A Digital Therapeutic Application (ePAL) to Manage Pain in Patients With Advanced Cancer: A Randomized Controlled Trial.

BACKGROUND: Patients with advanced cancer often experience immense cancer pain that negatively impacts their quality of life. Interventions to address cancer-related pain are limited. METHODS: We conducted a randomized trial of a digital therapeutic app (ePAL) for patients with advanced cancer receiving care in a specialty palliative care clinic at a tertiary care hospital. Patients were randomized to ePAL or usual care. ePAL included 1) active pain monitoring; 2) artificial intelligence algorithm to triage patient symptoms; and 3) patient education to address barriers to pain management. Participants were instructed to use ePAL over eight weeks. Patient-reported pain symptoms were assessed at baseline, Week-4, and Week-8 (primary endpoint) using the Brief Pain Inventory. Secondary outcomes include pain-related hospitalizations by Week-8. RESULTS: We enrolled 112 patients who were randomly assigned to ePAL (N = 56) or usual care (N = 56). Patients utilized ePAL on average 2.1 times per week to report pain symptoms, and 47.6% reported their pain at least once per week over eight weeks. Patients randomized to ePAL reported lower pain scores at Week-4 (mean: 3.16 vs. 4.28, P = 0.010) and week-8 (mean:2.99 vs. 4.05, P = 0.017), compared to those receiving usual care. Participants randomized to ePAL were less likely to experience a pain-related hospitalization compared to those in the usual care group (7.1% vs. 23.2% P = 0.018) CONCLUSIONS: ePAL was associated with lower patient-reported pain and fewer pain-related hospitalizations compared to usual care in patients with advanced cancer. This study demonstrates the promise of digital therapeutics for improving patients' symptoms while reducing burdensome hospitalizations.

Let Us Have the Conversation: Serious Illness Communication in Oncology: Definitions, Barriers, and Successful Approaches.

Serious illness communications are crucial elements of care delivery for patients with cancer. High-quality serious illness communications are composed of open, honest discussions between patients, caregivers, and clinicians regarding patient's communication preferences, expected illness trajectory, prognosis, and risks and benefits of any recommended care. High-quality communication ideally starts at the time of a patients' cancer diagnosis, allows space for and response to patient emotions, elicits patients' values and care preferences, and is iterative and longitudinal. When integrated into cancer care, such communication can result in improved patient experiences with their care, care that matches patients' goals, and reduced care intensity at the end of life. Despite national recommendations for routine integration of these communication into cancer care, a minority of patients with cancer receive such communication. In this chapter, we describe elements of high-quality serious illness communication, patient-, clinician-, institution-, and payer-level barriers, and successful strategies that can routinely integrate such communication into cancer care delivery.

Attitudes and Beliefs Regarding Pain Medicine: Results of a National Palliative Physician Survey.

CONTEXT: Pain is a prevalent symptom in patients with serious illness and often requires interventional approaches for adequate treatment. Little is known about referral patterns and collaborative attitudes of palliative physicians regarding pain management specialists. OBJECTIVES: To evaluate referral rates, co-management strategies, and beliefs of palliative physicians about the value of Pain Medicine specialists in patients with serious illness. METHODS: A 30-question survey with demographic, referral/practice, and attitudes/belief questions was mailed to 1000 AAHPM physician members. Responses were characterized with descriptive statistics and further analyzed for associations between training experiences, practice environment, and educational activities with collaborative practice patterns and beliefs. RESULTS: The response rate was 52.6%. Most survey respondents had initial board certification primarily in internal medicine (n = 286, 56%) or family medicine (n = 144, 28%). A minority of respondents had completed a formal ABMS Hospice and Palliative Medicine fellowship (n = 178, 34%). Respondents had been in practice for a median of nine years, (range 1-38 years) primarily in community hospitals (n = 249, 47%) or academic hospitals (n = 202, 38%). The variables best associated with collaborative practices and attitudes was practice in an academic hospital setting and participation in regular joint academic conferences with pain medicine clinicians. CONCLUSION: This study shows that Palliative Care physicians have highly positive attitudes toward Pain Medicine specialists, but referrals remain low. Facilitating professional collaboration via joint educational/clinical sessions is one possible solution to drive ongoing interprofessional care in patients with complex pain.

