Feasibility and Acceptability of a Pharmacogenomic Decision Support System in Palliative Care.

Context: Pharmacogenomic analysis may improve the efficacy or safety of the drugs used in palliative care. Decision support systems may promote clinical integration of this information. Objectives: To determine the feasibility and acceptability of a pharmacist-directed pharmacogenomic decision support system in the care of patients with advanced illness and explore the drug-gene and drug-drug interactions that occur in this population. Methods: Physicians or nurse practitioners from two U.S. hospice agencies identified opioid-treated patients receiving multiple other drugs. Buccal samples and clinical data were obtained from consenting patients. A pharmacist used the proprietary MedWise™ platform to evaluate the current medications in terms of genotype and phenotype, created a standardized report describing potential interactions and recommended actions that may reduce the associated risk. Clinicians could access the report online and completed Likert-type scales to assess use and satisfaction with the system. Results: Twenty clinicians and 100 patients participated. The reports revealed that 74 drugs were subject to 462 drug-gene interactions and 77 were involved in 691 drug-drug interactions; only 4 and 16 patients, respectively, had no drug-gene or drug-drug interactions. Clinicians routinely checked the reports and used the information to change ≥1 treatments in 55 (55%) patients. Almost all clinicians rated the system likely to improve the quality of care and all "agreed" or "strongly agreed" to recommend the system to colleagues. Conclusion: This pharmacist-directed pharmacogenomic decision support system was perceived positively and was integrated into practice. Further studies are warranted to its clinical integration and its outcomes.

Clinician Perspectives Guiding Approach to Comprehensiveness of Palliative Care Assessment.

Background: National Consensus Project for quality palliative care guidelines emphasizes the importance of a comprehensive assessment of all care domains, including physical, psychosocial, and spiritual aspects of care, for seriously ill patients. However, less is known about how real-world practice compares with this guideline. Objective: To describe clinicians' assessment practices and factors influencing their approach. Design: This is a two-part web-based survey of palliative care clinicians from five academic groups in the United States. Results: Nineteen out of 25 invited clinicians (physicians, nurse practitioners, and physician assistants) completed the survey. A majority (62%) reported that, although some elements of assessment were mandatory, their usual practice was to tailor the focus of the consultation. Time limitations and workload received the highest mean scores as reasons for tailored assessment (6.1 on a 0-9 importance scale), followed by beliefs that comprehensive assessment is unnecessary (4.8) and absence of the full interdisciplinary team (4.4). All participants cited symptom acuity, and 91% cited reason for consult as factors influencing a tailored approach. Among domains "always" assessed, physical symptoms were reported most commonly (81%) and spiritual and cultural factors least commonly (24% and 19%, respectively). Although a majority of clinicians reported usually tailoring their consultations, mean importance scores for almost all assessment elements were high (range 3.9-8.8, mean 7.1); however, there was some variation based on reason for consult. Spiritual elements received lower importance scores relative to other elements (5.0 vs. 7.4 mean score for all others). Conclusion: Although clinicians placed high importance on most elements included in comprehensive palliative care, in practice they often tailored their consultations, and the perceived relative importance of domains shifted depending upon the type of consultation.

Specialty Palliative Care in COVID-19: Early Experiences from the Palliative Care Quality Collaborative.

Background: The COVID-19 pandemic has spurred unprecedented need for specialty palliative care. The Palliative Care Quality Collaborative (PCQC) provides unique infrastructure for rapid data collection and analysis. Objectives: To capture and describe real-time, real-world experiences of specialty palliative care professionals caring for patients with COVID-19 through a rapid reporting tool and registry. Setting: Palliative care clinicians consulted for patients either positive for COVID-19, under investigation for COVID-19, or recovered from COVID-19. Design: The PCQC created a 13-item COVID-19 case report form (CRF), modeled after the PCQC core dataset for specialty palliative care quality measurement. Twelve items offered discrete answer choices and one was open-ended. The CRF was publicized widely (e.g., social media, e-mail list serves) and completed through a link on the PCQC website. Results: Three hundred six reports (298 adult, 8 pediatric) were submitted between April 6, 2020 and October 7, 2020. The majority of patients (83%) were 50 years or older; 25% were 80 or older, and 78% were COVID-19 positive. Male gender identity was significantly more prevalent than female (58% vs. 40%, p < 0.002). The most common comorbidity was cardiovascular disease (23%). Of adult hospital-based patients, 69% were full code before palliative care consultation versus 28% after (p < 0.05). All pediatric patients were full code before and after palliative care consult. Qualitative themes were strained communication with patients, family visitation challenges, communication barriers between clinicians and families, rapid changes in palliative care medical management, community care options difficult to find, lack of testing in community-based settings, and guardianship and legal challenges. Conclusion: Preliminary data from the first 306 patients reported to the PCQC COVID-19 Registry describe palliative care use concentrated among older and higher risk patients and challenges to the provision of palliative care during this pandemic.

