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.).

Pre-implementation planning for a sepsis intervention in a large learning health system: a qualitative study.

BACKGROUND: Sepsis survivors experience high morbidity and mortality. Though recommended best practices have been established to address the transition and early post hospital needs and promote recovery for sepsis survivors, few patients receive recommended post-sepsis care. Our team developed the Sepsis Transition and Recovery (STAR) program, a multicomponent transition intervention that leverages virtually-connected nurses to coordinate the application of evidence-based recommendations for post-sepsis care with additional clinical support from hospitalist and primary care physicians. In this paper, we present findings from a qualitative pre-implementation study, guided by the Consolidated Framework for Implementation Research (CFIR), of factors to inform successful STAR implementation at a large learning health system prior to effectiveness testing as part of a Type I Hybrid trial. METHODS: We conducted semi-structured qualitative interviews (n = 16) with 8 administrative leaders and 8 clinicians. Interviews were transcribed and analyzed in ATLAS.ti using a combination deductive/inductive strategy based on CFIR domains and constructs and the Constant Comparison Method. RESULTS: Six facilitators and five implementation barriers were identified spanning all five CFIR domains (Intervention Characteristics, Outer Setting, Inner Setting, Characteristics of Individuals and Process). Facilitators of STAR included alignment with health system goals, fostering stakeholder engagement, sharing STAR outcomes data, good communication between STAR navigators and patient care teams/PCPs, clinician promotion of STAR with patients, and good rapport and effective communication between STAR navigators and patients, caregivers, and family members. Barriers of STAR included competing demands for staff time and resources, insufficient communication and education of STAR's value and effectiveness, underlying informational and technology gaps among patients, lack of patient access to community resources, and patient distrust of the program and/or health care. CONCLUSIONS: CFIR proved to be a robust framework for examining facilitators and barriers for pre-implementation planning of post-sepsis care programs within diverse hospital and community settings in a large LHS. Conducting a structured pre-implementation evaluation helps researchers design with implementation in mind prior to effectiveness studies and should be considered a key component of Type I hybrid trials when feasible. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04495946 . Registered August 3, 2020.

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.

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.

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.

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.

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.

Research nurses as practice facilitators to disseminate an asthma shared decision making intervention.

BACKGROUND: Practice facilitation is a method of introducing and sustaining organizational change. It involves the use of skilled healthcare professionals called practice facilitators (PFs) to help address the challenges associated with implementing evidence-based guidelines and complex interventions into practice. PFs provide a framework for translating research into practice by building relationships, improving communication, fostering change, and sharing resources. Nurses are well positioned to serve as PFs for the implementation of complex interventions, however, there is little evidence currently available to describe nurses in this role. Additionally, the best strategies to implement complex interventions into practices are still not fully understood. Combining practice facilitation with the train-the-trainer model has the potential to spread knowledge and skills. Shared decision making (SDM), which involves patients and providers jointly engaging in decisions around treatment options, has been shown to improve outcomes for patients with asthma. The goal of this manuscript is to describe and evaluate the practice facilitation process from the ADAPT-NC Study which successfully utilized research nurses to implement a complex asthma SDM toolkit intervention into primary care practices. METHODS: As part of a larger study, 10 primary care practices were recruited for a facilitator-led dissemination intervention involving a 12-week rollout of an asthma SDM toolkit (trial registration: 1.28.2014, #NCT02047929). An experienced lead PF trained research nurses as PFs from each of the 4 participating practice-based research networks (PBRNs) in a train-the-trainer model utilizing a one-day training event and subsequent remote meetings. Evaluation of PF engagement was measured through process improvement surveys. RESULTS: Overall, the asthma SDM intervention was successfully implemented within the 4 PBRNs. All 10 facilitator-led practices remained engaged with their PFs, with 8 out of the 10 practices able to incorporate and sustain SDM visits or clinics. Responses from the surveys for process improvement yielded improved PF communication and team dynamics over time. CONCLUSIONS: This study demonstrated effective use of research nurses as practice facilitators during the dissemination of an asthma SDM intervention into primary care practices, adding to the knowledge of best practices by describing a model of large-scale implementation of a complex intervention through practice facilitation with nurses. TRIAL REGISTRATION: "Comparing Traditional and Participatory Dissemination of a Shared Decision Making Intervention" was retrospectively registered at https://clinicaltrials.gov/ on January 28th, 2014 (NCT02047929).

