Latent Class Analysis of Symptom Burden Among Seriously Ill Adults at the End of Life.

BACKGROUND: Serious illness is characterized by high symptom burden that negatively affects quality of life (QOL). Although palliative care research has highlighted symptom burden in seriously ill adults with cancer, symptom burden among those with noncancer serious illness and multiple chronic conditions has been understudied. Latent class analysis is a statistical method that can be used to better understand the relationship between severity of symptom burden and covariates, such as the presence of multiple chronic conditions. Although latent class analysis has been used to highlight subgroups of seriously ill adults with cancer based on symptom clusters, none have incorporated multiple chronic conditions. OBJECTIVES: The objectives of this study were to (a) describe the demographic and baseline characteristics of seriously ill adults at the end of life in a palliative care cohort, (b) identify latent subgroups of seriously ill individuals based on severity of symptom burden, and (c) examine variables associated with latent subgroup membership, such as QOL, functional status, and the presence of multiple chronic conditions. METHODS: A secondary data analysis of a palliative care clinical trial was conducted. The latent class analysis was based on the Edmonton Symptom Assessment System, which measures nine symptoms on a scale of 0-10 (e.g., pain, fatigue, nausea, depression, anxiousness, drowsiness, appetite, well-being, and shortness of breath). Clinically significant cut-points for symptom severity were used to categorize each symptom item in addition to a categorized total score. RESULTS: Three latent subgroups were identified (e.g., low, moderate, and high symptom burden). Lower overall QOL was associated with membership in the moderate and high symptom burden subgroups. Multiple chronic conditions were associated with statistically significant membership in the high symptom burden latent subgroup. Older adults between 65 and 74 years had a lower likelihood of moderate or high symptom burden subgroup membership compared to the low symptom burden class. DISCUSSION: Lower QOL was associated with high symptom burden. Multiple chronic conditions were associated with high symptom burden, which underlines the clinical complexity of serious illness. Palliative care at the end of life for seriously ill adults with high symptom burden must account for the presence of multiple chronic conditions.

Incidence and associated factors of sudden unexpected death in advanced cancer patients: A multicenter prospective cohort study.

PURPOSE: A sudden unexpected death has significant negative impacts on patients, family caregivers, and medical staff in hospice/palliative care. This study aimed to clarify the incidence and associated factors of sudden unexpected death according to four definitions in advanced cancer patients. METHODS: We performed a prospective cohort study in 23 inpatient hospices/palliative care units in Japan. Advanced cancer patients aged ≥18 years who were admitted to inpatient hospices/palliative care units were included. The incidence and associated factors of sudden unexpected death were evaluated in all enrolled patients according to four definitions: (a) rapid decline death, defined as a sudden death preceded by functional decline over 1-2 days; (b) surprise death, defined if the primary responsible palliative care physician answered "yes" to the question, "Were you surprised by the timing of the death?"; (c) unexpected death, defined as a death that occurred earlier than the physicians had anticipated; and (d) performance status (PS)-defined sudden death, defined as a death that occurred within 1 week of functional status assessment with an Australia-modified Karnofsky PS ≥50. RESULTS: Among 1896 patients, the incidence of rapid decline death was the highest (30-day cumulative incidence: 16.8%, 95% CI: 14.8-19.0%), followed by surprise death (9.6%, 8.1-11.4%), unexpected death (9.0%, 7.5-10.8%), and PS-defined sudden death (6.4%, 5.2-8.0%). Male sex, liver metastasis, dyspnea, malignant skin lesion, and fluid retention were significantly associated with the occurrence of sudden unexpected death. CONCLUSION: Sudden unexpected death is not uncommon even in inpatient hospices/palliative care units, with range of 6.4-16.8% according to the different definitions.

