Early palliative care program in idiopathic pulmonary fibrosis patients favors at-home and hospice deaths, reduces unplanned medical visits, and prolongs survival: A pilot study.

BACKGROUND: Idiopathic Pulmonary Fibrosis (IPF) is a lethal disease; most patients die in hospitals because palliative care (PC) is not wildly and early available. We aimed to determine the impact of an early PC program in IPF patients on place of death, emergency department (ED) admission, unplanned medical visits and survival before and after its implementation at our clinic. METHODS: IPF patients from our ILD clinic who died between January 1st, 2018 and December 31th, 2023 were included in the analysis. Primary outcomes were location of death, number of ED access and unplanned medical visits; secondary outcomes was survival from diagnosis. RESULTS: A total of 46 decedents between 2018 and 2023 were analysed: (median age 71,5 ± 5,5 years, 89 % male): 26 died before the implementation of the early PC program and 20 after. Through χ2 test, location of death resulted significantly different in the two groups, showing the capacity of early PC to favor at home or in hospice death (p = 0,02); similarly, the number of unplanned visits was significantly lower (p = 0,03). Finally, survival was significantly lower in patients not receiving the early PC program (p = 0,01). CONCLUSION: The availability of an early PC program since the diagnosis significantly reduced both the death rate in hospital settings, favoring dying in hospice or at home, and the number of unplanned medical visits. Furthermore, IPF patients receiving early PC showed a longer survival than those who did not.

Effects of 24/7 palliative care consultation availability on the use of emergency department and emergency medical services resources from non-oncological patients: a before-and-after observational cohort study.

OBJECTIVES: The non-oncological population is relatively under-represented among end-of-life (EOL) patients managed by palliative care (PC) services, and the effects of different PC delivery models are understudied in this population.This retrospective observational study on routinely collected data aimed at evaluating the effects of the extension from workday-only to 24/7 mixed hands-on and advisory home PC service on emergency department (ED) access and emergency medical services (EMS) interventions needed by non-oncological patients during their last 90 days of life, and their probability to die in hospital. METHODS: A before-and-after design was adopted comparing preimplementation and postimplementation periods (2018-2019 and 2021-22).We used a difference-in-differences approach to estimate changes in ED access and EMS intervention rates in the postintervention period through binomial negative regression. The oncological population, always exposed to 24/7 PC, was used as a control. A robust Poisson regression model was adopted to investigate the differences regarding hospital mortality. The analyses were adjusted for age, sex and disease grouping by the system involved. Results were reported as incidence rate ratios (IRRs) and ORs. RESULTS: A total of 2831 patients were enrolled in the final analysis.After the implementation of 24/7 home PC, both ED admissions (IRR=0.390, p<0.001) and EMS interventions (IRR=0.413, p<0.001) dropped, as well as the probability to die in hospital (OR=0.321, p<0.001). CONCLUSIONS: The adoption of a 24/7 mixed hands-on and advisory model of home PC could have relevant effects in terms of ED access and EMS use by non-oncological EOL patients under PC. TRIAL REGISRATION NUMBER: NCT05640076.

Identification of palliative care needs and prognostic factors of survival in tailoring appropriate interventions in advanced oncological, renal and pulmonary diseases: a prospective observational protocol.

INTRODUCTION: It is estimated that of those who die in high-income countries, 69%-82% would benefit from palliative care with a high prevalence of advanced chronic conditions and limited life prognosis. A positive response to these challenges would consist of integrating the palliative approach into all healthcare settings, for patients with all types of advanced medical conditions, although poor clinician awareness and the difficulty of applying criteria to identify patients in need still pose significant barriers. The aim of this project is to investigate whether the combined use of the NECPAL CCOMS-ICO and Palliative Prognostic (PaP) Score tools offers valuable screening methods to identify patients suffering from advanced chronic disease with limited life prognosis and likely to need palliative care, such as cancer, chronic renal or chronic respiratory failure. METHODS AND ANALYSIS: This multicentre prospective observational study includes three patient populations: 100 patients with cancer, 50 patients with chronic renal failure and 50 patients with chronic pulmonary failure. All patients will be treated and monitored according to local clinical practice, with no additional procedures/patient visits compared with routine clinical practice. The following data will be collected for each patient: demographic variables, NECPAL CCOMS-ICO questionnaire, PaP Score evaluation, Palliative Performance Scale, Edmonton Symptom Assessment System, Eastern Cooperative Oncology Group Performance Status and data concerning the underlying disease, in order to verify the correlation of the two tools (PaP and NECPAL CCOMS-ICO) with patient status and statistical analysis. ETHICS AND DISSEMINATION: The study was approved by local ethics committees and written informed consent was obtained from the patient. Findings will be disseminated through typical academic routes including poster/paper presentations at national and international conferences and academic institutes, and through publication in peer-reviewed journals.

