Lifestyle Intervention and Excess Weight in Chronic Obstructive Pulmonary Disease (COPD): INSIGHT COPD Randomized Clinical Trial.

Rationale: Being overweight or obese is common among patients with chronic obstructive pulmonary disease (COPD), but whether interventions targeted at weight loss improve functional impairments is unknown. Objectives: INSIGHT (Intervention Study in Overweight Patients with COPD) tested whether a pragmatic low-intensity lifestyle intervention would lead to better physical functional status among overweight or obese participants with COPD. Methods: The trial was a 12-month, multicenter, patient-level pragmatic clinical trial. Participants were recruited from April 2017 to August 2019 from 38 sites across the United States and randomized to receive usual care or usual care plus lifestyle intervention. The intervention was a self-directed video program delivering the Diabetes Prevention Program's Group Lifestyle Balance curriculum. Results: The primary outcome was 6-minute-walk test distance at 12 months. Priority secondary outcomes were postwalk modified Borg dyspnea at 12 months and weight at 12 months. Participants (N = 684; mean age, 67.0 ± 8.0 yr [standard deviation]; 41.2% female) on average were obese (body mass index, 33.0 ± 4.6 kg/m2) with moderate COPD (forced expiratory volume in 1 second % predicted, 58.1 ± 15.7%). At 12 months, participants randomized to the intervention arm walked farther (adjusted difference, 42.3 ft [95% confidence interval (CI), 7.9-76.7 ft]; P = 0.02), had less dyspnea at the end of the 6-minute-walk test (adjusted difference, -0.36 [95% CI, -0.63 to -0.09]; P = 0.008), and had greater weight loss (adjusted difference, -1.34 kg [95% CI, -2.33 to -0.34 kg]; P = 0.008) than control participants. The intervention did not improve the odds of achieving clinically meaningful thresholds of walk distance (98.4 ft) or dyspnea (1 unit) but did achieve meaningful thresholds of weight loss (3% and 5%). Conclusions: Among participants with COPD who were overweight or obese, a self-guided low-intensity video-based lifestyle intervention led to modest weight loss but did not lead to clinically important improvements in physical functional status and dyspnea. Clinical trial registered with www.clinicaltrials.gov (NCT02634268).

Effect of a Remotely Delivered Self-directed Behavioral Intervention on Body Weight and Physical Health Status Among Adults With Obesity: The D-ELITE Randomized Clinical Trial.

Importance: The effectiveness of remotely delivered, self-directed, weight loss programs in routine clinical practice is largely unknown. Objective: To test whether a self-directed, remotely administered behavioral lifestyle intervention improves weight and self-reported general health status compared with usual care. Design, Setting, and Participants: In this randomized clinical trial, 511 adults with a body mass index (BMI) of 30 or more and less than 45 (based on electronic health record [EHR] weight and height), were enrolled from 30 Veterans Health Administration (VHA) sites between February 15, 2018, and December 18, 2018 (final follow-up February 18, 2021). Interventions: Participants were randomly assigned to the intervention group (n = 254) or the control group (n = 257). Both received usual care. Participants randomized to the intervention received Diabetes Prevention Program-based self-directed videos, handouts, and coaching messages via an online platform or US mail for 12 months. Main Outcomes and Measures: Coprimary outcomes were weight measured in primary care and recorded in the EHR and self-reported general health status using the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12) physical component score (PCS; higher scores are better [range, 0-100]) at the 12-month follow-up. The between-group minimal clinically important differences are 3 kg for weight and 5 points for the SF-12 PCS. Linear mixed models used weights and SF-12 PCS measured at either time point, with participants analyzed according to randomization assignment. Statistical significance for each coprimary outcome was based on a 2-sided α level of .025. Results: Among 511 participants randomized (mean age, 57.4 [SD, 13.9] years; 231 female [45%]), 429 (84.0%) had EHR-based weights and 410 (80.2%) had SF-12 PCS data at 12 months. The unadjusted mean weight at 12 months declined from 102.7 kg to 99.8 kg in the intervention group compared with 101.9 kg to 101.0 kg in the control group (adjusted between-group mean difference, -1.93 [97.5% CI, -3.24 to -0.61]; P = .001). At 12 months, the unadjusted mean SF-12 PCS scores declined from 44.8 to 44.3 among intervention participants compared with 44.5 to 43.2 among control participants (adjusted between-group mean difference, intervention minus control, 0.69 [97.5% CI, -1.11 to 2.49]; P = .39). Cardiovascular events represented the highest percentage of serious adverse events, accounting for 25% of events in the intervention group and 35% in the control group. Conclusions and Relevance: Among adults with obesity, a remotely delivered self-directed, behavioral lifestyle intervention, compared with usual care, resulted in statistically significantly greater weight loss at 12 months, although the difference was not clinically important. There was no significant difference in self-reported general physical health status at 12 months. Trial Registration: ClinicalTrials.gov Identifier: NCT03260140.

