Promoting Early Diagnosis of Congenital Hearing Loss through Patient Navigation

 描述(由申请人提供)：儿童听力损失是美国最常见的新生儿感觉障碍，发病率约为每1000名新生儿中有1.5人。在生命的早期阶段，听觉对于言语、语言和认知的最佳发展至关重要。儿童早期耳聋可能导致终身学习延迟和残疾，导致成年后在教育、就业和社交生活方面的挑战。听力损失和语言发育受损的经济代价是巨大的。及早识别和干预可以防止这些不利的经济、教育和社会后果。国家标准规定，耳聋或重听婴儿应在3个月大时被诊断出来，后续干预服务应在不晚于6个月大的时候开始。不幸的是，24%的婴儿在婴儿筛查异常后没有诊断测试，29%的听力损失儿童没有参加干预服务。1来自阿巴拉契亚农村和经济贫困地区的儿童对后续测试的依从性较差，在儿童听力损失的诊断和治疗方面经常延误。2为婴儿及时获得听力保健的过程是复杂的，许多因素，如沟通中断、缺乏决策支持和护理协调不力，都是造成这种差异的原因。早期婴儿听力检测和干预(EHDI)I在州一级进行协调，尽管有多项倡议减少不遵守EHDI，但没有既定的方法来解决这一问题。事实上，没有基于证据的研究来解决旨在减少不遵守诊断或干预措施的倡议的有效性。3本申请中提出的研究旨在通过一种涉及患者导航程序(PNP)的新型干预措施，通过解决生命第一年期间EHDI过程中的不坚持和延误来纠正这种健康差距。导航员是训练有素的医疗工作者，他们对患者进行健康状况和医疗系统的教育，并迅速促进对复杂医疗保健的坚持。PNPs已经成功地减少了在其他健康领域(例如癌症)不遵守临床测试和治疗的情况，但尚未被用于EHDI领域。这项研究的假设是，PNP将显著减少婴儿听力损失的诊断听力学测试和干预的不遵守和时机。其具体目标是：1)在阿巴拉契亚和非阿巴拉契亚地区的参与者中，检查PNP对于减少出生后3个月内推荐的婴儿听力测试的不遵守和时机的有效性；2)评估PNP对于减少被诊断为听力损失的婴儿不遵守和减少助听器试戴的时间的有效性；以及3)确定不遵守和延误测试和治疗所涉及的产妇的社会经济、教育、人口和婴儿因素。我们将通过将未通过新生儿听力筛查的母子二元组纳入随机前瞻性研究来实现目标1。参与者将根据居住的县被分成阿巴拉契亚和非阿巴拉契亚地区，然后在每个阶层内，受试者将被随机分为患者导航组或标准护理组。导航员组将在出生后每周与患者导航员进行电话联系，而对照组将仅接受标准护理，不与导航员接触。未坚持在出生后3个月前获得听力学门诊诊断测试(目标1)将是主要的结果衡量标准。在我们机构被确认为听力损失的婴儿将被登记在目标2中，并随机分为患者导航组或标准护理组，与目标1类似。在6个月之前不遵守助听器配戴将是目标2的主要结果。次要结果将包括出生后诊断测试的时间(目标1)和诊断后配戴助听器的时间(目标2。目标3将描述母婴不坚持的因素。候选人是肯塔基大学耳鼻喉科的临床科学家，他已经表现出致力于临床和转化性研究的职业生涯。这项申请的导师南希·舍恩伯格博士、卡尔·怀特博士、理查德·克里西索博士将在健康差距、婴儿听力损失和干预措施以及临床研究设计和实施方面提供平衡的培训和指导。这个项目的总体目标是 K23奖是为候选人提供研究和培训活动，重点是在健康差距的背景下加快婴儿听力损失的诊断和治疗。培训将扩大候选人在儿科听力健康差异研究、EHDI研究和患者导航仪集成以及临床试验设计和分析方面的知识和经验。这位候选人独一无二地准备研究加快农村先天性听力损失诊断和干预的方法。这项申请旨在形成一个研究组合，包括后续的R01资金，致力于加快对面临护理障碍的儿童的听力损失干预。候选人的总体职业目标是成为一名独立资助的外科科学家，专注于转变有效的多学科听力干预的交付。这些目标符合NIH和NIDCD的优先领域，即改善听力损失的诊断和治疗，并开发以证据为基础的方法，提高那些经历健康差距的人的意识、获得机会和负担能力。

 DESCRIPTION (provided by applicant): With the incidence of approximately 1.5 per 1000 births, pediatric hearing loss is the most common neonatal sensory disorder in the United States. During the early years of life, the sense of hearing is vital for the optimal development o speech, language, and cognition. Deafness in early childhood can result in lifelong learning delay and disability leading to adulthood challenges in education, employment, and social life. The economic costs of hearing loss and impaired language development are substantial. Early identification and intervention can prevent these adverse economic, educational, and social consequences. National standards dictate that infants who are deaf or hard of hearing should be diagnosed by 3 months of age and subsequent intervention services should be initiated no later than 6 months of age. Unfortunately, 24% of infants have no diagnostic testing after abnormal infant screening and 29% of children with hearing loss are not enrolled in intervention services.1 Children from rural Appalachia and economically depressed regions have poor adherence to follow-up testing and are often delayed in diagnosis and treatment of pediatric hearing loss.2 The process of obtaining timely hearing health care for infants is complex and many factors, such as communication breakdowns, lack of decisional support, and poor care coordination, contribute to the disparity. Early infant hearing detection and intervention (EHDI) i coordinated on a state level and, in spite of multiple initiatives to decrease EHDI non-adherence, there is no established method to address this problem. In fact, there is no evidence-based research that addresses the effectiveness of initiatives designed to decrease non-adherence for diagnosis or intervention.3 The research proposed in this application seeks to rectify this health disparity by addressing non-adherence and delays in the EHDI process during the first year of life through a novel intervention involving a patient navigator program (PNP). Navigators are trained healthcare workers who educate patients on health