Emotional Distress, Anxiety, and General Health Status in Patients With Newly Identified Small Pulmonary Nodules: Results From the Watch the Spot Trial.

BACKGROUND: Anxiety and emotional distress have not been studied in large, diverse samples of patients with pulmonary nodules. RESEARCH QUESTION: How common are anxiety and distress in patients with newly identified pulmonary nodules, and what factors are associated with these outcomes? STUDY DESIGN AND METHODS: This study surveyed participants in the Watch the Spot Trial, a large, pragmatic clinical trial of more vs less intensive strategies for radiographic surveillance of patients with small pulmonary nodules. The survey included validated instruments to measure patient-centered outcomes such as nodule-related emotional distress (Impact of Event Scale-Revised) and anxiety (Six-Item State Anxiety Inventory) 6 to 8 weeks following nodule identification. Mixed-effects models were used to compare outcomes between study arms following adjustment for potential confounders and clustering within enrollment site, while also examining a limited number of prespecified explanatory factors, including nodule size, mode of detection, type of ordering clinician, and lack of timely notification prior to contact by the study team. RESULTS: The trial enrolled 34,699 patients; 2,049 individuals completed the baseline survey (5.9%). Respondents and nonrespondents had similar demographic and nodule characteristics, although more respondents were non-Hispanic and White. Impact of Event Scale-Revised scores indicated mild, moderate, or severe distress in 32.2%, 9.4%, and 7.2% of respondents, respectively, with no difference in scores between study arms. Following adjustment, greater emotional distress was associated with larger nodule size and lack of timely notification by a clinician; distress was also associated with younger age, female sex, ever smoking, Black race, and Hispanic ethnicity. Anxiety was associated with lack of timely notification, ever smoking, and female sex. INTERPRETATION: Almost one-half of respondents experienced emotional distress 6 to 8 weeks following pulmonary nodule identification. Strategies are needed to mitigate the burden of distress, especially in younger, female, ever smoking, and minoritized patients, and those with larger nodules. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT02623712; URL: www. CLINICALTRIALS: gov.

The impact of timing of initiating invasive mechanical ventilation in COVID-19-related respiratory failure.

PURPOSE: Optimal timing of initiating invasive mechanical ventilation (IMV) in coronavirus disease 2019 (COVID-19)-related respiratory failure is unclear. We hypothesized that a strategy of IMV as opposed to continuing high flow oxygen or non-invasive mechanical ventilation each day after reaching a high FiO2 threshold would be associated with worse in-hospital mortality. METHODS: Using data from Kaiser Permanente Northern/Southern California's 36 medical centers, we identified patients with COVID-19-related acute respiratory failure who reached ≥80% FiO2 on high flow nasal cannula or non-invasive ventilation. Exposure was IMV initiation each day after reaching high FiO2 threshold (T0). We developed propensity scores with overlap weighting for receipt of IMV each day adjusting for confounders. We reported relative risk of inpatient death with 95% Confidence Interval. RESULTS: Of 28,035 hospitalizations representing 21,175 patient-days, 5758 patients were included (2793 received and 2965 did not receive IMV). Patients receiving IMV had higher unadjusted mortality (63.6% versus 18.2%, P < 0.0001). On each day after reaching T0 through day >10, the adjusted relative risk was higher for those receiving IMV compared to those not receiving IMV (Relative Risk>1). CONCLUSIONS: Initiation of IMV on each day after patients reach high FiO2 threshold was associated with higher inpatient mortality after adjusting for time-varying confounders. Remaining on high flow nasal cannula or non-invasive ventilation does not appear to be harmful compared to IMV. Prospective evaluation is needed.

Anakinra or high-dose corticosteroids in COVID-19 pneumonia patients who deteriorate on low-dose dexamethasone: an observational study of comparative effectiveness.