Estudio preliminar del proceso fin de vida mediante triangulación de datos en un hospital comarcal / Preliminary study of the end-of-life process through data triangulation in a regional Hospital

OBJETIVO: Conocer las características del proceso de final de vida en un Hospital Comarcal, según los actores implicados, estableciendo los elementos de convergencia/divergencia en el proceso asistencial, toma de decisiones, información y conocimientos. MÉTODO: Estudio observacional, transversal, descriptivo, convergente y analítico de métodos mixtos y triangulación de datos. Se realizó sobre una muestra de 63 sujetos, de los que 25 fueron profesionales, 19 familiares cuidadores y 19 historias clínicas de pacientes fallecidos a lo largo de un año. RESULTADOS: La triangulación de datos muestra discrepancias entre familiares y profesionales de salud en cuanto a la calidad de la asistencia y la información facilitada. Destaca la falta de registro en las historias clínicas revisadas sobre aspectos del proceso asistencial relacionados con la toma de decisiones o la sedación terminal. CONCLUSIÓN: Este estudio proporciona una visión integrada sobre la atención sanitaria en el proceso de final de vida prestada en un Hospital Comarcal. Muestra áreas prioritarias de intervención, para mejorar la calidad de vida en este proceso, como son la implicación del paciente en la toma de decisiones, la cumplimentación adecuada en las historias clínicas y la formación de los profesionales

OBJECTIVE: To know the characteristics of the end-of-life process in a Regional Hospital, according to the actors involved, establishing convergence/divergence elements in care process, decision-making, information and knowledge. METHOD: Observational, cross-sectional, descriptive, convergent of mixed methods and data triangulation study. Carried out on a sample of 63 subjects, of which 25 were health professionals, 19 family caregivers and 19 medical records of patients who died in the course of a year. RESULTS: Data triangulation shows discrepancies between family members and health professionals regarding care quality and the information provided. The lack of documentation in medical records of care aspects related to decision-making or terminal sedation stands out. CONCLUSION: This study provides an integrated view of end-of-life care provided in a Regional Hospital, identifying priority areas of intervention in order to improve quality of life in this process, such as patient involvement in decision-making, appropriate completion of medical records and health professional training

Off-label drugs in palliative care: a Group Delphi treatment recommendation process.

OBJECTIVES: The use of drugs beyond their marketing authorisation, that is, off-label use, is common practice in palliative care with over 70% of off-label use having little or no scientific support. The lack of evidence makes recommendations for off-label use essential, in order to increase the safety of drug therapy and thus patient safety. The aim of this study was to develop a guide for preparing and consenting drug-specific recommendations for off-label use in palliative care. METHODS: Group Delphi Study with three rounds and a prior online survey to identify topics of dissent. Participants represented professional groups working in palliative care involved in direct patient care and/or drug management and various care settings. Furthermore, representatives of relevant professional associations, experts with academic, non-clinical background and experts with international expertise were invited. RESULTS: 18/20 invited professionals participated in the prior online-survey. 15 experts participated in the Group Delphi process. Six domains, including identification of drugs, drug uses, assessment of evidence, formulation, consensus and updating of recommendations were generated and respective statements were included in the Group Delphi process. The consensus process resulted in 28 statements forming the guide for recommendations. CONCLUSIONS: The resultant systematic approach for preparing and consenting drug-specific recommendations for off-label use will allow the development of recommendations with transparent and reproducible monographs. This will help to increase treatment quality and patient safety as well as security of decision-making in palliative care. The developed guide is part of a larger project aiming to provide therapy recommendations for areas that have little or no scientific evidence.

Comparison of Perceptions of Spiritual Care Among Patients With Life-Threatening Cancer, Primary Family Caregivers, and Hospice/Palliative Care Nurses in South Korea.

