The Development and Pilot Testing of a Caregiver-Child Shared Decision-Making Intervention to Improve Asthma in Urban Youth

改善城市青少年哮喘的看护者-儿童共同决策干预措施的开发和试点测试

• 批准号: 10302390
• 负责人: Jean-Marie Bruzzese
• 金额: $ 19.99万
• 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: 2021-07-28 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10302390
• 关键词: 14 year old; Address; Adolescent; Adult; Adverse effects; Affect; Age; Area; Asthma; Caregivers; Caring; Centers for Population Health; Child; Childhood; Childhood Asthma; Chronic Disease; Client; Clinical; Communities; Counseling; Detection; Development; Disease; Dose; Federally Qualified Health Center; Focus Groups; Foundations; Future; Goals; Health; Health behavior; High Prevalence; Hispanics; Intervention; Interview; Measures; Medical; Methods; Morbidity - disease rate; Office Visits; Outcome; Participant; Patients; Pattern; Pediatrics; Performance; Phase; Pilot Projects; Population; Preparation; Prevalence; Procedures; Protocols documentation; Proxy; Public Health; Quality of life; Questionnaires; Randomized; Randomized Controlled Trials; Reporting; Research; Schools; Self Management; Services; Testing; Time; Treatment Protocols; Validation; Vulnerable Populations; Youth; acceptability and feasibility; aged; attentional control; benefit sharing; brief intervention; care providers; clinical application; clinical practice; disability-adjusted life years; disorder control; early adolescence; efficacy testing; experience; health inequalities; high risk; improved; improved outcome; intervention effect; minority children; minority communities; motivational enhancement therapy; novel; post intervention; primary care setting; primary outcome; pulmonary function; randomized trial; recruit; reduce symptoms; safety net; satisfaction; secondary outcome; shared decision making; symptom management; two-arm study; urban minority

PROJECT SUMMARY / ABSTRACT Background and Rationale: Minority children experience high asthma prevalence and morbidity. Asthma self- management can achieve and sustain disease control. However, urban early adolescents have sub-optimal self-management. Notably, critical health behaviors that emerge at this age affect lifelong patterns. Therefore, early adolescence offers a unique opportunity to intervene, allowing the youth to become effective self- managers. Successful self-management requires the right division of responsibility between caregivers and adolescents. Thus, intervening simultaneously with early adolescent and their caregivers who can help support the early adolescent’s growing autonomy to self-manage asthma has the potential for a synergistic effect, further facilitating the adolescents’ self-management, and thus asthma control. Objective: We propose to develop and pilot test BREATHE-Peds (BRief intervention to Evaluate Asthma THErapy for Pediatrics), a novel dyadic (caregiver-early) shared decision-making (SDM) intervention, to improve asthma control in 10- to 14- year-old youth with asthma in federally-qualified health centers (FQHCs). Hypotheses: Hyp 1: The intervention will be feasible and acceptable as evidenced by: high rates of dyad recruitment and retention; primary care provider (PCP) fidelity to the treatment protocol; and PCP and caregiver-child dyad satisfaction. Hyp 2. Over 3-months post-intervention, relative to controls, BREATHE-Peds children will have improvement in asthma control as measured by the Asthma Control Questionnaire (primary outcome), higher perceived SDM, reduced symptoms, missed school days and other secondary outcomes. Methods: The proposed study includes two phases: (1) a development phase where we will develop BREATHE-Peds using focus groups with caregiver-early adolescent dyads (n=30) and expert input, and (2) a pilot validation phase where we will conduct a group-randomized trial in two FQHCs with 80 caregiver-early adolescent dyads treated by 8 PCPs (4/FQHC; 10 dyads/PCP) randomized within FQHCs to 1 of 2 study arms: (a) BREATHE-Peds (n=40 dyads), or (b) dose-matched attention control (n=40 dyads). We will follow caregiver-child dyads for 3 months post- intervention to assess the impact of BREATHE-Peds on asthma outcomes; we will conduct post-trial interviews with PCPs, caregivers, and their children to evaluate satisfaction with the intervention. Significance: The study has high public health significance because it (1) tests the application of SDM to pediatric asthma; (2) targets caregiver-early adolescent dyads, which may have a synergistic effect, (3) tests a sustainable and scalable real-world pragmatic approach to improving asthma in FQHCs, unique primary care settings that provide safety net services for vulnerable populations, and (4) contributes to the scientific foundation for clinical practice and managing symptoms, thus addressing an important health inequity issue.

项目摘要/摘要 背景和理由：少数族裔儿童的哮喘患病率和发病率很高。哮喘自身-- 管理可以实现和维持疾病控制。然而，城市早期青少年的情况并不理想 自我管理。值得注意的是，在这个年龄段出现的关键健康行为会影响终生模式。因此， 青春期早期提供了一个独特的介入机会，让年轻人成为有效的自我 经理们。成功的自我管理需要正确划分照顾者和 青少年。因此，同时对青少年及其照顾者进行干预，他们可以帮助 早期青少年自我管理哮喘的自主性越来越强，这可能会产生协同效应， 进一步促进青少年的自我管理，从而控制哮喘。目标：我们建议 开发和试点呼吸-PEDS(评估儿科哮喘治疗的简短干预)，一种新的 二分(照顾者早期)共享决策(SDM)干预，以改善10-14-14岁的哮喘控制 患有哮喘的一岁青年在联邦合格的卫生中心(FQHC)。假设：Hyp 1：The 干预措施将是可行和可接受的，这证明了：高二元体招募和留存率； 初级保健提供者(PCP)对治疗方案的忠诚度；PCP和照顾者-儿童双方的满意度。 超过3个月的干预后，相对于对照组，呼吸-儿科儿童将有改善 哮喘控制问卷(主要结果)测量的哮喘控制，较高的SDM知觉， 症状减轻，缺课天数和其他次要结果。方法：建议的研究 包括两个阶段：(1)开发阶段，我们将使用焦点小组和 护理者-青春期早期(n=30)和专家输入，以及(2)试点验证阶段，在此阶段我们将 在两个FQHC中进行一项分组随机试验，其中80名照顾者-早期青春期夫妇接受8种PCP治疗 (4/FQHC；10个DADS/PCP)在FQHC内随机分配到2个研究组中的1个：(A)呼吸-儿科(n=40个DYAD)， 或(B)剂量匹配的注意对照组(n=40对)。我们将在3个月内跟踪照顾者和孩子的二人组- 干预评估呼吸-儿科疾病对哮喘预后的影响；我们将进行试验后访谈 与儿科医生、照顾者和他们的孩子一起评估对干预的满意度。意义：这项研究 具有很高的公共卫生意义，因为它(1)测试SDM在儿童哮喘中的应用；(2)目标 照顾者-青春期早期的二人组，可能具有协同效应，(3)测试可持续和可扩展的 改善FQHC中哮喘的现实世界务实方法，提供安全的独特初级保健环境 Net为弱势人群提供的服务，以及(4)为临床实践和 管理症状，从而解决一个重要的健康不平等问题。