Patient and provider perspectives on uptake of a shared decision making intervention for asthma in primary care practices.

OBJECTIVE: Poor outcomes and health disparities related to asthma result in part from difficulty disseminating new evidence such as shared decision making (SDM) into clinical practice. As part of a three-arm cluster randomized dissemination study, evaluation of the impact of different dissemination methods was studied. Here we evaluate themes from patient and provider focus groups to assess the impact of a facilitated, traditional dissemination approach, or no intervention, on patient and provider perspectives of asthma care. METHODS: Using semi-structured questions, twenty-four pre- and post-intervention focus groups with patients and providers took place across primary care practices. Discussions were held in all three arms both before and after the time of intervention rollout. Audio recordings were transcribed and analyzed for themes. RESULTS: Across all sites patients and providers discussed themes of communication, asthma self-management, barriers, education, and patient awareness. After the intervention, compared to traditional sites, facilitated practices were more likely to discuss themes related to SDM, such as patient-centered communication, patient-provider negotiation on treatment plan, planning, goal-setting, and solutions to barriers. CONCLUSIONS: Emergent themes allowed for further understanding of how the SDM implementation was perceived at the patient and provider level. The facilitated implementation was associated with higher adoption of the SDM intervention. These themes and supporting quotes add to knowledge of best practices associated with implementing an evidence-based SDM intervention for asthma into primary care and will inform researchers, practices, and providers as they work to improve adoption of evidence-based interventions into practice.

Asthma dissemination around patient-centered treatments in North Carolina (ADAPT-NC): a cluster randomized control trial evaluating dissemination of an evidence-based shared decision-making intervention for asthma management.

Objective: To compare three dissemination approaches for implementing an asthma shared decision-making (SDM) intervention into primary care practices. Methods: We randomized thirty practices into three study arms: (1) a facilitator-led approach to implementing SDM; (2) a one-hour lunch-and-learn training on SDM; and (3) a control group with no active intervention. Patient perceptions of SDM were assessed in the active intervention arms using a one-question anonymous survey. Logistic regression models compared the frequency of asthma exacerbations (emergency department (ED) visits, hospitalizations, and oral steroid prescriptions) between the three arms. Results: We collected 705 surveys from facilitator-led sites and 523 from lunch-and-learn sites. Patients were more likely to report that they participated equally with the provider in making the treatment decision in the facilitator-led sites (75% vs. 66%, p = 0.001). Comparisons of outcomes for patients in the facilitator-led (n = 1,658) and lunch-and-learn (n = 2,613) arms respectively vs. control (n = 2,273) showed no significant differences for ED visits (Odds Ratio [OR] [95%CI] = 0.77[0.57-1.04]; 0.83[0.66-1.07]), hospitalizations (OR [95%CI] = 1.30[0.59-2.89]; 1.40 [0.68-3.06]), or oral steroids (OR [95%CI] =0.95[0.79-1.15]; 1.03[0.81-1.06]). Conclusion: Facilitator-led dissemination was associated with a significantly higher proportion of patients sharing equally in decision-making with the provider compared to a traditional lunch-and-learn approach. While there was no significant difference in health outcomes between the three arms, the results were most likely confounded by a concurrent statewide asthma initiative and the pragmatic implementation of the intervention. These results offer support for the use of structured approaches such as facilitator-led dissemination of complex interventions into primary care practices.

Shared decision making and time to exacerbation in children with asthma.

Objective: Although shared decision making (SDM) is a promising approach for improving outcomes for patients with chronic diseases, no evidence currently supports the use of SDM to delay asthma exacerbations. We evaluated the impact of an SDM intervention implemented by providers in a real-world setting on time to exacerbation in children with asthma. Methods: This study used a prospective cohort observed between 2011 and 2013 at five primary care practices that serve vulnerable populations (e.g., Medicaid and uninsured patients) in Charlotte, NC. Patients aged 2 to 17 receiving SDM were matched to those receiving usual care using propensity scores. Time to asthma exacerbation (asthma hospitalization, emergency department visit or oral steroid prescription in the outpatient setting) was compared between groups using Kaplan-Meier curves and conditional Cox proportional hazards models. Results: The cohort included 746 children, 60.5% male and 54.2% African American, with a mean age of 8.6 years. Of these, 625 received usual care and 121 received SDM. The final analysis included 100 matched pairs of children. Kaplan-Meier curves showed longer exacerbation-free time for patients in the SDM intervention compared to those in usual care (p = 0.005). The difference in risk of experiencing an exacerbation was marginally significant between the two groups (HR = 0.56, 95% C.I. = 0.29-1.08, p = 0.08). Conclusions: SDM was found to delay exacerbations among children with asthma. Clinicians should consider incorporating patient preferences in treatment decisions through SDM as a means for longer exacerbation-free time among children with poor asthma control.