Clinician Perceptions of Barriers and Facilitators for Delivering Early Integrated Palliative Care via Telehealth.

Early integrated palliative care (EIPC) significantly improves clinical outcomes for patients with advanced cancer. Telehealth may be a useful tool to deliver EIPC sustainably and equitably. Palliative care clinicians completed a survey regarding their perceptions of the barriers, facilitators, and benefits of using telehealth video visits for delivering EIPC for patients with advanced lung cancer. Forty-eight clinicians across 22 cancer centers completed the survey between May and July 2022. Most (91.7%) agreed that telehealth increases access to EIPC and simplifies the process for patients to receive EIPC (79.2%). Clinicians noted that the elderly, those in rural areas, and those with less-resourced backgrounds have greater difficulty using telehealth. Perceived barriers were largely patient-based factors, including technological literacy, internet and device availability, and patient preferences. Clinicians agreed that several organizational factors facilitated telehealth EIPC delivery, including technological infrastructure (85.4%), training (83.3%), and support from study coordinators (81.3%). Other barriers included systems-based factors, such as insurance reimbursement and out-of-state coverage restrictions. Patient-, organization-, and systems-based factors are all important to providing and improving access to telehealth EIPC services. Further research is needed to investigate the efficacy of telehealth EIPC and how policies and interventions may improve access to and dissemination of this care modality.

Effect of an Artificial Intelligence Decision Support Tool on Palliative Care Referral in Hospitalized Patients: A Randomized Clinical Trial.

CONTEXT: Palliative care services are commonly provided to hospitalized patients, but accurately predicting who needs them remains a challenge. OBJECTIVES: To assess the effectiveness on clinical outcomes of an artificial intelligence (AI)/machine learning (ML) decision support tool for predicting patient need for palliative care services in the hospital. METHODS: The study design was a pragmatic, cluster-randomized, stepped-wedge clinical trial in 12 nursing units at two hospitals over a 15-month period between August 19, 2019, and November 17, 2020. Eligible patients were randomly assigned to either a medical service consultation recommendation triggered by an AI/ML tool predicting the need for palliative care services or usual care. The primary outcome was palliative care consultation note. Secondary outcomes included: hospital readmissions, length of stay, transfer to intensive care and palliative care consultation note by unit. RESULTS: A total of 3183 patient hospitalizations were enrolled. Of eligible patients, A total of 2544 patients were randomized to the decision support tool (1212; 48%) and usual care (1332; 52%). Of these, 1717 patients (67%) were retained for analyses. Patients randomized to the intervention had a statistically significant higher incidence rate of palliative care consultation compared to the control group (IRR, 1.44 [95% CI, 1.11-1.92]). Exploratory evidence suggested that the decision support tool group reduced 60-day and 90-day hospital readmissions (OR, 0.75 [95% CI, 0.57, 0.97]) and (OR, 0.72 [95% CI, 0.55-0.93]) respectively. CONCLUSION: A decision support tool integrated into palliative care practice and leveraging AI/ML demonstrated an increased palliative care consultation rate among hospitalized patients and reductions in hospitalizations.

Prazosin for nightmares in serious illness.

Nightmares can be a distressing symptom in patients living with serious illness. Prazosin, a selective alpha-1 adrenergic antagonist, has been suggested to treat nightmares, with most data supporting its use in post-traumatic stress disorder (PTSD). We present the case of a 60-year-old woman with metastatic breast cancer who experienced healthcare-associated nightmares following hospitalisation. She did not meet diagnostic criteria for PTSD. Atypical antipsychotics and benzodiazepines were ineffective in controlling her nightmares, resulting in referral to our outpatient palliative medicine clinic. Prazosin was initiated alongside interdisciplinary psychosocial support, resulting in rapid resolution of her nightmares. To our knowledge, this is the first case to report on use of prazosin to manage nightmares in the outpatient palliative medicine setting.

Impact of Massage Therapy on the Quality of Life of Hospice Patients and Their Caregivers: A Pilot Study.