This study aimed to compare perceptions of spiritual care among patients with life-threatening cancer, their primary family caregivers, and hospice/palliative care nurses.Data were collected using both structured and unstructured approaches. Structured questionnaire data were examined using statistical analysis methods, and unstructured data were examined using content analysis to compare the 3 participant groups. The questionnaire revealed that among all 3 groups, spiritual care was commonly perceived to relate to "having the opportunity for internal reflection," "finding meaning," "encouraging hope," and "listening to and being with patients." Content analysis of the unstructured data revealed 5 themes: "Caring with sincerity," "Strengthening spiritual resources," "Alleviating physical pain and discomfort" (among patients and primary family caregivers only), "Improving spiritual care service," and "Multifaceted cooperation" (among hospice/palliative care nurses only). Our findings suggest that for patients with life-threatening illnesses such as terminal cancer, spiritual care should not be limited to religious practice but should also satisfy inner existential needs, for example, by encouraging hope, providing empathy, and helping patients find meaning in their circumstances.

The pervasive relevance of COVID-19 within routine paediatric palliative care consultations during the pandemic: A conversation analytic study.

BACKGROUND: The importance of caring for children with complex and serious conditions means that paediatric palliative care must continue during pandemics. The recent pandemic of Coronavirus Disease 2019 (COVID-19) provides a natural experiment to study health communication during pandemic times. However, it is unknown how communication within consultations might change during pandemics. AIM: This study, a sub-study of a larger project, aimed to examine real-world instances of communication in paediatric palliative care consultations prior to and during the COVID-19 pandemic to understand how clinicians and families talk about the pandemic. DESIGN: Paediatric palliative care consultations prior to, during, and immediately following the initial peak of COVID-19 cases in Australia were video recorded and analysed using Conversation Analysis methods. SETTING/PARTICIPANTS: Twenty-five paediatric palliative care consultations (including face-to-face outpatient, telehealth outpatient and inpatient consultations) were video recorded within a public children's hospital in Australia. Participants included 14 health professionals, 15 child patients, 23 adult family members and 5 child siblings. RESULTS: There was a pervasive relevance of both serious and non-serious talk about COVID-19 within the consultations recorded during the pandemic. Topics typical of a standard paediatric palliative care consultation often led to discussion of the pandemic. Clinicians (55%) and parents (45%) initiated talk about the pandemic. CONCLUSIONS: Clinicians should not be surprised by the pervasiveness of COVID-19 or other pandemic talk within standard paediatric palliative care consultations. This awareness will enable clinicians to flexibly address family needs and concerns about pandemic-related matters that may impact health and wellbeing.

Learning a palliative care approach during the COVID-19 pandemic: A case study in an Infectious Diseases Unit.

BACKGROUND: Hospital palliative care is an essential part of the COVID-19 response, but relevant data are lacking. The recent literature underscores the need to implement protocols for symptom control and the training of non-specialists by palliative care teams. AIM: The aim of the study was to describe a palliative care unit's consultation and assistance intervention at the request of an Infectious Diseases Unit during the COVID-19 pandemic, determining what changes needed to be made in delivering palliative care. DESIGN: This is a single holistic case study design using data triangulation, for example, audio recordings of team meetings and field notes. SETTING/PARTICIPANTS: This study was conducted in the Palliative Care Unit of the AUSL-IRCCS hospital of Reggio Emilia, which has no designated beds, consulting with the Infectious Diseases Unit of the same hospital. RESULTS: A total of 9 physicians and 22 nurses of the Infectious Diseases Unit and two physicians of the Palliative Care Unit participated in the study.Our Palliative Care Unit developed a feasible 18-day multicomponent consultation intervention. Three macro themes were identified: (1) new answers to new needs, (2) symptom relief and decision-making process, and (3) educational and training issues. CONCLUSION: From the perspective of palliative care, some changes in usual care needed to be made. These included breaking bad news, patients' use of communication devices, the limited time available for the delivery of care, managing death necessarily only inside the hospital, and relationships with families.

Palliative care in the emergency department: A survey assessment of patient and provider perspectives.