OBJECTIVES: To assess whether escalating to high-dose corticosteroids or anakinra compared with continuing low-dose corticosteroids reduced mortality in patients with severe COVID-19 whose respiratory function deteriorated while receiving dexamethasone 6 mg daily. METHODS: We conducted a retrospective cohort study between March 1 to December 31, 2020, of hospitalized patients with confirmed COVID-19 pneumonia. In-hospital death was analyzed using logistic regression with inverse probability of treatment weighting of receiving anakinra, high-dose corticosteroid (dexamethasone >10 mg daily), or remaining on low-dose corticosteroids on the day of first respiratory deterioration. RESULTS: We analyzed 6671 patients whose respiratory status deteriorated while receiving dexamethasone 6 mg daily for COVID-19 pneumonia, of whom 6265 stayed on low-dose corticosteroids, 232 were escalated to high-dose corticosteroids, and 174 to anakinra in addition to corticosteroids. The propensity score-adjusted odds of death were higher in the anakinra (odds ratio [OR] 1.76; 95% CI 1.13-2.72) and high-dose corticosteroid groups (OR 1.53; 95% CI 1.14-2.07) compared with those who continued low-dose corticosteroids on the day of respiratory deterioration. The odds of hospital-acquired infections were also higher in the anakinra (OR 2.00; 95% CI 1.28-3.11) and high-dose corticosteroid groups (OR 1.43; 95% CI 1.00-2.04) compared with low-dose corticosteroid group. CONCLUSION: Our findings do not support escalating patients with COVID-19 pneumonia who deteriorate on low-dose corticosteroids to high-dose corticosteroids or anakinra.

The intensity of anticoagulant dosing in hospitalized patients with COVID-19: An observational, comparative effectiveness study.

BACKGROUND: The question of anticoagulant dosing in hospitalized patients with coronavirus disease-2019 (COVID-19) is unresolved, with randomized trials showing mixed results and heterogeneity of treatment effects for in-hospital death. OBJECTIVE: To examine the association between the intensity of anticoagulation and clinical outcomes in hospitalized patients with COVID-19. DESIGN, SETTING AND PARTICIPANTS: Retrospective cohort study of patients with COVID-19 and respiratory impairment who were hospitalized between 3/1/2020-12/31/2020 in two Kaiser Permanente regions. EXPOSURE AND MAIN OUTCOME: We fit propensity score models using categorical regression to estimate the probability of receiving standard prophylactic, intermediate, or full-dose anticoagulation beginning on the day of admission or on the day of first respiratory deterioration. Exposure was defined by the highest dose on the day of admission or within 24 hours after deterioration. The primary outcome was in-hospital death. RESULTS: We included 17,130 patients in the day of admission analysis and 4,924 patients who experienced respiratory deterioration. There were no differences in propensity score-adjusted odds of in-hospital death for patients who received either intermediate (odds ratio [OR]: 1.00, 95% confidence intervals [CI] 0.89-1.12) or full anticoagulation (OR: 1.00, 95% CI: 0.85-1.17) compared with standard prophylaxis beginning on the day of admission. Similarly, there were no differences in in-hospital death for either intermediate (OR: 1.22, 95% CI: 0.82-1.82) or full anticoagulation (OR: 1.50, 95% CI: 0.90-2.51) compared with standard prophylaxis on the day of deterioration. CONCLUSION: Results of this real-world, comparative effectiveness study showed no differences in in-hospital death among newly admitted or deteriorating patients with COVID-19 who received intermediate-dose or full anticoagulation compared with standard prophylaxis.

Development and validation of the COVID-19 Hospitalized Patient Deterioration Index.

OBJECTIVES: To develop a COVID-19-specific deterioration index for hospitalized patients: the COVID Hospitalized Patient Deterioration Index (COVID-HDI). This index builds on the proprietary Epic Deterioration Index, which was not developed for predicting respiratory deterioration events among patients with COVID-19. STUDY DESIGN: A retrospective observational cohort was used to develop and validate the COVID-HDI model to predict respiratory deterioration or death among hospitalized patients with COVID-19. Deterioration events were defined as death or requiring high-flow oxygen, bilevel positive airway pressure, mechanical ventilation, or intensive-level care within 72 hours of run time. The sample included hospitalized patients with COVID-19 diagnoses or positive tests at Kaiser Permanente Southern California between May 3, 2020, and October 17, 2020. METHODS: Machine learning models and 118 candidate predictors were used to generate benchmark performance. Logit regression with least absolute shrinkage and selection operator and physician input were used to finalize the model. Split-sample cross-validation was used to train and test the model. RESULTS: The area under the receiver operating curve was 0.83. COVID-HDI identifies patients at low risk (negative predictive value [NPV] > 98.5%) and borderline low risk (NPV > 95%) of an event. Of all patients, 74% were identified as being at low or borderline low risk at some point during their hospitalization and could be considered for discharge with or without home monitoring. A high-risk group with a positive predictive value of 51% included 12% of patients. Model performance remained high in a recent cohort of patients. CONCLUSIONS: COVID-HDI is a parsimonious, well-calibrated, and accurate model that may support clinical decision-making around discharge and escalation of care.

