Communities Helping the Hearing of Infants by Reaching Parents: The CHHIRP Navigator Trial

社区通过接触父母来帮助婴儿听力：CHHIRP Navigator 试验

• 批准号: 10378081
• 负责人: Matthew Lee Bush
• 金额: $ 65.15万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10378081
• 关键词: Address; Adherence; Adoption; Advisory Committees; Age-Months; Behavior Disorders; Birth; Caring; Characteristics; Child; Clinic; Collaborations; Communication impairment; Communities; Community Health; Complex; Congenital Disorders; Consolidated Framework for Implementation Research; Cost Savings; Cost effectiveness research; Data; Detection; Development; Diagnosis; Diagnostic; Diagnostic tests; Early Diagnosis; Early Intervention; Education; Effectiveness; Emotional; Employment; Environment; Failure; Family; Feedback; Funding; Health Services Accessibility; Healthcare; Healthcare Systems; Hearing; Hearing Tests; Impairment; Improve Access; Incidence; Individual; Infant; Intervention; Joints; Kentucky; Language Development; Learning; Learning Disorders; Life; Measures; Medical; Methods; Modality; Neonatal Screening; Newborn Infant; Occupational; Outpatients; Parents; Patient Care; Patients; Penetration; Preventive service; Process; Public Health; Randomized Controlled Trials; Recording of previous events; Reporting; Research; Research Methodology; Research Personnel; Self Efficacy; Sensory; Social Development; Speech; System; Testing; Third-Party Payer; Time; Training; Translational Research; United States; cancer care; care systems; childhood hearing loss; cognitive development; community clinic; community intervention; community setting; cost; cost effective; cost effectiveness; cost estimate; deafness; disparity reduction; early childhood; economic cost; effectiveness implementation design; effectiveness implementation study; effectiveness implementation trial; effectiveness research; effectiveness testing; effectiveness trial; falls; hearing impairment; hearing loss treatment; hearing screening; hybrid type 1 trial; implementation cost; implementation determinants; implementation evaluation; implementation intervention; implementation outcomes; implementation research; implementation strategy; improved; innovation; intervention program; navigator intervention; neonatal sensory disorder; peer support; prevent; programs; randomized trial; recruit; research to practice; scale up; screening; social; socioeconomics; standard care; standard of care; trial design

PROJECT SUMMARY As the most common neonatal sensory disorder in the United States, infant hearing loss has an incidence of 1.7 per 1000 births. The consequences of delayed diagnosis and failure to obtain timely intervention include significant communication impairment and negative socioeconomic effects. The overall lifetime medical, educational, and occupational costs due to deafness is estimated to be over $2.1 billion. Early detection of hearing may prevent language development and learning disorders. National standards dictate that all infants should be screened by 1 month of age, diagnosed by 3 months of age, and initiate treatment by 6 months of age (1-3-6 rule) and no more than 10% of infants should be non-adherent to diagnosis within 3 months after birth. In 2015, 59.4% of U.S. infants failed to obtain a diagnosis within 3 months after abnormal screening. There is a need for the development and implementation of interventions that promote adherence to timely diagnosis and treatment standards. Early infant hearing detection and intervention (EHDI) programs are coordinated on a state level, and the diagnostic process is complex and difficult for parents to navigate. Families of children with hearing loss report that they lack confidence and support in obtaining care for their child. Patient navigator (PN) programs have improved adherence to recommended diagnostic testing in cancer care after the detection of a screening abnormality, resulting in substantial healthcare system cost savings. PNs are trained individuals who mitigate barriers to promote healthcare adherence by educating patients and improving self-efficacy. We have recently demonstrated the PN efficacy to decrease non-adherence with infant hearing diagnostic care; however, PN has yet to be tested in diverse communities or implemented into EHDI programs, and there is a gap in this field regarding effectiveness and implementation research on interventions to reduce non-adherence. The proposed research is a community-engaged, type 1 hybrid effectiveness- implementation trial of a PN intervention aimed at decreasing infant hearing diagnosis non-adherence after failed newborn hearing screening, delivered in state-funded EHDI clinics. Guided by our community advisory board and partners, we aim to 1) to test the effectiveness of PN to decrease non-adherence to receipt of infant hearing diagnosis within 3 months after birth using a stepped-wedge trial design, 2) investigate implementation outcomes and factors influencing implementation, and 3) determine the cost-effectiveness of PN from the perspective of third party payers. This study is significant because it aims to reduce non-adherence to timely infant diagnostic hearing testing to prevent life-long negative consequences. This research is innovative in testing an intervention not previously assessed in hearing healthcare within a state-funded EHDI program, and in integrating implementation research and cost-effectiveness methods with our effectiveness aim. Our results will impact the field by partnering with communities to inform the scale-up of this and other innovative patient supportive interventions to create efficient and effective EHDI programs and maximize public health impact.

项目总结 作为美国最常见的新生儿感觉障碍，婴儿听力损失的发病率为 每1000名新生儿中有1.7名。延误诊断和得不到及时干预的后果包括 严重的沟通障碍和负面的社会经济影响。整个一生的医疗， 由于耳聋造成的教育和职业成本估计超过21亿美元。早期发现 听力可能会阻止语言发展和学习障碍。国家标准规定，所有婴儿 应在1个月前进行筛查，在3个月前确诊，并在6个月前开始治疗 年龄(1-3-6规则)和不超过10%的婴儿应在诊断后3个月内未坚持诊断 出生。2015年，59.4%的美国婴儿在异常筛查后3个月内未能获得诊断。 有必要制定和实施干预措施，以促进遵守及时 诊断和治疗标准。早期婴儿听力检测和干预(EHDI)计划 在州一级进行协调，诊断过程复杂，父母很难驾驭。 听力损失儿童的家庭报告说，他们在获得照顾他们的孩子方面缺乏信心和支持 孩子。患者导航仪(PN)计划提高了对癌症推荐诊断测试的依从性 在检测到筛查异常后进行护理，从而大幅节省了医疗系统成本。 PNS是训练有素的个人，他们通过教育患者和 提高自我效能感。我们最近证明了PN对减少婴儿的不依从性的有效性。 听力诊断护理；然而，PN尚未在不同的社区进行测试或实施到EHDI中 方案，这一领域在干预措施的有效性和实施研究方面存在差距 以减少不遵守。拟议的研究是一项社区参与的、类型1的混合有效性- 降低婴幼儿听力诊断不依从性的PN干预的实施试验 未通过新生儿听力筛查，在国家资助的EHDI诊所提供。在我们社区咨询的指导下 董事会和合作伙伴，我们的目标是1)测试PN对减少不遵守婴儿接收的有效性 使用阶梯式楔形试验设计在出生后3个月内进行听力诊断，2)调查实施情况 结果和影响实施的因素，以及3)从以下方面决定PN的成本效益 第三方付款人的视角。这项研究具有重要意义，因为它旨在减少不遵守及时 婴儿诊断性听力测试，防止终生负面后果。本研究在以下方面具有创新性 在国家资助的EHDI项目中测试以前没有在听力保健方面进行评估的干预措施，以及 将实施研究和成本效益方法与我们的实效目标结合起来。我们的结果 将通过与社区合作，告知该患者和其他创新患者的规模扩大，从而对该领域产生影响 支持性干预措施，以创建高效和有效的EHDI方案，并最大限度地发挥公共卫生影响。