Evidence for massage therapy (MT) in hospice patients remains limited. We conducted a prospective pilot study on MTs impact on quality of life of hospice patients and caregivers. Patient-caregiver dyads were enrolled if patients scored ≥5 on pain, depression, anxiety, or well-being using the revised Edmonton Symptom Assessment System Revised (ESAS-r). The patient received MT weekly for up to 3 massages with assessments completed at baseline, after each massage, and 1 week after the final massage for patients and at baseline and 1 week after final massage for caregivers. A satisfaction survey was completed at study completion. A pro-rated area under the curve (AUC) was utilized to assess the primary endpoints of change in ESAS-r for patient ratings of pain, depression and anxiety as well as the Linear Analogue Self-Assessment (LASA). Median difference scores (end of study value)-(baseline value) for each participant and caregiver were calculated. Of 27 patients and caregivers enrolled, 25 patients received MT. Fifteen patients completed all 3 MT sessions and were given the final symptom assessment and satisfaction survey and their caregivers completed final assessments. The proportion of patients considered success (AUC > baseline) in the primary endpoints were the following: pain 40.9%, depression 40.9%, anxiety 54.5%, LASA 54.5%. Median difference scores were largely zero indicating no significant temporal change in symptoms. Patients were highly satisfied with MT. This pilot study indicated that MT was a feasible and well-received intervention in our population of patients with inadequately controlled symptoms.

Palliative care utilization in calciphylaxis: a single-center retrospective review of 121 patients (1999-2016).

BACKGROUND: Calciphylaxis is a debilitating dermatological condition associated with high rates of morbidity and mortality. Palliative care offers a multidisciplinary approach to addressing symptoms and goals of care in patients with serious medical diagnoses. Involvement of palliative services for calciphylaxis is infrequently reported in the literature. The purpose of this report is to assess rates of palliative and pain consultation for patients with calciphylaxis. METHODS: This is a comprehensive, single-institution retrospective chart review of 121 eligible patients with a diagnosis of calciphylaxis treated at Mayo Clinic in Rochester, Minnesota, from 1999 to 2016. Inclusion criteria were an indisputable diagnosis of calciphylaxis based on clinical, histopathologic, and radiographic features. One hundred twenty-one patients met inclusion criteria. RESULTS: Fifty-one patients (42%) received either a palliative (n = 15) or pain (n = 20) consultation, or both (n = 16). Patients with a palliative care consultation were younger compared with those without (mean ages 57 vs. 62 years, P = 0.046). In 104 patients (86%), psychiatric symptoms were not assessed. CONCLUSIONS: In this cohort of patients with calciphylaxis, the majority do not receive palliative and pain care consultations. Psychiatric complications are inconsistently addressed. These observations highlight practice gaps in the care of patients with calciphylaxis.

Improving time to palliative care review with predictive modeling in an inpatient adult population: study protocol for a stepped-wedge, pragmatic randomized controlled trial.

BACKGROUND: Palliative care is a medical specialty centered on improving the quality of life (QOL) of patients with complex or life-threatening illnesses. The need for palliative care is increasing and with that the rigorous testing of triage tools that can be used quickly and reliably to identify patients that may benefit from palliative care. METHODS: To that aim, we will conduct a two-armed stepped-wedge cluster randomized trial rolled out to two inpatient hospitals to evaluate whether a machine learning algorithm accurately identifies patients who may benefit from a comprehensive review by a palliative care specialist and decreases time to receiving a palliative care consult in hospital. This is a single-center study which will be conducted from August 2019 to November 2020 at Saint Mary's Hospital & Methodist Hospital both within Mayo Clinic Rochester in Minnesota. Clusters will be nursing units which will be chosen to be a mix of complex patients from Cardiology, Critical Care, and Oncology and had previously established relationships with palliative medicine. The stepped wedge design will have 12 units allocated to a design matrix of 5 treatment wedges. Each wedge will last 75 days resulting in a study period of 12 months of recruitment unless otherwise specified. Data will be analyzed with Bayesian hierarchical models with credible intervals denoting statistical significance. DISCUSSION: This intervention offers a pragmatic approach to delivering specialty palliative care to hospital patients in need using machine learning, thereby leading to high value care and improved outcomes. It is not enough for AI to be utilized by simply publishing research showing predictive performance; clinical trials demonstrating better outcomes are critically needed. Furthermore, the deployment of an AI algorithm is a complex process that requires multiple teams with varying skill sets. To evaluate a deployed AI, a pragmatic clinical trial can accommodate the difficulties of clinical practice while retaining scientific rigor. TRIAL REGISTRATION: ClinicalTrials.gov NCT03976297 . Registered on 6 June 2019, prior to trial start.

