The Hearing Aid Effectiveness After Aural Rehabilitation (HEAR) Trial

Hearing Loss Clinical Trial

Official title:

The Hearing Aid Effectiveness After Aural Rehabilitation (HEAR) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00260663
• Other study ID #: SLI 04-265
• Status: Completed
• Phase: N/A
• First received: November 29, 2005
• Last updated: April 6, 2015
• Start date: February 2006
• Est. completion date: June 2008

Study information

• Verified date: January 2008
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study compares the effectiveness of hearing aid appointments provided in a group format to those provided in an individual format. We are asking if hearing aid training with group appointments is as good as or better than with individual appointments.

Description:

Background: The number of hearing aids dispensed by the VA has nearly quadrupled from 75,000 in 1996 to over 283,000 in 2003. However, the number of audiologists serving this population has less than doubled (72% increase) in the same period. This imbalance has resulted in burgeoning waiting times for audiology appointments, negatively impacting the quality of life of thousands of veterans while they wait for hearing aids. Reduction in waiting times through more efficient use of limited resources while maintaining high quality care is of great interest to VA leadership. Objectives: The orientation portion of the hearing aid fitting appointment and the hearing aid follow-up visit 4 The researcherseks later impart standard information relevant to all new hearing aid patients, and may be highly conducive to group format. Our specific aims are to compare group and the current standard of individual aural rehabilitation appointments to determine if: 1) group visits are at least as effective ('non-inferior') as individual visits for each audiology appointment, and 2) the use of group visits leads to lower costs for the VA. Methods: The researchers propose a non-inferiority, randomized clinical trial to compare the effectiveness of group vs. individual audiology appointments. The researchers will compare group vs. individual visits for two types of audiology appointments: hearing aid fitting (orientation only) and hearing aid follow-up. The researchers hypothesize that: 1) group visits are at least as effective as individual visits, as measured by hearing-related quality of life and hearing aid adherence, and 2) group visits lead to cost savings, not just in the immediate treatment period, but throughout a 6-month aural rehabilitation period. Setting and Population. The researchers propose to enroll 660 new hearing aid patients from the audiology clinics at the Seattle and American Lake Divisions of VA Puget Sound Health Care System. Randomized Interventions. Patients will be randomized to group vs. individual orientation (intervention #1) and group vs. individual follow-up (intervention #2) visits. Status: Recruitment is completed. The primary effectiveness outcome will be hearing-related quality of life 6 months after the hearing aid fitting. Secondary effectiveness outcomes will include hearing aid adherence and satisfaction with hearing amplification. Cost and utilization outcomes will include audiology labor for the initial visits and subsequent unplanned visits, the cost of hearing aids, and the number of hearing aid repairs. The researchers selected a time frame of 6 months because pilot data show that 75% of unplanned visits occur in the first 6 months. Analysis. An intention-to-treat analysis will be used to minimize bias due to subject self-selection. The researchers have chosen a sample size adequate to detect non-inferiority of hearing-related quality of life in patients undergoing group rehabilitation in either intervention. Analyses for each intervention will be stratified by degree of hearing loss, binaural vs. monaural hearing aid use, and group vs. individual appointment of the other intervention. Cost-effectiveness analyses will be pursued if greater effectiveness and higher costs are both documented, in which case pilot calculations of the unit cost to obtain an additional successfully treated patient (those with a clinically important improvement of 6 points on the Inner EAR scale) will be made. Benefit to VA. This proposal directly addresses three of the VA's designated research areas: sensory disorders, aging, and health services. In addition, this application is directly responsive to an HSR&D Solicitation on sensory disorders and loss. This project has the potential to help VA leadership identify more efficient treatment that maintains high quality care for one of the most common disabilities in veterans, and to provide insight into the value of group visits as a model of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: June 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

New hearing aid users at VA Puget Sound; eligible for VA hearing aids

Exclusion Criteria:

Prior hearing aid users; Inability to participate in a group rehabilitation sessions or to complete follow-up

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Procedure:
• Group hearing aid fittings

• Group hearing aid follow-up

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (6)

Collins MP, Liu CF, Taylor L, Souza PE, Yueh B. Hearing aid effectiveness after aural rehabilitation: individual versus group trial results. J Rehabil Res Dev. 2013;50(4):585-98. — View Citation

Collins MP, Souza PE, Liu CF, Heagerty PJ, Amtmann D, Yueh B. Hearing aid effectiveness after aural rehabilitation - individual versus group (HEARING) trial: RCT design and baseline characteristics. BMC Health Serv Res. 2009 Dec 15;9:233. doi: 10.1186/147 — View Citation

Collins MP, Souza PE, O'Neill S, Yueh B. Effectiveness of group versus individual hearing aid visits. J Rehabil Res Dev. 2007;44(5):739-49. — View Citation

Liu CF, Collins MP, Souza PE, Yueh B. Long-term cost-effectiveness of screening strategies for hearing loss. J Rehabil Res Dev. 2011;48(3):235-43. — View Citation

Yueh B, Collins MP, Souza PE, Heagerty PJ, Liu CF, Boyko EJ, Loovis CF, Fausti SA, Hedrick SC. Screening for Auditory Impairment-Which Hearing Assessment Test (SAI-WHAT): RCT design and baseline characteristics. Contemp Clin Trials. 2007 May;28(3):303-15. — View Citation

Yueh B, Shekelle P. Quality indicators for the care of hearing loss in vulnerable elders. J Am Geriatr Soc. 2007 Oct;55 Suppl 2:S335-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hearing-related quality of life, hearing aid adherence			No
Secondary	Satisfaction, costs, utilization			No

External Links

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