Telehealth vs In-Person Early Palliative Care for Patients With Advanced Lung Cancer: A Multisite Randomized Clinical Trial.

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.

Patient Perceptions of Specialist Palliative Care Intervention in Surgical Oncology Care.

INTRODUCTION: Surgical oncology patients have a high symptom burden and increased risk of morbidity. The aim of palliative care is to evaluate and treat the patient in a holistic manner focusing on the unique attributes of each patient. This goal-concordant approach could help surgical patients cope with the stress and uncertainty that often accompany serious illness and surgery, improving overall outcomes. This qualitative analysis sought to explore whether unmet specialist palliative care or end-of-life needs exist in this population. METHODS: Qualitative interviews were completed with a subset of participants in a randomized, controlled trial of a specialist palliative care intervention for patients undergoing abdominal oncologic surgery. The interview guide sought to elicit respondents' perceptions of palliative care and end-of-life needs perioperatively and postoperatively. Recurring themes were identified by two independent coders. RESULTS: Analysis of 47 interview transcripts revealed few serious concerns about end-of-life issues, however appreciation for the supportive presence offered by palliative care was present. Among participants who received specialist palliative care, many found the intervention helpful, but few were able to articulate issues that the intervention improved. CONCLUSION: These findings suggest low levels of unmet palliative care needs among this population, which is consistent with the results of the parent trial. Targeting patients with a higher symptom burden perioperatively may allow for improved symptom management and better adherence to the treatment plan postoperatively, as well as be a more focused use of specialist palliative care clinicians' efforts.

Factors and Barriers to Goals-of-Care Conversations for Patients With Cancer and Inpatient Mortality.

PURPOSE: Conversations about personal values and goals of care (GOC) at the end of life are essential in caring for patients with advanced cancer. However, GOC conversations may be influenced by patient and oncologist factors during transitions of care. METHODS: We electronically administered surveys to medical oncologists of inpatients who died from May 1, 2020, to May 31, 2021. Primary outcomes included oncologists' knowledge of inpatient death, anticipation of patient death, and recollection of GOC discussions. Secondary outcomes, including GOC documentation and advance directives (ADs), were collected retrospectively from electronic health records. Outcomes were analyzed for association with patient, oncologist, and patient-oncologist relationship factors. RESULTS: For 75 patients who died, 104/158 (66%) surveys were completed by 40 inpatient and 64 outpatient oncologists. Eighty-one oncologists (77.9%) were aware of patients' deaths, 68 (65.4%) anticipated patients' deaths within 6 months, and 67 (64.4%) recalled having GOC discussions before or during the terminal hospitalization. Outpatient oncologists were more likely to report knowledge of patient death (P < .001), as were those with longer therapeutic relationships (P < .001). Inpatient oncologists were more likely to correctly anticipate patient death (P = .014). Secondary outcomes revealed 21.3% of patients had documented GOC discussions before admission and 33.3% had ADs; patients with a longer duration of cancer diagnosis were more likely to have ADs (P = .003). Oncologist-reported barriers to GOC included unrealistic expectations from patients or family (25%) and decreased patient participation because of clinical conditions (15%). CONCLUSION: Most oncologists recalled having GOC discussions for patients with inpatient mortality, yet documentation of serious illness conversations remained suboptimal. Further studies are needed to examine barriers to GOC conversations and documentation during transitions of care and across health care settings.

Effects of Specialist Palliative Care for Patients Undergoing Major Abdominal Surgery for Cancer: A Randomized Clinical Trial.