BACKGROUND: Palliative care has been identified as an area of low outpatient referral from our emergency department, yet palliative care has been shown to improve the quality of patient's lives. AIM: This study investigates both provider and patient perspectives on palliative care for the purpose of identifying barriers to increased palliative care utilization within our healthcare system. DESIGN: Two surveys were developed, one for patients/caregivers and one for healthcare providers. SETTING/PARTICIPANTS: This was a single-center study completed at a quaternary academic emergency department. A survey was sent to emergency medicine providers with 47% response rate. Research staff approached Emergency Department patients who had been identified to be high risk to fill out paper surveys with 76% response rate. RESULTS: Only 28% of patients had already undergone palliative care, with an additional 25% interested in palliative care. Nearly half of the patients felt that they needed more resources to prevent hospital visits. Patients identified low understanding of palliative care and difficulty accessing appointments as barriers to consultation. Among providers, 98% indicated that they had patients who would benefit from palliative care. A majority of providers highlighted patient understanding of palliative care and access to appointments as barriers to palliative care. Notably, 52% of providers reported that emergency medicine provider knowledge was a barrier to palliative care consultation. CONCLUSIONS: Despite emergency department patients' self-identified need for resources and emergency medicine providers' recognition of patients who would benefit from palliative care, few patients receive palliative care consultation.

Changing patterns of mortality during the COVID-19 pandemic: Population-based modelling to understand palliative care implications.

BACKGROUND: COVID-19 has directly and indirectly caused high mortality worldwide. AIM: To explore patterns of mortality during the COVID-19 pandemic and implications for palliative care, service planning and research. DESIGN: Descriptive analysis and population-based modelling of routine data. PARTICIPANTS AND SETTING: All deaths registered in England and Wales between 7 March and 15 May 2020. We described the following mortality categories by age, gender and place of death: (1) baseline deaths (deaths that would typically occur in a given period); (2) COVID-19 deaths and (3) additional deaths not directly attributed to COVID-19. We estimated the proportion of people who died from COVID-19 who might have been in their last year of life in the absence of the pandemic using simple modelling with explicit assumptions. RESULTS: During the first 10 weeks of the pandemic, there were 101,614 baseline deaths, 41,105 COVID-19 deaths and 14,520 additional deaths. Deaths in care homes increased by 220%, while home and hospital deaths increased by 77% and 90%, respectively. Hospice deaths fell by 20%. Additional deaths were among older people (86% aged ⩾ 75 years), and most occurred in care homes (56%) and at home (43%). We estimate that 22% (13%-31%) of COVID-19 deaths occurred among people who might have been in their last year of life in the absence of the pandemic. CONCLUSION: The COVID-19 pandemic has led to a surge in palliative care needs. Health and social care systems must ensure availability of palliative care to support people with severe COVID-19, particularly in care homes.

An Adapted Conceptual Model Integrating Palliative Care in Serious Illness and Multiple Chronic Conditions.

OBJECTIVE: Seriously ill adults with multiple chronic conditions (MCC) who receive palliative care may benefit from improved symptom burden, health care utilization and cost, caregiver stress, and quality of life. To guide research involving serious illness and MCC, palliative care can be integrated into a conceptual model to develop future research studies to improve care strategies and outcomes in this population. METHODS: The adapted conceptual model was developed based on a thorough review of the literature, in which current evidence and conceptual models related to serious illness, MCC, and palliative care were appraised. Factors contributing to patients' needs, services received, and service-related variables were identified. Relevant patient outcomes and evidence gaps are also highlighted. RESULTS: Fifty-eight articles were synthesized to inform the development of an adapted conceptual model including serious illness, MCC, and palliative care. Concepts were organized into 4 main conceptual groups, including Factors Affecting Needs (sociodemographic and social determinants of health), Factors Affecting Services Received (health system; research, evidence base, dissemination, and health policy; community resources), Service-Related Variables (patient visits, service mix, quality of care, patient information, experience), and Outcomes (symptom burden, quality of life, function, advance care planning, goal-concordant care, utilization, cost, death, site of death, satisfaction). DISCUSSION: The adapted conceptual model integrates palliative care with serious illness and multiple chronic conditions. The model is intended to guide the development of research studies involving seriously ill adults with MCC and aid researchers in addressing relevant evidence gaps.