Impact of shared decision making on asthma quality of life and asthma control among children.

OBJECTIVE: Few studies have examined the effectiveness of shared decision making (SDM) in clinical practice. This study evaluated the impact of SDM on quality of life and symptom control in children with asthma. METHODS: We conducted a prospective 3-year study in six community-based practices serving a low-income patient population. Practices received training on SDM using an evidence-based toolkit. Patients aged 2-17 with a diagnosis of asthma were identified from scheduling and billing data. At approximate 6-month intervals, patients completed a survey consisting of the Mini Pediatric Asthma Quality of Life Questionnaire (range 1-7) and the control domain of the Pediatric Asthma Therapy Assessment Questionnaire (range 0-7). We used propensity scores to match 46 children receiving SDM to 46 children receiving usual care with decision support. Included children had completed a baseline survey and at least one follow-up survey. Random coefficient models incorporated repeated measures to assess the effect of SDM on asthma quality of life and asthma control. RESULTS: The sample was primarily of non-White patients (94.6%) with Medicaid insurance (92.4%). Receipt of SDM using an evidence-based toolkit was associated with higher asthma quality of life [mean difference 0.9; 95% confidence interval (CI) 0.4-1.4] and fewer asthma control problems (mean difference -0.9; 95% CI -1.6--0.2) compared to usual care with decision support. CONCLUSIONS: Implementation of SDM within clinical practices using a standardized toolkit is associated with improved asthma quality of life and asthma control for low-income children with asthma when compared to usual care with decision support.

Using Community-Based Participatory Research to Develop Geospatial Models Toward Improving Community Health for Disadvantaged Hispanic Populations in Charlotte, NC.

Hispanic immigrant communities across the U.S. experience persistent health disparities and barriers to primary care. We examined whether community-based participatory research (CBPR) and geospatial modeling could systematically and reproducibly pinpoint neighborhoods in Charlotte, North Carolina with large proportions of Hispanic immigrants who were at-risk for poor health outcomes and health disparities. Using a CBPR framework, we identified 21 social determinants of health measures and developed a geospatial model from a subset of those measures to identify neighborhoods with large proportions of Hispanic immigrant populations at risk for poor health outcomes. The geospatial model included four measures-poverty, English ability, acculturation and violent crime-which comprised our Hispanic Health Risk Index (HHRI). We developed a Primary Care Barrier Index (PCBI) to determine (1) how well the HHRI correlated with a statistically derived composite measure incorporating all 21 measures identified through the CBPR process as being associated with access to primary care; (2) whether the HHRI predicted primary care access as well as the statistically-derived composite measure in a statistical model; and (3) whether the HHRI identified similar neighborhoods as the statistically derived composite measure. We collapsed 17 of the 21 social determinants using principal components analysis to develop the PCBI. We determined the correlation of each index with inappropriate emergency department (ED) visits, a proxy for primary care access, using logistic generalized estimating equations. Results from logistic regression models showed positive associations of both the HHRI and the PCBI with the use of the ED for primary care treatable conditions. Enhanced by the knowledge of the local community, the CBPR process with geospatial modeling can guide the multi-tiered validation of social determinants of health and identify neighborhoods that are at-risk for poor health outcomes and health disparities.

Results from a pragmatic prospective cohort study: Shared decision making improves outcomes for children with asthma.

