Evaluation of a health system's implementation of a monkeypox care model under the RE-AIM framework.

Objective: Emerging infectious diseases challenge healthcare systems to implement new models of care. We aim to evaluate the rapid implementation of a new care model for monkeypox in our health system. Design: This is a retrospective case series evaluation under the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework of implementation of a testing and care model for monkeypox in a large, integrated health system. Methods: Atrium Health implemented education of providers, testing protocols, and management of potential monkeypox cases using electronic health record (EHR) data capabilities, telehealth, and collaboration between multiple disciplines. The first 4 weeks of care model implementation were evaluated under the RE-AIM framework. Results: One hundred fifty-three patients were tested for monkeypox by 117 unique providers at urgent care, emergency departments, and infectious disease clinics in our healthcare system between 18 July 2022 and 14 August 2022. Fifty-eight monkeypox cases were identified, compared with 198 cases in the state during the time period, a disproportionate number compared with the health system service area, and 52 patients were assessed for need for tecovirimat treatment. The number of tests performed and providers sending tests increased during the study period. Conclusion: Implementation of a dedicated care model leveraging EHR data support, telehealth, and cross-disciplinary collaboration led to more effective identification and management of emerging infectious diseases and is important for public health. Plain Language Summary: Impact of care model implementation on monkeypox New infectious diseases challenge health systems to implement new care practices. Our health system responded to this challenge by implementing a care model for education, testing, and clinical care of monkeypox patients. We analyzed results from implementing the model. We were able to identify a disproportionate number of monkeypox cases compared with the rest of our state by using our model to educate medical providers, encourage testing, and ensure patients had access to best disease care. Implementation of care models for testing and management of new diseases will improve patient care and public health.

Discriminative Accuracy of the CAPTURE Tool for Identifying Chronic Obstructive Pulmonary Disease in US Primary Care Settings.

Importance: Chronic obstructive pulmonary disease (COPD) is underdiagnosed in primary care. Objective: To evaluate the operating characteristics of the CAPTURE (COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk) screening tool for identifying US primary care patients with undiagnosed, clinically significant COPD. Design, Setting, and Participants: In this cross-sectional study, 4679 primary care patients aged 45 years to 80 years without a prior COPD diagnosis were enrolled by 7 primary care practice-based research networks across the US between October 12, 2018, and April 1, 2022. The CAPTURE questionnaire responses, peak expiratory flow rate, COPD Assessment Test scores, history of acute respiratory illnesses, demographics, and spirometry results were collected. Exposure: Undiagnosed COPD. Main Outcomes and Measures: The primary outcome was the CAPTURE tool's sensitivity and specificity for identifying patients with undiagnosed, clinically significant COPD. The secondary outcomes included the analyses of varying thresholds for defining a positive screening result for clinically significant COPD. A positive screening result was defined as (1) a CAPTURE questionnaire score of 5 or 6 or (2) a questionnaire score of 2, 3, or 4 together with a peak expiratory flow rate of less than 250 L/min for females or less than 350 L/min for males. Clinically significant COPD was defined as spirometry-defined COPD (postbronchodilator ratio of forced expiratory volume in the first second of expiration [FEV1] to forced vital capacity [FEV1:FVC] <0.70 or prebronchodilator FEV1:FVC <0.65 if postbronchodilator spirometry was not completed) combined with either an FEV1 less than 60% of the predicted value or a self-reported history of an acute respiratory illness within the past 12 months. Results: Of the 4325 patients who had adequate data for analysis (63.0% were women; the mean age was 61.6 years [SD, 9.1 years]), 44.6% had ever smoked cigarettes, 18.3% reported a prior asthma diagnosis or use of inhaled respiratory medications, 13.2% currently smoked cigarettes, and 10.0% reported at least 1 cardiovascular comorbidity. Among the 110 patients (2.5% of 4325) with undiagnosed, clinically significant COPD, 53 had a positive screening result with a sensitivity of 48.2% (95% CI, 38.6%-57.9%) and a specificity of 88.6% (95% CI, 87.6%-89.6%). The area under the receiver operating curve for varying positive screening thresholds was 0.81 (95% CI, 0.77-0.85). Conclusions and Relevance: Within this US primary care population, the CAPTURE screening tool had a low sensitivity but a high specificity for identifying clinically significant COPD defined by presence of airflow obstruction that is of moderate severity or accompanied by a history of acute respiratory illness. Further research is needed to optimize performance of the screening tool and to understand whether its use affects clinical outcomes.

