Cost-effective Hearing Aid Delivery Models
Primary Purpose
Presbycusis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audiologist-based fitting
Over-the-counter fitting
Hybrid fitting
Sponsored by
About this trial
This is an interventional health services research trial for Presbycusis focused on measuring Presbycusis, Hearing aid
Eligibility Criteria
Inclusion Criteria:
- adult-onset, bilateral, mild-to-moderately severe sensorineural hearing loss
- no previous hearing aid experience
Exclusion Criteria:
- Non-native speaker of English
Sites / Locations
- University of IowaRecruiting
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
AUD (audiologist-based)
OTC (over-the-counter)
OTC-Plus
Arm Description
In this group, the audiologist-based fitting will be used to provide hearing aids.
In this group, the over-the-counter fitting will be used to provide hearing aids.
In this group, the hybrid fitting will be used to provide hearing aids.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
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).
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.
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).
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).
Full Information
NCT ID
NCT03579563
First Posted
June 25, 2018
Last Updated
May 11, 2023
Sponsor
Yu-Hsiang Wu
Collaborators
Vanderbilt University Medical Center, National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT03579563
Brief Title
Cost-effective Hearing Aid Delivery Models
Official Title
Cost-effective Hearing Aid Delivery Models: Outcomes, Value, and Candidacy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yu-Hsiang Wu
Collaborators
Vanderbilt University Medical Center, National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbycusis
Keywords
Presbycusis, Hearing aid
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AUD (audiologist-based)
Arm Type
Active Comparator
Arm Description
In this group, the audiologist-based fitting will be used to provide hearing aids.
Arm Title
OTC (over-the-counter)
Arm Type
Experimental
Arm Description
In this group, the over-the-counter fitting will be used to provide hearing aids.
Arm Title
OTC-Plus
Arm Type
Experimental
Arm Description
In this group, the hybrid fitting will be used to provide hearing aids.
Intervention Type
Other
Intervention Name(s)
Audiologist-based fitting
Intervention Description
Hearing aids will be fitted by audiologists using established procedures.
Intervention Type
Other
Intervention Name(s)
Over-the-counter fitting
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Hybrid fitting
Intervention Description
Audiology professionals provide streamlined services to fit pre-configured amplification devices.
Primary Outcome Measure Information:
Title
Hearing aid benefit as measured by the Glasgow Hearing Aid Benefit Profile (GHABP)
Description
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).
Time Frame
6-week post intervention
Secondary Outcome Measure Information:
Title
Hearing aid performance/benefit as measured using the Profile of Hearing Aid Performance (PHAP)
Description
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).
Time Frame
6-week post-intervention
Title
Speech recognition performance as measured by the Connected Speech Test (CST)
Description
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).
Time Frame
6-week post-intervention
Title
Hearing handicap as measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)
Description
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).
Time Frame
6-week post-intervention
Title
Hearing aid satisfaction as measured by the Hearing Aid Satisfaction Survey (HASS)
Description
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).
Time Frame
6-week post-intervention
Title
Willingness-to-pay
Description
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.
Time Frame
6-week post-intervention
Title
Quality of life as measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0)
Description
The WHODAS is a questionnaire designed to measure quality of life. The summary score ranges from 0 (No disability) to 100 (Full disability).
Time Frame
6-week post-intervention
Title
Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL)
Description
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).
Time Frame
6-week post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult-onset, bilateral, mild-to-moderately severe sensorineural hearing loss
no previous hearing aid experience
Exclusion Criteria:
Non-native speaker of English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Hsiang Wu, PhD
Phone
319-335-8728
Email
yu-hsiang-wu@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Stangl, AuD
Phone
31-335-9758
Email
elizabeth-stangl@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Hsiang Wu, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Hsiang Wu, PhD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Ricketts, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The proposed research will include data from a total of 240 participants with hearing loss recruited State of Iowa, State of Tennessee and surrounding areas. The final dataset will include laboratory data (e.g., speech recognition score) and self-reported demographic and behavioral data (e.g., questionnaire). Contact the principle investigator for data access.
IPD Sharing Time Frame
The date will be available starting 6 months after publication of the main findings of the trial.
IPD Sharing Access Criteria
Even though the final dataset will be stripped of identifiers prior to release for sharing, there remains the possibility of deductive disclosure of subjects with the survey data being collected. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate technologies; and (3) a commitment to destroying or returning the data after analyses are completed.
Citations:
PubMed Identifier
23169194
Citation
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.
Results Reference
background
PubMed Identifier
1487096
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.
Results Reference
background
PubMed Identifier
24521924
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.
Results Reference
background
PubMed Identifier
18519576
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).
Results Reference
background
PubMed Identifier
20040828
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.
Results Reference
background
PubMed Identifier
21514179
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.
Results Reference
background
PubMed Identifier
21357188
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.
Results Reference
background
PubMed Identifier
17580727
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.
Results Reference
background
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Cost-effective Hearing Aid Delivery Models
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