Caregiver-guided pain coping skills training for patients with advanced cancer: Results from a randomized clinical trial.

BACKGROUND: Pain is a major concern among patients with advanced cancer and their family caregivers. Evidence suggests that pain coping skills training interventions can improve outcomes, however they have rarely been tested in this population. AIM: To test the efficacy of a caregiver-guided pain coping skills training intervention. The primary outcome was caregiver self-efficacy for helping the patient manage pain. DESIGN: A randomized controlled trial compared the intervention to an enhanced treatment-as-usual control. Dyads in both conditions received pain education, and those in the intervention received three sessions of pain coping skills training. Caregiver outcomes (self-efficacy; caregiver strain, caregiving satisfaction, psychological distress) and patient outcomes (self-efficacy, pain intensity and interference, psychological distress) were collected at baseline and post-intervention. SETTING/PARTICIPANTS: Two hundred two patients with stage III-IV cancer and pain and their family caregivers were enrolled from four outpatient oncology clinics and a free-standing hospice/palliative care organization. RESULTS: Compared to those in the control arm, caregivers in the intervention reported significant increases in caregiving satisfaction (p < 0.01) and decreased anxiety (p = 0.04). In both conditions, caregivers reported improvements in self-efficacy, and patients reported improvements in self-efficacy, pain severity and interference, and psychological distress. CONCLUSIONS: This is the first study to test a pain coping skills intervention targeted to patients and caregivers facing advanced cancer. Findings suggest that pain education provides benefits for patients and caregivers, and coping skills training may be beneficial for caregivers. Further research is needed to optimize the benefits of education and pain coping skills training for improving cancer pain outcomes.Trial registration: ClinicalTrials.gov NCT02430467, Caregiver-Guided Pain Management Training in Palliative Care.

Selection Bias in Observational Studies of Palliative Care: Lessons Learned.

CONTEXT: Palliative care (PC) programs are typically evaluated using observational data, raising concerns about selection bias. OBJECTIVES: To quantify selection bias because of observed and unobserved characteristics in a PC demonstration program. METHODS: Program administrative data and 100% Medicare claims data in two states and a 20% sample in eight states (2013-2017). The sample included 2983 Medicare fee-for-service beneficiaries aged 65+ participating in the PC program and three matched cohorts: regional; two states; and eight states. Confounding because of observed factors was measured by comparing patient baseline characteristics. Confounding because of unobserved factors was measured by comparing days of follow-up and six-month and one-year mortality rates. RESULTS: After matching, evidence for observed confounding included differences in observable baseline characteristics, including race, morbidity, and utilization. Evidence for unobserved confounding included significantly longer mean follow-up in the regional, two-state, and eight-state comparison cohorts, with 207 (P < 0.001), 192 (P < 0.001), and 187 (P < 0.001) days, respectively, compared with the 162 days for the PC cohort. The PC cohort had higher six-month and one-year mortality rates of 53.5% and 64.5% compared with 43.5% and 48.0% in the regional comparison, 53.4% and 57.4% in the two-state comparison, and 55.0% and 59.0% in the eight-state comparison. CONCLUSION: This case study demonstrates that selection of comparison groups impacts the magnitude of measured and unmeasured confounding, which may change effect estimates. The substantial impact of confounding on effect estimates in this study raises concerns about the evaluation of novel serious illness care models in the absence of randomization. We present key lessons learned for improving future evaluations of PC using observational study designs.

Associations of Patient Characteristics and Care Setting with Complexity of Specialty Palliative Care Visits.