Breakthrough SARS-CoV-2 Infections after Vaccination in North Carolina.

We characterize the overall incidence and risk factors for breakthrough infection among fully vaccinated participants in the North Carolina COVID-19 Community Research Partnership cohort. Among 15,808 eligible participants, 638 reported a positive SARS-CoV-2 test after vaccination. Factors associated with a lower risk of breakthrough in the time-to-event analysis included older age, prior SARS-CovV-2 infection, higher rates of face mask use, and receipt of a booster vaccination. Higher rates of breakthrough were reported by participants vaccinated with BNT162b2 or Ad26.COV2.S compared to mRNA-1273, in suburban or rural counties compared to urban counties, and during circulation of the Delta and Omicron variants.

Implementation of Coach McLungsSM into primary care using a cluster randomized stepped wedge trial design.

BACKGROUND: Asthma is a prevalent chronic disease that is difficult to manage and associated with marked disparities in outcomes. One promising approach to addressing disparities is shared decision making (SDM), a method by which the patient and provider cooperatively make a decision about asthma care. SDM is associated with improved outcomes for patients; however, time constraints and staff availability are noted implementation barriers. Use of health information technology (IT) solutions may facilitate the utilization of SDM. Coach McLungsSM is a collaborative web-based application that involves pediatric patients, their caregivers, and providers in a personalized experience while gathering patient-reported data. Background logic provides decision support so both audiences can develop a well-informed treatment plan together. The goal of this study is to evaluate the implementation of the Coach McLungsSM intervention into primary care. METHODS: Implementation will be evaluated using a stepped wedge randomized control study design at 21 pediatric and family medicine practices within a large, integrated, nonprofit healthcare system. We will measure changes in emergency department visits, hospitalizations, and oral steroid use, which serve as surrogate measures for patient-centered asthma outcomes. We will use a generalized linear mixed models with logit link to test the hypothesis for the reduction in exacerbation rates specifying the fixed effects of intervention and time and random effects for practice and practice*time. This design achieves 84% power to detect the hypothesized effect size difference of 10% in overall exacerbation between control (40%) and intervention (30%) periods (two-sided, p = 0.05). Implementation will be guided using the Expert Recommendations for Implementing Change (ERIC), a compilation of implementation strategies, and evaluated using the CFIR (Consolidated Framework for Implementation Research) and RE-AIM (Reach Effectiveness, Adoption, Implementation, Maintenance). DISCUSSION: We anticipate that a tailored implementation of Coach McLungsSM across diverse primary care practices will lead to a decrease in emergency department visits, hospitalizations, and oral steroid use for patients in the intervention group as compared to the control condition. TRIAL REGISTRATION: Clincaltrials.gov, NCT05059210. Registered 28 September 2021, https://www. CLINICALTRIALS: gov/ct2/show/NCT05059210.

Primary Care Evaluation of a Hepatitis C Virus (HCV) Screening Education Intervention.

INTRODUCTION: Increased screening efforts and the development of effective antiviral treatments have led to marked improvement in Hepatitis C (HCV) patient outcomes. However, many people in the US are believed to have undiagnosed HCV. Successful screening strategies and access to a coordinated system of care are critical for HCV affected adults. The objective of this study was to evaluate a primary care HCV screening education intervention that took place 2018 to 2019 to improve primary care training and management of patients after the implementation of the electronic medical record (EMR) screening alert. METHODS: Using 15 primary care practices located in vicinity of neighborhoods at-risk for higher rates of HCV infections, a stepped wedge randomized control study design was utilized to deliver an educational screening intervention. The education intervention was implemented sequentially with 5 practices being presented to every 3 months. Number of patients within the Baby Boomer cohort (birth years 1945-1965) were collected 3 months before the first practice receiving the intervention to 3 months after the last practice receiving the education intervention. The main outcome collected was the HCV screening. Generalized linear mixed models were used to test the hypothesis of improved screening rates after intervention implementation. RESULTS: There were a total of 85,697 patients within the Baby Boomer cohort seen at the 15 practices. Practices receiving the intervention had patients who were more likely to be screened for HCV (ß = 0.259, P < .001; Odds Ratio [OR] [95%CI] 1.296 [1.098-1.529]).In terms of demographics, results showed that females are less likely to be screened than males (ß = -0.141, P < .001; OR [95%CI] 0.868[0.813 to 0.927]), Baby Boomer patients aged less than 65 were more likely to be screened than Baby Boomer patients aged 65 and older (ß = 0.293, P < .001; OR [95%CI] 1.340[1.251 to 1.436]). DISCUSSION: This study looked at screening rates before and after an educational intervention which happened subsequent to the activation of an EMR alert. Whereas HCV EMR alerts showed an increase in HCV screenings before the education intervention, the addition of the education showed a modest increase in HCV screening rates for Baby Boomer patients.

Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma.

BACKGROUND: Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations. METHODS: In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 µg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed. RESULTS: Of 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI, 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI, 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups. CONCLUSIONS: Among Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations. (Funded by the Patient-Centered Outcomes Research Institute and others; PREPARE ClinicalTrials.gov number, NCT02995733.).

From crisis to opportunity in a big data study: barriers and facilitators in a national web-based COVID-19 surveillance study.

Context: In March 2020 a COVID-19 Community Research Partnership (CRP) surveillance study was launched. We describe the barriers and facilitators to recruitment and retention during enrollment of >12,000 participants. Objective: To describe the barriers and facilitators to recruitment and retention while collecting daily syndromic and serologic data in a virtual setting. Methods: Key communication strategies designed to proactively enhance participation and retention were: Set up of a study call center; FAQs were emailed to participants and placed on the study webpage; preemptive messaging for getting started after enrollment, updating addresses, and in-home testing were designed; Later setup of a central call center for National team; design and implementation of national messaging for large scale in-home serological testing. Setting and Participants: Healthcare System linked to Six other National study sites. Healthcare system employees and patients, North Carolina residents and bordering counties. Atrium enrolled >12,000 participants, with over 65,000 participants enrolled nationally. Results: Key barriers: missing email communications, incorrectly entered participant information, participant fatigue due to longevity of study, use and return of serology kits. Facilitators: developing appropriate tailored messaging, preemptive communication for pending and failed validations, and development of "Unsubscribe" or "Paused" statuses. Proactive strategies kept the "Pending" enrollment below 10% and "Failed Validation" below 1% of total enrollees. The "Unsubscribe" option allowed withdraw rates to stay below 1% while the unsubscribe rate stayed below 10%. Tailored messaging supported the return of ~79% of test kits with ~43% of missing kits recovered. Conclusions: Large participant enrollment and data accrual resulted in the need for creative approaches to trouble shooting "big data" challenges associated with the rapid start-up of a high enrolling COVID -19 surveillance study. Preemptive messaging and anticipating participants' needs enhanced enrollment, participation and retention.

Enhancing participant diversity during recruitment for a national COVID-19 surveillance study using stakeholder engagement.

In May 2020 A COVID-19 Community Research Partnership, a surveillance study aimed at learning about the spread of the COVID-19 virus in local communities and among healthcare workers, began. Recognizing the disproportionate impact of COVID-19 on low-income and racial/ethnic minority groups, recruitment strategies that enabled diverse representation and engagement were used. We describe a community based participatory approach to engage a stakeholder advisory board to guide recruitment and data collection. Study Design was a community based participatory research study. Approximately 30 participants comprise the SAB. The study recruits participants from a large metropolitan area, and Atrium Health, a large, vertically integrated, not-for-profit healthcare system. Population Studied >12,000 community participants Outcome Measures recruitment and demographics of participants Results With SAB guidance we recruited >12,000 participants. The highly engaged stakeholders provided valuable input to guide the development of recruitment materials (¬flyers, emails, social media, websites, videos); use of incentives (free phones to complete the online symptom survey); and community outreach opportunities (primary care practices in underserved neighborhoods; COVID-19 mobile testing units located in underserved communities; mask giveaway events; and the local public school system) The SAB identified groups that the research team then partnered with to share information about the study (Village Heart BEAT, a community-based organization aimed at improving the health of African American and Hispanic populations; and HealthCare System employee affinity groups serving Hispanic/Latino and African American communities). Demographics include 90% White/Caucasian, 5% Black/African American; 3% Hispanic and 2% Asian or Pacific Islander; 38% are healthcare workers; 67% are female. Conclusions Use of a community stakeholder advisory board has enhanced understanding and participation in a COVID-19 Community Research Partnership. Engaging diverse community stakeholders early in the research process was essential for ensuring data collection efforts are patient-centered and tailored to reach diverse communities.

