Department of Otolaryngology - Head and Neck Surgery, University of Kentucky Medical Center, Lexington, Kentucky, USA
Department of Otolaryngology - Head and Neck Surgery, University of Kentucky Medical Center, Lexington, Kentucky, USA.
BMJ Open. 2022 Apr 19;12(4):e054548. doi: 10.1136/bmjopen-2021-054548.
As the most common neonatal sensory disorder in the USA, 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. Early Hearing Detection and Intervention (EHDI) national standards dictate that all infants should be screened and diagnosed by 3 months of age and there is a need for interventions that promote adherence to timely diagnosis. Patient navigation (PN) has been shown to be efficacious to decrease non-adherence with infant hearing diagnostic care; however, PN has yet to be tested in diverse communities or implemented into real-world settings.
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) 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. The study will be conducted from April 2019 until March 2024.
This protocol was approved by the University of Kentucky Institutional Review Board. Although all research involving human subjects contains some risk, there are no known serious risks anticipated from participating in this study. We will seek to disseminate our results in a systematic fashion to patients, key stakeholder, policymakers and the scientific community. Our results will impact the field by partnering with communities to inform the scale-up of this innovative patient supportive intervention to create efficient and effective EHDI programmes and maximise public health impact.
Clinicaltrials.gov (Pre-results phase): NCT03875339.
在美国，婴儿听力损失是最常见的新生儿感觉障碍，发病率为每 1000 名新生儿中有 1.7 名。诊断延迟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。早期听力检测和干预（EHDI）国家标准规定，所有婴儿都应在 3 个月龄内进行筛查和诊断，并且需要采取干预措施来促进及时诊断。患者导航（PN）已被证明可以有效地减少婴儿听力诊断护理的不依从性；然而，PN 尚未在不同的社区进行测试，也尚未在实际环境中实施。
拟议的研究是一项社区参与的、1 型混合有效性-实施试验，针对在新生儿听力筛查失败后，PN 干预措施旨在减少婴儿听力诊断的不依从性，该试验在州资助的 EHDI 诊所中进行。在我们的社区咨询委员会和合作伙伴的指导下，我们旨在：（1）使用阶梯式试验设计测试 PN 降低婴儿出生后 3 个月内接受听力诊断的不依从性的有效性；（2）调查实施结果和影响实施的因素；（3）从第三方支付者的角度确定 PN 的成本效益。研究将于 2019 年 4 月至 2024 年 3 月进行。
本方案已获得肯塔基大学机构审查委员会的批准。虽然所有涉及人类受试者的研究都包含一定的风险，但预计从参与这项研究中不会有任何严重的风险。我们将寻求以系统的方式向患者、主要利益相关者、政策制定者和科学界传播我们的研究结果。我们的研究结果将通过与社区合作，为这一创新的患者支持性干预措施的扩大提供信息，以创建高效和有效的 EHDI 计划并最大限度地发挥公共卫生的影响，从而对该领域产生影响。
Clinicaltrials.gov（预结果阶段）：NCT03875339。