Utility of the integrated palliative care outcome scale (IPOS): a cross-sectional study in hospitalised patients with heart failure.

AIM: The aim of this study was to evaluate the suitability and comprehensibility of the integrated palliative care outcome scale for the evaluation of palliative care needs in patients with heart failure. METHODS AND RESULTS: This cross-sectional study investigated 100 heart failure patients (40 women, 60 men; median age 79 years) within the first few days of their hospitalisation by applying the integrated palliative care outcome scale (3-day recall period) and two additional self-developed questions about the suitability and comprehensibility of the integrated palliative care outcome scale. Clinically relevant somatic and psycho-emotional symptoms were reported very frequently (approximately 75% each), followed by communicational needs or practical issues. Ninety-five per cent of patients thought the integrated palliative care outcome scale very easy to understand, and 91% judged the integrated palliative care outcome scale suitable to assess palliative care needs. CONCLUSION: The integrated palliative care outcome scale was well accepted by hospitalised patients with heart failure and identified a high burden of both physical and psycho-emotional symptoms. Screening for palliative care has to consider patients and their relatives alike, and should be part of a comprehensive care concept jointly integrated into clinical routine by primary and specialised palliative care teams.

Use of Palliative Care Consultation Services for Infants With Life-Threatening Conditions in a Metropolitan Hospital.

BACKGROUND: Palliative care is becoming an important component for infants with life-limiting or life-threatening conditions and their families. Yet palliative care practices appear to be inconsistent and sporadically used for infants. PURPOSE: The purpose of this study was to describe the use of an established pediatric palliative care team for seriously ill infants in a metropolitan hospital. METHODS: This was a retrospective medical record review. FINDINGS: The population included 64 infants who were admitted to a level IV neonatal intensive care unit (NICU) and then died during hospitalization between January 2015 and December 2016. Most infants died in an ICU (n = 63, 95%), and only 20 infants (31%) received palliative care consultation. Most common reasons for consultation were care coordination, defining goals of care and end-of-life planning, and symptom management. IMPLICATIONS FOR PRACTICE: Palliative care consultation at this institution did not change the course of end-of-life care. Interventions provided by the ICU team to infants surrounding end of life were similar to those in infants receiving palliative care services from the specialists. Our findings may be useful for developing guidelines regarding how to best utilize palliative care services for infants with life-threatening conditions who are admitted to an ICU. IMPLICATIONS FOR RESEARCH: These finding support continued research in neonatal palliative care, more specifically the impact of palliative care guidelines and algorithms.

Bahrain: care in the island kingdom.

Dion Smyth's review of palliative nursing on the internet.

Which symptoms and problems do advanced cancer patients admitted to specialized palliative care report in addition to those included in the EORTC QLQ-C15-PAL? A register-based national study.

PURPOSE: Patients in palliative care are willing to answer short questionnaires, like the EORTC QLQ-C15-PAL; however, patients may suffer from other symptoms and problems (S/Ps) not covered by such questionnaires. Therefore, to identify which other S/Ps patients experience, in addition to those already included in the EORTC QLQ-C15-PAL, we developed a brief instrument to supplement this questionnaire named WISP (Write In three Symptoms/Problems), permitting patients to report 1-3 additional S/Ps and their severity. We aim to investigate the nature, prevalence, and severity of S/Ps reported on WISP. METHODS: A register-based study with data obtained from the Danish Palliative Care Database. This study included adults with advanced cancer admitted to specialized palliative care in Denmark, who reported S/Ps on WISP. S/Ps were categorized qualitatively, and their prevalence and severity were calculated. RESULTS: Of the 5447 patients who completed the EORTC QLQ-C15-PAL, 1788 (32.8%) reported at least one symptom/problem using WISP. In total, 2796 S/Ps were reported; 24.8% were already covered by EORTC QLQ-C15-PAL; 63.6% were new, 10.1% were diagnoses and 1.6% could not be coded. S/Ps already covered and new were grouped into 61 categories. The most prevalent S/Ps reported were (in decreasing order) pain, edema, dizziness, impaired physical or emotional function, cough, and sweats. Overall, 85% of the S/Ps were rated as moderate to severe. CONCLUSIONS: The WISP instrument strongly improves the recognition of S/Ps by combining standardization with individualization. We recommend its use for comprehensive symptom assessment alongside the EORTC QLQ-C15-PAL, and potentially also alongside the EORTC QLQ-C30.

