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.

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.

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.

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.

Novel Models to Identify Census Tracts for Hepatitis C Screening Interventions.

BACKGROUND: 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 United States are still believed to have undiagnosed HCV. Geospatial modeling using variables representing at-risk populations in need of screening for HCV and social determinants of health (SDOH) provide opportunities to identify populations at risk of HCV. METHODS: A literature review was conducted to identify variables associated with patients at risk for HCV infection. Two sets of variables were collected: HCV Transmission Risk and SDOH Level of Need. The variables were combined into indices for each group and then mapped at the census tract level (n = 233). Multiple linear regression analysis and the Pearson correlation coefficient were used to validate the models. RESULTS: A total of 4 HCV Transmission Risk variables and 12 SDOH Level of Need variables were identified. Between the 2 indexes, 21 high-risk census tracts were identified that scored at least 2 standard deviations above the mean. The regression analysis showed a significant relationship with HCV infection rate and prevalence of drug use (B = 0.78, P < .001). A significant relationship also existed with the HCV infection rate for households with no/limited English use (B = -0.24, P = .001), no car use (B = 0.036, P < .001), living below the poverty line (B = 0.014, P = .009), and median household income (B = -0.00, P = .009). CONCLUSIONS: Geospatial models identified high-priority census tracts that can be used to map high-risk HCV populations that may otherwise be unrecognized. This will allow future targeted screening and linkage-to-care interventions for patients at high risk of HCV.

What types of dissemination of information occurred between researchers, providers and clinical staff while implementing an asthma shared decision-making intervention: a directed content analysis.

OBJECTIVE: To qualitatively analyse different types of dissemination of information during monthly group calls between researchers, providers and clinical staff used to establish best practices for implementing an asthma shared decision-making (SDM) intervention. Evaluating dissemination of information can provide a better understanding of how best practices are shared, informing implementation approaches to improve the uptake of new evidence and overcome barriers. SETTING: 10 primary care practices in North Carolina. PARTICIPANTS: Providers and clinical staff participated in monthly group phone calls with researchers to share best practices during implementation of a SDM intervention for asthma patients. DESIGN: The research team transcribed and coded statements using content analysis into three different knowledge types: Knowledge Position, Knowledge Form and Knowledge Object. Knowledge Objects were further classified using directed content analysis where the research team interpreted the content objects through a classification process of identifying themes or patterns to describe three different types of dissemination of information: (A) Confirmation of Existing Knowledge, (B) Generation of New Knowledge and (C) Spreading of New Knowledge. RESULTS: Across the 8 transcripts, 4 Knowledge Positions, 7 Knowledge Forms and 18 types of Knowledge Objects were identified. From the Knowledge Objects, Confirmation of Existing Knowledge occurred during the training of participating practices. The review also identified Generation of New Knowledge by providers and clinical staff raised in these calls. This Generation of New Knowledge was later documented being used by other practices with the identification of Spreading of New Knowledge. CONCLUSION: The research team described the types of dissemination of information that occurred between researchers, providers and clinical staff during implementation of an asthma SDM intervention. Both Confirmation of Existing Knowledge and Generation of New Knowledge in response to barriers occurred. These exploratory dissemination of information results provide additional mechanisms for evaluating implementation science. TRIAL REGISTRATION NUMBER: NCT02047929; Post-results.

Electronic medical record alert activation increase hepatitis C and HIV screening rates in primary care practices within a large healthcare system.

Societal and economic burdens of hepatitis C virus (HCV) and human immunodeficiency virus (HIV) continue to grow. The Centers for Disease Control and Prevention recommends a one-time HCV screen for individuals in the Baby Boomer population (those born between 1945 and 1965) and a one-time HIV screen for all individuals between ages 13-64 years regardless of risk factors, with more frequent screening for both conditions based on individual risk factors. This study took place at Atrium Health, a healthcare system with approximately 12 million patient encounters per year. The aims of this study were to assess the impact of the HCV and HIV electronic medical record (EMR) alerts recently implemented on screening rates and linkage to care. Data were collected from 12 primary care practices. Implementation of EMR alerts increased HCV and HIV screening from 1,934 of 59,632 (3.2%) to 13,726 of 60,422 (22.7%) and 6,950 of 112,813 (6.2%) to 12,379 of 109,173 (11.3%) respectively. The HCV screening resulted in an increase of patients with antibody positive results having a subsequent RNA test from 68% (122/179) to 98% (430/442). 74 of 81 (91%) of HCV and 15 of 15 (100%) of HIV positive patients were linked into care. The addition of an EMR alert was associated with improved screening for HCV and HIV in primary care practices. Screening all patients decreases testing stigma since there is a lowered risk of disease transmission for those who test positive. However, post-intervention screening rates indicate further opportunities exist for additional interventions to increase screening rates.

