Challenges and solutions of conducting dementia clinical trials: A palliative care at home pilot for persons with dementia.

BACKGROUND: Recruitment and retention are common challenges in clinical trials, particularly with older adults and their caregivers who often benefit from palliative care but have significant strain from caregiving. In recent years, there has been an expansion in home-based palliative care programs, especially for patients with dementia. Because these programs often rely on physicians or advanced practice nurses, they are quite costly and may be difficult to staff due to workforce shortages. METHODS: We created a novel program of home-based palliative care for patients with advanced dementia and their families, which centers around a community health worker, a social worker, and a nurse. We report on challenges our trial encountered and corresponding solutions. RESULTS: We enrolled 30 patients and their 30 caregivers in our pilot trial of home-based palliative care. We found two significant barriers to enrollment: (1) the electronic health record was insufficient to determine the severity of patients' dementia; and (2) rates of follow-up survey completion were low, with completion rates at 6 months between 14 and 44%. We created an iterative training process to determine dementia severity from electronic health records and applied person-centered approaches to improve survey completion. CONCLUSIONS: Electronic health records are not set up to include discrete fields for dementia severity, which makes enrollment of older adults with dementia in a clinical trial challenging. The strain of caring for a loved one with advanced dementia may also make participation in health-services research difficult for patients and their families. Novel approaches have the potential to counteract these challenges, improve recruitment and retention, and ultimately improve care for people with dementia and their caregivers.

Palliative Care Across the Spectrum of Heart Failure.

Persons with heart failure (HF) often suffer from poor symptom control, decreased quality of life, and poor communication with their health care providers. These needs are particularly acute in advanced HF, a leading cause of death in the United States. Palliative care, when offered alongside HF disease management, offers improved symptom control, quality of life, communication, and caregiver satisfaction as well as reduced caregiver anxiety. The dynamic nature of the clinical trajectory of HF presents distinct symptom patterns, changing functional status, and uncertainty, which requires an adaptive, dynamic model of palliative care delivery. Due to a limited specialty-trained palliative care workforce, patients and their caregivers often cannot access these benefits, especially in the community. To meet these needs, new models are required that are better informed by high-quality data, engage a range of health care providers in primary palliative care principles, and have clear triggers for specialty palliative care engagement, with specific palliative interventions tailored to patient's illness trajectory and changing needs.

Association of Functional Status and Symptom Severity Among Patients Who Received Palliative Care Consultations.

Background: The relationship between functional status and the severity of different symptoms in patients with serious illnesses has not been explored in detail. Methods: We retrospectively evaluated registry data of hospitalized patients who received inpatient palliative care consults at the Mount Sinai Health System between January 01, 2020, and December 31, 2022. The registry was approved by the local institutional review board. During the initial consult, palliative care clinicians administered the Australia-modified Karnofsky Performance Status (KPS) and the Edmonton Symptom Assessment System (ESAS). We extracted these measures and other variables of interest from electronic health records and billing data, and assessed the association of functional status and symptom severity for different symptoms using ordinal logistic regression models. Results: The study included 9800 patients who received a palliative care consult. When modeling the association of functional status and the severity of different symptoms, two distinct groups of symptoms emerged: Nausea, physical discomfort, anxiety, depression, and constipation were more prevalent and severe among patients with higher functional status. Conversely, drowsiness, inactivity, dyspnea, anorexia, and agitation were more prevalent and severe among patients with lower functional status. These findings remained statistically significant after adjusting for possible confounders. Conclusion: Among patients who received inpatient palliative care consults, lower functional status was associated with a higher symptom burden. Furthermore, symptom profiles differed between patients with reduced functional status and those with preserved functional status.

Referral Versus Embedded Palliative Care Consultation Among People Hospitalized With Heart Failure: A Report From a Single Center Pilot Program.