Comparing race and ethnicity across safety-net and non-safety net practices pre- and post-an HIV screening alert.

CONTEXT: Societal and economic burdens of human immunodeficiency virus (HIV) continue to grow, even as treatments and prevention for this disease becomes more readily available and efficacious. HIV screening is more likely to be performed in minority (including Black) patient populations compared to whites. The likelihood of getting screened also depends on primary care practice attributes. OBJECTIVE: Evaluate HIV screening demographics by safety-net and non-safety net practices. STUDY DESIGN and ANALYSIS: Pre-post analysis. SETTING: Atrium Health is a non-profit, vertically integrated healthcare system with approximately 16 million patient encounters per year across the Southeast US. POPULATION STUDIED: Twelve primary care practices, including four safety-net practices serving predominantly Medicaid and uninsured patients, with over 115,00 patients between the ages of 18 and 64 were selected for the educational intervention. INTERVENTION/INSTRUMENT: A system-wide electronic medical record alert prompting HIV screening was implemented in October 2017 targeting adults between 18-64 years old. In addition to the system alert, a provider peer-to-peer educational program detailing HIV disease epidemiology, screening recommendations, and algorithms to guide screening efforts was developed. OUTCOME MEASURES: HIV screenings. RESULTS: From October 2016- April 2017, 3,413 patients were screened for HIV at the twelve participating primary care practices. Immediately after the HIV alert activation, from October 2017 - April 2018, 6,256 patients were screened, resulting in an 83% increase in screening. However, increases were different based on practice type, race and ethnicity. Black patients in safety net clinics had higher screening rates prior to the alert and showed less of an increase in screening (37%) compared to whites (102%) after the alert was activated. Hispanic/Latino patients showed similar increases at both safety net (99%) and non-safety net (108%) practices. Both Black and white patients showed larger increases of 99% and 139% in non-safety net clinics. Chi-squared analysis comparing the percentage of patients screened during these time periods was significantly different (p=0.001). CONCLUSION: While race and practice characteristics influence the likelihood of HIV screening, EMR modifications and provider education can significantly enhance screening and care for patients with HIV regardless of race and practice type.

Protocol for a two-arm pragmatic stepped-wedge hybrid effectiveness-implementation trial evaluating Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship (ENCOMPASS).

BACKGROUND: Sepsis survivors experience high morbidity and mortality, and healthcare systems lack effective strategies to address patient needs after hospital discharge. The Sepsis Transition and Recovery (STAR) program is a navigator-led, telehealth-based multicomponent strategy to provide proactive care coordination and monitoring of high-risk patients using evidence-driven, post-sepsis care tasks. The purpose of this study is to evaluate the effectiveness of STAR to improve outcomes for sepsis patients and to examine contextual factors that influence STAR implementation. METHODS: This study uses a hybrid type I effectiveness-implementation design to concurrently test clinical effectiveness and gather implementation data. The effectiveness evaluation is a two-arm, pragmatic, stepped-wedge cluster randomized controlled trial at eight hospitals in North Carolina comparing clinical outcomes between sepsis survivors who receive Usual Care versus care delivered through STAR. Each hospital begins in a Usual Care control phase and transitions to STAR in a randomly assigned sequence (one every 4 months). During months that a hospital is allocated to Usual Care, all eligible patients will receive usual care. Once a hospital transitions to STAR, all eligible patients will receive STAR during their hospitalization and extending through 90 days from discharge. STAR includes centrally located nurse navigators using telephonic counseling and electronic health record-based support to facilitate best-practice post-sepsis care strategies including post-discharge review of medications, evaluation for new impairments or symptoms, monitoring existing comorbidities, and palliative care referral when appropriate. Adults admitted with suspected sepsis, defined by clinical criteria for infection and organ failure, are included. Planned enrollment is 4032 patients during a 36-month period. The primary effectiveness outcome is the composite of all-cause hospital readmission or mortality within 90 days of discharge. A mixed-methods implementation evaluation will be conducted before, during, and after STAR implementation. DISCUSSION: This pragmatic evaluation will test the effectiveness of STAR to reduce combined hospital readmissions and mortality, while identifying key implementation factors. Results will provide practical information to advance understanding of how to integrate post-sepsis management across care settings and facilitate implementation, dissemination, and sustained utilization of best-practice post-sepsis management strategies in other heterogeneous healthcare delivery systems. TRIAL REGISTRATION: NCT04495946 . Submitted July 7, 2020; Posted August 3, 2020.

