Test-Retest Reliability of the Verran Professional Governance Scale©.

Background and Purpose: Stability testing, conducted using a test-retest protocol, measures an instrument's reliability by evaluating the consistency of participant responses to survey questions with repeated testing within a short interval. No studies have measured the stability of the Verran Professional Governance Scale© (VPGS). The purpose of this study was to evaluate the test-retest reliability of the VPGS. Methods: Volunteers from a parent study using the VPGS were sent a link to a retest version of the survey 14 days after taking the initial survey with a reminder email sent 5 days after the first request. Item-level and subscale comparisons were made between participants' initial and retest responses using intraclass correlation coefficients (ICCs) applying a two-way random-effects model. Results: VPGS subscales had ICC scores of 0.71 for decision-making, 0.73 for collateral relationships, and 0.86 for professional obligation. Conclusions: Findings suggest that the VPGS demonstrates test-retest reliability. Future research should evaluate the instrument's responsiveness.

Testing of a novel questionnaire of Household Exposure to Wood Smoke.

Household air pollution from wood smoke (WS), contributes to adverse health effects in both low- and high-income countries. However, measurement of WS exposure has been limited to expensive in-home monitoring and lengthy face-to-face interviews. This paper reports on the development and testing of a novel, self-report nine-item measure of WS exposure, called the Household Exposure to Wood Smoke (HEWS). A sample of 149 individuals using household wood stoves for heating from western states in the U.S., completed the HEWS during the winter months (November to March) of 2013 through 2016 with 30 subjects having in-home particle monitoring. Hard copy or online surveys were completed. Cronbach's alpha (α), intraclass correlations (ICC), exploratory factor analysis (EFA) and tests of associations were done to evaluate reliability and validity of the HEWS. Based on initial analysis, only 9 of the 12 items were retained and entered in the EFA. The EFA did not support a unitary scale as the 9 items demonstrated a 3-factor solution (WS exposure duration, proximity, and intensity) with Cronbach's α of 0.79, 0.91, and 0.62, respectively. ICC was 0.86 of the combined items with single items ranging from 0.46 to 0.95. WS intensity was associated with symptoms and levoglucosan levels, while WS duration was associated with stove and flume maintenance. The three-dimensional HEWS demonstrated internal consistency and test-retest reliability, structural validity, and initial criterion and construct validity.

Cleaning the Flue in Wood-Burning Stoves Is a Key Factor in Reducing Household Air Pollution.

In experimental settings, replacing old wood stoves with new wood stoves results in reduced personal exposure to household air pollution. We tested this assumption by measuring PM2.5 and levoglucosan concentrations inside homes and correlated them with wood stove age. Methods: Thirty homes in the Albuquerque, NM area were monitored over a seven-day period using in-home particulate monitors placed in a common living area during the winter months. Real-time aerosol monitoring was performed, and filter samples were analyzed gravimetrically to calculate PM2.5 concentrations and chemically to determine concentrations of levoglucosan. A linear regression model with backward stepwise elimination was performed to determine the factors that would predict household air pollution measures. Results: In this sample, 73.3% of the households used wood as their primary source of heating, and 60% burned daily or almost daily. The mean burn time over the test week was 50 ± 38 h, and only one household burned wood 24/day (168 h). The average PM2.5 concentration (standard deviation) for the 30 homes during the seven-day period was 34.6 µg/m3 (41.3 µg/m3), and median (min, max) values were 15.5 µg/m3 (7.3 µg/m3, 193 µg/m3). Average PM2.5 concentrations in 30 homes ranged from 0−15 µg/m3 to >100 µg/m3. Maximum PM2.5 concentrations ranged from 100−200 µg/m3 to >3000 µg/m3. The levoglucosan levels showed a linear correlation with the total PM2.5 collected by the filters (R2 = 0.92). However, neither mean nor peak PM2.5 nor levoglucosan levels were correlated with the age (10.85 ± 8.54 years) of the wood stove (R2 ≤ 0.07, p > 0.23). The final adjusted linear regression model showed that average PM2.5 was associated with reports of cleaning the flue with a beta estimate of 35.56 (3.47−67.65) and R2 = 0.16 (p = 0.04). Discussion: Cleaning the flue and not the wood stove age was associated with household air pollution indices. Education on wood stove maintenance and safe burning practices may be more important in reducing household air pollution than the purchase of new stoves.

Wood smoke exposure affects lung aging, quality of life, and all-cause mortality in New Mexican smokers.