conditions and healthcare systems and expeditiously facilitate adherence to complex healthcare. PNPs have successfully decreased non- adherence to clinical testing and treatment in other health areas (e.g., cancer) but have not been utilized in the EHDI field. The hypothesis of this study is that a PNP will significantly decrease non-adherence to and timing of diagnostic audiological testing and intervention for infant hearing loss. The specific aims are to 1) examine the efficacy of a PNP to decrease non-adherence to and timing of recommended infant audiological testing within 3 months after birth, in Appalachian and non-Appalachian participants, 2) assess the efficacy of a PNP to decrease non-adherence to and timing of hearing aid fitting in infants diagnosed with hearing loss, and 3) determine the maternal socioeconomic, educational, demographic and infant factors involved in non- adherence and delays to testing and treatment. We will accomplish Aim 1 by enrolling mother-child dyads, in which the child fails newborn hearing screening, into a randomized prospective study. The participants will be stratified into Appalachian and non-Appalachian based on county of residence and then within each stratum the subjects will be randomized into either the patient navigator group or the standard of care group. The navigator group will have weekly phone contact with a patient navigator after birth while the control group will receive the standard of care only and will have no contact with a navigator. Non-adherence to obtain audiological outpatient diagnostic testing before 3 months after birth (Aim 1) will be the primary outcome measure. Infants identified with hearing loss at our institution will be enrolled in Aim 2 and randomized into a patient navigator group or standard of care group, similar to Aim 1. Non-adherence with fitting of hearing aids before 6 months of age will be the primary outcome for Aim 2. Secondary outcomes will include timing of diagnostic testing after birth (Aim 1) and the timing of hearing aid fitting after diagnosis (Aim 2. Aim 3 will characterize maternal and infant factors in non-adherence. The candidate is a clinician scientist at the University of Kentucky in the Department of Otolaryngology who has demonstrated commitment to a career in clinical and translational research. The mentors in this application, Nancy Schoenberg, Ph.D., Karl White, Ph.D., Richard Kryscio, Ph.D., will provide balanced training and guidance in the areas of health disparity, infant hearing loss and intervention initiatives, and clinical research design and implementation. The overall goal of this K23 award is to provide the candidate with research and training activities that are focused on expediting diagnosis and treatment of infant hearing loss in the setting of health disparity. The training will expand the candidate's knowledge and experience with pediatric hearing health disparities research, EHDI research and patient navigator integration, and clinical trial design and analysis. The candidate is uniquely poised to investigate methods to expedite rural congenital hearing loss diagnosis and intervention. This application is intended to result in a research portfolio, including subsequent R01 funding, devoted to expediting hearing loss intervention in children who face barriers to care. The overall career goal of the candidate is to become an independently funded surgeon scientist focused on transforming the delivery of effective multidisciplinary hearing interventions. These goals are in line with NIH and NIDCD priority areas of improving diagnosis and treatment of hearing loss and developing evidence-based approaches that increase awareness, access, and affordability for those experiencing health disparities.