High-dose corticosteroids in patients hospitalized for COVID-19 pneumonia: an observational study of comparative effectiveness.

OBJECTIVES: To assess whether high- compared with low-dose corticosteroids started upon hospitalization reduce mortality in patients with severe COVID-19 pneumonia or in subgroups stratified by severity of respiratory impairment on admission. METHODS: We conducted a retrospective cohort study of patients with confirmed SARS-CoV-2 infection who required oxygen supplementation upon hospitalization between March 1 and December 31, 2020. In-hospital death was analyzed using logistic regression with inverse probability of treatment weighting of receiving low- or high-dose corticosteroid (dexamethasone 6-10 mg daily or >10-20 mg daily or other corticosteroid equivalents). RESULTS: We analyzed 13,366 patients who received low-dose and 948 who received high-dose corticosteroids, of whom 31.3% and 40.4% had severe respiratory impairment (>15 l/min of oxygen or mechanical ventilation) upon admission, respectively. There were no differences in the propensity score-adjusted odds of death (odds ratio 1.17, 95% CI 0.72-1.90) or infections (odds ratio 0.70, 95% CI 0.44-1.11) for patients who received high-dose compared with low-dose corticosteroids, beginning on the day of admission. No significant differences in subgroups stratified by severity of respiratory impairment were found. CONCLUSION: Initiating high-dose compared with low-dose corticosteroids among newly hospitalized patients with COVID-19 pneumonia did not improve survival. However, benefit of high-dose corticosteroids in specific subgroups cannot be excluded.

Patient responses to passive enrollment into a large, pragmatic clinical trial: A qualitative content analysis.

BACKGROUND: While passive enrollment or "opt-out" recruitment methods facilitate pragmatic clinical trials, they pose unique challenges, and it is unclear how participants feel about them. Here, we describe patient responses to passive enrollment into the Watch the Spot Trial, a pragmatic trial comparing two sets of guidelines for small lung nodule follow-up. METHODS: For this nested qualitative study, we analyzed participant-initiated calls and emails. We performed a qualitative content analysis, using a team-coding approach to identify reasons that eligible participants contacted the study team. We calculated the proportion of contacts containing each code, and how often each code coincided with study opt-outs and other codes. RESULTS: Of 23,412 eligible participants across seven sites, 1494 (6.4%) contacted the study team, with 1560 total contacts. Among the total contacts, the most common codes (i.e., reasons for contacting the team) were study opt-outs (n = 614, 39.0%), clarification of study procedures (n = 328, 21.0%), and unawareness of the nodule prior to research notification (n = 244, 15.6%). The least common codes were concerns about sharing of protected health information with the study team (n = 22, 1.4%) or outside of the healthcare system (n = 26, 1.7%), and disapproval of the opt-out approach (n = 10, 0.6%); most patients with these concerns opted-out. Nodule unawareness sometimes coincided with anger (n = 24) or distress (n = 15), and questions about nodule care sometimes coincided with distress (n = 20) and questions about follow-up surveys (n = 26). CONCLUSION: Most participants did not report concerns about passive enrollment. Patient perspectives are an invaluable resource for minimizing risks and inconveniences of future pragmatic trials using this recruitment method.

Healthcare Utilization Among Patients Diagnosed with COVID-19 in a Large Integrated Health System.