CONTEXT: Despite calls for integration into routine heart failure (HF) care, optimal palliative care delivery for people living with HF remains unclear. OBJECTIVES: Describe an innovative model of an embedded palliative care nurse practitioner (NP) within a HF team. Compare demographics and utilization among people hospitalized with HF receiving referral or embedded consultation. METHODS: Using an electronic health record-based palliative care registry, we conducted descriptive analyses and t-tests and χ2 tests, as appropriate, to examine bivariate associations between sociodemographic, clinical and utilization data of hospitalized people with HF receiving a traditional, referral-based palliative care consultation generated exclusively by the primary team vs. a novel, embedded-based consultation generated by collaboration between a palliative care NP and the advanced HF team at an urban, quaternary care academic medical center in New York City. RESULTS: During the study period from January 1, 2019-December 31, 2021, consultation volume nearly doubled with 363 consults from traditional referrals and an additional 317 consults from the newly embedded NP. People in the embedded group, as compared to referral, were younger (mean age: 60.1 vs. 71.9 years (2019); 59.2 vs. 70.4 (2020); 61.3 vs. 69.6 (2021), p-value < 0.001), more functional (median Karnofsky Performance Status: 40% vs. 30%, p-value = 0.01 (2019); 40% vs 20%, p-value < 0.0001 (2020); 40% vs. 20%, p-value = 0.02 (2021)), more likely had capacity to designate a medical decision maker (56.4% vs. 20.6%, p-value < 0.001 (2020); 76.3% vs. 49.5%, p-value < 0.001 (2021)), received earlier consultation (median days before discharge: 9.5 vs. 4 (2019); 11 vs. 5 (2020); 7 vs. 3 (2021), p-value ≤ 0.001), and more likely to discharge home (60% vs. 26%, p-value ≤ 0.001 (2019); 62.7% vs 20.6%, p-value ≤ 0.001 (2020); 42.3% vs. 28%, p-value = 0.03 (2021)). CONCLUSION: Hospitalized people living with advanced HF who received an embedded palliative care consult were younger, had higher functional status and less illness severity compared to those served by a traditional, referral-based consult.

Palliative care in heart failure guidelines: A comparison of the 2021 ESC and the 2022 AHA/ACC/HFSA guidelines on heart failure.

The role of palliative care for patients with heart failure (HF) is discussed in both most recent HF guidelines, the 2021 ESC guideline and the 2022 AHA/ACC/HFSA guideline. This review compares the definitions, concepts and specific recommendations regarding palliative care for patients with HF in these two guidelines. Both HF guidelines define palliative care as a multidisciplinary approach aimed at alleviating physical, psychological and spiritual distress of patients and caregivers. Both agree emphatically on the importance of palliative care across all stages of HF with integration early in the illness trajectory. Also, the guidelines concur that palliative care should include symptom management, communication about prognosis and life-sustaining therapies, as well as advance care planning. Despite this consensus, only the AHA/ACC/HFSA guideline gives official recommendations on the provision of palliative care. Moreover, the AHA/ACC/HFSA guideline advocates for a needs-based approach to palliative care allocation while the ESC guideline ties palliative care closely to advanced HF and end-of-life care. The ESC guideline highlights the need for regular symptom assessment and provides detailed guidance on symptom management. The AHA/ACC/HFSA guideline elaborates further on shared decision-making, caregiver and bereavement support, as well as hospice care, and distinguishes between primary palliative care (provided by all clinicians) and secondary (specialty-level) palliative care. Although there is strong agreement on the importance and components of palliative care for patients with HF, there are nuanced differences between the two HF guidelines. Most notably, only the AHA/ACC/HFSA guideline issues recommendations for the provision of palliative care.

Using Functional Status at the Time of Palliative Care Consult to Identify Opportunities for Earlier Referral.

Background: In order to improve early access to palliative care, strategies for monitoring referral practices in real-time are needed. Objective: To evaluate how Australia-Modified Karnofsky Performance Status (AKPS) at the time of initial palliative care consult differs between serious illnesses and could be used to identify opportunities for earlier referral. Methods: We retrospectively evaluated data from an inpatient palliative care consult registry. Serious illnesses were classified using ICD-10 codes. AKPS was assessed by palliative care clinicians during consult. Results: The AKPS distribution varied substantially between the different serious illnesses (p < 0.001). While patients with cancer and heart disease often had preserved functional status, the majority of patients with dementia, neurological, lung, liver, and renal disease were already completely bedbound at the time of initial palliative care consult. Conclusion: Measuring functional status at the time of palliative care referral could be helpful for monitoring referral practices and identifying opportunities for earlier referral.

