title: Liverpool Care Pathway for patients with cancer in hospital: a cluster randomised trial.
abstract: BACKGROUND
  The quality of care provided to patients with cancer who are dying in hospital and their families is suboptimum. The UK Liverpool Care Pathway (LCP) for patients who are dying was developed with the aim of transferring the best practice of hospices to hospitals. We therefore assessed the effectiveness of LCP in the Italian context (LCP-I) in improving the quality of end-of-life care for patients with cancer in hospitals and for their family.
  
  
  METHODS
  In this pragmatic cluster randomised trial, 16 Italian general medicine hospital wards were randomly assigned to implement the LCP-I programme or standard health-care practice. For each ward, we identified all patients who died from cancer in the 3 months before randomisation (preintervention) and in the 6 months after the completion of the LCP-I training programme. The primary endpoint was the overall quality of care toolkit scale. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01081899.
  
  
  RESULTS
  During the postintervention assessment, data were gathered for 308 patients who died from cancer (147 in LCP-I programme wards and 161 in control wards). 232 (75%) of 308 family members were interviewed, 119 (81%) of 147 with relatives cared for in the LCP-I wards (mean cluster size 14·9 [range eight to 22]) and 113 (70%) of 161 in the control wards (14·1 [eight to 22]). After implementation of the LCP-I programme, no significant difference was noted in the distribution of the overall quality of care toolkit scores between the wards in which the LCP-I programme was implemented and the control wards (score 70·5 of 100 vs 63·0 of 100; cluster-adjusted mean difference 7·6 [95% CI -3·6 to 18·7]; p=0·186).
  
  
  CONCLUSIONS
  The effect of the LCP-I programme in our study is less than the effects noted in earlier phase 2 trials. However, if the programme is implemented well it has the potential to reduce the gap in quality of care between hospices and hospitals. Further research is needed to ascertain what components of the LCP-I programme might be effective and to develop and assess a wider range of approaches to quality improvement in hospital care for people at the end of their lives and for their families.
  
  
  BACKGROUND
  Italian Ministry of Health and Maruzza Lefebvre D'Ovidio Foundation-Onlus.
authors.affiliation: Palliative Care Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Arcispedale S Maria Nuova, Reggio Emilia, Italy. Electronic address: costantini.massimo@asmn.re.it.
authors.forename: Massimo
authors.initials: M
authors.lastname: Costantini
authors.affiliation: Regional Palliative Care Network, IRCCS Azienda Ospedaliera Universitaria San Martino-Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
authors.forename: Vittoria
authors.initials: V
authors.lastname: Romoli
authors.affiliation: Regional Palliative Care Network, IRCCS Azienda Ospedaliera Universitaria San Martino-Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
authors.forename: Silvia Di
authors.initials: SD
authors.lastname: Leo
authors.affiliation: Regional Palliative Care Network, IRCCS Azienda Ospedaliera Universitaria San Martino-Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Beccaro
authors.affiliation: Regional Palliative Care Network, IRCCS Azienda Ospedaliera Universitaria San Martino-Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Bono
authors.affiliation: Hospice Maria Chighine, IRCCS Azienda Ospedaliera Universitaria San Martino-Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Pilastri
authors.affiliation: Clinical and Descriptive Epidemiology Unit, Istituto per lo Studio e la Prevenzione Oncologica, Florence, Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Miccinesi
authors.affiliation: Palliative Care Network, Azienda Unità Sanitaria Locale di Bologna, Bologna, Italy.
authors.forename: Danila
authors.initials: D
authors.lastname: Valenti
authors.affiliation: Palliative Care Unit, Biella Hospital, Biella, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Peruselli
authors.affiliation: Clinical and Descriptive Epidemiology Unit, Istituto per lo Studio e la Prevenzione Oncologica, Florence, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Bulli
authors.affiliation: Foundation Hospice Maria Teresa Chiantore Seragnoli, Bologna, Italy.
authors.forename: Catia
authors.initials: C
authors.lastname: Franceschini
authors.affiliation: Palliative Care Unit, Biella Hospital, Biella, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Grubich
authors.affiliation: Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; European Palliative Care Research Centre, Norwegian University of Science and Technology, Faculty of Medicine, Trondheim, Norway.
authors.forename: Cinzia
authors.initials: C
authors.lastname: Brunelli
authors.affiliation: Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Cinzia
authors.initials: C
authors.lastname: Martini
authors.affiliation: Mario Negri Sud Institute, Mario Negri Sud Consortium, Chieti, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Pellegrini
authors.affiliation: King's College London, Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, London, UK.
authors.forename: Irene J
authors.initials: IJ
authors.lastname: Higginson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D016000:Cluster Analysis; D019091:Critical Pathways / Q000458:organization & administration / Q000592:standards*; D005260:Female; D006760:Hospitalization; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy*; D010166:Palliative Care / Q000458:organization & administration / Q000592:standards*; D015397:Program Evaluation; D011787:Quality of Health Care