Perceptions of Hematology Among Palliative Care Physicians: Results of a Nationwide Survey.

CONTEXT: Palliative care integration for patients with hematologic diseases has lagged behind solid-organ malignancies. Previous work has characterized hematologist perspectives, but less is known about palliative care physician views of this phenomenon. OBJECTIVES: To examine palliative care physician attitudes and beliefs regarding hematologic diseases, patient care, and collaboration. METHODS: A 44-item survey containing Likert and free-response items was mailed to 1000 AAHPM physician members. Sections explored respondent comfort with specific diagnoses, palliative care integration, relationships with hematologists, and hematology-specific patient care. Logistic regression models with generalized estimating equations were used to compare parallel Likert responses. Free responses were analyzed using thematic analysis. RESULTS: The response rate was 55.5%. Respondents reported comfort managing symptoms in leukemia (84.0%), lymphoma (92.1%), multiple myeloma (92.9%), and following hematopoietic stem cell transplant (51.6%). Fewer expressed comfort with understanding disease trajectory (64.9%, 75.7%, 78.5%, and 35.4%) and discussing prognosis (71.0%, 82.6%, 81.6%, and 40.6%). 97.6% of respondents disagreed that palliative care and hematology are incompatible. 50.6% felt that palliative care physicians' limited hematology-specific knowledge hinders collaboration. 89.4% felt that relapse should trigger referral. 80.0% felt that hospice referrals occurred late. In exploring perceptions of hematology-palliative care relationships, three themes were identified: misperceptions of palliative care, desire for integration, and lacking a shared model of understanding. CONCLUSION: These data inform efforts to integrate palliative care into hematologic care at large, echoing previous studies of hematologist perspectives. Palliative care physicians express enthusiasm for caring for these patients, desire for improved understanding of palliative care, and ongoing opportunities to improve hematology-specific knowledge and skills.

Improving the delivery of palliative care through predictive modeling and healthcare informatics.

OBJECTIVE: Access to palliative care (PC) is important for many patients with uncontrolled symptom burden from serious or complex illness. However, many patients who could benefit from PC do not receive it early enough or at all. We sought to address this problem by building a predictive model into a comprehensive clinical framework with the aims to (i) identify in-hospital patients likely to benefit from a PC consult, and (ii) intervene on such patients by contacting their care team. MATERIALS AND METHODS: Electronic health record data for 68 349 inpatient encounters in 2017 at a large hospital were used to train a model to predict the need for PC consult. This model was published as a web service, connected to institutional data pipelines, and consumed by a downstream display application monitored by the PC team. For those patients that the PC team deems appropriate, a team member then contacts the patient's corresponding care team. RESULTS: Training performance AUC based on a 20% holdout validation set was 0.90. The most influential variables were previous palliative care, hospital unit, Albumin, Troponin, and metastatic cancer. The model has been successfully integrated into the clinical workflow making real-time predictions on hundreds of patients per day. The model had an "in-production" AUC of 0.91. A clinical trial is currently underway to assess the effect on clinical outcomes. CONCLUSIONS: A machine learning model can effectively predict the need for an inpatient PC consult and has been successfully integrated into practice to refer new patients to PC.

Inpatient Palliative Care Use in Patients With Pulmonary Arterial Hypertension: Temporal Trends, Predictors, and Outcomes.