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.

Deploying a telemedicine collaborative care intervention for posttraumatic stress disorder in the U.S. Department of Veterans Affairs: A stepped wedge evaluation of an adaptive implementation strategy.

OBJECTIVE: To address barriers to trauma-focused psychotherapy for veterans with posttraumatic stress disorder (PTSD), we compared two implementation strategies to promote the deployment of telemedicine collaborative care. METHOD: We conducted a Hybrid Type III Effectiveness Implementation trial at six VA medical centers and their 12 affiliated Community Based Outpatient Clinics. The trial used a stepped wedge design and an adaptive implementation strategy that started with standard implementation, followed by enhanced implementation for VA medical centers that did not achieve the performance benchmark. Implementation outcomes for the 544 veterans sampled from the larger population targeted by the intervention were assessed from chart review (care management enrollment and receipt of trauma-focused psychotherapy) and telephone survey (perceived access and PTSD symptoms) after each implementation phase. The primary outcome was enrollment in care management. RESULTS: There was no significant difference between standard implementation and enhanced implementation on any of the implementation outcomes. 41.6% of sampled veterans had a care manager encounter, but only 6.0% engaged in trauma-focused psychotherapy. CONCLUSIONS: While telemedicine collaborative care was shown to be effective at engaging veterans in trauma-focused psychotherapy in a randomized controlled trial, neither standard nor enhanced implementation strategies were sufficient to support successful deployment into routine care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02737098.

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).

Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.

Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate due to factors like distance and preferences, mirroring barriers in the general population. Practical alternatives to standard in-person programs are needed to improve access and engagement. A self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious in a general primary care population, may provide such an alternative. This pragmatic clinical trial will evaluate whether D-ELITE improves weight and general health status among Veterans with obesity, relative to VA usual care. The yearlong intervention includes one orientation by phone, supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions over 3 months, and continued self-directed weight management for months 4-12. Participants use MyFitnessPal.com or paper booklets for self-monitoring weight, diet, and physical activity. Follow-up assessments at 12 and 24 months are administered by mail or phone. The study hypothesis is that compared with usual care, D-ELITE will lead to greater improvements in 12-month weight loss, per VA electronic health records, and general physical health status, assessed using the self-reported SF-12 physical composite score. We will also explore D-ELITE's effects on secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact. If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.

Symptom Burden and Palliative Care Needs Among High-Risk Veterans With Multimorbidity.

