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: 10458106
• 负责人: Jean-Marie Bruzzese
• 金额: $ 21.58万
• 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 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10458106
• 关键词: 14 year old; Address; Adolescent; Adult; Adverse effects; Affect; Age; Area; Asthma; Black Populations; Black race; 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; Hispanic; Hispanic Populations; 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; pilot test; 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.

项目概要/摘要 背景和理由：少数民族儿童哮喘患病率和发病率较高。 管理可以实现并维持疾病控制，但是，城市早期青少年的情况并不理想。 值得注意的是，这个年龄段出现的关键健康行为会影响终生模式。 青春期早期提供了一个独特的干预机会，使青少年能够有效地自我保护。 成功的自我管理需要护理人员和管理者之间正确的责任划分。 因此，与早期青少年及其照顾者同时进行干预，以提供帮助。 青少年早期自我管理哮喘的自主性不断增强，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。 开发并试点测试 BREATHE-Peds（评估儿科哮喘治疗的简短干预），一种新颖的 二元（护理人员早期）共同决策 (SDM) 干预，以改善 10 至 14 岁儿童的哮喘控制 联邦合格健康中心 (FQHC) 中患有哮喘的 1 岁青少年 假设：Hyp 1： 干预措施是可行且可接受的，具体表现如下： 较高的二人招募率和保留率； 初级保健提供者 (PCP) 对治疗方案的忠诚度；以及 PCP 和看护者与儿童的满意度。 Hyp 2. 干预后 3 个月内，相对于对照组，BREATHE-Peds 儿童的以下方面将有所改善： 通过哮喘控制问卷（主要结果）衡量的哮喘控制、较高的 SDM 感知、 症状减轻、缺课和其他次要结果 方法：拟议的研究。 包括两个阶段：(1) 开发阶段，我们将利用焦点小组开发 BREATHE-Peds 照顾者-青少年早期二人组 (n=30) 和专家意见，以及 (2) 试点验证阶段，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-青少年早期二人组由 8 名 PCP 治疗 （4/FQHC；10 组/PCP）在 FQHC 内随机分配到 2 个研究组中的 1 个：(a) BREATHE-Ped（n=40 组）， (b) 剂量匹配的注意力控制（n=40 组） 我们将在术后 3 个月内跟踪看护者-儿童组。 我们将进行试验后访谈，以评估 BREATHE-Peds 对哮喘结果的影响； 与 PCP、护理人员及其孩子一起评估对干预措施的满意度。 意义：该研究。 具有很高的公共卫生意义，因为它 (1) 测试了 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 在 FQHC 中改善哮喘的现实务实方法，提供安全的独特初级保健环境 为弱势群体提供网络服务，(4) 为临床实践和 管理症状，从而解决重要的健康不平等问题。