BACKGROUND: Pulmonary arterial hypertension (PAH) is a progressive disease associated with significant morbidity and mortality. Despite the negative impact of PAH on quality of life and survival, data on use of specialty palliative care services (PCS) is scarce. RESEARCH QUESTION: We sought to evaluate the inpatient use of PCS in patients with PAH. STUDY DESIGN AND METHODS: Using the National (Nationwide) Inpatient Sample, 30,495 admissions with a primary diagnosis of PAH were identified from 2001 through 2017. The primary outcome of interest was temporal trends and predictors of inpatient PCS use in patients with PAH. RESULTS: The inpatient use of PCS was low (2.2%), but increased during the study period from 0.5% in 2001 to 7.6% in 2017, with a significant increase starting in 2009. White race, private insurance, higher socioeconomic status, hospital-specific factors, higher comorbidity burden (Charlson Comorbidity Index), cardiac and noncardiac organ failure, and use of extracorporeal membrane oxygenation and noninvasive mechanical ventilation were independent predictors of increased PCS use. PCS use was associated with a higher prevalence of do-not-resuscitate status, a longer length of stay, higher hospitalization costs, and increased in-hospital mortality with less frequent discharges to home, likely because these patients were also sicker (higher comorbidity index and illness acuity). INTERPRETATION: The inpatient use of PCS in patients with PAH is low, but has been increasing over recent years. Despite increased PCS use over time, patient- and hospital-specific disparities in PCS use continue. Further studies evaluating these disparities and the role of PCS in the comprehensive care of PAH patients are warranted.

Multisite, Randomized Trial of Early Integrated Palliative and Oncology Care in Patients with Advanced Lung and Gastrointestinal Cancer: Alliance A221303.

Background: We conducted a multicenter, randomized trial of early integrated palliative and oncology care in patients with advanced cancer to confirm the benefits of early palliative care (PC) seen in prior single-center studies. Methods: We randomly assigned patients with newly diagnosed incurable cancer to early integrated palliative and oncology care (n = 195) or usual oncology care (n = 196) at sites through the Alliance for Clinical Trials in Oncology. Patients assigned to the intervention were expected to meet with a PC clinician at least monthly until death, whereas usual care patients consulted PC on request. The primary endpoint was the change in quality of life from baseline to week 12 per the Functional Assessment of Cancer Therapy-General (FACT-G). Secondary outcomes included anxiety, depression, and communication about prognosis and end-of-life care. Results: Due to significant morbidity and a high proportion of measures that were not completed within the protocol window or for unknown reasons, the rate of missing data was high. We anticipated that 70% of patients (n = 280) would complete the FACT-G at baseline and week 12, but only 49.3% (n = 193/391) completed the measure. Delivery of the intervention was also suboptimal, as 14.9% (n = 29/195) of intervention patients had no PC visits by week 12. Intervention patients reported a mean 3.35 (standard deviation [SD] = 14.7) increase in FACT-G scores from baseline to week 12 compared with usual care patients who reported a 0.12 (SD = 12.7) increase from baseline (p = 0.10). Conclusion: This study highlights the difficulties of conducting multicenter trials of supportive care interventions in patients with advanced cancer. Clinical Trials Registration: NCT02349412.

Curing Opioid Toxicity with Intrathecal Targeted Drug Delivery.

Pain is one of the most feared symptoms that concern cancer patients and their families. Despite well-established guidelines set forth by the World Health Organization (WHO) on the treatment of cancer pain, nearly half of cancer patients report poorly controlled pain. One of the most serious side effects of systemic oral opioid use is neurotoxicity, which is characterized by altered mental status and systemic neurologic impairments. Treatment strategies are supportive in nature and focused on reducing or changing the offending opioid and correcting any metabolic deficiencies. Herein, we discuss a case of opioid-induced neurotoxicity treated with intrathecal targeted drug delivery (TDD). The timing and implementation of advanced therapies such as intrathecal TDD is not well delineated. More importantly, patients and their oncologic providers are often unaware of this useful tool in treating challenging cancer-associated pain and significantly minimizing systemic opioid side effects. To ensure that patients have comprehensive oncologic care, best-practice guidelines suggest involvement of an interdisciplinary team and coordinated care. Early referral to a pain and palliative specialist may allow for improved patient outcomes and removal of unnecessary barriers to optimal patient care.

Attitudes of Hospice Providers Regarding Intrathecal Targeted Drug Delivery for Patients With Cancer.

