Supporting Evidence-based Responses to Emotional Needs in Emphysema (SERENE): protocol for a randomized, open-label mechanistic trial comparing Coping Skills Training and disease-specific education for depressive symptoms conducted in United States health systems

Trials · 2026-02-25

BACKGROUND: Depressive symptoms and anxiety are highly prevalent among people with chronic obstructive pulmonary disease (COPD), strongly associated with poor outcomes, and rarely recognized or treated. Integrating families into interventions may amplify supportive care treatment effects and overcome common challenges, yet this strategy is understudied. The Supporting Evidence-based Responses to Emotional Needs in Emphysema (SERENE) trial's main objective is to identify the mechanisms through which a family-partnered Coping Skills Training (CST) reduces depressive symptoms among patients with COPD, testing five putative mechanisms: family relationship quality, patient and caregiver self-efficacy, patient loneliness, and caregiver psychological distress. METHODS: SERENE will enroll 375 patient-support person (i.e., family caregiver) dyads from two academic health systems. Eligible patients have documented COPD, elevated levels of depressive symptoms (i.e. PHQ-8 scores ≥ 8), and age ≥ 18 years old. Ineligible participants are those with new or changing behavioral health treatments or behavioral health emergencies. After enrollment by research staff, we randomize dyads in a 2:1 ratio to receive either a 12-week CST program or a 12-week COPD education program, respectively. Both are delivered to the dyads via phone or videoconferencing sessions and, therefore, arm assignment is not blinded to staff nor participants. We will test whether randomization to receipt of CST leads to improvements in patients' depressive symptoms and test mechanisms of efficacy. The primary efficacy outcome is PHQ-9 scores 14 weeks following enrollment. Our five putative mechanisms, corresponding to those previously specified, are measured with the Family Emotional Involvement and Criticism Scale, the General Self-efficacy Scale, the UCLA Loneliness Scale, the PHQ-9, and the Generalized Anxiety Disorder-7. We will measure secondary outcomes through 12 months. Those performing data analyses will remain blinded to group assignments at the individual level until completion of the primary analyses. The study team identifies and reports serious adverse events (i.e., suicidal behaviors or psychiatric hospitalizations). DISCUSSION: SERENE will determine how scalable supportive care interventions that strengthen existing social networks, including the crucial support of family caregivers, improve outcomes in COPD. The results will lay the foundation for paradigm-shifting approaches to managing COPD and similar illnesses through family-directed supportive care interventions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT06600126. Registered 6 September 2024, https://clinicaltrials.gov/study/NCT06600126 . The first enrollment occurred on 30 September 2024.

A Qualitative Study Identifying the Potential Risk Mechanisms Leading to Hospitalization for Patients With Chronic Lung Disease

CHEST Pulmonary · 2024-05-03 · 2 citations

BACKGROUND: Care management programs for chronic lung disease attempt to reduce hospitalizations, yet have not reliably achieved this goal. A key limitation of many programs is that they target patients with characteristics associated with hospitalization risk, but do not specifically modify the mechanisms that lead to hospitalization. RESEARCH QUESTION: What are the common mechanisms underlying known patient-level risk characteristics leading to hospitalizations for acute exacerbations of chronic lung disease? STUDY DESIGN AND METHODS: We conducted a qualitative study of patients admitted to the University of Pennsylvania Health System with acute exacerbations of chronic lung disease between January and September 2019. We interviewed patients, their family caregivers, and their inpatient and outpatient clinicians about experiences leading up to the hospitalization. We analyzed the interview transcripts using triangulation and abductive analytic methods. RESULTS: We conducted 69 interviews focused on the admission of 22 patients with a median age of 66 years (interquartile range, 60-70 years), of whom 16 patients (73%) were female and 14 patients (64%) were Black. We interviewed 22 patients, 14 caregivers, 19 inpatient clinicians, and 14 outpatient clinicians. We triangulated the available interview data for each patient admission and identified the underlying mechanisms of how several known patient characteristics associated with risk actually led to hospitalization. These mechanisms included limited capacity for home management of acute symptom changes, barriers to accessing care, chronic functional limitations, and comorbid behavioral health disorders. Importantly, many of the clinical, social, and behavioral mechanisms underlying hospitalizations were present for months or years before the symptoms that prompted inpatient care. INTERPRETATION: Care management programs should be built to target specific clinical, social, and behavioral mechanisms that directly lead to hospitalization. Upstream interventions that reduce hospitalization risk are possible given that many contributory mechanisms are present for months or years before the onset of acute exacerbations.