BACKGROUND: The role of wood smoke (WS) exposure in the etiology of chronic obstructive pulmonary disease (COPD), lung cancer (LC), and mortality remains elusive in adults from countries with low ambient levels of combustion-emitted particulate matter. This study aims to delineate the impact of WS exposure on lung health and mortality in adults age 40 and older who ever smoked. METHODS: We assessed health impact of self-reported "ever WS exposure for over a year" in the Lovelace Smokers Cohort using both objective measures (i.e., lung function decline, LC incidence, and deaths) and two health related quality-of-life questionnaires (i.e., lung disease-specific St. George's Respiratory Questionnaire [SGRQ] and the generic 36-item short-form health survey). RESULTS: Compared to subjects without WS exposure, subjects with WS exposure had a more rapid decline of FEV1 (- 4.3 ml/s, P = 0.025) and FEV1/FVC ratio (- 0.093%, P = 0.015), but not of FVC (- 2.4 ml, P = 0.30). Age modified the impacts of WS exposure on lung function decline. WS exposure impaired all health domains with the increase in SGRQ scores exceeding the minimal clinically important difference. WS exposure increased hazard for incidence of LC and death of all-cause, cardiopulmonary diseases, and cancers by > 50% and shortened the lifespan by 3.5 year. We found no evidence for differential misclassification or confounding from socioeconomic status for the health effects of WS exposure. CONCLUSIONS: We identified epidemiological evidence supporting WS exposure as an independent etiological factor for the development of COPD through accelerating lung function decline in an obstructive pattern. Time-to-event analyses of LC incidence and cancer-specific mortality provide human evidence supporting the carcinogenicity of WS exposure.

Burnout of the US midwifery workforce and the role of practice environment.

OBJECTIVES: To determine the prevalence of burnout among the midwifery workforce and the association between fixed personal and practice characteristics and modifiable organizational factors, specifically practice environment, to burnout among midwives in the United States. DATA SOURCE: Primary data collection was conducted via an online survey of the complete national roster of certified nurse-midwives and certified midwives over 3 weeks in April 2017. STUDY DESIGN: The study was a cross-sectional observational survey consisting of 95 items about personal and practice characteristics, respondents' practice environments, and professional burnout. DATA COLLECTION METHODS: The inclusion criterion was actively practicing midwifery in the United States. Data were analyzed with bivariate analyses to determine the association between personal and practice characteristics and burnout. A hierarchal multilinear regression evaluated the interrelationship between personal and practice characteristics, practice environment, and burnout. PRINCIPAL FINDINGS: Of the almost one third (30.9%) of certified nurse-midwives and certified midwives who responded to the survey, 40.6% met criteria for burnout. Weak negative correlations existed between burnout and indicators of career longevity: age (r(2256) = -0.09, p < 0.01), years as a midwife (r(2267) = -0.07, p = 0.01), and years with employer (r(2271) = -0.05, p = 0.02). There were significant relationships between burnout score and patient workload indicators: patients per day in outpatient setting (F(5,2292) = 13.995, p < 0.01), birth volume (F(3,1864) = 8.35, p < 0.01), and patient acuity (F(2,2295) = 20.21, p < 0.01). When the practice environment was entered into the model with personal and practice characteristics, the explained variance increased from 6.4% to 26.5% (F(20,1478) = 27.98, p < 0.01). CONCLUSIONS: Our findings suggested that a key driver of burnout among US midwives was the practice environment, specifically practice leadership and participation and support for the midwifery model of care. Structural and personal characteristics contributed less to burnout score than the practice environment, implying that prevention of burnout may be achieved through organizational support and does not require structural changes to the provision of perinatal health.

Stress and Coping Among Family Caregivers of Patients With a Destination Therapy Left Ventricular Assist Device: A Multicenter Mixed Methods Study.

