Cost-effective Hearing Aid Delivery Models

Presbycusis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03579563
• Other study ID #: 201804771
• Secondary ID: 1R01DC015997-01A
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2019
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2023
• Source: University of Iowa
• Contact: Yu-Hsiang Wu, PhD
• Phone: 319-335-8728
• Email: yu-hsiang-wu[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• adult-onset, bilateral, mild-to-moderately severe sensorineural hearing loss
• no previous hearing aid experience

Exclusion Criteria:

• Non-native speaker of English

Related Conditions & MeSH terms

• Presbycusis

Intervention

Other:
• Audiologist-based fitting
Hearing aids will be fitted by audiologists using established procedures.
• Over-the-counter fitting
In this group, pre-configured Hearing aids will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
• Hybrid fitting
Audiology professionals provide streamlined services to fit pre-configured amplification devices.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Yu-Hsiang Wu	National Institute on Deafness and Other Communication Disorders (NIDCD), Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

Abrams HB, Chisolm TH, McManus M, McArdle R. Initial-fit approach versus verified prescription: comparing self-perceived hearing aid benefit. J Am Acad Audiol. 2012 Nov-Dec;23(10):768-78. doi: 10.3766/jaaa.23.10.3. — View Citation

Abrams HB, Hnath-Chisolm T, Guerreiro SM, Ritterman SI. The effects of intervention strategy on self-perception of hearing handicap. Ear Hear. 1992 Oct;13(5):371-7. doi: 10.1097/00003446-199210000-00013. — View Citation

Bainbridge KE, Ramachandran V. Hearing aid use among older U.S. adults; the national health and nutrition examination survey, 2005-2006 and 2009-2010. Ear Hear. 2014 May-Jun;35(3):289-94. doi: 10.1097/01.aud.0000441036.40169.29. — View Citation

Callaway SL, Punch JL. An electroacoustic analysis of over-the-counter hearing aids. Am J Audiol. 2008 Jun;17(1):14-24. doi: 10.1044/1059-0889(2008/003). — View Citation

Donahue A, Dubno JR, Beck L. Guest editorial: accessible and affordable hearing health care for adults with mild to moderate hearing loss. Ear Hear. 2010 Feb;31(1):2-6. doi: 10.1097/AUD.0b013e3181cbc783. No abstract available. — View Citation

Gopinath B, Schneider J, Hartley D, Teber E, McMahon CM, Leeder SR, Mitchell P. Incidence and predictors of hearing aid use and ownership among older adults with hearing loss. Ann Epidemiol. 2011 Jul;21(7):497-506. doi: 10.1016/j.annepidem.2011.03.005. Epub 2011 Apr 21. — View Citation

Lin FR, Thorpe R, Gordon-Salant S, Ferrucci L. Hearing loss prevalence and risk factors among older adults in the United States. J Gerontol A Biol Sci Med Sci. 2011 May;66(5):582-90. doi: 10.1093/gerona/glr002. Epub 2011 Feb 27. — View Citation

Takahashi G, Martinez CD, Beamer S, Bridges J, Noffsinger D, Sugiura K, Bratt GW, Williams DW. Subjective measures of hearing aid benefit and satisfaction in the NIDCD/VA follow-up study. J Am Acad Audiol. 2007 Apr;18(4):323-49. doi: 10.3766/jaaa.18.4.6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hearing aid benefit as measured by the Glasgow Hearing Aid Benefit Profile (GHABP)	The Glasgow Hearing Aid Benefit Profile (GHABP) is a questionnaire that measures hearing aid users' listening experience in four situations (TV listening, small conversation in quiet, conversation in noise, and group conversation). The GHABP will be administered using a smartphone-based ecological momentary assessment methodology. The score ranges from 0 (no benefit) to 5 (lots of benefit).	6-week post intervention
Secondary	Hearing aid performance/benefit as measured using the Profile of Hearing Aid Performance (PHAP)	The PHAP is a questionnaire designed to measures the performance of hearing aids in speech communication. The score ranges from 1 (good performance) to 99 (poor performance).	6-week post-intervention
Secondary	Speech recognition performance as measured by the Connected Speech Test (CST)	The CST is a speech recognition test designed to simulate daily speech communication. The score ranges from 0 (understand no speech) to 100 (understand all speech).	6-week post-intervention
Secondary	Hearing handicap as measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)	The HHIE and HHIA are questionnaires designed to measure subject's perceived hearing handicap. For subjects order and younger 65 years old, the HHIE and HHIA will be used, respectively. The score ranges from 0 (no handicap) to 24 (more handicap).	6-week post-intervention
Secondary	Hearing aid satisfaction as measured by the Hearing Aid Satisfaction Survey (HASS)	The HASS is a questionnaire developed to measures subject's perceived hearing aid satisfaction. The score ranges from 0 (low satisfaction) to 10 (high satisfaction).	6-week post-intervention
Secondary	Willingness-to-pay	Willingness-to-pay (WTP) estimates the extent to which (in dollars) a subjects, at a maximum, is willing to pay out-of-pocket for the amplification devices and the associated services used in the study.	6-week post-intervention
Secondary	Quality of life as measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0)	The WHODAS is a questionnaire designed to measure quality of life. The summary score ranges from 0 (No disability) to 100 (Full disability).	6-week post-intervention
Secondary	Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL)	The SADL is a questionnaire designed to measures subject's perceived hearing aid satisfaction. The score ranges from 1 (low satisfaction) to 7 (high satisfaction).	6-week post-intervention