Functional Status Changes in Patients Receiving Palliative Care Consult During COVID-19 Pandemic.

CONTEXT: Hospitalized patients with functional impairment have higher symptom burden and mortality. Little is known about how increased patient volume and acuity during the coronavirus disease 2019 (COVID-19) pandemic affected access to palliative care among patients with functional impairment. OBJECTIVES: To examine changes in functional status and hospital outcomes among patients receiving inpatient palliative care consultation before, during and after the COVID-19 pandemic. METHODS: We conducted a retrospective, multisite cohort study of all adult patients (≥ 18 years) admitted to four hospitals in New York City, USA, who received inpatient palliative care consultation between March 1, 2019 and February 28, 2022 with documented functional status at the time of consultation measured by Karnofsky Performance Status scale. RESULTS: Among 13,180 eligible patients identified, patients' functional status at the time of consultation decreased as palliative care consult volume increased with the onset of the pandemic. Compared to pre-pandemic, there was a statistically significant trend of lower functional status (P < 0.001) and higher in-hospital mortality (P < 0.001) among patients with noncancer and non-COVID-19 diagnoses two years after the pandemic. In contrast, patients with cancer had a statistically significant trend of higher functional status (P < 0.001) and no significant changes in in-hospital mortality over time. CONCLUSION: As the healthcare system was stressed with high demand and limited resources, palliative care consultation prioritized highest acuity patients by shifting towards those with lower functional status and higher in-hospital mortality. This shift disproportionately affected noncancer patients. Innovative approaches to ensure upstream palliative care consultation during increased resource constraints are needed.

Using Latent Class Analysis to Identify Different Clinical Profiles Among Patients With Advanced Heart Failure.

Context: Although palliative care is guideline-indicated for patients with advanced heart failure (HF), the scarcity of a specialty-trained palliative care workforce demands better identification of patients who are most burdened by the disease. Objectives: We sought to identify latent subgroups with variations regarding symptom burden, functional status, and multimorbidity in an advanced HF population. Methods: We performed a latent class analysis (LCA) of baseline data from a trial enrolling advanced HF patients. As LCA input variables, we chose indicators of HF severity, physical and psychological symptom burden, functional status, and the number of comorbidities. Results: Among 563 patients, two subgroups emerged from LCA, Class A (352 [62.5%]) and Class B (211 [37.5%]). Patients in Class A were less often classified as NYHA class III or IV (88.0% vs. 97.5%, P < 0.001), as compared to Class B patients. Class A patients had fewer symptoms, fewer comorbidities, only 25.9% had impairments in activities of daily living (ADL), and virtually none suffered from clinically significant anxiety (0.4%) or depression (0.9%). In Class B, every patient reported more than three symptoms, almost all patients (92.6%) had some impairment in ADL, and nearly a third had anxiety (30.2%) or depression (28.3%). All-cause mortality after 12 months was higher in Class B, as compared to Class A (18.5% vs. 12.5%, P = 0.047). Conclusion: Among advanced HF patients, we identified a distinct subgroup characterized by a conjunction of high symptom burden, anxiety, depression, multimorbidity, and functional status impairment, which might profit particularly from palliative care interventions. J Pain Symptom Manage 2022;000:1-9.

Building a Cardiac Palliative Care Program: A Qualitative Study of the Experiences of Ten Program Leaders From Across the United States.