BACKGROUND: Family caregivers of patients with a destination therapy left ventricular assist device play a central and formalized role in postimplant care. We aimed to characterize longitudinal stress, predictors and correlates of stress, and coping processes among left ventricular assist device caregivers. METHODS: We performed a sequential, exploratory, mixed-methods study from 6 diverse left ventricular assist device programs. The primary outcome for the quantitative analysis was the Perceived Stress Scale-10 at 6 months (0-40). Based on the quantitative findings and guided by the Transactional Model of Stress and Coping, semistructured interviews explored causes of stress and coping processes. Integration was performed during the qualitative and interpretation phase. RESULTS: A total of 96 caregivers met inclusion criteria for quantitative analysis. Mean (SD) Perceived Stress Scale score was 14.3 (5.5) preimplant and 11.8 (6.9) at 6 months. Preimplant, only decreased preparedness for caregiving was associated with higher Perceived Stress Scale score at 6 months. At 6 months, increased caregiver depressive symptoms, decreased caregiver preparedness for caregiving, and lower patient quality of life were associated with higher Perceived Stress Scale score. Qualitative analysis of 25 caregivers revealed the causes of stress coalesced around 3 themes: (1) lack of preparedness to be a caregiver, (2) uniqueness of stress for the caregiver and patient situation, and (3) caregiving responsibilities physically and emotionally impacting caregivers. To cope with stress, most caregivers employed emotion-focused coping. CONCLUSIONS: In family caregivers of patients with a left ventricular assist device, higher perceived stress was associated with lower caregiver preparedness, higher caregiver depressive symptoms, and lower patient quality of life. Emotion-focused coping strategies were common for caregivers. Future work should better prepare caregivers for this role and support them through the caregiving experience. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02344576.

Patient-centered Outcomes Research in Interstitial Lung Disease: An Official American Thoracic Society Research Statement.

Background: In the past two decades, many advances have been made to our understanding of interstitial lung disease (ILD) and the way we approach its treatment. Despite this, many questions remain unanswered, particularly those related to how the disease and its therapies impact outcomes that are most important to patients. There is currently a lack of guidance on how to best define and incorporate these patient-centered outcomes in ILD research. Objectives: To summarize the current state of patient-centered outcomes research in ILD, identify gaps in knowledge and research, and highlight opportunities and methods for future patient-centered research agendas in ILD. Methods: An international interdisciplinary group of experts was assembled. The group identified top patient-centered outcomes in ILD, reviewed available literature for each outcome, highlighted important discoveries and knowledge gaps, and formulated research recommendations. Results: The committee identified seven themes around patient-centered outcomes as the focus of the statement. After a review of the literature and expert committee discussion, we developed 28 research recommendations. Conclusions: Patient-centered outcomes are key to ascertaining whether and how ILD and interventions used to treat it affect the way patients feel and function in their daily lives. Ample opportunities exist to conduct additional work dedicated to elevating and incorporating patient-centered outcomes in ILD research.

Home-Based Palliative Care: Perspectives of Chronic Obstructive Pulmonary Disease Patients and Their Caregivers.

BACKGROUND: Home-based palliative care (HBPC) is an important aspect of care for patients with moderate to advanced stages of chronic obstructive pulmonary disease (COPD) and their caregivers. HBPC provides symptom management, advanced care planning and goals of care conversations in the home, with the goal of maximizing quality of life and minimizing health care utilization. There is a gap in the knowledge of how the patients with COPD and their caregivers experience HBPC. The overall purpose of this study is to describe which aspects of HBPC were the most meaningful to patients with COPD, and their caregivers. METHODS: Through a descriptive design with narrative analysis methodology, we interviewed COPD patients and their caregivers to investigate their experience of HBPC received in the 30 days post hospitalization for a COPD exacerbation. A thematic analysis was conducted and the patient and caregiver interviews were analyzed in dyad using thematic analysis. RESULTS: A total of 10 dyads were interviewed. Patients and their caregivers perceived 3 times as many facilitators as barriers of receiving home-based palliative care in the 30 days post hospitalization for a COPD exacerbation. The outcomes of this study provide information that describes the aspects of HBPC that patients and their caregivers found most meaningful. CONCLUSION: An understanding of the most meaningful aspects of HBPC from the perspectives of the patients with COPD and their caregivers can be used to inform the development of the best model for HBPC for this patient population.

Pharmacologic Management of Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline.