Development and validation of a prediction model for actionable aspects of frailty in the text of clinicians’ encounter notes

Journal of the American Medical Informatics Association · 2021-10-28 · 16 citations

OBJECTIVE: Frailty is a prevalent risk factor for adverse outcomes among patients with chronic lung disease. However, identifying frail patients who may benefit from interventions is challenging using standard data sources. We therefore sought to identify phrases in clinical notes in the electronic health record (EHR) that describe actionable frailty syndromes. MATERIALS AND METHODS: We used an active learning strategy to select notes from the EHR and annotated each sentence for 4 actionable aspects of frailty: respiratory impairment, musculoskeletal problems, fall risk, and nutritional deficiencies. We compared the performance of regression, tree-based, and neural network models to predict the labels for each sentence. We evaluated performance with the scaled Brier score (SBS), where 1 is perfect and 0 is uninformative, and the positive predictive value (PPV). RESULTS: We manually annotated 155 952 sentences from 326 patients. Elastic net regression had the best performance across all 4 frailty aspects (SBS 0.52, 95% confidence interval [CI] 0.49-0.54) followed by random forests (SBS 0.49, 95% CI 0.47-0.51), and multi-task neural networks (SBS 0.39, 95% CI 0.37-0.42). For the elastic net model, the PPV for identifying the presence of respiratory impairment was 54.8% (95% CI 53.3%-56.6%) at a sensitivity of 80%. DISCUSSION: Classification models using EHR notes can effectively identify actionable aspects of frailty among patients living with chronic lung disease. Regression performed better than random forest and neural network models. CONCLUSIONS: NLP-based models offer promising support to population health management programs that seek to identify and refer community-dwelling patients with frailty for evidence-based interventions.

Identifying Actionable Aspects of Frailty in the Text of Encounter Notes.

AMIA · 2020-01-01

1711: MULTIORGAN DYSFUNCTION SYNDROME IN A TRACK ATHLETE WITH SCT: ROLE OF PLASMAPHERESIS AND RBC EXCHANGE

Critical Care Medicine · 2016-11-16

Bhardwaj, Abhishek; Matthias, Isaac; Lam, Jason; Bonk, Michael; Malsin, Elizabeth; Mikkelsen, Mark; Sims, Michael; Gay, Roy

Acute Respiratory Failure Due to Chronic Obstructive Pulmonary Disease

Elsevier eBooks · 2014-01-01 · 1 citations

Surfactant Dysfunction and Lung Inflammation in the Female Mouse Model of Lymphangioleiomyomatosis

American Journal of Respiratory Cell and Molecular Biology · 2014-12-04 · 21 citations

Pulmonary lymphangioleiomyomatosis (LAM) is a rare lung disease caused by mutations of the tumor suppressor genes, tuberous sclerosis complex (TSC) 1 or TSC2. LAM affects women almost exclusively, and it is characterized by neoplastic growth of atypical smooth muscle-like TSC2-null LAM cells in the pulmonary interstitium, cystic destruction of lung parenchyma, and progressive decline in lung function. In this study, we hypothesized that TSC2-null lesions promote a proinflammatory environment, which contributes to lung parenchyma destruction. Using a TSC2-null female murine LAM model, we demonstrate that TSC2-null lesions promote alveolar macrophage accumulation, recruitment of immature multinucleated cells, an increased induction of proinflammatory genes, nitric oxide (NO) synthase 2, IL-6, chemokine (C-C motif) ligand 2 (CCL2)/monocyte chemotactic protein 1 (MCP1), chemokine (C-X-C motif) ligand 1 (CXCL1)/keratinocyte chemoattractant (KC), and up-regulation of IL-6, KC, MCP-1, and transforming growth factor-β1 levels in bronchoalveolar lavage fluid. Bronchoalveolar lavage fluid also contained an increased level of surfactant protein (SP)-D, but not SP-A, significant reduction of SP-B levels, and a resultant increase in alveolar surface tension. Consistent with the growth of TSC2-null lesions, NO levels were also increased and, in turn, modified SP-D through S-nitrosylation, forming S-nitrosylated SP-D, a known consequence of lung inflammation. Progressive growth of TSC2-null lesions was accompanied by elevated levels of matrix metalloproteinase-3 and -9. This report demonstrates a link between growth of TSC2-null lesions and inflammation-induced surfactant dysfunction that might contribute to lung destruction in LAM.

Aerosol Therapy for Obstructive Lung Diseases

CHEST Journal · 2011-09-01 · 32 citations

Effect of Single vs Bilateral Lung Transplantation on Plasma Surfactant Protein D Levels in Idiopathic Pulmonary Fibrosis

CHEST Journal · 2011-02-24 · 18 citations

Profile of aclidinium bromide in the treatment of chronic obstructive pulmonary disease

International Journal of COPD · 2011-09-01 · 18 citations

Bronchodilators provide the mainstay of pharmacologic therapy for chronic obstructive pulmonary disease (COPD), and anticholinergic bronchodilators, in particular, appear to be the most effective. There are currently two anticholinergic agents available in the US for the treatment of COPD (ipratropium bromide and tiotropium bromide), but several others are in various stages of development. Aclidinium bromide, a novel, long-acting, anticholinergic bronchodilator, is currently in Phase III trials for the management of COPD. Available evidence suggests that aclidinium is a safe and well tolerated drug with a relatively rapid onset and a sufficient duration of action to provide once-daily dosing. This article will provide a pharmacologic profile of aclidinium bromide and review the preclinical and clinical studies evaluating its safety and efficacy in the treatment of COPD.