Importance: Specialist palliative care benefits patients undergoing medical treatment of cancer; however, data are lacking on whether patients undergoing surgery for cancer similarly benefit from specialist palliative care. Objective: To determine the effect of a specialist palliative care intervention on patients undergoing surgery for cure or durable control of cancer. Design, Setting, and Participants: This was a single-center randomized clinical trial conducted from March 1, 2018, to October 28, 2021. Patients scheduled for specified intra-abdominal cancer operations were recruited from an academic urban referral center in the Southeastern US. Intervention: Preoperative consultation with palliative care specialists and postoperative inpatient and outpatient palliative care follow-up for 90 days. Main Outcomes and Measures: The prespecified primary end point was physical and functional quality of life (QoL) at postoperative day (POD) 90, measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Trial Outcome Index (TOI), which is scored on a range of 0 to 56 with higher scores representing higher physical and functional QoL. Prespecified secondary end points included overall QoL at POD 90 measured by FACT-G, days alive at home until POD 90, and 1-year overall survival. Multivariable proportional odds logistic regression and Cox proportional hazards regression models were used to test the hypothesis that the intervention improved each of these end points relative to usual care in an intention-to-treat analysis. Results: A total of 235 eligible patients (median [IQR] age, 65.0 [56.8-71.1] years; 141 male [60.0%]) were randomly assigned to the intervention or usual care group in a 1:1 ratio. Specialist palliative care was received by 114 patients (97%) in the intervention group and 1 patient (1%) in the usual care group. Adjusted median scores on the FACT-G TOI measure of physical and functional QoL did not differ between groups (intervention score, 46.77; 95% CI, 44.18-49.04; usual care score, 46.23; 95% CI, 43.08-48.14; P = .46). Intervention vs usual care group odds ratio (OR) was 1.17 (95% CI, 0.77-1.80). Palliative care did not improve overall QoL measured by the FACT-G score (intervention vs usual care OR, 1.09; 95% CI, 0.75-1.58), days alive at home (OR, 0.87; 95% CI, 0.69-1.11), or 1-year overall survival (hazard ratio, 0.97; 95% CI, 0.50-1.88). Conclusions and Relevance: This randomized clinical trial showed no evidence that early specialist palliative care improves the QoL of patients undergoing nonpalliative cancer operations. Trial Registration: ClinicalTrials.gov Identifier: NCT03436290.

Characteristics of Post-ICU and Post-COVID Recovery Clinics in 29 U.S. Health Systems.

The multifaceted long-term impairments resulting from critical illness and COVID-19 require interdisciplinary management approaches in the recovery phase of illness. Operational insights into the structure and process of recovery clinics (RCs) from heterogeneous health systems are needed. This study describes the structure and process characteristics of existing and newly implemented ICU-RCs and COVID-RCs in a subset of large health systems in the United States. DESIGN: Cross-sectional survey. SETTING: Thirty-nine RCs, representing a combined 156 hospitals within 29 health systems participated. PATIENTS: None. INTERVENTIONS: None. MEASUREMENT AND MAIN RESULTS: RC demographics, referral criteria, and operating characteristics were collected, including measures used to assess physical, psychologic, and cognitive recoveries. Thirty-nine RC surveys were completed (94% response rate). ICU-RC teams included physicians, pharmacists, social workers, physical therapists, and advanced practice providers. Funding sources for ICU-RCs included clinical billing (n = 20, 77%), volunteer staff support (n = 15, 58%), institutional staff/space support (n = 13, 46%), and grant or foundation funding (n = 3, 12%). Forty-six percent of RCs report patient visit durations of 1 hour or longer. ICU-RC teams reported use of validated scales to assess psychologic recovery (93%), physical recovery (89%), and cognitive recovery (86%) more often in standard visits compared with COVID-RC teams (psychologic, 54%; physical, 69%; and cognitive, 46%). CONCLUSIONS: Operating structures of RCs vary, though almost all describe modest capacity and reliance on volunteerism and discretionary institutional support. ICU- and COVID-RCs in the United States employ varied funding sources and endorse different assessment measures during visits to guide care coordination. Common features include integration of ICU clinicians, interdisciplinary approach, and focus on severe critical illness. The heterogeneity in RC structures and processes contributes to future research on the optimal structure and process to achieve the best postintensive care syndrome and postacute sequelae of COVID outcomes.

Statistical analysis plan for the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) trial: a randomized controlled trial of a specialist palliative care intervention for patients undergoing surgery for cancer.

BACKGROUND: The impact of specialist palliative care intervention in patients undergoing surgery for cancer has not been studied extensively. The SCOPE randomized controlled trial will investigate the effect of specialist palliative care intervention in cancer patients undergoing surgery for selected abdominal malignancies. The study protocol of the SCOPE Trial was published in December 2019. METHODS AND DESIGN: The SCOPE Trial is a single-center, single-blind, prospective, randomized controlled trial that will investigate specialist palliative care intervention for cancer patients undergoing surgery for selected abdominal malignancies. The study plans to enroll 236 patients that will be randomized to specialist palliative care (intervention arm) and usual care (control arm) in a 1:1 ratio. RESULTS: The primary outcome of the study is the Functional Assessment of Cancer Therapy-General (FACT-G) Trial Outcome Index (TOI) at 90 days postoperatively. Secondary outcomes of the study include the total FACT-G score at 90 days postoperatively, days alive at home without an emergency room visit within 90 days of operation, and all-cause mortality at 1 year after operation. Time frames for all outcomes will start on the day of surgery. CONCLUSION: This manuscript serves as the formal statistical analysis plan (version 1.0) for the SCOPE randomized controlled trial. The statistical analysis plan was completed on 6 April 2021. TRIAL REGISTRATION: ClinicalTrials.gov NCT03436290 . Registered on 16 February 2018.

