Randomized Trial of Telehealth vs Conventional Hearing Care Delivery in the ACHIEVE Study

项目摘要 听力损失是一种慢性疾病，在三分之二的70岁以上的成年人中普遍存在， 包括痴呆症在内的不良健康结果的可改变风险因素。然而，吸收和持续使用 助听器在成年人中的使用率很低，<20%的听力损失老年人报告使用助听器，其中高达30- 40%的人可能会随着时间的推移而停止使用助听器。这些限制可能部分源于对 目前最佳实践模式的听力保健（HHC）基于诊所的访问，需要多次亲自 听力学家和患者之间的会话，用于所有正在进行的技术和自我管理支持服务。 将异步和同步远程保健纳入HHC，以补充诊所就诊， 允许对沟通挑战、助听器技术问题和加固进行常规故障排除 自我管理支持策略。确定包含听力学远程保健的HHC模型是否 改善助听器的长期使用和其他以患者为中心的结果指标， 未来的临床护理标准和正在进行的医疗保险立法法案有关的HHC覆盖面。我们 跨学科的研究者联盟有一个独特的机会来评估一个 远程保健听力学模型对长期助听器使用和其他结果在一个大的队列种族- 不同的，居住在社区的老年人谁是现有的助听器用户。在正在进行的老龄化和认知 老年人健康评估（ACHIEVE）随机试验，我们招募了977名年龄在70-84岁的成年人， 从2018年1月至2019年10月，轻度至中度听力损失，以1：1的比例随机分配至听力 干预（即，传统的基于诊所的听力服务和技术的提供）与成功的 老龄化教育控制干预。参与者在随机化后3年接受随访， 四个ACHIEVE现场研究中心，该NIA资助的多中心试验（R 01 AG 055426）的目标是确定 听力损失治疗与老龄化教育控制干预可减少认知能力下降。从2021年起- 2022年，听力干预组的参与者（n=490）完成了他们预先指定的三年的听力干预。 在ACHIEVE试验的随访中，我们建议招募这些现有的助听器使用者，并将他们随机分配到 继续接受传统的以诊所为基础的听力保健服务， 包括远程保健。随机化后1年，主要结局（助听器使用小时数）将为 两组之间进行对比，然后传统HHC组的参与者将交叉， 也接受远程保健HHC。所有受试者将在随机化后继续接受2年随访。目标1： 比较远程医疗与传统HHC交付模式对助听器使用时间的影响 （主要结局）和其他以患者为中心的听力和沟通结局， 随机化目标2：比较远程保健与传统HHC提供模式对以下方面的影响： 随机化后1年的社会、心理、身体和认知功能的次要结局。

PROJECT SUMMARY Hearing loss is a chronic condition prevalent in two-thirds of adults >70 years and may be a potentially modifiable risk factor for adverse health outcomes including dementia. However, uptake and sustained use of hearing aids in adults is low, with <20% of older adults with hearing loss reporting use, among whom up to 30- 40% may discontinue hearing aid use over time. These limitations may stem in part from the reliance of the current best-practice model of hearing healthcare (HHC) on clinic-based visits that requires multiple in-person sessions between an audiologist and a patient for all ongoing technical and self-management support services. Incorporation of asynchronous and synchronous telehealth into HHC to complement clinic-based visits would allow for routine troubleshooting of communication challenges, hearing aid technical issues, and reinforcement of self-management support strategies. Determining if a HHC model that incorporates audiological telehealth improves long-term hearing aid use and other patient-centered outcome measures has direct implications for both future clinical care standards and ongoing Medicare legislative bills pertaining to HHC coverage. Our interdisciplinary consortium of investigators has a singular opportunity to evaluate the potential benefits of a telehealth audiology model on long-term hearing aid use and other outcomes in a large cohort of racially- diverse, community-dwelling older adults who are existing hearing aid users. In the ongoing Aging & Cognitive Health Evaluation in Elders (ACHIEVE) randomized trial, we recruited 977 adults ages 70-84 with untreated mild-to-moderate hearing loss from January 2018 to October 2019 who were randomized 1:1 to a hearing intervention (i.e., conventional clinic-based delivery of hearing services and technologies) versus a successful aging education control intervention. Participants are now being followed for 3 years post-randomization at the four ACHIEVE field sites, and the goal of this NIA-funded multisite trial (R01AG055426) is to determine if hearing loss treatment versus an aging education control intervention reduces cognitive decline. From 2021- 2022, as participants in the hearing intervention group (n=490) complete their pre-specified three years of follow-up in the ACHIEVE trial, we propose to recruit these existing hearing aid users and randomize them to receive either continued conventional clinic-based delivery of hearing care services or a model that incorporates telehealth. At 1 year post-randomization, the primary outcome (hours of hearing aid use) will be contrasted between the two groups, and participants in the conventional HHC arm will then cross-over and also receive telehealth HHC. All participants will continue to be followed for 2 years post-randomization. Aim 1: To compare the effect of the telehealth versus conventional HHC delivery model on hours of hearing aid use (primary outcome) and other patient-centered hearing and communication outcomes at 1 year post- randomization. Aim 2: To compare the effect of the telehealth versus the conventional HHC delivery model on secondary outcomes of social, mental, physical, and cognitive functioning at 1 year post-randomization.