CONTEXT: Palliative care is guideline-recommended for patients with advanced heart failure (HF). However, studies on how cardiac palliative care is provided in the United States are lacking. OBJECTIVES: To study how cardiac palliative care programs provide services, and to identify challenges and facilitators they encountered in program development. METHODS: In this qualitative descriptive study, we used purposive and snowball sampling approaches to identify cardiac palliative care program leaders across the United States, administered a survey and conducted semi-structured interviews. Interview transcripts were coded and evaluated using thematic analysis. RESULTS: While cardiac palliative care programs vary in their organizational setup, they all provide comprehensive interdisciplinary palliative care services, ideally across the care continuum. They predominantly serve HF patients who are evaluated for advanced therapies or have complex needs. The challenges which cardiac palliative care programs face include reaching those cardiac patients who need palliative care the most and collaborating with cardiologists who do not see value added from palliative care for their patients. Facilitators of cardiac palliative care program development include building personal relationships with cardiology providers, proactively assessing local institution needs, and tailoring palliative care services to meet patient and provider needs. CONCLUSION: Cardiac palliative care programs vary in their organizational setup but provide similar services and face similar challenges. The challenges and facilitators we identified can inform the development of future cardiac palliative care programs.

An Update: National Institutes of Health Research Funding for Palliative Medicine 2016-2020.

Background: The evidence base to support palliative care clinical practice is inadequate and opportunities to improve the evidence base remain despite the field's rapid growth. Objective: The aim of this study was to examine current National Institutes of Health (NIH) funding of palliative medicine research and trends over time. Design: We sought to identify NIH funding of palliative medicine (2016-2020) in two stages: (1) we searched the NIH grant database, RePORTER, for grants with the keywords, "palliative care," "end-of-life care," "hospice," and "end of life," and (2) identified palliative care researchers likely to have secured NIH funding using three strategies. Methods: We abstracted (1) the first and last authors' names from original investigations published in major palliative medicine journals from 2016 to 2018; (2) names from a PubMed-generated list of original articles published in major medicine, nursing, and subspecialty journals using the above keywords; and (3) palliative medicine journal editorial board members and members of key palliative medicine initiatives. We cross-matched the pooled names against NIH grants funded from 2016 to 2021. Results: A crosswalk analysis of the author search and NIH RePORTER search identified 1658 grants. Of those, 541 were categorized as relevant to palliative medicine, which represented 419 unique principal investigators (mean of 1.34 grants per investigator). Compared with 2011-2015, the number of NIH-funded grants increased by 25%, NIH dollars increased by 35%, and the distribution of grant types remained stable. Conclusions: Despite the challenging NIH funding climate, the number of NIH grants and funding to palliative care have increased. Given the increased funding allocation toward Alzheimer's dementia and related dementia research at the congressional level, this increase in funding reflects this funding allocation and does not represent overall growth. Dedicated federal funding for palliative care research remains critical to grow the evidence base for persons living with serious illnesses and their families.

Lessons Learned from an Embedded Palliative Care Model in the Medical Intensive Care Unit.

OBJECTIVE: To describe a physician (MD) and registered nurse (RN) led palliative care consultation team embedded in the medical intensive care unit (MICU). To compare patterns of palliative care consultation, and rates of goals of care documentation and in-ICU mortality before and after the implementation of the embedded team. CONTEXT: By embedding MD/RN palliative care team in the MICU, more critically ill patients with unmet palliative care needs could receive an earlier palliative care consultation. METHODS: In a retrospective cohort study of patients admitted to the MICU who received a palliative care consultation, we compared sociodemographic and clinical characteristics of patients who received a referral-based consultation (01/01/2019-06/30/2019) and those who received an embedded MD/RN consult (09/01/2019-02/28/2020). Using the electronic health record data, we compared palliative care consultation characteristics, rates of documentation of medical decision-maker and goals of care, and percentage of in-ICU mortality between the referral group and the embedded group. RESULTS: In a six-month period, 169 MICU patients received an embedded consultation, as compared to 52 MICU patients who received a referral-based consultation. As compared to the referral-based period, those patients who received an embedded consult were seen significantly earlier in hospitalization (median number of days from hospital admission to consult: 10 days [pre] vs. 3 days [embedded], P<0.001), more likely to have documentation of medical decision-makers (40% [pre] vs. 66% [embedded], P=0.002) and goals of care (37% [pre] vs. 71% [embedded], P<0.001) and less likely to die in the hospital (75% [pre] vs. 44% [embedded], P<0.001). CONCLUSIONS: After embedding a palliative care MD/RN team into the MICU, patients received earlier palliative care consultation, were more likely to have medical decision-maker and goals of care documented, and less likely to die in the hospital. Future work will examine how to adapt this model to other ICUs to improve palliative care access for critically ill patients broadly.