BACKGROUND: The demands for healthcare resources following a COVID-19 diagnosis are substantial, but not currently quantified. OBJECTIVE: To describe trends in healthcare utilization within 180 days for patients diagnosed with COVID-19 and identify patient factors associated with increased healthcare use. DESIGN: Observational cohort study. PATIENTS: A total of 64,011 patients with a test-confirmed COVID-19 diagnosis from March to September 2020 in a large integrated healthcare system in Southern California. MAIN MEASURES: Overall healthcare utilization during the 180 days following COVID-19 diagnosis, as well as encounter types and reasons for visits during the first 30 days. Poisson regression was used to identify patient factors associated with higher utilization. Analyses were performed separately for patients who were and were not hospitalized for COVID-19. KEY RESULTS: Healthcare utilization was about twice as high for hospitalized patients compared to non-hospitalized patients in all time periods. The average number of visits was highest in the first 30 days (hospitalized: 12.3 visits/30 person-days; non-hospitalized: 6.6) and gradually decreased over time. In the first 30 days, the majority of healthcare visits were telehealth encounters (hospitalized: 9.0 visits; non-hospitalized: 5.6 visits), and the most prevalent reasons for visits were COVID-related diagnoses, COVID-related symptoms, and respiratory-related conditions. For hospitalized patients, older age (≥65: RR 1.27, 95% CI 1.15-1.41), female gender (RR 1.07, 95% CI 1.05-1.09), and higher BMI (≥40: RR 1.07, 95% CI 1.03-1.10) were associated with higher total utilization. For non-hospitalized patients, older age, female gender, higher BMI, non-white race/ethnicity, former smoking, and greater number of pre-existing comorbidities were all associated with increased utilization. CONCLUSIONS: Patients with COVID-19 seek healthcare frequently within 30 days of diagnosis, placing high demands on health systems. Identifying ways to support patients diagnosed with COVID-19 while adequately providing the usual recommended care to our communities will be important as we recover from the pandemic.

Comparing Smoking Cessation Interventions among Underserved Patients Referred for Lung Cancer Screening: A Pragmatic Trial Protocol.

Smoking burdens are greatest among underserved patients. Lung cancer screening (LCS) reduces mortality among individuals at risk for smoking-associated lung cancer. Although LCS programs must offer smoking cessation support, the interventions that best promote cessation among underserved patients in this setting are unknown. This stakeholder-engaged, pragmatic randomized clinical trial will compare the effectiveness of four interventions promoting smoking cessation among underserved patients referred for LCS. By using an additive study design, all four arms provide standard "ask-advise-refer" care. Arm 2 adds free or subsidized pharmacologic cessation aids, arm 3 adds financial incentives up to $600 for cessation, and arm 4 adds a mobile device-delivered episodic future thinking tool to promote attention to long-term health goals. We hypothesize that smoking abstinence rates will be higher with the addition of each intervention when compared with arm 1. We will enroll 3,200 adults with LCS orders at four U.S. health systems. Eligible patients include those who smoke at least one cigarette daily and self-identify as a member of an underserved group (i.e., is Black or Latinx, is a rural resident, completed a high school education or less, and/or has a household income <200% of the federal poverty line). The primary outcome is biochemically confirmed smoking abstinence sustained through 6 months. Secondary outcomes include abstinence sustained through 12 months, other smoking-related clinical outcomes, and patient-reported outcomes. This pragmatic randomized clinical trial will identify the most effective smoking cessation strategies that LCS programs can implement to reduce smoking burdens affecting underserved populations. Clinical trial registered with clinicaltrials.gov (NCT04798664). Date of registration: March 12, 2021. Date of trial launch: May 17, 2021.

COVID-19 morbidity and mortality associated with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers use among 14,129 patients with hypertension from a US integrated healthcare system.

OBJECTIVE: Although recent evidence suggests no increased risk of severe COVID-19 outcomes associated with angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) use, the relationship is less clear among patients with hypertension and diverse racial/ethnic groups. This study evaluates the risk of hospitalization and mortality among patients with hypertension and COVID-19 in a large US integrated healthcare system. METHODS: Patients with hypertension and COVID-19 (between March 1- September 1, 2020) on ACEIs or ARBs were compared with patients on other frequently used antihypertensive medications. RESULTS: Among 14,129 patients with hypertension and COVID-19 infection (mean age 60 years, 48% men, 58% Hispanic), 21% were admitted to the hospital within 30 days of COVID-19 infection. Of the hospitalized patients, 24% were admitted to intensive care units, 17% required mechanical ventilation, and 10% died within 30 days of COVID-19 infection. Exposure to ACEIs or ARBs prior to COVID-19 infection was not associated with an increased risk of hospitalization or all-cause mortality (rate ratios for ACEIs vs other antihypertensive medications â€‹= â€‹0.98, 95% CI: 0.88, 1.08; ARBs vs others â€‹= â€‹1.00, 95% CI: 0.90, 1.11) after applying inverse probability of treatment weights. These associations were consistent across racial/ethnic groups. Use of ACEIs or ARBs during hospitalization was associated with a lower risk of all-cause mortality (odds ratios for ACEIs or ARBs vs others â€‹= â€‹0.50, 95% CI: 0.34, 0.72). CONCLUSION: Our study findings support continuation of ACEI or ARB use for patients with hypertension during the COVID-19 pandemic and after COVID-19 infection.