European Cancer Organisation Essential Requirements for Quality Cancer Care (ERQCC): Pancreatic Cancer.

European Cancer Organisation Essential Requirements for Quality Cancer Care (ERQCC) are written by experts representing all disciplines involved in cancer care in Europe. They give patients, health professionals, managers and policymakers a guide to essential care throughout the patient journey. Pancreatic cancer is an increasing cause of cancer mortality and has wide variation in treatment and care in Europe. It is a major healthcare burden and has complex diagnosis and treatment challenges. Care must be carried out only in pancreatic cancer units or centres that have a core multidisciplinary team (MDT) and an extended team of health professionals detailed here. Such units are far from universal in European countries. To meet European aspirations for comprehensive cancer control, healthcare organisations must consider the requirements in this paper, paying particular attention to multidisciplinarity and patient-centred pathways from diagnosis, to treatment, to survivorship.

Palliative Sedation in Terminal Cancer Patients Admitted to Hospice or Home Care Programs: Does the Setting Matter? Results From a National Multicenter Observational Study.

CONTEXT: Few studies regarding palliative sedation (PS) have been carried out in home care (HC) setting. A comparison of PS rate and practices between hospice (HS) and HC is also lacking. OBJECTIVES: Comparing HC and HS settings for PS rate, patient clinical characteristics before and during PS, decision-making process, and clinical aspects of PS. METHODS: About 38 HC/HS services in Italy participated in a multicenter observational longitudinal study. Consecutive adult cancer patients followed till death during a four-month period and undergoing PS were eligible. Symptom control and level of consciousness were registered every eight hours to death. RESULTS: About 4276 patients were screened, 2894 followed till death, and 531 (18%) underwent PS. PS rate was 15% in HC and 21% in HS (P < 0.001). Principal refractory symptoms were delirium (54%) and dyspnea (45%), respectively, more common in HC (P < 0.001) and HS (P = 0.03). Informed consent was not obtained in 72% of patients but achieved by 96% of families. Midazolam was the most used drug (94% HS vs. 75% HC; P < 0.001) mainly by continuous infusion (74% HC vs. 89% HS; P < 0.001). PS duration was less than 48 hours in 67% of patients. Hydration during PS was less frequent in HC (27% vs. 49%; P < 0.001). In the eight hours before death, consciousness level was unrousable to mild physical stimulation in 81% and symptom control complete in 89% of cases. CONCLUSION: Our results show feasibility of PS in HC and HS and suggest setting differences in rates, indications, and practice of PS, possibly related to patients' selection or care organization.

Validity, reliability and responsiveness to change of the Italian palliative care outcome scale: a multicenter study of advanced cancer patients.

BACKGROUND: There is an increasing requirement to assess outcomes, but few measures have been tested for advanced medical illness. We aimed to test the validity, reliability and responsiveness of the Palliative care Outcome Scale (POS), and to analyse predictors of change after the transition to palliative care. METHODS: Phase 1: multicentre, mixed method study comprising cognitive and qualitative interviews with patients and staff, cultural refinement and adaption. Phase 2: consecutive cancer patients on admission to 8 inpatient hospices and 7 home-based teams were asked to complete the POS, the EORTC QLQ-C15-PAL and the FACIT-Sp (T0), to assess internal consistency, convergent and divergent validity. After 6 days (T1) patients and staff completed the POS to assess responsiveness to change (T1-T0), and agreement between self-assessed POS and POS completed by the staff. Finally, we asked hospices an assessment 24-48 h after T1 to assess its reliability (test re-test analysis). RESULTS: Phase I: 209 completed POS questionnaires and 29 cognitive interviews were assessed, revisions made and one item substituted. Phase II: 295 consecutive patients admitted to 15 PCTs were approached, 175 (59.3 %) were eligible, and 150 (85.7 %) consented. Consent was limited by the severity of illness in 40 % patients. We found good convergent validity, with strong and moderate correlations (r ranged 0.5-0.8) between similar items from the POS, the QLQ-C15-PAL and the FACIT-Sp. As hypothesised, the physical function subscale of QLQ-C15-PAL was not correlated with any POS item (r ranged -0.16-0.02). We found acceptable to good test re-test reliability in both versions for 6 items. We found significant clinical improvements during the first week of palliative care in 7/10 items assessed-pain, other symptoms, patient and family anxiety, information, feeling at peace and wasted time. CONCLUSIONS: Both the patient self-assessed and professional POS versions are valid and with an acceptable internal consistency. POS detected significant clinical improvements during palliative care, at a time when patients are usually expected to deteriorate. These results suggest that there is room for substantial improvement in the management of patients with advanced disease, across all key domains-symptoms, psychological, information, social and spiritual.