Background: This document provides clinical recommendations for the pharmacologic treatment of chronic obstructive pulmonary disease (COPD). It represents a collaborative effort on the part of a panel of expert COPD clinicians and researchers along with a team of methodologists under the guidance of the American Thoracic Society.Methods: Comprehensive evidence syntheses were performed on all relevant studies that addressed the clinical questions and critical patient-centered outcomes agreed upon by the panel of experts. The evidence was appraised, rated, and graded, and recommendations were formulated using the Grading of Recommendations, Assessment, Development, and Evaluation approach.Results: After weighing the quality of evidence and balancing the desirable and undesirable effects, the guideline panel made the following recommendations: 1) a strong recommendation for the use of long-acting ß2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) combination therapy over LABA or LAMA monotherapy in patients with COPD and dyspnea or exercise intolerance; 2) a conditional recommendation for the use of triple therapy with inhaled corticosteroids (ICS)/LABA/LAMA over dual therapy with LABA/LAMA in patients with COPD and dyspnea or exercise intolerance who have experienced one or more exacerbations in the past year; 3) a conditional recommendation for ICS withdrawal for patients with COPD receiving triple therapy (ICS/LABA/LAMA) if the patient has had no exacerbations in the past year; 4) no recommendation for or against ICS as an additive therapy to long-acting bronchodilators in patients with COPD and blood eosinophilia, except for those patients with a history of one or more exacerbations in the past year requiring antibiotics or oral steroids or hospitalization, for whom ICS is conditionally recommended as an additive therapy; 5) a conditional recommendation against the use of maintenance oral corticosteroids in patients with COPD and a history of severe and frequent exacerbations; and 6) a conditional recommendation for opioid-based therapy in patients with COPD who experience advanced refractory dyspnea despite otherwise optimal therapy.Conclusions: The task force made recommendations regarding the pharmacologic treatment of COPD based on currently available evidence. Additional research in populations that are underrepresented in clinical trials is needed, including studies in patients with COPD 80 years of age and older, those with multiple chronic health conditions, and those with a codiagnosis of COPD and asthma.

"Connection": The Integration of a Person-Centered Narrative Intervention into the Electronic Health Record: An Implementation Study.

Background: Incorporating patient narratives into the electronic health record (EHR) is an opportunity to integrate patients' values and beliefs into their care and improve patient-clinician communication. Objective: The study's aims were to (1) identify barriers and facilitators influencing the implementation of a cocreated patient narrative intervention and (2) assess the acceptability/usability of the patient's narrative from the perspective of key stakeholders-the patient and acute care bedside nurse. Design: We used an implementation design using mixed methods. Setting/Subjects: Twenty patients and 18 nurses were enrolled from five units in an acute care hospital. Results: For patients, the narrative intervention provided an avenue to discuss and share how illness has impacted their life in psychological, social, and spiritual belief domains. For nurses, the ability to read the patient's narrative provided benefits that fostered improved communication and more connection with their patients. Despite successfully meeting recruitment targets, time was the largest barrier for patient and nurse participants. Overall, the nurse participants gave high ratings on most of the items on the System Usability Scale with one exception-EHR integration. The lack of EHR integration on the System Usability Survey corresponds with the nurses' stated desire for a prominent location of patient narratives in the EHR. Conclusions: The patient narrative intervention was acceptable and usable for hospitalized patients and nurse participants. Our study demonstrates that a cocreated patient narrative intervention provides avenues for patients and nurses to connect despite being in hectic acute care settings. Trial Registration: ClinicalTrials.gov NCT03391115.

Feasibility of a Telemedicine-Delivered Cognitive Behavioral Therapy for Insomnia in Rural Breast Cancer Survivors.

OBJECTIVES: To evaluate a nurse-led, telemedicine-delivered cognitive behavioral therapy for insomnia (CBTI) in rural breast cancer survivors (BCSs). SAMPLE & SETTING: 18 BCSs diagnosed with stage I-III breast cancer in the rural western United States. METHODS & VARIABLES: In this prospective, pre-/post-test, quasiexperimental feasibility pilot trial, BCSs attended six weekly sessions of CBTI via Internet videoconference. Feasibility was assessed using recruitment and acceptability of the intervention. Primary outcomes were diary-based sleep efficiency (SE), sleep latency (SL), total sleep time, wake after sleep onset, and number of nightly awakenings; secondary outcomes included quality of life (QOL), mental health, and daily functioning. RESULTS: Following the intervention, participants reported improvements in sleep outcomes, including SE and SL. QOL and daily functioning improved, but anxiety and depression did not. IMPLICATIONS FOR NURSING: Nurse-led, telemedicine-delivered CBTI for rural BCSs is feasible and may be effective in managing insomnia. Additional research is needed to determine widespread effectiveness and best practices for dissemination and implementation.

Chronic Obstructive Pulmonary Disease Education in Pulmonary Rehabilitation. An Official American Thoracic Society/Thoracic Society of Australia and New Zealand/Canadian Thoracic Society/British Thoracic Society Workshop Report.