OBJECTIVE: Patient/provider shared decision making (SDM) improves asthma control in a pragmatic clinical trial setting. This study evaluated the impact of an evidence-based SDM toolkit on outcomes for patients with asthma implemented by providers in a real world setting. We hypothesized that these patients with asthma would demonstrate improved outcomes such as reduced emergency department (ED) visits, hospitalizations, and oral steroid use in the 12 months following a SDM visit compared to those who did not receive the intervention. METHODS: Patients with asthma were identified within six primary care practices that serve vulnerable populations in Charlotte, NC (746 children; 718 adult patients). Propensity scores were used to match 200 children and 206 adults for analysis. The primary outcome variable was asthma exacerbation defined as an ED visit or hospitalization for asthma or outpatient prescription of an oral steroid. Patients were monitored at 3, 6, and 12 months after the intervention date. The outcome variables of ED visits, hospitalizations, and oral steroids were compared between intervention and matched control patients. RESULTS: The proportion of pediatric patients with one or more exacerbations was significantly lower in the SDM intervention group compared to controls during 12 months after exposure to the intervention (33% vs. 47%, p = 0.023). For adults, there was not a strong association between use of the SDM intervention and outcomes improvement. CONCLUSIONS: The evidence-based SDM intervention implemented in this study was associated with improved asthma outcomes for pediatric patients but not adult patients in a real world clinical setting.

Patient perspectives on engagement in shared decision-making for asthma care.

Introduction: Engagement of patient and advocacy group stakeholders is increasingly considered essential to meaningful outcomes research. Patient-centred research benefits from partnership formation between patients, clinicians and research team members. Here, we describe the rationale for engaging patients on a research team and a case study of patient engagement on an asthma shared decision-making study. Methods: Here, we describe a case study of patient engagement in outcomes research and examine the variety of roles patients are engaged in and the associated impact on the study. Results: Patients assisted the project at various levels and were integrated into the research team by (i) advising on study development; (ii) assisting with design and usability of study materials, including the toolkit, patient surveys and dissemination strategies; and (iii) advocacy via membership in external disease-specific organizations and participating in outcomes research conferences. Patients were engaged both individually and as members of a patient advisory board. Primary lessons learned were the importance of building a trusting partnership with patients through understanding perspectives, being aware of clearly explaining patients' roles, research methods and jargon, providing training, listening to patients' needs and understanding what the partnership means from a patient perspective. Conclusions: For the case study described, patient engagement directly influenced multiple aspects of the study, including study design, implementation, data analysis and dissemination through incorporation of the patients' and caregivers' input and concerns.

The North American Primary Care Research Group's Patient and Clinician Engagement Program (PaCE): Demystifying patient engagement through a dyad model.

Background: Community engagement in research is essential for translating the best evidence into community and clinical practice to improve the health and well-being of the population. Objective: North American Primary Care Research Group's Patient and Clinician Engagement Program (PaCE) program aims to develop a robust community of patients and primary care providers with knowledge and understanding of the unique features of patient-centred outcomes research related to primary care in order to advocate for and engage in research. Methods: PaCE employs a 'dyad' model in which a patient and a primary care provider collaborate to learn about and engage in primary care, primary care research, grant review, proposal development and advocacy. A series of educational trainings held in conjunction with national primary care conferences, international webinars and local symposia make up the foundation of the PaCE curriculum. Results and Conclusions: To date, 186 participants have completed the full-day, interactive PaCE training, and more than 250 people have participated in PaCE webinars and/or symposia. A 6-month follow-up sent to PaCE participants evaluates engagement activities following training.

Patients' and providers' perceptions of asthma and asthma care: a qualitative study.

BACKGROUND: Differences in patients' and providers' perceptions of asthma and asthma care can create barriers to successful treatment. The primary goal of this qualitative study was to further explore patient and provider perceptions of asthma and asthma care as part of a larger Asthma Comparative Effectiveness Study. METHODS: Focus groups held every 6 months for 3 years were designed to have a mix of both patients and providers allowing for unique understanding around asthma care. RESULTS: The discussion centered on goal setting, asthma action plans and prevention strategies for asthma exacerbations. Three overarching themes, with a variety of subthemes, emerged as the main findings of this study. The three main themes were Cost/Economic Barriers/Process, Self-Governance/Adherence and Education. CONCLUSIONS: These themes indicated a strong need for patient educational interventions around asthma as well as education for providers around cost, insurance coverage and patient-centered communication. Specifically, education on learning to use inhalers properly, avoiding triggers and understanding the importance of a controller medication will benefit patients in the long-term management of asthma.