A Multidisciplinary Diabetes Clinic Improves Clinical and Behavioral Outcomes in a Primary Care Setting.

The percentage of adults achieving hemoglobin A1c goals less than 7% remains a challenge. The study objective was to evaluate effects of a multidisciplinary approach on behavioral outcomes and mean change in A1c in immediate start (intervention) versus 6-month delay (control) groups at 6 months. The study assessed 111 patients recruited from a safety-net primary care clinic with a pharmacist-led multidisciplinary team and found that the intervention improved mean A1c outcomes for patients with type 2 diabetes. A1c values were measured every 3 months, and a self-efficacy scale to measure behaviors was evaluated at baseline and 6 months. After 6 months from baseline, the intervention group showed an A1c decrease of 2.4 compared with the control group's 1.1 decrease. Mean increase in self-efficacy score in the intervention group at baseline versus after 6 months showed a statistically significant change (P = .01) compared with the control group (P = .26). Results revealed a post hoc association between A1c and PHQ-9 such that patients with higher baseline PHQ-9 scores experienced greater mean decrease in A1c. In the immediate start arm, mean A1c values decreased from 10.6 at baseline to 7.7 at month 12. For the delayed intervention group, mean A1c values decreased from 10.2 at baseline to 9.0 after 6 months.

Racial Disparities in Prostate Specific Antigen Screening and Referral to Urology in a Large, Integrated Health Care System: A Retrospective Cohort Study.

PURPOSE: Contemporary trends and racial disparities in prostate cancer screening and referral to urology for prostate cancer risk are not well characterized, despite consensus that Black men are at higher risk for poor prostate cancer outcomes. The objective of this study was to characterize current racial disparities in prostate cancer screening and referral from primary care to urology for prostate cancer concern within our large, integrated health care system. MATERIALS AND METHODS: This retrospective cohort study used data from Atrium Health's enterprise data warehouse, which includes patient information from more than 900 care locations across North Carolina, South Carolina and Georgia. We included all men seen in the ambulatory or outpatient setting between 2014 and 2019 who were ≥40 years old. Clinical and demographic data were collected for all men, including age and race. Racial outcomes were reported for all groups with >2% representation in the population. Between-group comparisons were determined using chi-squared analysis, Wilcoxon rank sum testing and multivariable logistic regression, with significance defined as p <0.05. RESULTS: We observed a significant decrease in prostate specific antigen testing across all age and racial groups in a cohort of 606,985 men at Atrium Health, including 87,189 Black men, with an overall relative decline of 56%. As compared to White men, Black men were more likely to undergo prostate specific antigen testing (adjusted OR 1.24, 95% CI 1.22-1.26) and be referred to urology for prostate cancer (adjusted OR 1.94, 95% CI 1.75-2.16). CONCLUSIONS: There was a continued significant decline in prostate cancer screening between 2014 and 2019. Despite having modestly elevated odds of being screened for prostate cancer compared to White men, Black men are relatively underscreened when considering that those who undergo prostate specific antigen screening are more likely to be referred by primary care to urology for additional prostate cancer diagnostic evaluation.

Using the Consolidated Framework for Implementation Research (CFIR) to evaluate implementation effectiveness of a facilitated approach to an asthma shared decision making intervention.

OBJECTIVE: To describe the evaluation of implementation effectiveness of an asthma shared decision making (SDM) intervention at the 10 individual facilitator-led primary care practices in the ADAPT-NC Study using the Consolidated Framework for Implementation Research (CFIR). METHODS: Practices were scored across 40 CFIR constructs within 5 domains using a previously published scoring system of -2 to +2. Based on overall construct scores, practices were then classified as high, medium, or low adopters. To evaluate clinical outcomes, changes in asthma exacerbations were assessed for emergency department (ED) visits, hospitalizations, and oral steroid prescription orders. Using regression analysis, the absolute change in percent for each outcome relative to the CFIR score for each practice was analyzed. (Trial registration #NCT02047929). RESULTS: Implementation effectiveness was reflected in CFIR score differences with 7 high, 1 medium, and 2 low adopter practices. High adopters mostly scored well across all domains. Weaknesses were consistent amongst the 2 low adopters with lower scores in the Inner Setting, Characteristics of Individuals, and Process domains. While no significant correlations were seen between the practices' CFIR scores and the absolute change in ED visits, hospitalizations, or oral steroid prescription orders, practices with higher percentages of children had greater improvements in clinical outcomes. CONCLUSIONS: The CFIR was used to evaluate the asthma SDM intervention implementation at 10 facilitator-led practices. While there was no significant correlation between higher implementation effectiveness and greater improvement in clinical outcomes, practices with a higher proportion of pediatric patients did experience a significant reduction in overall exacerbations post-implementation.