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.

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.

[End-of-life medical decisions: study of physician's opinions in four Italian centres]. / Decisioni mediche di fine vita: uno studio sulle opinioni dei medici in quattro aree italiane.

OBJECTIVE: Knowing the physicians' opinions on end-of-life decisions. DESIGN: In 2002, in the context of an European collaborative study (EURELD) a structured questionnaire has been sent to the physicians of the 9 specialties mostly involved in the assistance of terminal patients. The questionnaire asked to express an opinion on 13 statements on end-of-life decisions and to express his/her intention to behave about 4 hypothetical clinical cases. SETTING: four Italian centres: Florence-Prato, Venice, Trento and Bologna. PARTICIPANTS: 1508 questionnaires were studied, the response rate ranged between 34% (Firenze) to 50% (Trento). RESULTS: In the univariate analysis, there were no significant differences between centres for the 13 statements on end-of-life decisions. In all centres, about one third physicians accepted euthanasia; about one half supported advance directives whereas most physicians would have withheld treatment on the request of patient or intensified the alleviation of symptom and pain. The intended behaviours of withholding treatment, intensifying the alleviation of pain/symptoms, euthanasia, deep sedation until death were more frequently expressed in case of the request of patient than on the physicians own initiative or on request of the family CONCLUSION: The physicians' attitudes were homogeneous between the various centers and they may well be representative of the phenomenon which has been investigated, at least in Northern-Central Italy.

Gemcitabine plus mitoxantrone and prednisone in the palliative treatment of hormone-resistant prostate cancer (HRPC): A phase II study (GOAM 01.01 study).

BACKGROUND: The present exploratory phase II study was performed to evaluate the activity and tolerability of adding a second agent (gemcitabine) to the well-tolerated mitoxantrone/prednisone regimen in patients with locally advanced or metastatic prostate cancer no longer responsive to hormonal treatment. PATIENTS AND METHODS: Forty-three patients with hormone-refractory prostate cancer (HRPC) were included in the study from May 2000 to April 2004. Their median age was 71 years (range, 56-81) and their median Karnofsky performance status (KPS) was 90 (range, 70-100). The treatment schedule consisted of intravenous (i.v.) mitoxantrone (8 mg/m2 on day 1), i.v. gemcitabine 800 mg/m2 on days 1 and 8, recycled every 21 days and oral prednisone administered at a dose of 10 mg per day. Hormonal treatment with LHRH was continued in all patients. Up to six cycles of treatment were planned in the absence of progressive disease. RESULTS: Sixteen patients had measurable disease (six patients only measurable disease, ten patients bone disease plus measurable disease) and 27 patients had only bone disease. Concerning the PSA levels, a partial response (PR) was observed in 15 patients (38%), stable disease (SD) in 16 patients (41%) and progressive disease (PD) in eight patients (21%). The objective response was evaluable in 16 patients; one patient was not evaluable because he had received only one cycle. Ten patients (63%) had SD and five patients (31%) PD. In the ten evaluable patients with objective SD, depending upon the PSA response, three PR, six SD and one PD were observed. Among the five patients who progressed, three PD and two SD were observed as a PSA response. Pain remission was recorded in 15/41 patients (36%) and the KPS remained stable in most patients. The median overall survival was 15 months (range, 1-41) (95% CI: 10-20 months). The 1-year survival rate was 61%. Hematological toxicity was mild: G 3-4 neutropenia was observed in five (12%) patients. There were no neutropenic, fevers. No significant non-hematological toxicity was observed. CONCLUSION: The mitoxantrone, gemcitabine and prednisone combination, in accordance with the present regimen, was feasible, had a palliative effect, good tolerance and antitumor activity. Nonetheless, our results do not seem to be superior to those previously described for mitoxantrone plus prednisone.