A Randomized Trial of a Nurse-Led Palliative Care Intervention for Patients with Newly Diagnosed Lung Cancer.

Background: Specialist palliative care improves quality of life (QOL), symptom burden, and may prolong survival among patients with advanced lung cancer. Previous trials focused on advanced disease, and less is known about patients across a broad range of stages. Objective: We sought to assess the effect of a nurse-led telephone-based primary palliative care intervention that focused on patients across a broad range of stages. Design, Setting, and Participants: We conducted a multisite randomized controlled trial in the United States involving patients diagnosed within two months with any stage or histology of lung cancer to compare the effects of a telephone-based palliative care intervention delivered by registered nurses trained in primary palliative care versus usual care. Main Outcomes and Measures: The primary outcome was the Functional Assessment of Cancer Therapy-Lung Scale Total Outcome Index (FACT-L TOI), which measures QOL and symptoms. We estimated having 80% power to detect a 5-point change from baseline to three months. Secondary outcome was a change in satisfaction of care, measured by the FAMCARE-P13. Results: A total of 151 patients were enrolled over 30 months. Patients were, on average, male (98%), age 70 years, White (85%), and 36% diagnosed with stage I-II, and 64% had stage III-IV. In comparison to usual care, patients in the nurse-led intervention did not report improvement in QOL from baseline to three months follow-up or demonstrate differences in treatment effect by site or cancer stage: FACT-L TOI 1.03 (95% confidence interval [CI]: -3.98 to 6.04). Satisfaction with care did not significantly improve: 0.66 (95% CI: -2.01 to 3.33). Conclusions: Among patients with newly diagnosed lung cancer, a nurse-led, primary palliative care intervention did not significantly improve QOL, symptom burden, or satisfaction of care. In contrast to several clinical trials demonstrating the effectiveness of delivering specialty palliative care with disease-modifying treatments on QOL among patients with advanced lung cancer, this intervention did not significantly improve QOL among patients with any stage lung cancer. Future research should identify which specific components of primary palliative care improve outcomes for patients newly diagnosed with lung cancer.

A comparison of patient-reported mental health outcomes for the Department of Veterans Affairs' regional telehealth and Community Care Programs.

OBJECTIVES: To compare patient-reported outcomes for veterans with limited access to Department of Veterans Affairs (VA) mental health services referred to the Veterans Community Care Program (VCCP) or regional telehealth Clinical Resource Hubs-Mental Health (CRH-MH). DATA SOURCES: This national evaluation used secondary data from the VA Corporate Data Warehouse, chart review, and primary data collected by baseline survey between October 8, 2019 and May 27, 2020 and a 4-month follow-up survey. STUDY DESIGN: A quasi-experimental longitudinal study design was used to sample 545 veterans with VCCP or CRH-MH referrals for new treatment episodes. Patient-reported outcomes included symptom severity, perceived access, utilization, and patient-centeredness. DATA COLLECTION: During the baseline and follow-up surveys, all veterans were administered the Patient Health Questionnaire-8 (PHQ-8) to assess depression severity, and veterans with a provisional diagnosis of posttraumatic stress disorder (PTSD) were also administered the PTSD Checklist for DSM-5 (PCL-5) to assess PTSD symptom severity. The 4-month follow-up survey also asked about perceived access using the Perceived Access Inventory, the number of encounters, and patient-centeredness of care using the Patient-Centered Care portion of the Veterans Satisfaction Survey. PRINCIPAL FINDINGS: Results indicated that compared to VCCP consults, veterans with CRH-MH consults reported 0.65 (CI95  = 0.51-0.83, p < 0.01) times the number of barriers to care, but a non-significant lower number of encounters (-0.792, CI95 -2.221, 0.636, p = 0.28). There was no significant (p = 0.24) difference in satisfaction with patient-centeredness, with both groups "agreeing" on average to positively worded questions. Veterans in both groups experienced little improvement in depression or PTSD symptom severity, and there were no clinically meaningful differences between groups. CONCLUSIONS: Overall findings indicate that the CRH-MH and VCCP generate similar patient-reported outcomes. Future research should compare the quality and cost of care delivered by the VCCP and CRH-MH programs.

