]. In the area of palliative care research, the new MORECARE statement provides guidance on the evaluation of complex interventions in end-of-life care [14 ]. &&
THE REVIEW For the purpose of this review, ‘end-of-life’ will be used as synonymous of ‘dying phase’. Following the model proposed by OPCARE9, [15] it refers to the last hours–days of life, and includes the hours immediately after the patient’s death.
CARE PATHWAYS IN END-OF-LIFE CARE Poor quality of end-of-life care is widely documented in many studies performed in all settings of care and in different countries [16–22]. Inappropriate end-of-life care may result in the continuation of invasive clinical examinations and treatments, negatively affecting quality of life of both patients and relatives [17,22]. The WHO recognises the importance of providing the best palliative care for dying patients and their families in all care settings [23]. Improving the quality of care at the end-of-life is becoming a global concern. [24] For improving the quality of care of patients dying in different settings, major initiatives and national strategies were developed, implemented, and partially assessed worldwide [25,26]. Since the second half of the 1990s, palliative care research groups in the United Kingdom and the USA developed, implemented, and started to evaluate the effect of the introduction of specific ‘Care Pathways’ for patients dying in hospitals [27–29]. The general objective of these pathways was to transfer the model of excellence for care of the dying from hospices into hospitals and other healthcare settings, with the aim of improving the quality of Volume 8 Number 4 December 2014
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End-of-life care: pathways and evidence Costantini et al.
care delivered to the dying patients and their family members.
EFFECTIVENESS OF CARE PATHWAYS IN END-OF-LIFE CARE A Cochrane systematic review published in 2010, aimed at assessing the effectiveness of end-of-life care pathways, searched for all published randomized controlled trials, quasi-experimental trials, including high-quality controlled before and after studies [30]. The authors identified 920 relevant titles, but no studies met the inclusion criteria for the review. Three years later, a new version of the Cochrane review, updated at June 2013, identified other 1122 potentially relevant articles, but no additional studies met the minimal methodological standards to be included in the review [31 ]. The authors concluded that without further evidence, definitive recommendations for the use of end-of-life pathways in caring for the dying could not be made. Both reviews called for urgent further research [30,31 ]. The studies identified and excluded by the systematic reviews were mainly qualitative, [32–34], often just reporting the description of experience in using the care pathway, or simple noncontrolled before and after [28,29,35,36 ,37]. Two major drawbacks are evident in the analysis of the quantitative studies performed on care pathways. The first one is the poor internal validity of the study designs. Uncontrolled before and after studies are intrinsically weak designs for assessing the effectiveness of an intervention. Secular trends or sudden changes occurred during the study independently by the intervention can produce an improvement. Moreover, the existence of Hawthorne effect and, in some circumstances, of regression to the mean, can make the results impossible to interpret. There is also consolidating evidence that the results of uncontrolled before and after studies overestimate the effects of interventions [38]. These studies could be reconsidered within the framework for the assessment of end-of-life care pathways. According to the results of the before and after studies, the care pathways showed the potential to improve quality of care, [36 ] symptom management, [28,37] clinical documentation, [29,37] appropriateness of medications’ prescription, [28,39] and bereavement levels of relatives. [40] These types of study designs can give important information in the process of evaluation of a complex intervention. [9,10,14 ] They can be useful for planning future phase III studies, but do not allow establishing an unbiased relationship between the introduction of the care pathway and the expected outcomes. Not surprisingly, they do not get to the minimum &&
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standard of quality for being included in the Cochrane systematic reviews [30,31 ]. Unfortunately, this is the second major drawback, these studies were not part of a process of assessment of the pathway. In most cases, the research group did not plan or perform any other studies. The MRC framework for the assessment of complex interventions recommends the development of a global strategy of evaluation, starting from the initial phases focused on the standardization of the intervention and the procedures for its evaluation, and getting to the assessment of its effectiveness. An example of a comprehensive strategy of assessment of a care pathway is the pool of studies performed in Italy between 2006 and 2013 for developing and assessing the Italian version of the Liverpool Care Pathways (LCPs) for the dying patient (Table 1). The LCP was developed during the late 1990s in United Kingdom at the Royal Liverpool University Hospital, Marie Curie Hospice Liverpool. The LCP is an example of care pathway focused on the care of dying patients. [27] It was developed to transfer hospice practices of care in the last days of life into hospitals and other care settings. When the Italian research group started the process of assessment of the LCP, over 15 countries were using the pathway, mainly in hospital, although the evidence supporting its use was only from qualitative studies. [32,33] The Italian version of the LCP (LCP-I) was developed by the Regional Palliative Care Network of the National Cancer Research Institute of Genoa (Italy) in compliance with the original format. The Central LCP Team of Liverpool approved the final Italian LCP version. In 2007, a multidisciplinary palliative care team successfully piloted the LCP-I programme in three medical wards of ‘Villa Scassi Hospital’ in Genoa. The research team evaluated the process of LCP-I implementation using a mixed approach, qualitative and quantitative. Focus group, performed on sample of doctors and nurses before and after the implementation of the LCP-I, showed a perception of effectiveness of the Programme, particularly in pain management and in communication with patients and their families. Conversely, the qualitative approach highlighted some limits of the programme, and this allowed the research team to introduce some changes in the strategy of implementation [34]. A quantitative phase II study was performed on consecutive series of cancer deaths before and after the introduction of the LCP-I Programme in four hospital wards [35]. The results of this study allowed testing the feasibility of the procedures of assessment and the validity of process and outcomes indicators for assessing the quality of end-of-life
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End of life management Table 1. The Italian programme for assessing the Liverpool Care Pathways for the dying patient Aims
Methodology
Setting
Main results
Phase 0–1 Di Leo S et al. [34]
Exploring the expectations Literature review. Focus Three General Medicine Professionals recognized that about and the impact groups before and hospital wards LCP might improve symptom on staff of the LCP-I after LCP-I management and professional implementation implementation awareness of the problems related to emotional and informative support in end-of-life care.