Background: Information routinely collected during a palliative care consultation request may help predict the level of complexity of that patient encounter. Objectives: We examined whether patient and consultation characteristics, as captured in consultation requests, are associated with the number of unmet palliative care needs that emerge during consultation, as an indicator of complexity. Design: We performed a retrospective cohort analysis of palliative care consultations. Setting: We analyzed quality-of-care data from specialty palliative care consultations contained in the Quality Data Collection Tool of the Global Palliative Care Quality Alliance from 2012 to 2017. Measurements: Using 13 point-of-care assessments of quality of life, symptoms, advance care planning, and prognosis, we created a complexity score ranging from 0 (not complex) to 13 (highest complexity). Using multivariable linear regression, we examined the relationships of consultation setting and patient characteristics with complexity score. Results: Patients in our cohort (N = 3121) had an average complexity score of 6.7 (standard deviation = 3.7). Female gender, nonwhite race, and neurological (e.g., dementia) and noncancer primary diagnosis were associated with increased complexity score. The hospital intensive care unit, compared with the general floor, was associated with higher complexity scores. In contrast, outpatient and residence, compared with the general floor, were associated with lower complexity scores. Conclusion: Patient, disease, and care setting factors known at the time of specialty palliative care consultation request are associated with level of complexity, and they may inform teams about the right service provisions, including time and expertise, required to meet patient needs.

Community-Based Palliative Care Consultations: Comparing Dementia to Nondementia Serious Illnesses.

Background: Little is known about the provision of palliative care to people with dementia (PWD). Objective: To examine demographic and clinical characteristics of PWD versus nondementia serious illnesses receiving community-based palliative care. Design: Retrospective study of people 65+ receiving an initial consultation from a community-based palliative care practice between September 2014 and February 2018 using registry data entered by clinicians into the Quality Data Collection Tool for Palliative Care. Setting: Large not-for-profit organization that provides community-based hospice and palliative care services. Measurements: Demographics, consult characteristics, advance care planning, and caregiver support. Results: Of 3883 older adults receiving a first palliative care consultation from this organization, 22% (855) had a dementia diagnosis. Compared to those with nondementia serious illnesses, PWD were older with more impaired function; 36% had a prognosis of less than six months. More PWD than those without dementia had a proxy decision maker and documented advance directive. A quarter of PWD were full code before consultation; nearly half changed to some limitation afterward. Symptom characteristics were missing for 67% of PWD due to collection through self-report. Caregivers of PWD were responsible for significantly more activities of daily living than caregivers of people with nondementia serious illnesses. Conclusions: This is the first comparison of a large cohort of people with and without dementia receiving a community-based palliative care consult in the United States. Alternative measures of symptom burden should be used in registries to capture data for PWD. Understanding the unique characteristics of PWD will guide future services for this growing population.

Prevalence and Predictors of Burnout Among Hospice and Palliative Care Clinicians in the U.S.

CONTEXT: Many clinical disciplines report high rates of burnout, which leads to low quality of care. Palliative care clinicians routinely manage patients with significant suffering, aiming to improve quality of life. As a major role of palliative care clinicians involves educating patients and caregivers regarding identifying priorities and balancing stress, we wondered how clinician self-management of burnout matches against the emotionally exhaustive nature of the work. OBJECTIVES: We sought to understand the prevalence and predictors of burnout using a discipline-wide survey. METHODS: We asked American Academy of Hospice and Palliative Medicine clinician members to complete an electronic survey querying demographic factors, job responsibilities, and the Maslach Burnout Inventory. We performed univariate and multivariable regression analyses to identify predictors of high rates of burnout. RESULTS: We received 1357 responses (response rate 30%). Overall, we observed a burnout rate of 38.7%, with higher rates reported by nonphysician clinicians. Most burnout stemmed from emotional exhaustion, with depersonalization comprising a minor portion. Factors associated with higher odds of burnout include nonphysician clinical roles, working in smaller organizations, working longer hours, being younger than 50 years of age, and working weekends. We did not observe different rates between palliative care clinicians and hospice clinicians. Higher rated self-management activities to mitigate burnout include participating in interpersonal relationships and taking vacations. CONCLUSION: Burnout is a major issue facing the palliative care clinician workforce. Strategies at the discipline-wide and individual levels are needed to sustain the delivery of responsive, available, high-quality palliative care for all patients with serious illness.