CONTEXT: Palliative care research has focused on patients with disease-specific conditions. However, older patients with multimorbidity may have unmet palliative care needs. OBJECTIVES: We assessed symptom burden and quality of life among veterans with multimorbidity and sought to determine if their bothersome symptoms were addressed and treated in the primary care setting. We sought to identify specific diagnoses that may account for greater symptom burden. We hypothesized that patients with a higher number of diagnoses would experience greater symptom burden and poorer quality of life. METHODS: We identified veterans at high risk of hospitalization or death using a validated prognostic model. We administered cross-sectional surveys via telephone, The Memorial Symptom Assessment Scale-Short Form and Veterans RAND 12, to randomly selected patients in primary care in the VA Health Care System from May to December 2015. We assessed if their most bothersome symptom was addressed and treated during their most recent visit. Regression models identified specific diagnoses accounting for greater symptom burden and patient predictors of high symptom burden and poor quality of life. RESULTS: Patients (n = 503) reported (10.6 ± 5.5) active symptoms and poor physical quality of life. Patients reported pain and dyspnea as their most bothersome symptoms (n = 145 [29%] and n = 57 [11%], respectively). Most patients acknowledged their clinicians assessed (n = 348 [74%]) and treated (n = 330 [70%]) their most bothersome symptom. Physical symptoms (78%, P < 0.0001) were more likely to be addressed than psychological symptoms (55%, P < 0.001). Patients diagnosed with obesity or depression experienced greater physical symptom burden. Younger patients reported greater symptom severity than older patients (P < 0.01). Younger patients and those with greater multimorbidities reported lower self-perceived quality of health than older patients and those with fewer multimorbidities (P = 0.01 and P < 0.01, respectively). CONCLUSION: Outpatients with multimorbidity have high symptom burden, unaddressed symptoms, poor quality of life, and unmet palliative care needs. Our findings support standardization of comprehensive symptom assessment and management in primary care for veterans with multimorbidities, which may ameliorate symptoms and improve quality of life.

Clinical presentations, social functioning, and treatment receipt among individuals with comorbid life-time PTSD and alcohol use disorders versus drug use disorders: findings from NESARC-III.

AIMS: To compare individuals with comorbid life-time post-traumatic stress disorder (PTSD) and alcohol use disorders [AUD; i.e. no drug use disorders (DUD)] with those with comorbid PTSD and DUD on past-year prevalence of these disorders, social functioning, life-time psychiatric comorbidities, and treatment receipt. The comorbid groups were also compared with their single diagnosis counterparts. DESIGN AND SETTING: Cross-sectional cohort study using data from the National Epidemiologic Survey of Alcohol and Related Conditions (NESARC-III). PARTICIPANTS: The total sample size was 36 309. Six groups were established: PTSD/AUD, PTSD/DUD, AUD, DUD, PTSD, and neither PTSD nor AUD/DUD. Life-time prevalence of AUD among those with PTSD/DUD was 80.2% and among those with DUD was 73.8%. MEASUREMENTS: The Alcohol Use Disorder and Associated Disabilities Interview Schedule-DSM-5 version assessed life-time and past-year psychiatric disorders and treatment receipt. Demographics and social stability indicators were queried. Group characteristics were summarized using weighted means. Prevalences and estimates for adjusted differences in means and adjusted odds ratios (aORs) were derived from multiple linear regression and logistic regression models, respectively. Analyses were conducted in R and accounted for the NESARC-III's complex survey design, clustering, and non-response. FINDINGS: Compared with those with life-time PTSD/AUD, those with life-time PTSD/DUD were significantly less likely to have neither disorder in the past year (PTSD/AUD = 16.1%; PTSD/DUD = 8.5%; aOR = 0.54), and were more likely to report worse social and psychiatric functioning, and to have received both addiction and mental health treatment (PTSD/AUD = 18.4%; PTSD/DUD = 43.2%; aOR = 3.88). Compared with their single disorder counterparts, those with PTSD/DUD reported greater impairment than both groups, whereas the comorbid PTSD/AUD group differed more from the AUD than the PTSD group. CONCLUSIONS: People with comorbid PTSD and drug use disorder have greater social and psychiatric impairment and may require different types and intensity of intervention than people with comorbid post-traumatic stress disorder and alcohol use disorder.

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.

A tutorial in assessing disclosure risk in microdata.

Statistical agencies are releasing statistical data to other agencies for research purposes or to inform public policy. Prior to data release, these agencies have a legal and ethical obligation to protect the confidentiality of individuals in the data. Agencies often release altered versions of the data, but there usually remains risks of disclosure. Many well-studied risk measures are available to assess risk; however, many agencies today continue to use subjective judgement, past experience, and ad hoc rules or checklists to assess disclosure risk. More recently, there has been a recognized demand for quantitative risk measures that provide a more objective criteria for data release. This tutorial provides an overview of the statistical disclosure control framework for microdata. We focus on the risk analysis stage within this framework by defining existing disclosure risk measures and how to estimate them with available software.

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.