Effects of a Primary Palliative Care Educational System for Teaching Learners at Different Levels of Training.

Interest and appreciation for palliative care (PC) has resulted in increased demand for both PC services and education. The PC rotation has been shown to improve PC knowledge in medical students (MS) and internal medicine (IM) residents, and PC specialists stand poised to direct the primary PC education of learners at different levels of training. To concurrently teach learners of different levels of training on a busy PC service, we created an educational system that emphasizes management of learner schedules, organization of teaching activities, faculty development to improve teaching skills, and learner self-evaluation. Both MS and IM residents showed an improvement in self-assessed competence as well as increased comfort level with seriously ill patients after PC rotation. Careful adjustment of learner schedules has accommodated an increasing number of learners, while maintaining a low learner to faculty ratio. The PC educators face an exciting and daunting challenge as the number of patients with PC needs and the number of learners requesting PC experience grow. We continue to improve milestone-based PC assessment tools, to invest in faculty development, and to explore innovative ways to support PC educators as they strive to provide consistent PC education that is both useful for learners and can be incorporated into busy PC clinical practice.

Psychometric Properties of the FACIT-Pal 14 Administered in an Outpatient Palliative Care Clinic.

BACKGROUND: The Functional Assessment of Chronic Illness Therapy-Palliative (FACIT-Pal) 14 instrument measures the quality of life in palliative care patients but its psychometric properties are not well characterized. OBJECTIVES: To establish the reliability and validity of the FACIT-Pal 14 in an outpatient palliative care clinic population. METHODS: The FACIT-Pal 14 was administered to 227 patients in an outpatient palliative care clinic at a large, urban academic medical center. Internal consistency reliability was assessed with Crohnbach's α, and principal component analysis was used to investigate for multiple underlying latent variables. Construct validity was tested by comparing mean scores in various subgroups. RESULTS: The FACIT-Pal 14 has Crohnbach's α of 0.76, which increases to 0.79 if 2 items are removed. Principal component analysis supports a single latent variable underlying the instrument. Significantly lower mean scores were found in patients with Eastern Cooperative Oncology Group (ECOG) functional status 3 to 4 compared with patients with ECOG functional status 1-2 ( P = .007), in patients with life expectancy under 6 months compared to those with 6 months or greater ( P = .003), and in patients referred to clinic for pain and symptom management compared with patients referred for other reasons ( P = .038). Instrument scores did not significantly differ between men and women or between white and nonwhite patients ( P = .525 and P = .263, respectively). CONCLUSIONS: In an outpatient palliative care clinic population, the FACIT-Pal 14 has good internal consistency, but removal of 2 items would improve consistency. One latent variable underlies the instrument and there is evidence of construct validity.

Five-Year Experience of an Inpatient Palliative Care Unit at an Academic Referral Center.

BACKGROUND: Palliative care units (PCUs) staffed by specialty-trained physicians and nurses have been established in a number of medical centers. The purpose of this study is to review the 5-year experience of a PCU at a large, urban academic referral center. METHODS: We retrospectively reviewed a prospectively collected database of all admissions to the PCU at Vanderbilt University Medical Center in the first 5 years of its existence, from 2012 through 2017. RESULTS: Over these 5 years, there were 3321 admissions to the PCU. No single underlying disease process accounted for the majority of the patients, but the largest single category of patients were those with malignancy, who accounted for 38% of admissions. Transfers from the intensive care unit accounted for 50% of admissions, with 43% of admissions from a hospital floor and 7% coming from the emergency department or a clinic. Median length of stay in the PCU was 3 days. In hospital deaths occurred for 50% of admitted patients, while 38% of patients were discharged from the PCU to hospice. CONCLUSION: These data show that a successful PCU is enabled by buy in from a wide variety of referring specialists and by a multidisciplinary palliative care team focused on care of the actively dying patient as well as pain and symptom management, advance care planning, and hospice referral since a large proportion of referred patients do not die in house.