Paying for Palliative Care in Medicare: Evidence From the Four Seasons/Duke CMMI Demonstration.

CONTEXT: Palliative care improves patient and family outcomes and may reduce the cost of care, but this service is underutilized among Medicare beneficiaries. OBJECTIVES: To describe enrollment patterns and outcomes associated with the Center for Medicare and Medicaid Innovation expansion of a multisetting community palliative care program in North and South Carolina. METHODS: This observational study characterizes the Center for Medicare and Medicaid Innovation cohort's care and cost trajectories after enrollment. Program participants were age-eligible Medicare fee-for-service beneficiaries living in Western North Carolina and South Carolina who enrolled in a palliative care program from September 1, 2014, to August 31, 2017. End-of-life costs were compared between enrolled and nonenrolled decedents. Program administrative data and 100% Medicare claims data were used. RESULTS: A total of 5243 Medicare beneficiaries enrolled in the program from community (19%), facility (21%), small hospital (27%), or large hospital (33%) settings. Changes in Medicare expenditures in the 30 days after enrollment varied by setting. Adjusted odds of hospice use were 60% higher (OR = 1.60; CI = 1.47, 1.75) for enrolled decedents relative to nonenrolled decedents. Participants discharged to hospice vs. participants not had 17% (OR = 0.83 CI = 0.72, 0.94) lower costs. Among enrolled decedents those enrolled for at least 30 days vs. <30 days had 42% (OR = 0.58, CI = 0.49, 0.69) lower costs in the last 30 days of life. CONCLUSIONS: Expansion of community palliative care programs into multiple enrollment settings is feasible. It may improve hospice utilization among enrollees. Heterogeneous program participation by program setting pose challenges to a standardizing reimbursement policy.

Caregiver-guided pain coping skills training for patients with advanced cancer: Background, design, and challenges for the CaringPals study.

BACKGROUND/AIMS: Pain is a major concern of patients with advanced cancer and their caregivers. There is strong evidence that pain coping skills training interventions based on cognitive-behavioral principles can reduce pain severity and pain interference. However, few such interventions have been tested for patients with advanced cancer and their family caregivers. This study aims to test the efficacy of a caregiver-guided pain coping skills training protocol on patient and caregiver outcomes. METHODS: A total of 214 patients age ≥18 with Stage III-Stage IV cancer and moderate to severe pain, along with their family caregivers, are being identified and randomized with a 1:1 allocation to the caregiver-guided pain coping skills training intervention or enhanced treatment-as-usual. Dyads in both conditions receive educational resources on pain management, and the caregiver-guided pain coping skills training intervention includes three weekly 60-min sessions conducted with the patient-caregiver dyad via videoconference. Measures of caregiver outcomes (self-efficacy for helping the patient manage pain, caregiver strain, caregiving satisfaction, psychological distress) and patient outcomes (self-efficacy for pain management, pain intensity and interference, psychological distress) are collected at baseline and post-intervention. Caregiver outcomes are also collected 3 and 6 months following the patient's death. The study is enrolling patients from four tertiary care academic medical centers and one free-standing hospice and palliative care organization. The primary outcome is caregiver self-efficacy for helping the patient manage pain. RESULTS: This article describes challenges in the design and implementation of the CaringPals trial. Key issues for trial design include the identification and recruitment of patients with advanced cancer and pain, and the follow-up and collection of data from caregivers following the patient's death. CONCLUSION: The CaringPals trial addresses a gap in research in pain coping skills training interventions by addressing the unique needs of patients with advanced cancer and their caregivers. Findings from this study may lead to advances in the clinical care of patients with advanced cancer and pain, as well as a better understanding of the effects of training family caregivers to help patients cope with pain.

Patient, Caregiver, and Taxpayer Knowledge of Palliative Care and Views on a Model of Community-Based Palliative Care.

