BREATHE: An efficacy-implementation trial of a brief shared decision making intervention among Black adults with uncontrolled Asthma in Federally Qualified Health Centers (FQHC).

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Background and Rationale: Black adults with asthma are an appropriate target for shared decision-making (SDM) interventions that support disease self-management as they experience a higher asthma burden and worse clinical outcomes than non-black adults and/or children with asthma of any racial-ethnic background. To date, the application of SDM and community-based interventions targeting black adults have failed to address these disparities. Therefore, we used patient input to develop BREATHE - BRief intervention to Evaluate Asthma THErapy – a 9-minute SDM intervention focused on reducing the impact of erroneous beliefs on asthma control - and established its efficacy in this health disparity population. Our intervention is unique in that is a one-time brief, tailored intervention integrated into office visits, using the patient's own provider as the interventionist (e.g. scalable). Our pilot trial demonstrated high fidelity to BREATHE delivery and improved asthma control and reduced symptoms among BREATHE participants compared to a dose-matched attention control condition. Objective: We propose an efficacy-implementation trial to: (1) evaluate systematically the efficacy of BREATHE in 200 black adults receiving care at urban federally qualified health centers (FQHCs) for uncontrolled asthma; and (2) identify multi-level barriers and facilitators to the widespread adoption and implementation of BREATHE. Hypotheses: Hyp 1.1 (primary outcome): Over 1 year, relative to controls, BREATHE participants will have significantly better asthma control as measured by higher scores on the Asthma Control Questionnaire. Hyp 1.2 (secondary outcomes): Over 1 year, relative to controls, BREATHE participants will have significantly better (a) SDM scores, (b) ICS adherence, (c) asthma and ICS beliefs, (d) asthma quality of life; and significantly lower rates of (e) asthma exacerbations, (f) symptoms days, (g) nights woken, (h) activity limitations, (i) shortness of breath, (j) wheeze, and (k) rescue medicine use. Methods: We will enroll 200 black adults with uncontrolled asthma from 2 New York City and 2 New Jersey urban FQHCs. Using a group-randomized design, clinicians in the FQHCs will be randomized to either BREATHE or a dose- matched attention control condition and trained to deliver the 9-minute active or control intervention during clinic visits. We will follow patient participants for 12-months post-treatment. For the process evaluation, which uses all dimensions of RE-AIM and all CFIR constructs together, we will collect qualitative and quantitative data from patient participants, their loved ones and providers. Together with stakeholders, we will develop strategies for the widespread implementation of BREATHE informed by our clinical efficacy and implementation results. Significance: The study has high public health significance because (1) it targets a population impacted greatly by asthma in unique care settings, (2) it concurrently targets the influence of asthma and treatment beliefs on asthma control, (3) it offers a highly scalable intervention, and (4) it bridges a gap between research and practice by identifying factors associated with implementation.