Association Between Financial Distress with Patient and Caregiver Outcomes in Home-Based Palliative Care: A Secondary Analysis of a Clinical Trial.

BACKGROUND: Serious illness often causes financial hardship for patients and families. Home-based palliative care (HBPC) may partly address this. OBJECTIVE: Describe the prevalence and characteristics of patients and family caregivers with high financial distress at HBPC admission and examine the relationship between financial distress and patient and caregiver outcomes. DESIGN, SETTINGS, AND PARTICIPANTS: Data for this cohort study were drawn from a pragmatic comparative-effectiveness trial testing two models of HBPC in Kaiser Permanente. We included 779 patients and 438 caregivers from January 2019 to January 2020. MEASUREMENTS: Financial distress at admission to HBPC was measured using a global question (0-10-point scale: none=0; mild=1-5; moderate/severe=6+). Patient- (Edmonton Symptom Assessment Scale, distress thermometer, PROMIS-10) and caregiver (Preparedness for Caregiving, Zarit-12 Burden, PROMIS-10)-reported outcomes were measured at baseline and 1 month. Hospital utilization was captured using electronic medical records and claims. Mixed-effects adjusted models assessed survey measures and a proportional hazard competing risk model assessed hospital utilization. RESULTS: Half of the patients reported some level of financial distress with younger patients more likely to have moderate/severe financial distress. Patients with moderate/severe financial distress at HBPC admission reported worse symptoms, general distress, and quality of life (QoL), and caregivers reported worse preparedness, burden, and QoL (all, p<.001). Compared to patients with no financial distress, moderate/severe financial distress patients had more social work contacts, improved symptom burden at 1 month (ESAS total score: -4.39; 95% CI: -7.61, -1.17; p<.01), and no increase in hospital-based utilization (adjusted hazard ratio: 1.11; 95% CI: 0.87-1.40; p=.41); their caregivers had improved PROMIS-10 mental scores (+2.68; 95% CI: 0.20, 5.16; p=.03). No other group differences were evident in the caregiver preparedness, burden, and physical QoL change scores. CONCLUSION: These findings highlight the importance and need for routine assessments of financial distress and for provision of social supports required to help families receiving palliative care services.

Spiritual distress: symptoms, quality of life and hospital utilisation in home-based palliative care.

OBJECTIVES: The purpose of this study was to use a spiritual screening question to quantify the prevalence of spiritual distress (SD) in a large cohort of seriously ill patients at admission to home-based palliative care (HBPC) and to examine the associations between SD with symptom burden, quality of life and hospital-based utilisation up to 6 months after admission to HBPC. METHODS: Data for this cohort study (n=658) were drawn from a pragmatic comparative-effectiveness trial testing two models of HBPC. At admission to HBPC, SD was measured using a global question (0-10-point scale: none=0; mild=1-4; moderate-to-severe=5+); symptoms and quality of life were measured with the Edmonton Symptom Assessment Scale (ESAS) and PROMIS-10. Hospital utilisation was captured using electronic records and claims. Median regression and proportional hazard competing risk models assessed the association between SD with symptoms and quality of life, and hospital utilisation, respectively. RESULTS: Nearly half of the patients/proxies reported some level of SD. Increasing SD was significantly associated with higher symptom burden (increase of 7-14 points on ESAS) and worse mental well-being (decrease of 2.7 to 4.6 points on PROMIS-10-mental) in adjusted models. Compared with patients/proxies who reported no SD, those with at least some level of SD were not at increased risk for hospital-based utilisation over a median follow-up period of 2 months. CONCLUSION: While SD is cross-sectionally associated with worse symptoms and mental well-being, it did not predict downstream hospital-based utilisation. Our results highlight the importance of assessing for and managing SD in patients with serious illness.

Clinician Perspectives on Implementing Video Visits in Home-Based Palliative Care.

Background: Despite the increasing use and acceptance of technology in health care, there is limited evidence on the usefulness and appropriate use of telehealth in home-based palliative care (HBPC). As part of the process evaluation of a pragmatic trial of video visits in HBPC, we assessed clinician experience with video visit implementation. Methods: We assessed clinicians' experiences with and perception of the usefulness and appropriateness of video visits using anonymous surveys and brief qualitative interviews with a subset of survey participants. Qualitative analyses were guided by sociotechnical frameworks that emphasize technology's "value proposition" for its end users as being key to adoption. Results: Clinicians (36 physicians and 48 registered nurses) generally had favorable attitudes toward video visits and telehealth. Respondents felt confident in the skills needed to make their role in video visits successful. Clinicians were neutral on whether video visits were useful for their practice or enhanced the patient-caregiver experience. Clinicians found video visits to be most appropriate for follow-up care (as opposed to start of care). The interviews yielded two themes that complemented the survey findings: (1) factors enhancing the value proposition (positive responses from patients and families and convenience) and (2) factors diminishing the value proposition (issues related to the technology and scheduling). Discussion: Our findings provide insights into clinicians' experiences with implementing remote video physician consultations, facilitated by a nurse in the patient's home in the pre-COVID-19 era. Clinician views about video visits may have shifted with the pandemic, which occurred after our data collection was complete. Clinical Trials Registration No. NCT#03694431.

Findings and lessons learnt from early termination of a pragmatic comparative effectiveness trial of video consultations in home-based palliative care.

BACKGROUND: Health systems need evidence about how best to deliver home-based palliative care (HBPC) to meet the growing needs of seriously ill patients. We hypothesised that a tech-supported model that aimed to promote timely inter-professional team coordination using video consultation with a remote physician while a nurse is in the patient's home would be non-inferior compared with a standard model that includes routine home visits by nurses and physicians. METHODS: We conducted a pragmatic, cluster randomised non-inferiority trial across 14 sites (HomePal Study). Registered nurses (n=111) were randomised to the two models so that approximately half of the patients with any serious illness admitted to HBPC and their caregivers were enrolled in each study arm. Process measures (video and home visits and satisfaction) were tracked. The primary outcomes for patients and caregivers were symptom burden and caregiving preparedness at 1-2 months. RESULTS: The study was stopped early after 12 months of enrolment (patients=3533; caregivers=463) due to a combination of low video visit uptake (31%), limited substitution of video for home visits, and the health system's decision to expand telehealth use in response to changes in telehealth payment policies, the latter of which was incompatible with the randomised design. Implementation barriers included persistent workforce shortages and inadequate systems that contributed to scheduling and coordination challenges and unreliable technology and connectivity. CONCLUSIONS: We encountered multiple challenges to feasibility, relevance and value of conducting large, multiyear pragmatic randomised trials with seriously ill patients in the real-world settings where care delivery, regulatory and payment policies are constantly shifting.

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.