According to the 2013 American Thoracic Society/European Respiratory Society statement on pulmonary rehabilitation (PR), education to promote effective self-management is a cornerstone of this intervention. Despite education's stature within PR, there is currently limited evidence supporting its overall efficacy, and minimal evidence guiding its optimal design and delivery. This workshop was convened to focus on the current state of education in PR for patients with chronic obstructive pulmonary disease, who are the most common people referred to PR. The workshop explored the learning needs and limitations of patients participating in PR, promising design features (from work done outside of PR) that may inform our approach to education, and professional development of PR healthcare educators. Areas identified as needing development include: 1) outcome assessment for the educational component; 2) screening patients for conditions that will impede the learning process (anxiety, depression, cognitive deficits and health literacy issues); 3) tailoring content and optimizing delivery of the educational component; and 4) training PR professionals in their roles as educators. By necessity, the workshop conclusions are painted in broad strokes. However, with ongoing interest in improving quality through individualized patient assessment, educational design innovations, and scientific scrutiny comparable to that given to exercise training, the educational component of PR may achieve effective self-management, leading to successful behavior change and enhancement in health.

Effect of a Collaborative Care Intervention vs Usual Care on Health Status of Patients With Chronic Heart Failure: The CASA Randomized Clinical Trial.

Importance: Many patients with chronic heart failure experience reduced health status despite receiving conventional therapy. Objective: To determine whether a symptom and psychosocial collaborative care intervention improves heart failure-specific health status, depression, and symptom burden in patients with heart failure. Design, Setting, and Participants: A single-blind, 2-arm, multisite randomized clinical trial was conducted at Veterans Affairs, academic, and safety-net health systems in Colorado among outpatients with symptomatic heart failure and reduced health status recruited between August 2012 and April 2015. Data from all participants were included regardless of level of participation, using an intent-to-treat approach. Interventions: Patients were randomized 1:1 to receive the Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) intervention or usual care. The CASA intervention included collaborative symptom care provided by a nurse and psychosocial care provided by a social worker, both of whom worked with the patients' primary care clinicians and were supervised by a study primary care clinician, cardiologist, and palliative care physician. Main Outcomes and Measures: The primary outcome was patient-reported heart failure-specific health status, measured by difference in change scores on the Kansas City Cardiomyopathy Questionnaire (range, 0-100) at 6 months. Secondary outcomes included depression (measured by the 9-item Patient Health Questionnaire), anxiety (measured by the 7-item Generalized Anxiety Disorder Questionnaire), overall symptom distress (measured by the General Symptom Distress Scale), specific symptoms (pain, fatigue, and shortness of breath), number of hospitalizations, and mortality. Results: Of 314 patients randomized (157 to intervention arm and 157 to control arm), there were 67 women and 247 men, mean (SD) age was 65.5 (11.4) years, and 178 (56.7%) had reduced ejection fraction. At 6 months, the mean Kansas City Cardiomyopathy Questionnaire score improved 5.5 points in the intervention arm and 2.9 points in the control arm (difference, 2.6; 95% CI, -1.3 to 6.6; P = .19). Among secondary outcomes, depressive symptoms and fatigue improved at 6 months with CASA (effect size of -0.29 [95% CI, -0.53 to -0.04] for depressive symptoms and -0.30 [95% CI, -0.55 to -0.06] for fatigue; P = .02 for both). There were no significant changes in overall symptom distress, pain, shortness of breath, or number of hospitalizations. Mortality at 12 months was similar in both arms (10 patients died receiving CASA, and 13 patients died receiving usual care; P = .52). Conclusions and Relevance: This multisite randomized clinical trial of the CASA intervention did not demonstrate improved heart failure-specific health status. Secondary outcomes of depression and fatigue, both difficult symptoms to treat in heart failure, improved. Trial Registration: clinicaltrials.gov Identifier: NCT01739686.

Patient Perceptions of the Adequacy of Supplemental Oxygen Therapy. Results of the American Thoracic Society Nursing Assembly Oxygen Working Group Survey.

