Clinical Care Conditions and Needs of Palliative Care Patients from Five Italian Regions: Preliminary Data of the DEMETRA Project.

In order to plan the right palliative care for patients and their families, it is essential to have detailed information about patients' needs. To gain insight into these needs, we analyzed five Italian local palliative care networks and assessed the clinical care conditions of patients facing the complexities of advanced and chronic disease. A longitudinal, observational, noninterventional study was carried out in five Italian regions from May 2017 to November 2018. Patients who accessed the palliative care networks were monitored for 12 months. Sociodemographic, clinical, and symptom information was collected with several tools, including the Necesidades Paliativas CCOMS-ICO (NECPAL) tool, the Edmonton Symptom Assessment System (ESAS), and interRAI Palliative Care (interRAI-PC). There were 1013 patients in the study. The majority (51.7%) were recruited at home palliative care units. Cancer was the most frequent diagnosis (85.4%), and most patients had at least one comorbidity (58.8%). Cancer patients reported emotional stress with severe symptoms (38.7% vs. 24.3% in noncancer patients; p = 0.001) and were less likely to have clinical frailty (13.3% vs. 43.9%; p < 0.001). Our study confirms that many patients face the last few months of life with comorbidities or extreme frailty. This study contributes to increasing the general knowledge on palliative care needs in a high-income country.

Discussions about palliative sedation in hospice: Frequency, timing and factors associated with patient involvement.

OBJECTIVE: To investigate whether and when palliative sedation was discussed with hospice patients with cancer and/or with their families and factors associated with patient involvement in such discussions. METHODS: Medical records of all patients with cancer who died in an Italian hospice in 2014-2015 (N = 326) were retrospectively reviewed. Multiple logistic regression was used to assess the association between patients' characteristics and palliative sedation discussion with the patient versus palliative sedation discussion only with the family. RESULTS: Palliative sedation discussion was in 51.8% of the cases reported in the record. In most of the cases, discussions were conducted pre-emptively. Palliative sedation was used for 67.3% of the patients who were involved in the discussion and for 32.7% of the patients when the topic was discussed only with the family. Patient involvement in palliative sedation discussions was negatively associated with living with others (OR 0.34, CI 0.15; 0.77), and positively associated with awareness of prognosis (OR 5.61, CI 2.19; 14.33) and days of survival after hospice admission (OR 3.41, CI 1.55; 7.51). CONCLUSION: Policies encouraging patient involvement in palliative care decision-making, including palliative sedation, should be implemented and their adoption should be carefully examined. Prospective studies addressing this topic are needed.

Consensus document of the Italian Association of Medical Oncology and the Italian Society of Palliative Care on early palliative care.

A consensus document on early palliative care was produced by a committed Working Group of the Italian Society of Medical Oncology and the Italian Society of Palliative Care to improve the early integration of palliative care in medical oncology and to stimulate and guide the choices of those who daily face the problems of advanced stage cancer patients. The simultaneous administration of antineoplastic treatments and early palliative care was shown to be beneficial in metastatic cancer pathway outcomes. Patients who could benefit from early palliative care are those with an advanced cancer at presentation, a compromised PS for cancer, and/or morbidities, and who are too frail to receive treatment. According to the Bruera practice models, in which the combination of cancer management with early palliative care can be offered, three groups of patients needing simultaneous care were identified and three different models of the delivery of palliative care were proposed. In patients with good prognosis and low need of simultaneous care, the solo practice model and the request for consultations were suggested, while in patients with poor prognosis disease with high need of simultaneous care and in conditions with high need of simultaneous care, regardless of cancer prognosis, the integrated care approach should be offered. Palliative care consultation services are seldom accessible in the majority of Italian hospitals; thus the application of various practice models depends on available resources, and a shared care model with the structures of palliative care operating in the area is often required.

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.

Prospective observational Italian study on palliative sedation in two hospice settings: differences in casemixes and clinical care.