Natural Language Processing to Identify Pulmonary Nodules and Extract Nodule Characteristics From Radiology Reports.

BACKGROUND: There is an urgent need for population-based studies on managing patients with pulmonary nodules. RESEARCH QUESTION: Is it possible to identify pulmonary nodules and associated characteristics using an automated method? STUDY DESIGN AND METHODS: We revised and refined an existing natural language processing (NLP) algorithm to identify radiology transcripts with pulmonary nodules and greatly expanded its functionality to identify the characteristics of the largest nodule, when present, including size, lobe, laterality, attenuation, calcification, and edge. We compared NLP results with a reference standard of manual transcript review in a random test sample of 200 radiology transcripts. We applied the final automated method to a larger cohort of patients who underwent chest CT scan in an integrated health care system from 2006 to 2016, and described their demographic and clinical characteristics. RESULTS: In the test sample, the NLP algorithm had very high sensitivity (98.6%; 95% CI, 95.0%-99.8%) and specificity (100%; 95% CI, 93.9%-100%) for identifying pulmonary nodules. For attenuation, edge, and calcification, the NLP algorithm achieved similar accuracies, and it correctly identified the diameter of the largest nodule in 135 of 141 cases (95.7%; 95% CI, 91.0%-98.4%). In the larger cohort, the NLP found 217,771 reports with nodules among 717,304 chest CT reports (30.4%). From 2006 to 2016, the number of reports with nodules increased by 150%, and the mean size of the largest nodule gradually decreased from 11 to 8.9 mm. Radiologists documented the laterality and lobe (90%-95%) more often than the attenuation, calcification, and edge characteristics (11%-14%). INTERPRETATION: The NLP algorithm identified pulmonary nodules and associated characteristics with high accuracy. In our community practice settings, the documentation of nodule characteristics is incomplete. Our results call for better documentation of nodule findings. The NLP algorithm can be used in population-based studies to identify pulmonary nodules, avoiding labor-intensive chart review.

Identifying patients with symptoms suspicious for COVID-19 at elevated risk of adverse events: The COVAS score.

OBJECTIVE: Develop and validate a risk score using variables available during an Emergency Department (ED) encounter to predict adverse events among patients with suspected COVID-19. METHODS: A retrospective cohort study of adult visits for suspected COVID-19 between March 1 - April 30, 2020 at 15 EDs in Southern California. The primary outcomes were death or respiratory decompensation within 7-days. We used least absolute shrinkage and selection operator (LASSO) models and logistic regression to derive a risk score. We report metrics for derivation and validation cohorts, and subgroups with pneumonia or COVID-19 diagnoses. RESULTS: 26,600 ED encounters were included and 1079 experienced an adverse event. Five categories (comorbidities, obesity/BMI ≥ 40, vital signs, age and sex) were included in the final score. The area under the curve (AUC) in the derivation cohort was 0.891 (95% CI, 0.880-0.901); similar performance was observed in the validation cohort (AUC = 0.895, 95% CI, 0.874-0.916). Sensitivity ranging from 100% (Score 0) to 41.7% (Score of ≥15) and specificity from 13.9% (score 0) to 96.8% (score ≥ 15). In the subgroups with pneumonia (n = 3252) the AUCs were 0.780 (derivation, 95% CI 0.759-0.801) and 0.832 (validation, 95% CI 0.794-0.870), while for COVID-19 diagnoses (n = 2059) the AUCs were 0.867 (95% CI 0.843-0.892) and 0.837 (95% CI 0.774-0.899) respectively. CONCLUSION: Physicians evaluating ED patients with pneumonia, COVID-19, or symptoms suspicious for COVID-19 can apply the COVAS score to assist with decisions to hospitalize or discharge patients during the SARS CoV-2 pandemic.