Health System Approach to Improve Chronic Obstructive Pulmonary Disease Care after Hospital Discharge: Stepped-Wedge Clinical Trial.

Rationale: Patients discharged from the hospital for chronic obstructive pulmonary disease (COPD) exacerbation have impaired quality of life and frequent readmission and death. Clinical trials to reduce readmission demonstrate inconsistent results, including some demonstrating potential harms. Objectives: We tested whether a pragmatic proactive interdisciplinary and virtual review of patients discharged after hospitalization for COPD exacerbation would improve quality of life, using the Clinical COPD Questionnaire, and reduce all-cause 180-day readmission and/or mortality. Methods: We performed a stepped-wedge clinical trial. We enrolled primary care providers and their patients after hospital discharge for COPD at two Department of Veterans Affairs medical centers and 10 outpatient clinics. A multidisciplinary team reviewed health records and developed treatment recommendations delivered to primary care providers via E-consult. We facilitated uptake by entering recommendations as unsigned orders that could be accepted, modified, or canceled. Providers and patients made all final treatment decisions. Measurements and Main Results: We enrolled 365 primary care providers. Over a 30-month period, 352 patients met eligibility criteria, with 191 (54.3%) patients participating in the control and 161 (45.7%) in the intervention. The intervention led to clinically significant better Clinical COPD Questionnaire scores (-0.47; 95% confidence interval [CI], -0.85 to -0.09; 52.6% missing) but did not reduce 180-day readmission and/or mortality (adjusted odds ratio, 0.83; 95% CI, 0.49 to 1.38), in part because of wide CIs. Among the 161 patients in the intervention group, we entered 519 recommendations as unsigned orders, of which 401 (77.3%) were endorsed. Conclusions: A pragmatic health system-level intervention that delivered proactive specialty supported care improved quality of life but did not reduce 180-day readmission or death. Clinical trial registered with www.clinicaltrials.gov (NCT02021955).

Risk of Cardiovascular Disease Related to Smoking Is Greater Among Women With Sleep-Disordered Breathing.

STUDY OBJECTIVES: Although both sleep-disordered breathing (SDB) and smoking are associated with cardiovascular disease (CVD), the potential for an interactive effect on CVD risk has not been explored. Our objective was to determine if smoking-related risk for CVD rises with greater SDB severity. METHODS: Polysomnography and smoking history were obtained in 3,852 men and women in the Sleep Heart Health Study without baseline CVD. Fine-Gray proportional hazard models accounting for competing risk were used to calculate risk of incident CVD associated with SDB severity (defined by clinical cutoffs of the apnea-hypopnea index), smoking status (never, former, and current) and their interaction adjusting for potential confounders. RESULTS: Over a mean (standard deviation) follow-up period of 10.3 (3.4) years, there were 694 incident CVD events. We found a significant three-way interaction of sex, current smoking, and moderate to severe SDB (P = .039) in the adjusted proportional hazards model. In adjusted analyses, women who were current smokers with moderate to severe SDB had a hazard ratio for incident CVD of 3.5 (95% confidence interval 1.6-8.0) relative to women who were nonsmokers without SDB. No such difference in CVD risk was observed in men or women of other strata of smoking and SDB. CONCLUSIONS: In women, smoking-related risk for CVD is significantly higher among individuals with moderate to severe SDB.

Unhealthy alcohol use is associated with postoperative complications in veterans undergoing lung resection.

