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

呼吸：在联邦合格健康中心 (FQHC) 中对哮喘不受控制的黑人成年人进行简短的共同决策干预的功效实施试验。

• 批准号: 10589146
• 负责人: MAUREEN GEORGE
• 金额: $ 47.56万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-06 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10589146
• 关键词: Address; Adherence; Adoption; Adrenal Cortex Hormones; Adult; Affect; Aftercare; Asthma; Belief; Black Populations; Black race; Caring; Centers for Population Health; Cessation of life; Child; Chronic Disease; Client; Clinic Visits; Clinical; Clinical Management; Clinical Trials; Communities; Consolidated Framework for Implementation Research; Couples; Data; Death Rate; Dimensions; Disease; Disparity; Dose; Enrollment; Ethnic Origin; Federally Qualified Health Center; Foundations; General Population; Goals; Hispanic; Hospitalization; Inhalation; Intervention; Knowledge; Low income; Measures; Medicine; Methods; New Jersey; New York City; Office Visits; Outcome; Participant; Patients; Population; Poverty; Prevalence; Protocols documentation; Provider; Public Health; Quality of life; Questionnaires; Race; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Research; Self Management; Shortness of Breath; Standardization; Symptoms; Time; Training; Treatment Efficacy; Underinsured; Uninsured; Visit; Wheezing; acceptability and feasibility; asthma exacerbation; attentional control; brief intervention; clinical application; clinical efficacy; clinical implementation; clinical practice; design; disparity reduction; effective therapy; efficacy testing; efficacy/implementation trial; experience; health disparity; health disparity populations; implementation study; improved; loved ones; patient engagement; pilot trial; post intervention; prevent; primary care provider; primary care setting; primary outcome; process evaluation; randomized trial; reduce symptoms; secondary outcome; shared decision making; trial comparing

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.

背景和理由：患有哮喘的黑人成年人是共同决策的适当目标 (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， 临床结果比非黑人成人和/或任何种族背景的哮喘儿童更差。到 迄今为止，SDM的应用和针对黑人成年人的社区干预措施未能解决 这些差异。因此，我们使用患者输入来开发呼吸- Brief干预，以评估 哮喘治疗-一个9分钟的SDM干预，重点是减少错误信念的影响， 哮喘控制-并确定其在这一健康差异人群中的疗效。我们的干预是独一无二的， 这是一个一次性的简短，定制的干预整合到办公室访问，使用病人自己的提供者作为 干预主义者（例如可扩展）。我们的试点试验证明了对BREATHE交付的高保真度， 与剂量匹配的关注相比，呼吸参与者的哮喘控制和症状减轻 控制条件目的：我们提出一个有效性实施试验：（1）系统地评价 呼吸在200名黑人成年人中的有效性， 不受控制的哮喘;（2）确定广泛采用的多层次障碍和促进因素， 呼吸的实现。假设：Hyp 1.1（主要结局）：超过1年，相对于对照组， 呼吸参与者将有显着更好的哮喘控制，如通过较高的得分来衡量。 哮喘控制问卷。Hyp 1.2（次要结局）：1年以上，相对于对照组，呼吸 参与者将具有显著更好的（a）SDM评分，（B）ICS依从性，（c）哮喘和ICS信念，（d） 哮喘生活质量;以及（e）哮喘急性发作、（f）症状日、（g）夜间的发生率显著降低 苏醒，（h）活动受限，（i）呼吸短促，（j）喘息，和（k）急救药物使用。方法：我们 将从2个纽约市和2个新泽西城市的哮喘控制中心招募200名患有哮喘控制不佳的成年黑人。 使用分组随机设计，在CIMCs的临床医生将被随机分配到呼吸或剂量- 匹配的注意力控制条件，并接受培训，以提供9分钟的主动或控制干预， 诊所访问。我们将在治疗后12个月对患者进行随访。对于过程评价， 使用RE-AIM和所有CFIR结构的所有维度，我们将收集定性和定量数据， 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，我们将开发 根据我们的临床疗效广泛实施BREATHE的策略， 执行成果。意义：这项研究具有很高的公共卫生意义，因为（1）它针对的是一个 在独特的护理环境中受哮喘影响很大的人群，（2）它同时针对以下因素的影响 哮喘和哮喘控制的治疗信念，（3）它提供了一个高度可扩展的干预，（4）它连接了一个 研究和实践之间的差距，确定与执行有关的因素。