Nursing home hospital transfers in the terminally ill: night shift nurses matter!

BACKGROUND: French demographic projection expects an increasing number of older, dependent patients in the next few years. A large proportion of this population lives in nursing homes and their transfer to hospitals at the end of life is an ongoing issue. OBJECTIVE: This study explored the factors influencing the transfer of patients living in nursing homes to hospital at the end of life. DESIGN: We used a mixed-methods questionnaire developed by an expert group and assessing different characteristics of the nursing homes. PARTICIPANTS: All the nursing homes in the Rhône-Alpes area (n=680) were surveyed. RESULTS: We obtained 466 (68%) answers. We found that a palliative care programme was present in 336 (72%) nursing homes. The majority had a coordinating physician 428 (82%) and a mean number of 6 nurses for 83 beds, with 83 (18%) having a night shift nurse. There was a mean number of 19 deaths per nursing home during the recorded year. The main cause of death was dementia (41%), cancer-related death (13%). Death occurred mostly in the nursing home (14 74%). Night shift nurse attendance was significantly associated with the place of death: 27 deaths occurred in nursing homes with a night shift nurse versus 12 in those without one (p<0001). CONCLUSIONS: The location of the death of frail elderly patients is a major health issue that needs to be addressed. Our results suggests that the presence of a night shift nurse decreases the number of emergency transfers and deaths in the hospital.

Variations in hospital inpatient palliative care service use: a retrospective cohort study.

OBJECTIVE: Use of palliative care in hospitals for people at end of life varies. We examined rate and time of in-hospital palliative care use and associated interhospital variations. METHODS: We used admissions from all hospitals in New South Wales, Australia, within a 12-month period, for a cohort of adults who died in 73 public acute care hospitals between July 2010 and June 2014. Receiving palliative care and its timing were based on recorded use. RESULTS: Among 90 696 adults who died, 27% received palliative care, and the care was initiated 7.6 days (mean; SD: 3.3 days) before death. Over the 5-year period, the palliative care rate rose by 58%, varying extent across chronic conditions. The duration of palliative care before death declined by 7%. Patient (demographics, morbidities and service use) and hospital factors (size, location and availability of palliative care unit) explained half of the interhospital variation in outcomes: adjusted IQR in rate and duration of palliative care among hospitals were 23%-39% and 5.2-8.7 days, respectively. Hospitals with higher rates often initiated palliative care earlier (correlation: 0.39; p<0.01). CONCLUSION: Despite an increase over time in the palliative care rate, its initiation was late and of brief duration. Palliative care use was associated with patient and hospital characteristics; however, half of the between hospital variation remained unexplained. The observed suboptimal practices and variability indicate the need for expanded and standardised use of palliative care supported by assessment tools, service enhancement and protocols.

Persistent inequalities in Hospice at Home provision.

OBJECTIVE: To describe the nature and scope of a new Hospice at Home (H@H) service and to identify its equality of provision. METHODS: Case note review of patients supported by a H@H service for 1 year from September 2012 to August 2013 (n=321). Descriptive analysis to report frequencies and proportions of quantitative data extracted from service logs, referral forms and care records; thematic analysis of qualitative data from care record free text. RESULTS: Demand outstripped supply. Twice as many night care episodes were requested (n=1237) as were provided (n=613). Inequalities in access to the service related to underlying diagnosis and socioeconomic status. 75% of patients using the service had cancer (221/293 with documented diagnosis). Of those who died at home in the areas surrounding the hospice, 53% (163/311) of people with cancer and 11% (49/431) of those without cancer received H@H support. People who received H@H care were often more affluent than the population average for the area within which they lived. Roles of the service identified included: care planning/implementation, specialist end-of-life care assessment and advice, 'holding' complex patients until hospice beds become available and clinical nursing care. CONCLUSION: There is significant unmet need and potentially large latent demand for the H@H service. People without cancer or of lower socioeconomic status are less likely to access the service. Action is needed to ensure greater and more equitable service provision in this and similar services nationally and internationally.

