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.

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.

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).

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.

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.

Patient and care team perspectives on an app to support Hospital at Home admission decision making.

BACKGROUND: Hospital at Home (HaH) programs are used throughout the United States and are beneficial in both providing patients care in environments most comfortable to them and freeing up inpatient beds. Better informing patients about HaH programs, while promoting shared decision-making (SDM), should be prioritized by health systems. SDM apps may promote increased patient agency and understanding of complex HaH care decisions. We previously developed, usability tested, and refined a HaH SDM app. OBJECTIVES: To evaluate the utility of SDM apps in assisting pneumonia patients with HaH admission. METHODS: Usability surveys (N = 16) and semistructured interviews with patients (N = 9) and nurse navigators (N = 3) were utilized to evaluate our app in assisting pneumonia patients as they contemplated HaH admission. Recruitment occurred at three hospitals in the southeastern United States. Surveys were analyzed consistent with their validated measures, while interviews were analyzed using inductive coding methodologies. RESULTS: Patients supported receiving HaH information via an app, with many noting that presenting content via multiple modalities (e.g., videos, pictures, text) was helpful and that the app assisted their care decision. App-guided inquiries into patients' care preferences helped patients visualize their priorities and promoted feelings of agency, while providing important information to care teams. Participants found visuals effective at conveying program details, for example, HaH's in-home setup, which may assist with health literacy challenges. Potential barriers included the need to expand app accessibility for vision impaired and non-English speaking patients. CONCLUSIONS: SDM apps may better inform patients' HaH care decisions, allowing patients self-directed access to information and engagement with visual content, which may address challenges related to health literacy and navigating complex, time-sensitive decisions.

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.

Patient and Family Engagement in the Design of a Mobile Health Solution for Pediatric Asthma: Development and Feasibility Study.

BACKGROUND: Asthma is a highly prevalent, chronic disease with significant morbidity, cost, and disparities in health outcomes. While adherence to asthma treatment guidelines can improve symptoms and decrease exacerbations, most patients receive care that is not guideline-based. New approaches that incorporate shared decision-making (SDM) and health information technology (IT) are needed to positively impact asthma management. Despite the promise of health IT to improve efficiency and outcomes in health care, new IT solutions frequently suffer from a lack of widespread adoption and do not achieve desired results, as a consequence of not involving end-users in design. OBJECTIVE: To describe a case study of a pediatric asthma SDM health IT solution's development and demonstrate a methodology for engaging actual patients and families in IT development. Perspectives are shared from the vantage point of the research team and a parent of a child with asthma, who participated on the development team. METHODS: We adapted user-centric design principles to engage actual users across three main development phases: project initiation, ideation, and usability testing. To facilitate the necessary level of user engagement, our approach included: (1) a Development Workgroup consisting of patients, caregivers, and providers who met regularly with the research team; and (2) "real-world users" consisting of patients, caregivers, and providers recruited from a variety of care locations, including safety-net clinics. RESULTS: Using this methodology, we successful partnered with asthma patients and families to create an interactive, digital solution called Carolinas Asthma Coach. Carolinas Asthma Coach incorporates SDM principles to elicit patient information, including goals and preferences, and provides health-literate, tailored education with specific guideline-based recommendations for patients and their providers. Of the patients, caregivers, and providers surveyed, 100% (n=60) said they would recommend Carolinas Asthma Coach to a friend or colleague. Qualitative feedback from users provided support for the usability and engaging nature of the app. CONCLUSIONS: This project demonstrates the feasibility and benefits of deploying user-centric design methods that engage real patients and caregivers throughout the health IT design process.

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.

Planning for Action: The Impact of an Asthma Action Plan Decision Support Tool Integrated into an Electronic Health Record (EHR) at a Large Health Care System.

INTRODUCTION: Asthma is a chronic airway disease that can be difficult to manage, resulting in poor outcomes and high costs. Asthma action plans assist patients with self-management, but provider compliance with this recommendation is limited in part because of guideline complexity. This project aimed to embed an electronic asthma action plan decision support tool (eAAP) into the medical record to streamline evidence-based guidelines for providers at the point of care, create individualized patient handouts, and evaluate effects on disease outcomes. METHODS: eAAP development occurred in 4 phases: web-based prototype creation, multidisciplinary team engagement, pilot, and system-wide dissemination. Medical record and hospital billing data compared frequencies of asthma exacerbations before and after eAAP receipt with matched controls. RESULTS: Between December 2012 and September 2014, 5174 patients with asthma (∼10%) received eAAPs. Results showed an association between eAAP receipt and significant reductions in pediatric asthma exacerbations, including 33% lower odds of requiring oral steroids (P < .001), compared with controls. Equivalent adult measures were not statistically significant. CONCLUSIONS: This study supports existing evidence that patient self-management plays an important role in reducing asthma exacerbations. We show the feasibility of leveraging technology to provide guideline-based decision support through an eAAP, addressing known challenges of implementation into routine practice.