Guidelines for the Evaluation of Pulmonary Nodules Detected Incidentally or by Screening: A Survey of Radiologist Awareness, Agreement, and Adherence From the Watch the Spot Trial.

PURPOSE: The aim of this study was to examine radiologists' beliefs about existing guidelines for pulmonary nodule evaluation. METHODS: A self-administered survey was developed to ascertain awareness of, agreement with, and adherence to published guidelines, including those from the Fleischner Society and the Lung CT Screening Reporting and Data System (Lung-RADS™). Surveys were distributed to 514 radiologists at 13 health care systems that are participating in a large, pragmatic trial of pulmonary nodule evaluation. Prespecified comparisons were made among groups defined by type of health system, years of experience, reader volume, and study arm. RESULTS: The response rate was 26.3%. Respondents were most familiar with guidelines from Fleischner (94%) and Lung-RADS (71%). For both incidental and screening-detected nodules, self-reported adherence to preferred guidelines was very high (97% and 94%, respectively), and most respondents believed that the benefits of adherence outweigh the harms (81% and 74%, respectively). Underlying evidence was thought to be high in quality by 68% of respondents for screening-detected nodules and 41% for incidental nodules. Approximately 70% of respondents believed that the frequency of recommended follow-up was "just right" for both guidelines. Radiologists who practice in nonintegrated health care systems were more likely to believe that the evidence was high in quality (79.5% versus 57.1%) and that the benefits of adherence outweigh the harms (85.1% versus 67.5%). Low-volume readers had lower awareness and self-reported adherence than higher volume readers. CONCLUSIONS: Radiologists reported high levels of familiarity and agreement with and adherence to guidelines for pulmonary nodule evaluation, but many overestimated the quality of evidence in support of the recommendations.

Angiotensin-Converting Enzyme Inhibitors or Angiotensin Receptor Blockers Use and COVID-19 Infection Among 824 650 Patients With Hypertension From a US Integrated Healthcare System.

Background Previous reports suggest that the use of angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) may upregulate angiotensin-converting enzyme 2 receptors and increase severe acute respiratory syndrome coronavirus 2 infectivity. We evaluated the association between ACEI or ARB use and coronavirus disease 2019 (COVID-19) infection among patients with hypertension. Methods and Results We identified patients with hypertension as of March 1, 2020 (index date) from Kaiser Permanente Southern California. Patients who received ACEIs, ARBs, calcium channel blockers, beta blockers, thiazide diuretics (TD), or no therapy were identified using outpatient pharmacy data covering the index date. Outcome of interest was a positive reverse transcription polymerase chain reaction test for COVID-19 between March 1 and May 6, 2020. Patient sociodemographic and clinical characteristics were identified within 1 year preindex date. Among 824 650 patients with hypertension, 16 898 (2.0%) were tested for COVID-19. Of those tested, 1794 (10.6%) had a positive result. Overall, exposure to ACEIs or ARBs was not statistically significantly associated with COVID-19 infection after propensity score adjustment (odds ratio [OR], 1.06; 95% CI, 0.90-1.25) for ACEIs versus calcium channel blockers/beta blockers/TD; OR, 1.10; 95% CI, 0.91-1.31 for ARBs versus calcium channel blockers/beta blockers/TD). The associations between ACEI use and COVID-19 infection varied in different age groups (P-interaction=0.03). ACEI use was associated with lower odds of COVID-19 among those aged ≥85 years (OR, 0.30; 95% CI, 0.12-0.77). Use of no antihypertensive medication was significantly associated with increased odds of COVID-19 infection compared with calcium channel blockers/beta blockers/TD (OR, 1.32; 95% CI, 1.11-1.56). Conclusions Neither ACEI nor ARB use was associated with increased likelihood of COVID-19 infection. Decreased odds of COVID-19 infection among adults ≥85 years using ACEIs warrants further investigation.

Methods for the Watch the Spot Trial. A Pragmatic Trial of More- versus Less-Intensive Strategies for Active Surveillance of Small Pulmonary Nodules.

