O’Mahony, Sean

Importance Numerous studies show that early palliative care improves quality of life and other key outcomes in patients with advanced cancer and their caregivers, although most lack access to this evidence-based model of care. Objective To evaluate whether delivering early palliative care via secure video vs in-person visits has an equivalent effect on quality of life in patients with advanced non–small cell lung cancer (NSCLC). Design, Setting, and Participants Randomized, multisite, comparative effectiveness trial from June 14, 2018, to May 4, 2023, at 22 US cancer centers among 1250 patients within 12 weeks of diagnosis of advanced NSCLC and 548 caregivers. Intervention Participants were randomized to meet with a specialty-trained palliative care clinician every 4 weeks either via video visit or in person in the outpatient clinic from the time of enrollment and throughout the course of disease. The video visit group had an initial in-person visit to establish rapport, followed by subsequent virtual visits. Main Outcomes and Measures Equivalence of the effect of video visit vs in-person early palliative care on quality of life at week 24 per the Functional Assessment of Cancer Therapy-Lung questionnaire (equivalence margin of ±4 points; score range: 0-136, with higher scores indicating better quality of life). Participants completed study questionnaires at enrollment and at weeks 12, 24, 36, and 48. Results By 24 weeks, participants (mean age, 65.5 years; 54.0% women; 82.7% White) had a mean of 4.7 (video) and 4.9 (in-person) early palliative care encounters. Patient-reported quality-of-life scores were equivalent between groups (video mean, 99.7 vs in-person mean, 97.7; difference, 2.0 [90% CI, 0.1-3.9]; P = .04 for equivalence). Rate of caregiver participation in visits was lower for video vs in-person early palliative care (36.6% vs 49.7%; P < .001). Study groups did not differ in caregiver quality of life, patient coping, or patient and caregiver satisfaction with care, mood symptoms, or prognostic perceptions. Conclusions and Relevance The delivery of early palliative care virtually vs in person demonstrated equivalent effects on quality of life in patients with advanced NSCLC, underscoring the considerable potential for improving access to this evidence-based care model through telehealth delivery. Trial Registration ClinicalTrials.gov Identifier: NCT03375489

Objectives: To assess the feasibility and efficacy of implementing “Family Care Rituals” as a means of engaging family members in the care of patients admitted to the ICU with a high risk of ICU mortality on outcomes including stress-related symptoms in family members. Design: Prospective, before-and-after intervention evaluation. Setting: Two U.S. academic medical ICU’s, and one Italian academic medical/surgical ICU. Subjects: Family members of patients who had an attending predicted ICU mortality of greater than 30% within the first 24 hours of admission. Interventions: A novel intervention titled “Family Care Rituals” during which, following a baseline observation period, family members enrolled in the intervention phase were given an informational booklet outlining opportunities for engagement in care of the patient during their ICU stay. Measurements and Main Results: Primary outcome was symptoms of post-traumatic stress disorder in family members 90 days after patient death or ICU discharge. Secondary outcomes included symptoms of depression, anxiety, and family satisfaction. At 90-day follow-up, 131 of 226 family members (58.0%) responded preintervention and 129 of 226 family members (57.1%) responded postintervention. Symptoms of post-traumatic stress disorder were significantly higher preintervention than postintervention (39.2% vs 27.1%; unadjusted odds ratio, 0.58; p = 0.046). There was no significant difference in symptoms of depression (26.5% vs 25.2%; unadjusted odds ratio, 0.93; p = 0.818), anxiety (41.0% vs 45.5%; unadjusted odds ratio, 1.20; p = 0.234), or mean satisfaction scores (85.1 vs 89.0; unadjusted odds ratio, 3.85; p = 0.052) preintervention versus postintervention 90 days after patient death or ICU discharge. Conclusions: Offering opportunities such as family care rituals for family members to be involved with providing care for family members in the ICU was associated with reduced symptoms of post-traumatic stress disorder. This intervention may lessen the burden of stress-related symptoms in family members of ICU patients.

Background: Clinicians need to deliver prognostic information to surrogates of nondecisional, critically ill patients so that surrogates can make informed medical decisions that reflect the patient’s values. Our objective was to implement a new approach for communicating with surrogates of patients with chronic critical illness. Methods: Surrogate decision makers of patients who were difficult to liberate from mechanical ventilation were prospectively enrolled. Surrogates met with different members of the intensive care unit treatment team for sequential 15-minute appointments to receive patient-specific assessments and education on chronic critical illness. The feasibility and acceptability of this approach were determined. A 24-question comprehension instrument was developed to assess a participant’s understanding that a family member was displaying features of chronic critical illness. Each question was scored from 1 to 5, with larger scores indicating greater comprehension. Results: Over a 15-week period, educational sessions for 9 mechanically ventilated patients were conducted. On average, 2 surrogates per patient (range: 1-4) and 6 members of the interdisciplinary team (range: 4-6) were at each meeting. Surrogates and clinicians had very positive impressions of the communication intervention. The average preintervention comprehension score was 85 of 120 (standard deviation [SD]: 8, range: 71-101). The postintervention comprehension score was greater by 5 points on average (SD: 9, range: −11 to +20 points, P = .04). Conclusions: Surrogates of critically ill patients approved of this novel communication approach and had a greater understanding of the patient’s medical condition after the intervention.

Abstract Introduction: Early palliative care (PC) integrated with oncology care improves quality of life (QOL), depression symptoms, illness understanding, and end-of-life (EOL) care for patients with advanced lung cancer. The aims of this trial are to compare the effect of delivering early integrated PC through telehealth versus in-person on patient and caregiver outcomes. We hypothesize that both modalities for delivering early PC would be equivalent for improving patient QOL, communication about EOL care preferences with their oncologist, and length of stay in hospice. Methods: For this comparative effectiveness trial, we will enroll and randomize 1250 adult patients with advanced nonsmall cell lung cancer (NSCLC), who are not being treated with curative intent, to receive either early integrated telehealth or in-person PC at 20 cancer centers throughout the United States. Patients may also invite a family caregiver to participate in the study. Patients and their caregivers in both study groups meet at least every four weeks with a PC clinician from within 12 weeks of patient diagnosis of advanced NSCLC until death. Participants complete measures of QOL, mood, and quality of communication with oncologists at baseline before randomization and at 12, 24, 36, and 48 weeks. Information on health care utilization, including length of stay in hospice, will be collected from patients' health records. To test equivalence in outcomes between study groups, we will compute analysis of covariance and mixed linear models, controlling for baseline scores and study site. Study Implementation and Stakeholder Engagement: To ensure that this comparative effectiveness trial and findings are as patient centered and meaningful as possible, we have incorporated a robust patient and stakeholder engagement plan. Our stakeholder partners include (1) patients/families, (2) PC clinicians, (3) telehealth experts and clinician users, (4) representatives from health care systems and medical insurance providers, and (5) health care policy makers and advocates. These stakeholders will inform and provide feedback about every phase of study implementation.