Cost-effective Hearing Aid Delivery Models

Presbycusis Clinical Trial

Official title: Cost-effective Hearing Aid Delivery Models: Outcomes, Value, and Candidacy

Status Recruiting

Clinical Trial Summary

One of the most commonly reported reasons for people not seeking hearing aids (HAs) intervention is the high cost of HAs and the associated audiological fitting services. Because HAs fitted using the audiologist-based service-delivery model (AUD model) are unaffordable, more and more Americans purchase amplification devices via over-the-counter service-delivery models (OTC models) to compensate for their impaired hearing. Although OTC amplification devices are gaining popularity and are regarded as an important option for promoting accessible and affordable hearing healthcare, it is unclear if they are viable solutions for age-related hearing loss as OTC models exclude professional services. Further, if there are outcome differences between AUD and OTC models, it is unknown if the clinical improvement in outcomes will be offset by the improved value (outcome relative to cost), or if it is possible to identify appropriate candidacy for each model to ensure optimal patient care for all. Finally, no prior research has investigated if "hybrid" service-delivery models, in which professionals provide streamlined services to fit OTC amplification devices, offer affordable and quality amplification interventions as has been recently advocated. The overall goal of this project is to characterize the differential effect of service-delivery models on provision of amplification so that accessible and affordable hearing healthcare can be facilitated. This project proposes to conduct research that would provide new knowledge about the outcome, value, and candidacy of OTC, hybrid, and AUD models and the effect of professional evaluation/selection services, patient-centered services, and device-centered services on outcome and value. The proposed study will acquire this knowledge through a two-site, double-blinded, randomized controlled field trial. The results obtained will inform patients and hearing healthcare providers about what can be achieved with different service-delivery models, and will help us develop guidelines to facilitate the selection of the most appropriate and cost-effective intervention for a particular patient. The significance of the proposed project from the public health point of view is that it will facilitate not only accessible and affordable, but also quality, hearing healthcare.

Clinical Trial Description

Age-related hearing loss is a substantial national problem due to its high prevalence and significant psychosocial consequences. However, the adoption rate of the primary intervention of age-related hearing loss, i.e., hearing aids (HAs), is quite low (15-30%). One of the most commonly reported reasons that people do not seek HA intervention is the high cost of devices plus the costly professional (e.g., audiologist) fitting services. This type of intervention-HAs fitted using the audiologist-based service-delivery model (AUD model)-is considered to be the best practice for management of adults with hearing loss. Because the AUD model is unaffordable for many Americans who need HAs (64%), there has been increased advocacy for a variety of over-the-counter service-delivery models (OTC models). In 2010, 1.5 million Americans purchased amplification devices via OTC models to compensate for their impaired hearing. Although the OTC models are gaining popularity and are regarded as an important option for promoting accessible and affordable hearing healthcare, major questions remain unanswered. Specifically, the OTC models proposed to date rely on assumptions that patients can appropriately self-diagnose, self-select, self-fit and (in some cases) self-adjust amplification. However, there is little data to support any of the underlying assumptions. A recent study suggests that the AUD model yields better outcomes than the OTC models, but it is unclear if a rigorous randomized controlled trial can replicate this result. Furthermore, if there are outcome differences between AUD and OTC models, it is unknown if the clinical improvement in outcomes will be offset by the improved value (outcome relative to cost), or if it is possible to identify appropriate candidacy for each model to ensure optimal patient care for all. Finally, no prior research has investigated if "hybrid" service-delivery models, in which professionals provide streamlined services to fit OTC amplification devices, offer affordable and quality amplification interventions as has been recently advocated. The overall goal of this project is to characterize the differential effect of service-delivery models on provision of amplification so that accessible and affordable hearing healthcare can be facilitated. The central hypothesis is that an OTC model or a hybrid model is a viable solution for many, but not all, patients with mild-to-moderately-severe age-related hearing loss. Since the optimal OTC model and the definition of OTC amplification device is still in question, the investigators propose to focus on the role of professional services in the provision of cost-effective amplification. To answer the research questions, the investigators have designed procedures to implement an OTC model, in which research participants will take the full initiative and responsibility for learning and using amplification. The investigators then systematically add professional patient-centered services (e.g., device orientation and counselling) to the OTC model to create a hybrid model. Finally, the investigators add device-centered services (e.g., device adjustment under the guidance of real-ear measures) to the hybrid model to create an AUD model that serves as the control. The investigators will electronically configure HAs to simulate OTC devices (e.g., fixed frequency response) and will use the same devices as HAs in the AUD model. The investigators will conduct a two-site, randomized controlled study to document the intervention outcomes of these four models using a test battery that consists of behavioral and self-report measures. Several patient-centered variables, including degree and configuration of hearing loss, cognitive functions, and personality will be measured and used as candidacy predictors. Aim 1. To determine the outcome, value, and candidacy of the OTC model relative to the AUD model. The OTC model excludes professional services and represents the simplest form of the OTC model (referred to as the OTC model). The AUD model, in which professionals will use a core set of best practices to fit entry-level HAs, likely represents the most cost-effective AUD model (referred to as the AUD model). Based on the preliminary data, it is hypothesized that the OTC model will yield poorer outcomes than the AUD model. The value, which will be compared using cost-effectiveness analysis, is less predictable because the model hypothesized to yield better outcomes is more expensive. The investigators further hypothesize that at least some patient-centered variables will be predictive of outcome difference between the models and thus can be used to help decide which model a patient should choose. Aim 2. To determine the outcome, value, and candidacy of the hybrid model. The hybrid model is the OTC-Plus model, in which professionals provide streamlined services to fit OTC devices. It is hypothesized that the outcomes of the hybrid model will be poorer than the AUD model but better than the OTC model. Because the investigators are proposing a total of three levels of service (including no service), achieving this aim will also allow us to document the effect of professional service on outcome and value. It is hypothesized that professional services will contribute to outcomes, and that each increase in the level of professional service will lead to an incremental improvement in outcomes. The value of each level of service in the hybrid model is less predictable. It is also hypothesized that at least some patient-centered variables will predict equal outcomes for some individuals across hybrid and AUD models. ;

Related Conditions & MeSH terms

• Presbycusis

• NCT number: NCT03579563
• Study type: Interventional
• Source: University of Iowa
• Contact: Yu-Hsiang Wu, PhD
• Phone: 319-335-8728
• Email: yu-hsiang-wu@uiowa.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2019
• Completion date: May 1, 2024