BACKGROUND: Lung resections carry a significant risk of complications necessitating the characterization of peri-operative risk factors. Unhealthy alcohol use represents one potentially modifiable factor. In this retrospective cohort study, the largest to date of lung resections in the Veterans Health Administration (VHA), we examined the association between unhealthy alcohol use and postoperative complications and mortality. METHODS: Veterans Affairs Surgical Quality Improvement Program data recorded at 86 medical centers between 2007 and 2011 were used to identify 4,715 patients that underwent lung resection. Logistic regression models, adjusted for demographics and comorbidities, were fit to assess the association between unhealthy alcohol use (report of >2 drinks per day in the 2 weeks preceding surgery) and 30-day outcomes. RESULTS: Among 4,715 patients that underwent pulmonary resection, 630 (13.4%) reported unhealthy alcohol use (>2 drinks/day). Overall, postoperative complications occurred in 896 (19.0%) patients, including pneumonia in 524 (11.1%). The rate of mortality was 2.6%. In adjusted analyses, complications were significantly more common among patients with unhealthy alcohol use [odds ratio (OR), 1.42; 95% confidence interval (CI), 1.15-1.74] including, specifically, pneumonia (OR, 1.69; 95% CI, 1.32-2.15). No statistically significant association was identified between unhealthy alcohol use and mortality (OR, 1.27; 95% CI, 0.75-2.02). In secondary analyses that stratified by smoking status at the time of surgery, drinking more than 2 drinks per day was associated with post-operative complications in patients reporting current smoking (OR, 1.51; 95% CI, 1.18-1.91) and was not identified in those reporting no current smoking at the time of surgery (OR, 1.23; 95% CI, 0.79-1.85). CONCLUSIONS: In this large VHA study, 13% of patients undergoing lung resection reported drinking more than 2 drinks per day in the preoperative period, which was associated with increased risk of post-operative complications. Unhealthy alcohol use may be an important target for perioperative risk-mitigation interventions, particularly in patients who report current smoking.

Sleep Disturbance in Smokers with Preserved Pulmonary Function and with Chronic Obstructive Pulmonary Disease.

RATIONALE: Sleep disturbance frequently affects patients with chronic obstructive pulmonary disease (COPD), and is associated with reduced quality of life and poorer outcomes. Data indicate that smokers with preserved pulmonary function have clinical symptoms similar to those meeting spirometric criteria for COPD, but little is known about the driving factors for sleep disturbance in this population of emerging interest. OBJECTIVES: To compare the magnitude and correlates of sleep disturbance between smokers with preserved pulmonary function and those with airflow obstruction. METHODS: Using cross-sectional data from the COPD Outcomes-Based Network for Clinical Effectiveness and Research Translation multicenter registry, we identified participants clinically identified as having COPD with a smoking history of at least 20 pack-years and either preserved pulmonary function or airflow obstruction. We quantified sleep disturbance by T-score measured in the sleep disturbance domain of the Patient-Reported Outcomes Information System questionnaire, and defined a minimum important difference as a T-score difference of two points. We performed univariate and multivariable linear regression to evaluate correlates within each group. RESULTS: We identified 100 smokers with preserved pulmonary function and 476 with airflow obstruction. The sleep disturbance T-score was 4.1 points greater among individuals with preserved pulmonary function (95% confidence interval [CI], 2.0-6.3). In adjusted analyses, depression symptom T-score was associated with sleep disturbance in both groups (airflow obstruction: ß, 0.61 points; 95% CI, 0.27-0.94; preserved pulmonary function: ß, 0.25 points; 95% CI, 0.12-0.38). Of note, lower percent predicted FEV1 was associated with greater sleep disturbance among those with preserved pulmonary function (ß, -0.19 points; 95% CI, -0.31 to -0.07), whereas higher FEV1 was associated with greater sleep disturbance among individuals with airflow obstruction (ß, 0.06 points; 95% CI, 0.01-0.10). CONCLUSIONS: Among smokers with clinically identified COPD, the severity of sleep disturbance is greater among those with preserved pulmonary function compared with those with airflow obstruction. Nonrespiratory symptoms, such as depression, were associated with sleep disturbance in both groups, whereas the relationship of sleep disturbance with FEV1 differed.