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

项目摘要 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 1.7每1000名新生儿。延迟诊断和未能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。整体的终身医疗， 估计因失聪而引致的教育及职业成本超过二十一亿元。早期发现 听力可以防止语言发展和学习障碍。国家标准规定所有婴儿 应在1个月大时进行筛查，在3个月大时进行诊断，并在6个月大时开始治疗。 年龄（1-3-6规则）和不超过10%的婴儿应不遵守诊断后3个月内 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，促进及时遵守 诊断和治疗标准。早期婴儿听力检测和干预（EHDI）计划 在州一级协调，诊断过程复杂，父母难以驾驭。 听力损失儿童的家庭报告说，他们缺乏信心和支持， 孩子患者导航（PN）计划提高了对推荐的癌症诊断检测的依从性 在检测到筛查异常后进行护理，从而大大节省了医疗保健系统的成本。 PN是经过培训的个人，他们通过教育患者和 提高自我效能。我们最近证明了PN在减少婴儿不依从性方面的疗效 听力诊断护理;然而，PN尚未在不同社区进行测试或实施EHDI 在这一领域，关于干预措施的有效性和实施研究存在差距 以减少不遵守。拟议的研究是一个社区参与，1型混合有效性- 一项旨在减少婴儿听力诊断不依从性的PN干预实施试验， 在国家资助的EHDI诊所进行的新生儿听力筛查失败。在我们的社区咨询指导下， 董事会和合作伙伴，我们的目标是1）测试PN的有效性，以减少不遵守接收婴儿 听力诊断出生后3个月内使用阶梯楔形试验设计，2）调查实施 结果和影响实施的因素，以及3）确定PN的成本效益 第三方付款人的观点。这项研究意义重大，因为它旨在减少不遵守及时 婴儿诊断听力测试，以防止终身的负面后果。本研究具有创新性， 在国家资助的EHDI项目中测试之前未在听力保健中评估的干预措施，以及 将实施研究和成本效益方法与我们的有效性目标相结合。我们的结果 将通过与社区合作来影响该领域，以告知这种和其他创新患者的规模扩大 支持性干预措施，以创建高效和有效的EHDI计划，并最大限度地扩大公共卫生影响。

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.