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：哮喘的黑人成年人是共享决策的适当目标 （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伯恩（Burnen）和 比非黑人成年人和/或患有任何种族种族背景的哮喘的儿童更糟糕的临床结果。到 日期，针对黑人成年人的SDM和基于社区的干预措施未能解决 这些分布。因此，我们使用患者输入进行呼吸 - 简短干预来评估 哮喘治疗 - 9分钟的SDM干预措施旨在减少错误信念对 哮喘控制 - 并在这种健康差异人群中确立了其有效性。我们的干预是独一无二的 这是一项一次简短的简短，量身定制的干预措施，将患者自己的提供商作为办公室访问 干预主义者（例如可扩展）。我们的试点试验表明，呼吸交付和改进 与剂量匹配的注意力相比 控制条件。目的：我们提出了一项效率实施试验，向：（1）系统评估 呼吸功效在200名黑人成年人接受城市联邦资格卫生中心（FQHC）接受护理的功效 不受控制的哮喘； （2）确定多个障碍和促进者，以采用宽度和 呼吸的实施。假设：HYP 1.1（主要结果）：相对于对照组，超过1年 呼吸参与者将具有更高的哮喘控制能力，这是通过在 哮喘控制问卷。炒作1.2（次要结果）：在1年以上，相对于对照，呼吸 参与者的SDM得分将更好（a），（b）ICS依从性，（c）哮喘和ICS信念，（d） 哮喘的生活质量； （e）哮喘加重的发生率明显降低，（f）符号天数，（g）夜晚 唤醒，（h）活动限制，（i）呼吸急促，（j）喘息和（k）救助医学使用。方法：我们 将招募200名来自纽约市2个不受控制的哮喘的黑人成年人和2个新泽西城市FQHC。 使用组随机设计，FQHC中的临床医生将被随机分配给呼吸或剂量 - 匹配注意力控制条件，并接受了训练，可以在期间提供9分钟的主动或控制干预 诊所就诊。我们将跟随患者参与者进行12个月的治疗。用于过程评估 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 来自患者参与者，亲人和提供者的数据。与利益相关者一起，我们将发展 通过我们的临床效率和 实施结果。意义：该研究具有很高的公共卫生意义，因为（1）它针对 人口在独特的护理环境中受哮喘的影响很大，（2）同时针对 （3）它提供了高度可扩展的干预措施，并且（4）它桥接A 通过确定与实施相关的因素，研究和实践之间的差距。