Racial/ethnic differences in healthcare use among patients with uncontrolled and controlled diabetes.

OBJECTIVES: To examine racial/ethnic differences in healthcare use among patients classified as having controlled and uncontrolled diabetes. DESIGN: Data from the Carolinas HealthCare System electronic data warehouse were used. Glycemic control was defined as glycosylated hemoglobin (HbA1c) < 8% (64 mmol/mol) in 2012 (n = 9996). Patients with HbA1c ≥ 8% (64 mmol/mol) in 2012 were classified as uncontrolled (n = 2576). Race and ethnicity were jointly classified as non-Hispanic Black, non-Hispanic White or Other. Separate mixed effects negative binomial models estimated the independent effect of race/ethnicity on the number of emergency department (ED) visits, hospitalizations and physician office visits in 2013, in each patient group, adjusting for significant confounding variables. RESULTS: Rates of diabetes-related ED visits were two to three times higher for non-Hispanic Blacks compared to non-Hispanic Whites (uncontrolled rate ratio [RR]: 3.41 95% CI: 1.41-8.22; controlled RR: 2.95; 95% CI: 1.78-4.91). Similar differences were observed for all-cause ED visits (uncontrolled RR: 1.83, 95% CI: 1.50-2.24; controlled RR: 2.45, 95% CI: 2.17-2.77). Non-Hispanic Blacks with controlled and uncontrolled diabetes also had lower rates of all-cause physician office visits when compared to non-Hispanic Whites (uncontrolled RR: 0.84, 95% CI: 0.77-0.91; controlled RR: 0.81, 95% CI: 0.78-0.84). CONCLUSION: Notable racial/ethnic disparities exist in the use of emergency services and physician offices for diabetes care. Strategies such as patient education and care delivery changes that address healthcare access issues in racial/ethnic minorities should be considered to offer better diabetes management and address diabetes disparities.

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.

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.

Evaluation of a Pilot Asthma Care Program for Electronic Communication between School Health and a Healthcare System's Electronic Medical Record.

OBJECTIVE: Asthma is a common childhood chronic lung disease affecting greater than 10% of children in the United States. School nurses are in a unique position to close gaps in care. Indeed, effective asthma management is more likely to result when providers, family, and schools work together to optimize the patient's treatment plan. Currently, effective communication between schools and healthcare systems through electronic medical record (EMR) systems remains a challenge. The goal of this feasibility pilot was to link the school-based care team with primary care providers in the healthcare system network via electronic communication through the EMR, on behalf of pediatric asthma patients who had been hospitalized for an asthma exacerbation. The implementation process and the potential impact of the communication with providers on the reoccurrence of asthma exacerbations with the linked patients were evaluated. METHODS: By engaging stakeholders from the school system and the healthcare system, we were able to collaboratively design a communication process and implement a pilot which demonstrated the feasibility of electronic communication between school nurses and primary care providers. Outcomes data was collected from the electronic medical record to examine the frequency of asthma exacerbations among patients with a message from their school nurse. The percent of exacerbations in the 12 months before and after electronic communication was compared using McNemar's test. RESULTS: The pilot system successfully established communication between the school nurse and primary care provider for 33 students who had been hospitalized for asthma and a decrease in hospital admissions was observed with students whose school nurse communicated through the EMR with the primary care provider. CONCLUSIONS: Findings suggest a collaborative model of care that is enhanced through electronic communication via the EMR could positively impact the health of children with asthma or other chronic illnesses.

A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial.

Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH) services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32%) by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention, participants had a median of nine total documented contacts with PCMH providers compared to four in the control group. Three intervention and two control participants had controlled diabetes (hemoglobin A1C <9%). Multidisciplinary care that utilizes health coach-facilitated virtual visits is an intervention that could increase access to intensive primary care services in a vulnerable population. The methods tested are feasible and should be tested in a pragmatic randomized controlled trial to evaluate the impact on patient-relevant outcomes across multiple chronic diseases.

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.

Population pharmacokinetics of recombinant factor VIII Fc fusion protein.