A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial.

BACKGROUND: Asthma prevalence, morbidity, and mortality disproportionately impact African American/Black (AA/B) and Hispanic/Latinx (H/L) communities. Adherence to daily inhaled corticosteroid (ICS), recommended by asthma guidelines in all but the mildest cases of asthma, is generally poor. As-needed ICS has shown promise as a patient-empowering asthma management strategy, but it has not been rigorously studied in AA/B or H/L patients or in a real-world setting. Design and Aim The PeRson EmPowered Asthma RElief (PREPARE) Study is a randomized, open-label, pragmatic study which aims to assess whether a patient-guided, reliever-triggered ICS strategy called PARTICS (Patient-Activated Reliever-Triggered Inhaled CorticoSteroid) can improve asthma outcomes in AA/B and H/L adult patient populations. In designing and implementing the study, the PREPARE research team has relied heavily on advice from AA/B and H/L Patient Partners and other stakeholders. Methods PREPARE is enrolling 1200 adult participants (600 AA/Bs, 600H/Ls) with asthma. Participants are randomized to PARTICS + Usual Care (intervention) versus Usual Care (control). Following a single in-person enrollment visit, participants complete monthly questionnaires for 15 months. The primary endpoint is annualized asthma exacerbation rate. Secondary endpoints include asthma control; preference-based quality of life; and days lost from work, school, or usual activities. Discussion The PREPARE study features a pragmatic design allowing for the real-world assessment of a patient-centered, reliever-triggered ICS strategy in AA/B and H/L patients. Outcomes of this study have the potential to offer powerful evidence supporting PARTICS as an effective asthma management strategy in patient populations that suffer disproportionately from asthma morbidity and mortality.

Protocol Summary of the COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) Validation in Primary Care Study.

Chronic obstructive pulmonary disease (COPD) often remains undiagnosed and untreated. To date, COPD screening/case finding has not been designed to identify clinically significant COPD, disease ready for therapies beyond smoking cessation. Herein, we describe the ongoing prospective, pragmatic cluster-randomized controlled trial to assess specificity and sensitivity of the COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) tool consisting of 5 questions and peak expiratory flow. The tool is designed to identify clinically significant COPD (forced expiratory volume in 1 second [FEV1] to forced vital capacity [FVC] ratio <.70 plus FEV1% predicted <60% or increased risk for exacerbation) and the trial will explore the impact of CAPTURE-based screening on COPD diagnosis and treatment rates in primary care patients. Of a total planned enrollment of 5000 English- or Spanish-speaking patients 45 to 80 years of age without a prior COPD diagnosis from 100 primary care practices, a total of 68 practices and 3064 patients have been enrolled in the study. Practices are centrally randomized to either usual care or clinician receipt of patient-level CAPTURE results. All clinicians receive basic COPD education with those in intervention practices also receiving CAPTURE interpretation education. In a single visit, patient participants complete a CAPTURE screening, pre- and post-bronchodilator spirometry and baseline demographic and health questionnaires to validate CAPTURE sensitivity, specificity, and predictive value of identifying undiagnosed, clinically significant COPD. One-year follow-up chart reviews and participant surveys assess the impact of sharing versus not sharing CAPTURE results with clinicians on clinical outcomes including level of respiratory symptoms and events and clinicians' initiation of recommendation-concordant COPD care. This is one of the first U.S. studies to validate and assess impact of a simple COPD screening tool in primary care.

Reliability of Peer Review of Abstracts Submitted to Academic Family Medicine Meetings.

