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（由适用提供）：每1000个出生约1.5个事件，小儿听力损失是美国最常见的新生儿感觉障碍。在生命的早期，听力感对于最佳发展，语言和认知至关重要。幼儿期的耳聋会导致终生学习延迟和残疾，从而导致教育，就业和社会生活中的成年挑战。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进步的经济，教育和社会后果。国家标准规定，聋哑或听力难的婴儿应在3个月大时被诊断出，随后的干预服务应在不到6个月大的时间内开始。不幸的是，有24％的婴儿在异常筛查后没有进行诊断测试，听力损失的儿童中有29％没有参加干预服务。1阿巴拉契亚粗暴的儿童和经济上抑郁症的依从性较差，无法进行后续测试，并且通常会延迟延迟的诊断和治疗的诊断和治疗。决策支持和不良的护理协调助长了差异。婴儿听力检测和干预（EHDI）我在州一级进行了协调，尽管有多项倡议以降低EHDI不遵守，但没有确定的方法来解决此问题。实际上，尚无基于证据的研究来解决旨在降低诊断或干预措施不遵守的计划的有效性。3本申请中提出的研究试图通过涉及患者Navigator计划（PNP）在生命的第一年中解决EHDI过程中的不遵守情况来纠正这种健康差异。导航员是受过训练的医疗人员，他们对患者进行健康状况和医疗保健系统的教育，并迅速支持遵守复杂的医疗保健。 PNP已成功地提高了其他卫生领域（例如癌症）的临床测试和治疗，但在EHDI领域尚未使用。这项研究的假设是，PNP将显着降低对婴儿听力损失的诊断音频测试和干预措施的不遵守和时间。具体目的是1）检查PNP在出生后3个月内降低不遵守性和推荐婴儿音频测试的有效性，在阿巴拉契亚语和非appalachian参与者中，2）评估PNP的有效性，以评估PNP的有效性，以降低对听觉损失的效率和启用的效率，并确定型号的型号和3），以及3）的效率，以及3）的效率，3）涉及不遵守的婴儿因素，并延迟进行测试和治疗。我们将通过将儿童未通过新生儿听力筛查的母子二元组招募到一项随机的前瞻性研究中来完成AIM 1。参与者将根据居住县将参与者分为阿巴拉契亚语和非阿帕拉奇人，然后在每个阶层中，受试者将被随机分为患者导航员组或护理标准组。导航员小组将在出生后每周与患者导航员进行电话联系，而对照组只会获得护理标准，并且不会与导航员联系。出生后3个月之前获得听力学门诊诊断测试的不遵守性将是主要的结局指标。在我们机构中确定的听力损失的婴儿将被招募到AIM 2并随机分为患者导航员组或护理标准组，类似于目标1。不遵守助听器在6个月大之前的助听器拟合将是目标2的主要结果。次要结果将包括出生后的诊断时（AIM 1）的诊断和诊断时（AIM INTISS）的诊断时间（AIM FINES）（AIM FINS SIMATISS 2）（AIM FINS SIMATISS 2）（AIM FINS SIMATISS 2）。候选人是肯塔基大学的临床科学家。计划和临床研究设计和实施。 K23 Award旨在为候选人提供研究和培训活动，这些研究和培训活动旨在加快诊断和治疗健康差异的婴儿听力损失。该培训将通过儿科听力健康差异研究，EHDI研究和患者导航器整合以及临床试验设计和分析来扩大候选人的知识和经验。候选人被毒死了，以调查加快农村先天性听力损失诊断和干预的方法。该申请旨在导致研究组合，包括随后的R01资金，致力于加快面对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专注于转变有效的多学科听力干预措施的独立资助的外科医生。这些目标符合NIH和NIDCD的优先领域，即改善诊断和治疗听力损失以及开发基于证据的方法，以提高患有健康分配的人的认识，获取和负担能力。