Population pharmacokinetics (PK) of FVIII activity-time profiles following recombinant factor VIII Fc fusion protein (rFVIIIFc) and recombinant factor VIII (rFVIII) dosing were evaluated in previously treated patients with severe hemophilia A (from two clinical trials). Potential covariates that may be determinants of variability in FVIII activity were identified. A 2-compartment model adequately described the PK of both compounds. von Willebrand Factor (VWF) concentration was the major covariate for rFVIIIFc clearance, reflecting its protective role in FVIII activity clearance. The effect of body weight and hematocrit on the central volume of distribution of rFVIIIFc was minor. The results of these analyses confirmed that rFVIIIFc clearance (1.65 dL/h) is much lower than that of rFVIII (2.53 dL/h), while the steady state volumes of distribution were similar. The strong positive correlations between the PK parameters of rFVIIIFc and rFVIII suggest that individuals who have high time-related PK characteristics with rFVIII are likely to have comparable characteristics with rFVIIIFc. Steady-state activity-time profiles for selected rFVIIIFc dosing regimens were simulated accounting for uncertainty in model parameters. These population PK analyses and simulations provide a comprehensive characterization of the PK of rFVIIIFc and rFVIII and may be useful for designing dosing regimens.

Comparing traditional and participatory dissemination of a shared decision making intervention (ADAPT-NC): a cluster randomized trial.

BACKGROUND: Asthma is a common disease that affects people of all ages and has significant morbidity and mortality. Poor outcomes and health disparities related to asthma result in part from the difficulty of disseminating new evidence and care delivery methods such as shared decision making (SDM) into clinical practice. METHODS/DESIGN: This non-blinded study will randomize 30 primary care clinics in NC stratified by four PBRNs. We will test dissemination across these practices using a facilitator-led participatory approach to dissemination (FLOW), a novel method of participatory dissemination involving key principles of community-based participatory research, and a more typical "lunch and learn" dissemination method. Specifically, we will use cluster randomization to assign each of the 30 practices to one of three arms: (1) control, no dissemination; (2) traditional dissemination, one didactic session a year and distribution of educational material; and (3) FLOW dissemination. We hypothesize that at the unit of randomization, the clinic, patients in the FLOW dissemination arm will be more likely to share in their treatment decisions compared to patients in the traditional dissemination or control arms. All outcomes will be measured at the level of the clinic. Adoption of the SDM approach will be evaluated by 1) asthma exacerbations, 2) level of patient involvement in the decision making process, and 3) qualitative assessments from patients and providers. TRIAL REGISTRATION: The trial was registered on January 27, 2014 through the United States National Institutes of Health's ClinicalTrials.gov NCT02047929 and funded by the Patient-Centered Outcomes Research Institute (PCORI).

Population pharmacokinetic modelling of recombinant factor IX Fc fusion protein (rFIXFc) in patients with haemophilia B.

BACKGROUND AND OBJECTIVES: Recombinant factor IX Fc fusion protein (rFIXFc) is a clotting factor developed using monomeric Fc fusion technology to prolong the circulating half-life of factor IX. The objective of this analysis was to elucidate the pharmacokinetic characteristics of rFIXFc in patients with haemophilia B and identify covariates that affect rFIXFc disposition. METHODS: Population pharmacokinetic analysis using NONMEM(®) was performed with clinical data from two completed trials in previously treated patients with severe to moderate haemophilia B. Twelve patients from a phase 1/2a study and 123 patients from a registrational phase 3 study were included in this population analysis. RESULTS: A three-compartment model was found to best describe the pharmacokinetics of rFIXFc. For a typical 73 kg patient, the clearance (CL), volume of the central compartment (V 1) and volume of distribution at steady state (V ss) were 2.39 dL/h, 71.4 dL and 198 dL, respectively. Because of repeat pharmacokinetic profiles at week 26 for patients in a subgroup, inclusion of inter-occasion variability (IOV) on CL and V 1 were evaluated and significantly improved the model. The magnitude of IOV on CL and V 1 were both low to moderate (<20 %) and less than the corresponding inter-individual variability. Body weight (BW) was found to be the only significant covariate for rFIXFc disposition. However, the impact of BW was limited, as the BW power exponents on CL and V 1 were 0.436 and 0.396, respectively. CONCLUSION: This is the first population pharmacokinetic analysis that systematically characterized the pharmacokinetics of long-lasting rFIXFc in patients with haemophilia B. The population pharmacokinetic model for rFIXFc can be utilized to evaluate and optimize dosing regimens for the treatment of patients with haemophilia B.

Evaluating primary care delivery systems for an uninsured Hispanic immigrant population.

Hispanic populations experience disparities in health outcomes and health care. Using participatory methods, we evaluated 4 systems of primary care delivery for an uninsured Hispanic population. Best practices were determined that could be translated back to the partner clinics and the community. The assessment included patient service areas, provider discussion groups, patient surveys, calculation of travel distances, and costs. The following best practices were identified: improved proximity to services, enhanced bilingual services, affordable services, and integrated services. Researchers and providers not only identified translatable service delivery practices but also laid the foundation for ongoing research partnerships.