Phase 2 Costantini M et al. [35] & Costantini M et al. [36 ] Raijmakers N et al. [39]
Standardization of the Before and after intervention and of the uncontrolled study procedures of assessment. Preliminary assessment of the effectiveness of the LCP
Three General Medicine Validity of the procedures of and one Respiratory assessment of all indicators. Disease hospital Good psychometric properties wards of the scales. Significant improvement in four out of 10 outcomes.
Phase 3 Costantini M et al. [41] Effectiveness && Costantini M et al. [42 ]
Randomized cluster trial
16 General Medicine hospital wards
Smaller effects of the LCP-I than those observed in the phase II study. Nonsignificant the primary end-point, but two out of the nine secondary outcomes, showed significant improvements.
LCP, Liverpool Care Pathway.
care. The results were promising and supported the design of a phase III study [36 ,39]. It is interesting to note that the study group designed and performed the trial, contrarily to other similar before and after studies, with the primary aim to collect information to perform a subsequent phase III trial [41]. The study was just an intermediate step in the process of assessment of the LCP-I. According to the results of all the previous studies, the Italian research group designed a clusterrandomized trial with the aim of assessing the effectiveness of the LCP-I Programme in improving quality of end-of-life care [41,42 ]. In this phase III trial, pairs of General Medicine hospital medical wards from five Italian regions were randomized to implement the Italian version of the LCP Programme (LCP-I) or to follow standard healthcare practice. The procedures of assessment were the same the group used for the phase II study. According to what reported by family members, there was no difference between groups in the ‘Overall quality of care’ scale (P ¼ 0.186; effect size ¼ 0.33), the primary end-point of the trial [42 ]. A significant difference was observed for two secondary outcomes: the ‘Respect, dignity, and kindness’ scale (P ¼ 0.043; effect size ¼ 0.28), and the ‘breathlessness’ scale (P ¼ 0.026). The ‘Informing and making decisions’ scale showed a trend which did not reach significance, but of a level that may be clinically important (P ¼ 0.076; effect size ¼ 0.31). All &
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the other outcomes showed smaller improvements, but wide confidence intervals do not permit inference on the relevance of their potential clinical impact. The results of the trial suggested that, when carefully implemented, the LCP-I has the potential to reduce the gap between hospices and hospitals. In agreement with the literature [38], the magnitude of the observed effects was smaller than those observed in the earlier phase 2 study [36 ]. The results of this negative trial are not conclusive and other trials are needed to understand the role of end-of-life care pathways. This was the first (and unique until now) randomized trial assessing the effectiveness of an end-oflife care pathway. After the update of Cochrane review, at July 2014, no other studies potentially eligible for a Cochrane review have been published. By reviewing clinicaltrials.gov, we identified two unpublished trials potentially eligible for a Cochrane review. A randomized phase 3 cluster trial is recruiting in Belgium [43]. The trial is aimed at assessing the effectiveness of the Dutch version of the LCP in improving the quality of care of patients dying in acute geriatric hospital wards in Flanders. A second study was registered and completed in Sweden. This is a controlled before and after trial. The aim is assessing the effectiveness of the LCP in Swedish nursing homes [44]. The authors have not published the results of this trial yet. &
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End-of-life care: pathways and evidence Costantini et al.
THE NEUBERGER REPORT Notably, none of the published studies on care pathways reported any adverse effects or complaints from one of the involved subjects (patients, family members and professionals). Concerns about the LCP emerged during the last years in United Kingdom, especially for noncancer patients. As a result, the United Kingdom government set up an Independent Review [45]. The report gives details of repeated instances of poor practice, with the LCP used as a tick box exercise, usually joined to a poor discussion regarding appropriate treatment and respect for patients and families. The report recommends to phase out the LCP, raising concerns especially with the term ‘pathway’ and proposing more individual end-of-life care plans.
CONCLUSION After more than 20 years from the first implementation, the evidence supporting the use of end-of-life care pathways remains poor. The results from the only randomized trial appear promising, but we need more studies appropriately designed, conducted, implemented, and analysed. We need to understand the effects of care pathways in improving the quality of end-of-life care, but also which components of the care pathways work better, for whom and what circumstances. Finally, any future strategy of assessment of end-of-life care pathways should take into account what we have learned from the LCP debate, including what emerged from the Neuberger report. Acknowledgements All the studies of the Italian programme for assessing the Liverpool Care Pathways for the dying patient were funded by the Italian Ministry of Health (Progetto diRicerca Finalizzata, RFPS-2006–6-341619) and Maruzza Lefebvre D’Ovidio Foundation-Onlus, Rome, Italy. We want to thank all professionals involved in these studies. Conflicts of interest We declare that we have no conflicts of interest.
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