Trends of Hospital Palliative Care Utilization and Its Associated Factors Among Patients With Systemic Lupus Erythematosus in the United States From 2005 to 2014.

OBJECTIVE: To investigate trends and associated factors of utilization of hospital palliative care among patients with systemic lupus erythematosus (SLE) and analyze its impact on length of hospital stay, hospital charges, and in-hospital mortality. METHODS: Using the 2005-2014 National Inpatient Sample in the United States, the compound annual growth rate was used to investigate the temporal trend of utilization of hospital palliative care. Multivariate multilevel logistic regression analyses were performed to analyze the association with patient-related factors, hospital factors, length of stay, in-hospital mortality, and hospital charges. RESULTS: The overall proportion of utilization of hospital palliative care for the patient with SLE was 0.6% over 10 years. It increased approximately 12-fold from 0.1% (2005) to 1.17% (2014). Hospital palliative care services were offered more frequently to older patients, patients with high severity illnesses, and in urban teaching hospitals or large size hospitals. Patients younger than 40 years, the lowest household income group, or Medicare beneficiaries less likely received palliative care during hospitalization. Hospital palliative care services were associated with increased length of stay (ß = 1.407, P < .0001) and in-hospital mortality (odds ratio, 48.18; 95% confidence interval, 41.59-55.82), and reduced hospital charge (ß = -0.075, P = .009). CONCLUSION: Hospital palliative care service for patients with SLE gradually increased during the past decade in US hospitals. However, this showed disparities in access and was associated with longer hospital length of stay and higher in-hospital mortality. Nevertheless, hospital palliative care services yielded a cost-saving effect.

Protocol for a Noninferiority Comparative Effectiveness Trial of Home-Based Palliative Care (HomePal).

Introduction: As health care systems strive to meet the growing needs of seriously ill patients with high symptom burden and functional limitations, they need evidence about how best to deliver home-based palliative care (HBPC). We compare a standard HBPC model that includes routine home visits by nurses and prescribing clinicians with a tech-supported model that aims to promote timely interprofessional team coordination using video consultation with the prescribing clinician while the nurse is in the patient's home. We hypothesize that tech-supported HBPC will be no worse compared with standard HBPC. Methods: This study is a pragmatic, cluster randomized noninferiority trial conducted across 14 Kaiser Permanente sites in Southern California and the Pacific Northwest. Registered nurses (n = 102) were randomized to the two models so that approximately half of the participating patient-caregiver dyads will be in each study arm. Adult English or Spanish-speaking patients (estimate 10,000) with any serious illness and a survival prognosis of 1-2 years and their caregivers (estimate 4800) are being recruited to the HomePal study over ∼2.5 years. The primary patient outcomes are symptom improvement at one month and days spent at home. The primary caregiver outcome is perception of preparedness for caregiving. Study Implementation-Challenges and Contributions: During implementation we had to balance the rigors of conducting a clinical trial with pragmatic realities to ensure responsiveness to culture, structures, workforce, workflows of existing programs across multiple sites, and emerging policy and regulatory changes. We built close partnerships with stakeholders across multiple representative groups to define the comparators, prioritize and refine measures and study conduct, and optimize rigor in our analytical approaches. We have also incorporated extensive fidelity monitoring, mixed-method implementation evaluations, and early planning for dissemination to anticipate and address challenges longitudinally. Trial Registration: ClinicalTrials.gov: NCT#03694431.