Promoting Early Diagnosis of Congenital Hearing Loss through Patient Navigation

通过患者导航促进先天性听力损失的早期诊断

• 批准号: 8889813
• 负责人: Matthew Lee Bush
• 金额: $ 22.84万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-03-01 至 2018-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8889813
• 关键词: Address; Adherence; Adult; Affect; Age-Months; Appalachian Region; Area; Auditory; Awareness; Balance training; Behavioral; Birth; Caring; Child; Childhood; Clinical Research; Clinical Treatment; Clinical Trials Design; Cognition; Communication; Complex; Congenital Disorders; Control Groups; County; Data; Decision Making; Depressed mood; Detection; Development; Diagnosis; Diagnostic; Diagnostic tests; Doctor of Philosophy; Early Diagnosis; Early Intervention; Early identification; Economics; Education; Effectiveness; Employment; Enrollment; Face; Family; Funding; Goals; Health; Health Personnel; Health Services Accessibility; Healthcare; Healthcare Systems; Hearing; Hearing Aids; Hearing Impaired Persons; Hearing Tests; Incidence; Infant; Infant Care; Institution; Intervention; Intervention Studies; Joints; Kentucky; Knowledge; Language; Language Development; Learning; Life; Literature; Malignant Neoplasms; Medical; Mentored Patient-Oriented Research Career Development Award; Mentors; Methods; Mothers; National Institute on Deafness and Other Communication Disorders; Nature; Neonatal; Newborn Infant; Otolaryngology; Outcome; Outcome Measure; Outpatients; Parents; Participant; Patients; Plant Roots; Process; Prospective Studies; Randomized; Recruitment Activity; Research; Research Activity; Research Design; Rural; Rural Health; Scientist; Sensory; Sensory Disorders; Services; Speech; Surgeon; Telephone; Testing; Therapeutic Intervention; Time; Training; Training Activity; Translational Research; Trust; United States; United States National Institutes of Health; Universities; base; career; deafness; design; disability; early childhood; economic cost; effective therapy; evidence base; experience; follow-up; health disparity; hearing impairment; hearing screening; improved; multidisciplinary; novel; prevent; primary outcome; programs; public health relevance; research clinical testing; residence; screening; secondary outcome; service intervention; social; socioeconomics; sound; standard care; standard of care; success; theories; therapy development

 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.

 描述（由申请人提供）：在美国，儿童听力损失是最常见的新生儿感觉障碍，发病率约为1.5/1000例新生儿。在生命的早期，听觉对于言语、语言和认知的最佳发展至关重要。幼儿期耳聋可能导致终身学习延迟和残疾，导致成年后在教育、就业和社会生活方面的挑战。听力损失和语言发展受损的经济成本是巨大的。早期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，耳聋或听力困难的婴儿应在3个月大时得到诊断，随后的干预服务应在6个月大时开始。不幸的是，24%的婴儿在异常婴儿筛查后没有进行诊断性测试，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萧条地区的儿童对随访的依从性较差-儿童听力损失的诊断和治疗往往被延误。2为婴儿及时获得听力保健的过程是复杂的，沟通障碍、缺乏决策支持和护理协调不力等因素造成了这种差异。早期婴儿听力检测和干预（EHDI）在州一级进行协调，尽管有多项举措来减少EHDI不依从性，但没有既定的方法来解决这个问题。事实上，没有基于证据的研究来解决旨在减少诊断或干预不依从性的举措的有效性。3本申请中提出的研究旨在通过涉及患者导航程序（PNP）的新型干预来解决生命第一年EHDI过程中的不依从性和延迟来纠正这种健康差异。导航员是训练有素的医疗保健工作者，他们向患者提供健康状况和医疗保健系统方面的教育，并迅速促进对复杂医疗保健的坚持。PNPs已经成功地减少了其他健康领域（例如，癌症），但尚未用于EHDI领域。这项研究的假设是，PNP将显着减少不遵守和时间的诊断听力学测试和干预婴儿听力损失。具体目的是：1）在阿巴拉契亚和非阿巴拉契亚受试者中，检查PNP在降低出生后3个月内不依从和推荐婴儿听力学测试时间方面的功效，2）评估PNP在降低诊断为听力损失的婴儿不依从和助听器验配时间方面的功效，以及3）确定母亲的社会经济、教育、人口统计学和婴儿因素涉及不遵守和延迟测试和治疗。我们将通过招募未通过新生儿听力筛查的母子配对进入随机前瞻性研究来实现目标1。将根据居住县将受试者分层为阿巴拉契亚和非阿巴拉契亚，然后在每个分层中，将受试者随机分配至患者导航组或标准治疗组。导航员组在出生后每周与患者导航员进行电话联系，而对照组仅接受标准护理，不与导航员联系。出生后3个月内未坚持进行听力学门诊诊断测试（目标1）将是主要结局指标。在我们机构确定为听力损失的婴儿将入组目标2，并随机分配至患者导航组或标准治疗组，与目标1相似。目标2的主要结局是在6个月龄之前不坚持验配助听器。次要结果将包括出生后诊断测试的时间（目标1）和诊断后助听器验配的时间（目标2）。目标3将描述不依从的母婴因素。该候选人是肯塔基州大学耳鼻喉科的临床科学家，致力于临床和转化研究。本申请的导师南希·勋伯格博士，Karl白色，博士，理查德·克里西奥博士，将在健康差异、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均衡的培训和指导。这个项目的总体目标是 K23奖旨在为候选人提供研究和培训活动，重点是在健康差异的情况下加快婴儿听力损失的诊断和治疗。该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。这位候选人准备研究加快农村先天性听力损失诊断和干预的方法。该申请旨在产生一个研究组合，包括随后的R 01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医生科学家，专注于改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，并制定基于证据的方法，以提高那些经历健康差异的人的认识，获得和负担能力。