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.

项目总结/摘要 背景和原理：少数民族儿童哮喘患病率和发病率较高。哮喘自- 管理可以实现和维持疾病控制。然而，城市早期青少年有次优 自我管理值得注意的是，在这个年龄出现的关键健康行为会影响终身模式。因此，我们认为， 青春期早期提供了一个独特的干预机会，让年轻人成为有效的自我， 管理者成功的自我管理需要正确划分照顾者和 青少年。因此，与早期青少年及其照顾者同时进行干预， 早期青少年自我管理哮喘的自主性不断增长，这有可能产生协同效应， 进一步促进青少年的自我管理，从而控制哮喘。目的：我们建议 开发和试点测试呼吸儿科（BRief干预评估哮喘治疗儿科），一种新的 双元（早期）共享决策（SDM）干预，以改善10- 14岁儿童的哮喘控制， 在联邦合格的健康中心（FATHCs）的10岁的哮喘青年。英文名称：Hyp 1：The 干预措施是可行的和可接受的，证据是：高比率的二分体招募和保留; 初级保健提供者（PCP）的治疗方案的忠诚度和PCP和父母-儿童二分体的满意度。 Hyp 2.干预后3个月，相对于对照组，呼吸儿童在以下方面有所改善： 通过哮喘控制问卷（主要结果）测量的哮喘控制，较高的感知SDM， 症状减轻，缺课和其他次要结果。方法：拟定研究 包括两个阶段：（1）开发阶段，我们将使用焦点小组开发呼吸儿科， 青少年早期的二人组（n=30）和专家的输入，和（2）试点验证阶段，我们将 在两个有80名接受8种PCP治疗的青少年-早期青少年二对体的BHCs中进行分组随机试验 （4例/CRUHC; 10对/PCP）在CRUHC内随机分配至2个研究组之一：（a）呼吸-儿科（n=40对）， 或（B）剂量匹配的注意力控制（n=40对）。我们将跟踪两个孩子的配对3个月后， 评估BREATHE-Peds对哮喘结局影响的干预;我们将进行试验后访谈 与PCP，照顾者和他们的孩子一起评估对干预措施的满意度。意义：研究 具有很高的公共卫生意义，因为它（1）测试SDM在儿科哮喘中的应用;（2）靶向 早期青少年的二人组，这可能有协同效应，（3）测试一个可持续的和可扩展的 改善哮喘的现实世界务实的方法，在THEHC，独特的初级保健环境，提供安全 为弱势群体提供网络服务，以及（4）为临床实践的科学基础做出贡献， 控制症状，从而解决一个重要的健康不平等问题。