CONTEXT: Palliative care (PC) model delivered by two large hospices and PC providers. OBJECTIVES: To understand study participants' knowledge of PC and acceptability of a new community-based PC model. METHODS: Semistructured interview with patients and caregivers; focus groups with taxpayers. Descriptive content analysis with an inductive approach. RESULTS: Across 10 interviews and four focus groups (n = 4-10 per group), there was varying knowledge of PC. Gaps in interview and focus group participants' knowledge related to knowing the services available in PC, how PC is paid for, how to initiate PC, and how PC affects the patient's relationship with existing providers. Regarding the model, negative feedback from interview participants included not having PC explained adequately and PC providers seen as consultants and not as full-time providers. Focus group participants indicated that the model sounded promising but noted the likely difficulty in enacting it in our current health care system. Positive feedback from interview participants included the perception that clinicians spent more time and provided more support for patients and families and the developing ability of PC services to provide care more broadly than at the very end of life. Focus group participants had similar observations related to perceived attention to care and broader application of PC. Perceptions of time-constrained care delivery and suboptimal provider-patient communication persist for some patients getting PC services. CONCLUSION: Education for patients, caregivers, and community members about the roles and benefits of PC will be needed to successfully expand community-based PC.

Evaluating the Feasibility and Acceptability of a Telehealth Program in a Rural Palliative Care Population: TapCloud for Palliative Care.

CONTEXT: The impact of telehealth and remote patient monitoring has not been well established in palliative care populations in rural communities. OBJECTIVES: The objectives of this study were to 1) describe a telehealth palliative care program using the TapCloud remote patient monitoring application and videoconferencing; 2) evaluate the feasibility, usability, and acceptability of a telehealth system in palliative care; and 3) use a quality data assessment collection tool in addition to TapCloud ratings of symptom burden and hospice transitions. METHODS: A mixed-methods approach was used to assess feasibility, usability, and acceptability. Quantitative assessments included patient symptom burden and improvement, hospice transitions, and advanced directives. Qualitative semistructured interviews on a subpopulation of telehealth patients, caregivers, and providers were performed to learn about their experiences using TapCloud. RESULTS: One-hundred one palliative care patients in rural Western North Carolina were enrolled in the program. The mean age of patients enrolled was 72 years, with a majority (60%) being female and a pulmonary diagnosis accounting for the largest percentage of patients (23%). Remote patient monitoring using TapCloud resulted in improved symptom management, and patients in the model had a hospice transition rate of 35%. Patients, caregivers, and providers reported overwhelmingly positive experiences with telehealth with three main advantages: 1) access to clinicians, 2) quick responses, and 3) improved efficiency and quality of care. CONCLUSION: This is one of the first articles to describe a telehealth palliative care program and to demonstrate acceptability, feasibility, and usability as well as describe symptom outcomes and hospice transitions.

Will Changes to Medicare Payment Rates Alter Hospice's Cost-Saving Ability?

BACKGROUND: On January 1, 2016, Medicare implemented a new "two-tiered" model for hospice services, with per diem rates increased for days 1 through 60, decreased for days 61 and greater, and service intensity add-on payments made retrospectively for the last seven days of life. OBJECTIVE: To estimate whether the Medicare hospice benefit's potential for cost savings will change as a result of the January 2016 change in payment structure. DESIGN: Analysis of decedents' claims records using propensity score matching, logistic regression, and sensitivity analysis. SETTING/SUBJECTS: All age-eligible Medicare decedents who received care and died in North Carolina in calendar years 2009 and 2010. MEASUREMENTS: Costs to Medicare for hospice and other healthcare services. RESULTS: Medicare costs were reduced from hospice election until death using both 2009-2010 and new 2016 payment structures and rates. Mean cost savings were $1,527 with actual payment rates, and would have been $2,105 with the new payment rates (p < 0.001). Cost savings were confirmed by reducing the number of days used for cost comparison by three days for those with hospice stays of at least four days ($4,318 using 2009-2010 rates, $3,138 for 2016 rates: p < 0.001). Cost savings were greater for males ($3,393) versus females ($1,051) and greatest in cancer ($6,706) followed by debility and failure to thrive ($5,636) and congestive heart failure ($1,309); dementia patients had higher costs (+$1,880) (p < 0.001). When adding 3 days to the comparison period, hospice increased costs to Medicare. CONCLUSIONS: Medicare savings could continue with the 2016 payment rate change. Cost savings were found for all primary diagnoses analyzed except dementia.

Hospital-Based Palliative Care with Medicare Claims: Evidence From Colorado.