Small pulmonary nodules are most often managed by surveillance imaging with computed tomography (CT) of the chest, but the optimal frequency and duration of surveillance are unknown. The Watch the Spot Trial is a multicenter, pragmatic, comparative-effectiveness trial with cluster randomization by hospital or health system that compares more- versus less-intensive strategies for active surveillance of small pulmonary nodules. The study plans to enroll approximately 35,200 patients with a small pulmonary nodule that is newly detected on chest CT imaging, either incidentally or by screening. Study protocols for more- and less-intensive surveillance were adapted from published guidelines. The primary outcome is the percentage of cancerous nodules that progress beyond American Joint Committee on Cancer seventh edition stage T1a. Secondary outcomes include patient-reported anxiety and emotional distress, nodule-related health care use, radiation exposure, and adherence with the assigned surveillance protocol. Distinctive aspects of the trial include: 1) the pragmatic integration of study procedures into existing clinical workflow; 2) the use of cluster randomization by hospital or health system; 3) the implementation and evaluation of a system-level intervention for protocol-based care; 4) the use of highly efficient, technology-enabled methods to identify and (passively) enroll participants; 5) reliance on data collected as part of routine clinical care, including data from electronic health records and state cancer registries; 6) linkage with state cancer registries for complete ascertainment of the primary study outcome; and 7) intensive engagement with a diverse group of patient and nonpatient stakeholders in the design and execution of the study.

Expanding Home-Based Primary Care to American Indian Reservations and Other Rural Communities: An Observational Study.

BACKGROUND/OBJECTIVES: Home-based primary care (HBPC) is a comprehensive, interdisciplinary program to meet the medical needs of community-dwelling populations needing long-term care (LTC). The U.S. Department of Veterans Affairs (VA) expanded its HBPC program to underserved rural communities, including American Indian reservations, providing a "natural laboratory" to study change in access to VA LTC benefits and utilization outcomes for rural populations that typically face challenges in accessing LTC medical support. DESIGN: Pretest-Posttest quasi-experimental approach with interrupted time-series design using linked VA, Medicare, and Indian Health Service (IHS) records. SETTING: American Indian reservations and non-Indian communities in rural HBPC catchment areas. PARTICIPANTS: 376 veterans (88 IHS beneficiaries, 288 non-IHS beneficiaries) with a HBPC length of stay of 12 months or longer. MEASUREMENTS: Baseline demographic and health characteristics, activities of daily living (ADL), previous VA enrollment, and hospital admissions and emergency department (ED) visits as a function of time, accounting for IHS beneficiary and functional statuses. RESULTS: For HBPC users, VA enrollment increased by 22%. At baseline, 30% of IHS and non-IHS beneficiaries had 2 or more ADLs impairments; IHS populations were younger (P < .001) and had more diagnosed chronic diseases (P = .007). Overall, hospital admissions decreased by 0.10 (95% confidence interval (CI) = -0.14 to -0.05) and ED visits decreased by 0.13 (95% CI = -0.19 to -0.07) in the 90 days after HBPC admission (Ps < .001) and these decreases were maintained over 1 year follow-up. Before HBPC, probability of hospital admission was 12% lower for IHS than non-IHS beneficiaries (P = .02). CONCLUSION: Introducing HBPC to rural areas increased access to LTC and enrollment for healthcare benefits, with equitable outcomes in IHS and non-IHS populations.

Barriers and facilitators to implementation of VA home-based primary care on American Indian reservations: a qualitative multi-case study.

BACKGROUND: Veterans Health Affairs (VA) home-based primary care (HBPC) is an evidence-based interdisciplinary approach to non-institutional long-term care that was developed in urban settings to provide longitudinal care for vulnerable older patients. Under the authority of a Memorandum of Understanding between VA and Indian Health Service (IHS) to improve access to healthcare, 14 VA medical centers (VAMC) independently initiated plans to expand HBPC programs to rural American Indian reservations and 12 VAMC successfully implemented programs. The purpose of this study is to describe barriers and facilitators to implementation in rural Native communities with the aim of informing planners and policy-makers for future program expansions. METHODS: A qualitative comparative case study approach was used, treating each of the 14 VAMC as a case. Using the Consolidated Framework for Implementation Research (CFIR) to inform an open-ended interview guide, telephone interviews (n = 37) were conducted with HBPC staff and clinicians and local/regional managers, who participated or oversaw implementation. The interviews were transcribed, coded, and then analyzed using CFIR domains and constructs to describe and compare experiences and to identify facilitators, barriers, and adaptations that emerged in common across VAMC and HBPC programs. RESULTS: There was considerable variation in local contexts across VAMC. Nevertheless, implementation was typically facilitated by key individuals who were able to build trust and faith in VA healthcare among American Indian communities. Policy promoted clinical collaboration but collaborations generally occurred on an ad hoc basis between VA and IHS clinicians to optimize patient resources. All programs required some adaptations to address barriers in rural areas, such as distances, caseloads, or delays in hiring additional clinicians. VA funding opportunities facilitated expansion and sustainment of these programs. CONCLUSIONS: Since program expansion is a responsibility of the HBPC program director, there is little sharing of lessons learned across VA facilities. Opportunities for shared learning would benefit federal healthcare organizations to expand other medical services to additional American Indian communities and other rural and underserved communities, as well as to coordinate with other healthcare organizations. The CFIR structure was an effective analytic tool to compare programs addressing multiple inner and outer settings.

