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

背景和理由：患有哮喘的黑人成年人是共同决策的合适目标 (SDM)支持疾病自我管理的干预措施，因为他们经历了更高的哮喘负担和 与患有任何种族背景的哮喘的非黑人成年人和/或儿童相比，临床结果更差。至 迄今为止，针对黑人成年人的SDM和基于社区的干预措施的应用未能解决 这些差异。因此，我们使用患者的输入来开发呼吸短暂干预来评估 哮喘治疗-9分钟的SDM干预，重点是减少错误信念对 哮喘控制--并在这一健康差距人群中确立了其有效性。我们的干预是独一无二的 这是一种一次性的短暂、量身定做的干预措施，集成到办公室访问中，使用患者自己的提供者作为 干预主义者(例如，可扩展的)。我们的飞行员试验显示，呼吸交付的高保真度和改进 与剂量匹配的注意相比，呼吸参与者的哮喘控制和症状减轻 控制条件。目的：我们提出了一种疗效-实施试验：(1)系统地评价 在城市联邦合格卫生中心(FQHC)接受护理的200名黑人成年人呼吸的疗效 不受控制的哮喘；以及(2)确定广泛采用和推广的多层次障碍和促进者 实施呼吸。假设：Hyp 1.1(主要结果)：相对于对照组，超过1年， 呼吸参与者将有明显更好的哮喘控制，通过在 哮喘控制问卷。Hyp 1.2(次要结果)：1年以上，相对于对照组，呼吸 参与者将有明显更好的(A)SDM得分，(B)ICS坚持，(C)哮喘和ICS信念，(D) 哮喘的生活质量；显著降低(E)哮喘加重、(F)症状白天、(G)夜间的发生率 唤醒、(H)活动受限、(I)呼吸短促、(J)喘息和(K)抢救药物使用。方法：我们 将从纽约市和新泽西州的两个城市FQHC招收200名患有无法控制的哮喘的黑人成年人。 使用分组随机设计，FQHC中的临床医生将随机选择呼吸或剂量- 与注意力控制条件相匹配，并接受培训以提供9分钟的积极或控制干预 去诊所就诊。我们将在治疗后12个月跟踪观察患者参与者。用于流程评估，即 使用RE-AIM的所有维度和所有CFIR结构，我们将收集定性和定量 来自患者参与者、他们的亲人和提供者的数据。与利益相关者一起，我们将发展 从我们的临床疗效和信息了解广泛实施呼吸的策略 实施效果。意义：这项研究具有很高的公共卫生意义，因为(1)它针对的是 在独特的护理环境中受哮喘影响很大的人群，(2)它同时针对 哮喘和对哮喘控制的治疗信念，(3)它提供了高度可扩展的干预，以及(4)它连接了 通过确定与实施相关的因素，研究和实践之间的差距。

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.