BACKGROUND: The prevalence of hospital-based palliative care has been largely anecdotal as an increasing service being provided and there is a need to understand what trends can be analyzed with Medicare data. OBJECTIVE: To compare 2 methods of identifying hospital-based palliative care in the Medicare population in Colorado. STUDY DESIGN: Through Medicare claims data and phone surveys, we ascertained the presence of hospital-based palliative care services, number of patients receiving palliative care, and number of care visits provided during the previous year. DATA SOURCES/STUDY SETTING: Data were collected from every Medicare-certified hospital in Colorado during 2008 and 2013. MEASUREMENTS: We measured the presence of hospital-based palliative care teams and their average number of consultations through a phone survey and cross-referenced using a v-code modifier of Medicare claims indicating a palliative care consult visit. RESULTS: The number of hospital-based palliative care consultations increased five-fold from 2008-2013, and Medicare claims under-counted the number of these consultations compared to phone surveys. CONCLUSION: The systematic measurement of palliative care nationally is a key priority. More evidence is needed from other states to better understand the usefulness of Medicare claims in this effort.

The Use of Corticosteroids as Adjuvant Therapy for Painful Bone Metastases: A Large Cross-Sectional Survey of Palliative Care Providers.

CONTEXT: Bone metastases are a common complication in patients with advanced cancer but little is known regarding current practice patterns of palliative care providers when prescribing corticosteroids as adjuvant therapy for painful bone metastases. OBJECTIVE: To identify current practice patterns among palliative care providers when prescribing corticosteroids for the treatment of painful bone metastases. METHODS: A cross-sectional, online survey of the membership of the American Academy of Hospice and Palliative Medicine. Providers were asked to report how frequently they prescribed corticosteroids as adjuvant therapy in patients with painful bone metastases, and to specify the corticosteroid, dosage, treatment duration, and the gastroprotective strategy most frequently utilized. RESULTS: Seven hundred sixty-five participants responded to the survey and 600 (78%) of respondents completed the survey. Ninety-eight percent of respondents completing the survey reported having prescribed corticosteroids as adjuvant pain therapy, and 66% ordered corticosteroids for the majority of their patients with painful bone metastases. Dexamethasone was the most widely prescribed corticosteroid. Eight milligrams divided twice daily was the most common dosage selected and once started, it was usually continued indefinitely. CONCLUSION: Corticosteroids are commonly prescribed as adjuvant therapy in the treatment of painful bone metastases in patients with limited life expectancy. Dexamethasone is the most commonly selected corticosteroid by American palliative care providers with variation existing among providers regarding dosing schedule, treatment duration, and gastroprotective strategies. Clinical trials comparing a total daily dose of four versus eight milligrams of dexamethasone would be clinically useful to inform evidence-based practice.

Standardization and Scaling of a Community-Based Palliative Care Model.

BACKGROUND: Although limited, the descriptions of Community-Based Palliative Care (CBPC) demonstrates variability in team structures, eligibility, and standardization across care settings. OBJECTIVE: In 2014, Four Seasons Compassion for Life, a nonprofit hospice and palliative care (PC) organization in Western North Carolina (WNC), was awarded a Centers for Medicare and Medicaid Services Health Care Innovation (CMMI) Award to expand upon their existing innovative model to implement, evaluate, and demonstrate CBPC in the United States. The objective of this article is to describe the processes and challenges of scaling and standardizing the CBPC model. DESIGN: Four Season's CBPC model serves patients in both inpatient and outpatient settings using an interdisciplinary team to address symptom management, psychosocial/spiritual care, advance care planning, and patient/family education. Medicare beneficiaries who are ≥65 years of age with a life-limiting illness were eligible for the CMMI project. RESULTS: The CBPC model was scaled across numerous counties in WNC and Upstate South Carolina. Over the first two years of the project, scaling occurred into 21 counties with the addition of 2 large hospitals, 52 nursing facilities, and 2 new clinics. To improve efficiency and effectiveness, a PC screening referral guide and a risk stratification approach were developed and implemented. Care processes, including patient referral and initial visit, were mapped. CONCLUSION: This article describes an interdisciplinary CBPC model in all care settings to individuals with life-limiting illness and offers guidance for risk stratification assessments and mapping care processes that may help PC programs as they develop and work to improve efficiencies.