ADaPT to Engage: Assessing for Disparities and Potential Targets for Intervention to Engage Acutely Ill Children in Research

ADaPT 参与：评估差异和潜在干预目标，让重症儿童参与研究

• 批准号: 10668967
• 负责人: ERIN D Paquette
• 金额: $ 16.31万
• 依托单位: LURIE CHILDREN'S HOSPITAL OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10668967
• 关键词: Acute; Address; Asthma; Attention; Award; Child; Child health equity; Childhood; Clinical Research; Clinical Trials; Conceptions; Consensus; Consent; Coupled; Critical Care; Data; Decision Analysis; Decision Making; Development; Disease; Disparity; Dissemination and Implementation; Emergency Care; Emotional; Enrollment; Ensure; Equity; Ethics; Ethnic Origin; Evaluation; Failure; Funding; Future; Geography; Goals; Health; Health Disparities Research; Healthcare promotion; Individual; Institution; Interdisciplinary Study; Intervention; Intervention Studies; Interview; Justice; Knowledge; Life; Literature; Malignant Neoplasms; Medical; Mentors; Mentorship; Methods; Modeling; Morbidity - disease rate; Outcome; Outcomes Research; Output; Parents; Participant; Phase; Policy Developments; Population; Race; Reduce health disparities; Research; Research Methodology; Research Personnel; Risk; Rural; Sample Size; Sampling Studies; Self Administration; Sepsis; Site; Structure; Surveys; Time; Uncertainty; United States National Institutes of Health; Validation; Work; career development; disparity reduction; evidence base; experience; health communication; health disparity; health equity promotion; improved; improved outcome; innovation; insight; low socioeconomic status; mortality; multilevel analysis; novel; pediatric emergency; premature; prevent; prospective; racial minority; recruit; research and development; skills; success; tertiary care

PROJECT SUMMARY: Clinical research must enroll individuals from diverse backgrounds to yield generalizable knowledge and ensure that the benefits and burdens of research are fairly distributed. Under- representation of diverse groups may: (1) lead to poor enrollment leading to delays and/or study failure, (2) prevent diverse groups from experiencing the benefits of research and (3) result in investigators missing important diversity based differences in illness and treatment. The pediatric literature has not produced consensus regarding under/over enrollment of diverse groups in research and there is inadequate understanding as to why disparities may exist. Enrollment in emergency and critical care (ECC) settings presents unique challenges. These factors, coupled with knowledge that health outcomes are strongly tied to evidence supporting medical interventions, motivate the proposed research. The goal of this proposal is to characterize research participation by children at risk for health disparities (CRHDs) in pediatric ECC research and to determine the degree to which modifiable and potentially modifiable factors relate to participation. The central hypothesis—that CRHDs are underrepresented (losing research benefit) and overrepresented (risking exploitation) in others and that modifiable factors are the primary drivers of differential study enrollment—will be evaluated in a mixed-methods study with 3 interrelated but distinct aims: Aim 1: To prospectively characterize enrollment by CRHDs in pediatric ECC research and to identify factors associated with enrollment and retention. Aim 2: To elucidate qualitative insights into modifiable and non-modifiable factors impacting enrollment/retention in pediatric ECC research. Aim 3: To determine which factors are most associated with successful enrollment of CRHDs. Aim 1 will be addressed through prospective tracking of study enrollment/retention data in an anticipated 18 studies at a single site and factors associated with enrollment. Aim 2 will be accomplished through semi-structured interviews of parents and study team staff. Aim 3 combines prospective survey and interview methods to develop a priority order for the most important factors related to parental decisions to participate to plan future intervention studies. This project will advance the candidate’s long-term goal to engage in interdisciplinary research and policy development using evidence-based, stakeholder-informed, and ethically-sensitive practices to reduce health disparities, address bias, and promote health equity for children. Mentors with expertise in pediatric ethics, disparities, clinical trials, decision-making, and health communication augmented by essential institutional support will permit the candidate to expand knowledge of research methods relevant to decision- making, develop expertise in health disparities research, and cultivate dissemination and implementation skills to effectively improve the evidence base relied upon to treat the sickest children. The proposed plan is instrumental to a successful transition to independence and becoming a leader in the field.

项目摘要：临床研究必须招募来自潜水员背景的个人才能产生 可概括的知识，并确保研究的利益和伯恩斯相当分布。在下面- 不同群体的代表可能：（1）导致入学率不佳导致延迟和/或研究失败，（2） 防止潜水员群体体验研究的好处，（3）导致调查人员缺失 基于重要多样性的疾病和治疗差异。小儿文学尚未产生 关于潜水员群体在研究中/过度入学的共识，并且不足 了解为什么存在差异。急诊和重症监护（ECC）设置 提出了独特的挑战。这些因素，再加上健康结果与 支持医疗干预的证据，动机拟议的研究。该提议的目的是 表征有健康差异风险（CRHD）儿童在儿科ECC研究中的研究参与 并确定与参与的可修改和可能修改因素有关的程度。 中心假设 - CRHD的代表性不足（失去研究益处），并且代表过多 （冒剥削的风险）在他人中，可修改的因素是差异研究的主要驱动因素 入学率 - 将在一项具有3个相互关联但独特的目标的混合方法研究中评估：目标1： 前瞻性地表征CRHD在小儿ECC研究中的入学率，并确定相关的因素 招生和保留。目标2：阐明定性洞察力对可修改和不可修改的洞察力 影响小儿ECC研究的入学/保留率的因素。目标3：确定最大的因素 与成功入学的CRHD有关。 AIM 1将通过预期跟踪来解决 在一个现场的预期研究中，研究注册/保留数据以及与之相关的因素 注册。 AIM 2将通过对父母和学习团队工作人员的半结构化访谈来完成。目的 3结合了前瞻性调查和访谈方法，以制定最重要因素的优先顺序 与父母的决策有关，以计划未来的干预研究。 该项目将促进候选人的长期目标，以进行跨学科研究和 使用基于证据的，利益相关者信息和对道德敏感的实践制定政策 减少健康分布，解决偏见并促进儿童的健康公平。具有专业知识的导师 小儿伦理，分布，临床试验，决策和健康沟通的增强 机构支持将使候选人能够扩大与决策相关的研究方法的了解 - 建立，发展健康差异研究专业知识，并培养传播和实施 有效改善证据基础的技能依赖于治疗最病的孩子。拟议的计划是 成功地过渡到独立并成为该领域的领导者。