Access to Palliative Care Consultation for Hospitalized Adults with COVID-19 in an Urban Health System: Were There Disparities at the Peak of the Pandemic?

Background: Palliative care (PC) services expanded rapidly to meet the needs of coronavirus disease 2019 (COVID-19) patients, yet little is known about which patients were referred for PC consultation during the pandemic. Objective: Examine factors predictive of PC consultation for COVID-19 patients. Design: Retrospective cohort study of COVID-19 patients discharged from four hospitals (March 1-June 30, 2020). Exposures: Patient demographic, socioeconomic, and clinical factors and hospital-level characteristics. Outcome Measurement: Inpatient PC consultation. Results: Of 4319 hospitalized COVID-19 patients, 581 (14%) received PC consultation. Increasing age, serious illness (cancer, chronic obstructive pulmonary disease, and dementia), greater illness severity, and admission to the quaternary hospital were associated with receipt of PC consultation. There was no association between PC consultation and race/ethnicity, household crowding, insurance status, or hospital-factors, including inpatient, emergency department, and intensive care unit census. Conclusions: Although site variation existed, the highest acuity patients were most likely to receive PC consultation without racial/ethnic or socioeconomic disparities.

Palliative Care Consultation for Hospitalized Patients with Primary and Secondary Brain Tumors at a Single Academic Center.

Introduction: Studies addressing palliative care delivery in neuro-oncology are limited. Objectives: To compare inpatients with brain tumors who received palliative care (through referral or trigger) with those receiving usual care. Design: Retrospective cohort study. Setting/Subjects: Inpatients with primary or secondary brain tumors who did or did not receive palliative care at a U.S. medical center. Measurements: Sociodemographic, clinical, and utilization characteristics were compared. Results: Of 1669 brain tumor patients, 386 (23.1%) received palliative care [nontrigger: 246 (14.7%); trigger: 140 (8.4%)] and 1283 (76.9%) received usual care. Nontrigger patients were oldest (mean age 65.0 years; trigger: 61.1 years; usual care: 55.5 years; p < 0.001); sickest at baseline (mean Elixhauser comorbidity index 3.76; trigger: 3.49; usual care: 1.84; p < 0.001); and had highest in-hospital death [34 (13.8%), trigger: 10 (7.1%), usual care: 7 (0.5%); p < 0.001] and hospice discharge [54 (22.0%), trigger: 18 (12.9%), usual care: 14 (1.1%); p < 0.001]. Conclusions: Trigger criteria may promote earlier palliative care referral, yet criteria tailored for neuro-oncology are undeveloped.

Expanding the Palliative Care Workforce during the COVID-19 Pandemic: An Evaluation of Core Palliative Care Skills in Health Social Workers.

Background: Meeting the needs of seriously ill SARS-CoV-2 (COVID-19) patients requires novel models of deploying health social workers (SWs) to expand the palliative care workforce. To inform such expansion, understanding the current state of health SWs' core palliative care skills is necessary. Methods: Following minimal training, health SWs in one New York City hospital were surveyed about their frequency, competence, and confidence in using core palliative care skills. Results: Of the 170 health SWs surveyed, 46 (27%) responded, of whom 21 (46%) and 24 (52%) had palliative care training before and during the COVID-19 surge, respectively. Health SWs reported a "moderate improvement" in the use of three skills: "identify a medical decision maker," "assess prognostic understanding," and "coordinate care." There was "minimal decrease" to "no improvement" to "minimal improvement" in competence and confidence of skill use. Conclusion: Our findings suggest that educational initiatives can improve health SWs' use of core palliative care skills.