Pain is one of the most commonly experienced and feared symptoms faced by patients with a serious illness. For these patients, intrathecal drug delivery systems (IDDSs) provide greater potency and/or few systemic side effects. However, despite these benefits, the integration and management of IDDS for patients receiving hospice care has not been previous studied. An electronic, 18-question survey was sent to 200 hospice practitioners (physicians, nurse practitioners and nurses) in the state of Minnesota to explore their experience, confidence, and the perceived barriers to caring for patients with IDDS while being cared for on hospice. Providers were identified though mailing lists from the Minnesota Network of Hospice and Palliative Care organization. The survey was administered by the Mayo Clinic Survey Research Center with institutional review board approval. Slightly more than 50% of respondents have ever cared for a patient with an intrathecal pump. If a patient had a pump in place, only 28% of providers expressed confidence in managing their pain. Additionally, only 3 of 10 respondents felt that adjusting an intrathecal pump should be the first option when a patient with an IDDS in place had increased pain. Indeed, the vast majority (over 80%) of respondents preferred the use of systemic therapies for primary pain management. Access to IDDS vendors for changes/refills in the home is identified as another barrier with over 50% of respondents either unaware of an available vendor or reporting no vendor available. There are numerous self-reported barriers to ongoing use of IDDS with patients receiving hospice care.

Resurgence of Eating Disorders with Olanzapine.

BACKGROUND: Olanzapine is commonly utilized in palliative care for the treatment of nausea, and a known side effect of olanzapine is increased appetite. Olanzapine is also known to cause re-emergence of eating disorders (EDs) in patients utilizing olanzapine for its antipsychotic effects. It is unclear to what extent this may also occur in patients with serious/life-limiting illness. METHODS AND RESULTS: We present a case of a 70-year-old female with recurrent ovarian cancer and a history of bulimia nervosa (BN) that developed resurgence of her BN after initiation of olanzapine for cancer-associated nausea. Her BN resolved with reducing the dose of olanzapine. CONCLUSION: It is important to recognize that recurrence of EDs can occur when using olanzapine in the palliative care setting.

End-of-Life Care for Seriously Ill International Patients at a Global Destination Medical Center.

OBJECTIVE: To characterize the end-of-life care of all international patients who died at a global destination medical center from January 1, 2005, through December 31, 2015. PATIENTS AND METHODS: We performed a retrospective review of all adult international patients who died at a global destination medical center from January 1, 2005, through December 31, 2015. RESULTS: Eighty-two international patients from 25 countries and 5 continents died during the study period (median age, 59.5 years; 59% male). Of the study cohort, 11% (n=9) completed an advance directive, 61% (n=50) died in the intensive care unit, 26% (n=21) had a full code order at the time of death, and 73% (n=19 of 26) receiving cardiopulmonary resuscitation did not survive the resuscitation process. CONCLUSION: Seriously ill international patients who travel to receive health care in the United States face many barriers to receiving high-quality end-of-life care. Seriously ill international patients are coming to the United States in increasing numbers, and little is known about their end-of-life care. There are many unique needs in the care of this complex patient population, and further research is needed to understand how to provide high-quality end-of-life care to these patients.

The Organ Transplant Imperative.

More than 120,000 US patients were listed for solid organ transplants in 2016. Although data are scarce, we suspect that many of these patients will die while awaiting transplant and without engaging in goals-of-care discussions with their physicians. The challenges of addressing goals of care in patients with malignancy, end-stage renal disease, and heart failure have been studied. However, there is sparse literature on addressing goals of care throughout the dynamic process of transplant assessment and listing. We propose the concept of an organ transplant imperative, which is the perceived obligation by patients and health care providers to proceed with organ transplant and to avoid advance care planning and triggered goals-of-care discussions, even in situations in which patients' clinical trajectories have worsened, resulting in poor quality of life and low likelihood of meaningful survival. We situate this concept within the paradigms of clinical inertia and the treatment and technological imperatives. We illustrate this concept by describing a patient with end-stage liver disease (ESLD) who was hoping for a liver transplant, who was caught between the conflicting perspectives of specialist and primary care physicians, and who died of complications of ESLD without experiencing the benefits of advance care planning. Greater awareness of the transplant imperative should generate a shared understanding among specialists, generalists, and patients and will provide opportunities for more formalized involvement of palliative medicine experts in the care of transplant patients.