PURPOSE: Palliative sedation (PS) has been defined as the use of sedative medications to relieve intolerable suffering from refractory symptoms by a reduction in patient consciousness. It is sometimes necessary in end-of-life care when patients present refractory symptoms. We investigated PS for refractory symptoms in different hospice casemixes in order to (1) assess clinical decision-making, (2) monitor the practice of PS, and (3) examine the impact of PS on survival. METHODS: This observational longitudinal cohort study was conducted over a period of 9 months on 327 patients consecutively admitted to two 11-bed Italian hospices (A and B) with different casemixes in terms of median patient age (hospice A, 66 years vs. hospice B, 73 years; P = 0.005), mean duration of hospice stay (hospice A, 13.5 days vs. hospice B, 18.3 days; P = 0.005), and death rate (hospice A, 57.2% vs. hospice B, 89.9%; P < 0.0001). PS was monitored using the Richmond Agitation-Sedation Scale (RASS). Sedated patients constituted 22% of the total admissions and 31.9% of deceased patients, which did not prove to be significantly different in the two hospices after adjustment for casemix. RESULTS: Patient involvement in clinical decision-making about sedation was significantly higher in hospice B (59.3% vs. 24.4%; P = 0.007). Family involvement was 100% in both hospices. The maximum level of sedation (RASS, -5) was necessary in only 58.3% of sedated patients. Average duration of sedation was similar in the two hospices (32.2 h [range, 2.5-253.0]). Overall survival in sedated and nonsedated patients was superimposable, with a trend in favor of sedated patients. CONCLUSIONS: PS represents a highly reproducible clinical intervention with its own indications, assessment methodologies, procedures, and results. It does not have a detrimental effect on survival.

Eliciting individual preferences about death: development of the End-of-Life Preferences Interview.

The capability to make decisions about one's own dying and death is commonly considered a necessary component of a good death, but difficulties in communicating about imminent death have been documented. This paper attempts to describe the process of constructing an instrument to elicit individual preferences concerning dying, while respecting the patient's awareness, and to verify its applicability in a palliative care setting. The development of the End-of-Life Preferences Interview (ELPI) was performed through (a) a literature search aimed at identifying relevant issues; (b) examination by a panel of experts in the field of palliative care of the items generated; and (c) pretesting of feasibility on all eligible consecutive patients referred to three centers of palliative care during a two-month period. The final version of the ELPI consisted of two parts: The first level explores preferences about issues regarding the caregiving process, and the second level focuses on preparation for death. Each of the two parts is introduced by key questions aimed at allowing the patient to decide whether and when to stop exploring such sensitive matters. Among the 49 eligible patients (41%), the interview was proposed to only 13 of them (27%), and only one of them refused. The reasons for such a low compliance of physicians in proposing the ELPI were evaluated by a semi-structured interview and are herein discussed. The use of the ELPI in clinical practice can favor the passage to a greater consideration of the self-determination of the patient at the end of life, with due consideration of his or her cultural and emotional needs.

Edmonton symptom assessment scale: Italian validation in two palliative care settings.

In the palliative care setting, the Edmonton Symptom Assessment Scale (ESAS) was developed for use in daily symptom assessment of palliative care patients. ESAS considers the presence and severity of nine symptoms common in cancer patients: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath plus an optional tenth symptom, which can be added by the patient. The aim of this study was to validate the Italian version of ESAS and to evaluate an easy quality of life monitoring system that uses a patient's self-rating symptom assessment in two different palliative care settings: in-patients and home patients. Eighty-three in-patients and 158 home care patients were enrolled. In the latter group, the Italian validated version of the Symptom Distress Scale (SDS) was also administered at the admission of the patients. The two groups of patients have similar median survival, demographic and clinical characteristics, symptom prevalence and overall distress score at baseline. ESAS shows a good concurrent validity with respect to SDS. The correlation between the physical items of ESAS and SDS was shown to be higher than the correlation between the psychological items. The association of ESAS scores and performance status (PS) showed a trend: the higher the symptom score was, the worse was the PS level. Test-retest evaluation, applied in the in-patient group, showed good agreement for depression, well-being and overall distress and a moderate agreement for all the other items. In conclusion, ESAS can be considered a valid, reliable and feasible instrument for physical symptom assessment in routine "palliative care" clinical practice with a potentially different responsiveness in different situations or care settings.

Palliative home care reduces time spent in hospital wards: a population-based study in the Tuscany Region, Italy.

OBJECTIVE: To estimate the reduction of time spent in hospital obtained through palliative home care. METHODS: Retrospective analysis of the hospital admissions occurred during the last year of life. Cancer patients who were resident in the province of Florence, were registered at the Tuscan Cancer Registry, and died during the year 1997 were included in the study. Three palliative home care services were operating in the study area in 1997. MAIN RESULTS: 3423 cancer patients died in the study area during 1997. 9.2% of them received palliative home care. Palliative home care was effective in reducing the utilization of hospital care during the last three months of life. A 25% reduction of the relative risk (CI: 34-14%) to have in-patient admissions and a 49% reduction of relative risk (CI: 52-47%) of spending days in the hospital during the last 3 months of life were estimated through multivariable regression models. CONCLUSIONS: Palliative home care was effective in reducing time spent in hospital during the last 3 months of life.