PURPOSE: To assess the reliability of peer review of abstracts submitted to academic family medicine meetings in North America. METHODS: We analyzed reviewer ratings of abstracts submitted: 1) as oral presentations to the North American Primary Care Research Group (NAPCRG) meeting from 2016 to 2019, as well as 2019 poster session or workshop submissions; and 2) in 12 categories to the Society of Teachers of Family Medicine (STFM) Spring 2018 meeting. In each category and year, we used a multi-level mixed model to estimate the abstract-level intraclass correlation coefficient (ICC) and the reliability of initial review (using the abstract-level ICC and the number of reviewers per abstract). RESULTS: We analyzed review data for 1554 NAPCRG oral presentation abstracts, 418 NAPCRG poster or workshop abstracts, and 1145 STFM abstracts. Across all years, abstract-level ICCs for NAPCRG oral presentations were below 0.20 (range, 0.10 in 2019 to 0.18 in 2016) and were even lower for posters and workshops (range, 0.00-0.10). After accounting for the number of reviewers per abstract, reliabilities of initial review for NAPCRG oral presentations ranged from 0.24 in 2019 to 0.30 in 2016 and 0.00 to 0.18 for posters and workshops in 2019. Across 12 STFM submission categories, the median abstract-level ICC was 0.21 (range, 0.12-0.50) and the median reliability was 0.42 (range, 0.25-0.78). CONCLUSIONS: For abstracts submitted to North American academic family medicine meetings, inter-reviewer agreement is often low, compromising initial review reliability. For many submission categories, program committees should supplement initial review with independent postreview assessments.

The Changing Face of Primary Care Research and Practice-Based Research Networks (PBRNs) in Light of the COVID-19 Pandemic.

The COVID-19 outbreak is a stark reminder of the ongoing challenge of emerging and reemerging disease, the human cost of pandemics and the need for robust research.1 For primary care, the advent of COVID-19 has forced an unprecedented wave of practice change. In turn, Practice-Based Research Networks (PBRNs) must rapidly pivot to address the changing environment and the critical challenges faced by primary care. The pandemic has also impacted the ability of PBRNs to deploy traditional research methods such as face-to-face patient and provider interactions, practice facilitation, and stakeholder engagement. Providers need more relevant, patient-centered evidence and the skills to effect change. These skills will become more important than ever as primary care practices evolve in response to the current COVID-19 pandemic and the disparities in health outcomes highlighted by COVID-19 and the global Black Lives Matter social movement for justice. Throughout this issue, authors detail the work conducted by PBRNs that demonstrate many of these evolving concepts. Articles explore how PBRNs can evaluate COVID-19 in primary care, the role of PBRNs in quality improvement, stakeholder engagement, prevention and chronic care management, and patient safety in primary care.

Evaluation of a shared decision-making intervention for pediatric patients with asthma in the emergency department.

BACKGROUND: Asthma is a difficult-to-manage chronic disease marked with associated outcome disparities including an increase rate of emergency department (ED) visits for uncontrolled asthma among patients who are most at-risk. Shared decision making (SDM) is a process by which the patient and provider jointly make a healthcare choice. SDM improves patient outcomes; however, implementation barriers of time constraints and staff availability are limitations. The use of health IT solutions may increase the adoption of SDM, but best practices for implementation are not well understood. The Consolidated Framework for Implementation Research (CFIR) is a flexible comprehensive model used to identify barriers and facilitators influencing implementation. The goal of this study is to implement an innovative web-based pediatric SDM tool in the real-world setting of two large healthcare system EDs through the following aims: (1) convene a patient, research, and ED stakeholder advisory board to oversee review of protocol and study materials prior to implementation, (2) implement the SDM intervention where providers and staff will be trained to incorporate use of this SDM intervention, (3) conduct on-going evaluation of barriers, facilitators, and implementation outcomes to tailor implementation in the EDs, (4) evaluate patient-centered outcomes of primary care utilization and changes in ED visits and hospitalizations before and after the SDM intervention, and (5) understand and document best practices for ED implementation. METHODS: The CFIR model will guide the implementation evaluation. Researchers will administer surveys to the clinical team and patients at baseline, 3, 6, and 12 months to inform implementation design, determine barriers and facilitators, and resource-needs to allow for real-time process adjustments within the EDs. Focus group or key-informant interviews and analysis will provide additional feedback to the stakeholder team to iterate the implementation process. Researchers will track patient-centered outcomes including increased primary care, ED, and inpatient utilization over the duration of the study. DISCUSSION: To advance asthma care and the field of implementation science, further research is needed to assess best practices for incorporating SDM into high-need healthcare settings such as the ED. This knowledge will facilitate improved outcomes and appropriate policy changes towards further use of SDM interventions in local and national acute care settings.