Veterans Affairs Geriatric Scholars Program: Enhancing Existing Primary Care Clinician Skills in Caring for Older Veterans.

The Veterans Affairs Geriatric Scholars Program (GSP) is a continuing professional development program to integrate geriatrics into the clinical practices of primary care providers and select associated health professions that support primary care teams. GSP uses a blended program educational format, and the minimal requirements are to attend an intensive course in geriatrics, participate in an interactive workshop on quality improvement (QI), and initiate a local QI project to demonstrate application of new knowledge to benefit older veterans. Using a retrospective post/pre survey design, the effect of GSP on clinical practices and behaviors and variation of that effect on clinicians working in rural and nonrural settings were evaluated. Significant improvement was found in the frequency of using evidence-based brief standardized assessments, clinical decision-making, and standards of care. Significant subgroup differences were observed in peer-to-peer information sharing between rural and nonrural clinicians. Overall, 77% of the sample reported greater job satisfaction after participating in GSP. The program is a successful model for advancing postgraduate education in geriatrics and a model that might be replicated to increase access to quality health care, particularly in rural areas.

Improving access to noninstitutional long-term care for American Indian veterans.

Home-based primary care (HBPC) is an effective model of noninstitutional long-term care developed in the Department of Veterans Affairs (VA) to provide ongoing care to homebound persons. Significant rural populations of American Indians have limited access to services designed for frail older adults. Fourteen Veterans Affairs Medical Centers (VAMCs) initiated efforts to expand access to HBPC in concert with local tribes and Indian Health Service (IHS) facilities. This study characterizes the resulting emerging models of HBPC and co-management. Using an observational design, key respondent telephone interviews (n = 37) were conducted with stakeholders representing the 14 VAMCs to describe these HBPC programs, and HBPC models were evaluated in relation to VAMC organizational culture as revealed on the annual VA All Employee Survey. Twelve VAMCs independently developed HBPC expansion programs for American Indian veterans, and six different program models were implemented. Two models were unique to collaborations between VAMCs and tribes; in these collaborations, the tribes retained primary care responsibilities. VAMC used the other four models for delivery of care in remote rural areas to all veteran populations, American Indians and non-Indians alike. Strategies to improve access by reducing geographic barriers occur in all models. Comparing mean VAMC organizational culture ratings, as defined in the Competing Values Framework, revealed significant group differences for one of these six models. Findings from this study illustrate the flexibility of the HBPC program and opportunities for co-management and expansion of healthcare access for American Indians and non-Indians, particularly in rural areas.

Community fall prevention programs: comparing three InSTEP models by levels of intensity.

The Fall Prevention Center of Excellence designed three progressive-intensity fall prevention program models, Increasing Stability Through Evaluation and Practice (InSTEP), to reduce risk in community-dwelling older adults. Each model included physical activity, medical risk, and home safety components and was implemented as a 12-week program for small class sizes (12-15 people) in community and senior centers. Change in fall rates and fall risk factors was assessed using a battery of performance tests, self-reports of function, and fall diaries in a 3-group within-subjects (N = 200) design measured at baseline, immediately postintervention, and at 3 and 9 months postintervention. Overall, participants experienced a reduction in falls, improved selfperception of gait and balance, and improved dynamic gait function. The medium-intensity InSTEP model significantly (p = .003) reduced self-reported falls in comparison with the other models. InSTEP is a feasible model for addressing fall risk reduction in community-dwelling older adults.