RATIONALE: Pulmonary clinicians and patients anecdotally report barriers to home supplemental oxygen services including inadequate supply, unacceptable portable options, and equipment malfunction. Limited evidence exists to describe or quantify these problems. OBJECTIVES: To describe the frequency and type of problems experienced by supplemental oxygen users in the United States. METHODS: The Patient Supplemental Oxygen Survey, a self-report questionnaire, was posted on the American Thoracic Society Public Advisory Roundtable and patient and health care-affiliated websites. Respondents were invited to complete the questionnaire, using targeted e-mail notifications. Data were analyzed using descriptive statistics, paired t tests, and χ2 analysis. RESULTS: In total, 1,926 responses were analyzed. Most respondents reported using oxygen 24 h/d, for 1-5 years, and 31% used high flow with exertion. Oxygen use varied, with only 29% adjusting flow rates based on oximeter readings. The majority (65%) reported not having their oxygen saturation checked when equipment was delivered. Sources of instruction included the delivery person (64%), clinician (8%), and no instruction (10%). Approximately one-third reported feeling "very" or "somewhat" unprepared to operate their equipment. Fifty-one percent of the patients reported oxygen problems, with the most frequent being equipment malfunction, lack of physically manageable portable systems, and lack of portable systems with high flow rates. Most respondents identified multiple problems (average, 3.6 ± 2.3; range, 1-12) in addition to limitations in activities outside the home because of inadequate portable oxygen systems (44%). Patients living in Competitive Bidding Program areas reported oxygen problems more often than those who did not (55% [389] vs. 45% [318]; P = 0.025). Differences in sample characteristics and oxygen problems were noted across diagnostic categories, with younger, dyspneic, high-flow users, and respondents who did not receive oxygen education, relating more oxygen problems. Respondents reporting oxygen problems also experienced increased health care resource utilization. CONCLUSIONS: Supplemental oxygen users experience frequent and varied problems, particularly a lack of access to effective instruction and adequate portable systems. Initiatives by professional and patient organizations are needed to improve patient education, and to promote access to equipment and services tailored to each patient's needs.

Spirometric variability in smokers: transitions in COPD diagnosis in a five-year longitudinal study.

BACKGROUND: Spirometrically-defined chronic obstructive pulmonary disease (COPD) is considered progressive but its natural history is inadequately studied. We hypothesized that spirometrically-defined COPD states could undergo beneficial transitions. METHODS: Participants in the Lovelace Smokers' Cohort (n = 1553), primarily women, were longitudinally studied over 5 years. Spirometric states included normal postbronchodilator spirometry, COPD Stage I, Unclassified state, and COPD Stage II+, as defined by GOLD guidelines. Beneficial transitions included either a decrease in disease severity, including resolution of spirometric abnormality, or maintenance of non-diseased state. 'All smokers' (n = 1553) and subgroups with normal and abnormal spirometry at baseline (n = 956 and 597 respectively) were separately analyzed. Markov-like model of transition probabilities over an average follow-up period of 5 years were calculated. RESULTS: Among 'all smokers', COPD Stage I, Unclassified, and COPD Stage II+ states were associated with probabilities of 16, 39, and 22 % respectively for beneficial transitions, and of 16, 35, and 4 % respectively for resolution. Beneficial transitions were more common for new-onset disease than for pre-existing disease (p < 0.001). Beneficial transitions were less common among older smokers, men, or those with bronchial hyperresponsiveness but more common among Hispanics and smokers with excess weight. CONCLUSIONS: This observational study of ever smokers, shows that spirometrically-defined COPD states, may not be uniformly progressive and can improve or resolve over time. The implication of these findings is that the spirometric diagnosis of COPD can be unstable. Furthermore, COPD may have a pre-disease state when interventions might help reverse or change its natural history. TRIAL REGISTRATION: NA.

Rationale and study design of a patient-centered intervention to improve health status in chronic heart failure: The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) randomized trial.

While contemporary heart failure management has led to some improvements in morbidity and mortality, patients continue to report poor health status (i.e., burdensome symptoms, impaired function, and poor quality of life). The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) trial is a NIH-funded, three-site, randomized clinical trial that examines the effect of the CASA intervention compared to usual care on the primary outcome of patient-reported health status at 6months in patients with heart failure and poor health status. The CASA intervention involves a nurse who works with patients to treat symptoms (e.g., shortness of breath, fatigue, pain) using disease-specific and palliative approaches, and a social worker who provides psychosocial care targeting depression and adjustment to illness. The intervention uses a collaborative care team model of health care delivery and is structured and primarily phone-based to enhance reproducibility and scalability. This article describes the rationale and design of the CASA trial, including several decision points: (1) how to design a patient-centered intervention to improve health status; (2) how to structure the intervention so that it is reproducible and scalable; and (3) how to systematically identify outpatients with heart failure most likely to need and benefit from the intervention. The results should provide valuable information to providers and health systems about the use of team care to manage symptoms and provide psychosocial care in chronic illness.