Liverpool Care Pathway for patients with cancer in hospital: a cluster randomised trial.

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. FINDINGS: 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). INTERPRETATION: 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. FUNDING: Italian Ministry of Health and Maruzza Lefebvre D'Ovidio Foundation-Onlus.

Providing a nurse-led complex nursing INtervention FOcused on quality of life assessment on advanced cancer patients: The INFO-QoL pilot trial.

PURPOSE: Unmet needs for advanced-disease cancer patients are fatigue, pain, and emotional support. Little information is available about the feasibility of interventions focused on patient-reported outcome measurement developed according to the Medical Research Council (MRC) Framework in advanced-disease cancer patients. We aimed to pilot a nurse-led complex intervention focused on QoL assessment in advanced-disease cancer patients. METHODS: The INFO-QoL study was based on an exploratory, nonequivalent comparison group, pre-test-post-test design. Study sites received either the INFO-QoL intervention or usual care. Adult advanced-disease cancer patients admitted to hospice inpatient units that gave their informed consent were included in the study. Subjects were 187 patients and their families and 19 healthcare professionals. We evaluated feasibility, acceptability, and patients' outcomes using the Integrated Palliative Care Outcome Scale. RESULTS: Nineteen healthcare professionals were included. The mean competence score increased significantly over time (p < 0.001) and the mean usefulness score was high 8.63 (±1.36). In the post-test phase, 54 patients were allocated to the experimental unit and 36 in the comparison unit. Compared to the comparison unit, in the experimental unit anxiety (R2 = 0.07; 95% CI = -0.06; 0.19), family anxiety (R2 = 0.22; 95% CI = -0.03; 0.41), depression (R2 = 0.31; 95% CI = -0.05; 0.56) and sharing feelings (R2 = 0.09; 95% CI = -0.05; 0.23), were improved between pre-test and post-test phase. CONCLUSIONS: The INFO-QoL was feasible and potentially improved psychological outcomes. Despite the high attrition rate, the INFO-QoL improved the quality and safety culture for patients in palliative care settings.

A phase 2 quasi-experimental trial evaluating the feasibility, acceptability, and potential effectiveness of complex nursing intervention focused on QoL assessment on advanced cancer patients with palliative care needs: study protocol.

BACKGROUND: Palliative care (PC) is an approach that improves the quality of life (QoL) of patients and their families facing the problem associated with incurable terminal disease. A number of QoL assessment tools have been validated in PC and their use described for research purposes, to support clinical practice, and as part of the quality improvement programs. There is a paucity of evidence on the implementation of a nursing intervention focused on QoL assessment in PC practice.The aim of this study is to model and determine the feasibility of a nursing complex intervention focused on QoL assessment in PC practice. METHODS: The intervention will be evaluated through a quasi-experimental non-equivalent comparison group before-after study design. This project can be classified as phases 1-2, according to the Medical Research Council (MRC) framework for the development and evaluation of complex interventions.The study setting will take place in two inpatient hospice units in Italy. The study sample will be constituted of 39 multidisciplinary healthcare professionals and a sample of 46 advanced cancer patients admitted to hospices during the implementation of the intervention. DISCUSSION: This study will generate information to address the implementation of QoL measurement in palliative care practice. Findings of this study will be used to inform a phase 3 trial according to the MRC framework. TRIAL REGISTRATION: ISRCTN41201864 retrospectively registered.

Implementation of the Liverpool Care Pathway (LCP) for the dying patient in the inpatient hospice setting: development and preliminary assessment of the Italian LCP program.

BACKGROUND: The Liverpool Care Pathway (LCP) is extensively used in hospices, but the literature on the process of implementation is scarce. AIM: Developing, piloting, and preliminarily assessing the LCP program within the inpatient hospice setting. METHODS: This is a phase 0-1 study, according to the Medical Research Council (MRC) Framework, divided into three phases: literature review on LCP in hospice and development of the Italian version of the LCP program (LCP-I), development of a procedure for assessing the quality of the implementation process and assessing the feasibility of the implementation process, and piloting the procedure in 7 inpatient Italian hospices. RESULTS: The LCP was implemented in all the hospices involved. A high proportion of physicians (50%-100%) and nurses (94%-100%) attended the self-education program. The self-implementation of the LCP-I program was completed in all hospices. The proportion of patients who died on LCP-I ranged between 35.6% and 89.1%. Professionals from 2 hospices reported a positive impact of the LCP-I. Conversely, professionals from 2 hospices did not recognize a positive impact of the program and did not agree to maintain the LCP-I in hospice. Finally, professionals from the other 3 hospices reported intermediate evaluations (1 stopped to use the LCP-I). Some weaknesses emerged from the external audits, related to the self-education and the self-implementation approach. Professionals required an external support from a trained palliative care team with reference to both phases. CONCLUSIONS: The LCP-I implementation within hospices is feasible, and the process of implementation is evaluable. Issues that occurred within the implementation process suggest the introduction of an external support from a trained palliative care team in implementing the LCP program.