A Simplified Patient-Centered Educational Tool for Improved Hearing-Aid Outcomes

This study is currently recruiting participants.
Verified February 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01940705
First received: September 9, 2013
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

Hearing loss is the second most prevalent service-connected disability among Veterans. Hearing aids are the most common technological intervention for hearing loss. The VA, therefore, spends a considerable amount of money on them. Despite these expenditures, there are some Veterans who do not use their hearing aids successfully. Research has demonstrated that this inconsistent use may be related to a patient's inability to effectively take care of, and use, hearing aids. The proposed investigation will compare the effectiveness of three different tools for enhancing the educational efforts (hearing-aid orientation) typically provided by clinical audiologists when dispensing hearing aids. Each of these educational tools were developed using established methods for improving patient-provider communication. We hypothesize that the use of these tools will result in better hearing-aid outcomes for our Veteran patients than using the current standard-of-care procedures.


Condition Intervention
Hearing Loss
Other: Hearing-Aid Informational Guide
Other: Hearing-Aid DVD
Behavioral: Teach-back Technique
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Simplified Patient Centered Educational Tool for Improved Hearing Aid Outcomes

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Practical Hearing Aid Skills Test [ Time Frame: 4 weeks after the hearing-aid fitting ] [ Designated as safety issue: No ]
    a test that measures the ability to handle and manipulate hearing aids


Secondary Outcome Measures:
  • The Hearing Aid Probed Recall Inventory [ Time Frame: 4 weeks after the hearing-aid fitting ] [ Designated as safety issue: No ]
    "quiz" examining an individual's knowledge about their hearing aids

  • The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids [ Time Frame: 4 weeks after the hearing-aid fitting ] [ Designated as safety issue: No ]
    questionnaire regarding self-efficacy when it comes to using hearing aids

  • International Outcome Inventory for Hearing Aids [ Time Frame: 4 weeks after the hearing-aid fitting ] [ Designated as safety issue: No ]
    hearing-aid outcomes questionnaire

  • Practical Hearing Aid Skills Test [ Time Frame: 6 months after the hearing-aid fitting ] [ Designated as safety issue: No ]
    a test that measures the ability to handle and manipulate hearing aids

  • The Hearing Aid Probed Recall Inventory [ Time Frame: 6 months after the hearing-aid fitting ] [ Designated as safety issue: No ]
    "quiz" examining an individual's knowledge about their hearing aids

  • The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids [ Time Frame: 6 months after the hearing-aid fitting ] [ Designated as safety issue: No ]
    questionnaire regarding self-efficacy when it comes to using hearing aids

  • International Outcome Inventory for Hearing Aids [ Time Frame: 6 months after the hearing-aid fitting ] [ Designated as safety issue: No ]
    hearing-aid outcomes questionnaire


Estimated Enrollment: 468
Study Start Date: January 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of care
standard of care hearing-aid orientation as provided by clinical audiologist
Other: Standard of Care
standard of care hearing-aid orientation as provided by clinical audiologist
Experimental: SoC plus hearing-aid informational guide
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids
Other: Hearing-Aid Informational Guide
Printed take-home guide on hearing aids
Other: Standard of Care
standard of care hearing-aid orientation as provided by clinical audiologist
Experimental: SoC plus a take-home DVD
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids
Other: Hearing-Aid DVD
Take-home DVD about hearing aids
Other: Standard of Care
standard of care hearing-aid orientation as provided by clinical audiologist
Experimental: SoC plus counseling with the teach-back technique
standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids
Behavioral: Teach-back Technique
Counseling/Educational session using the teach-back technique to review information about their hearing aids
Other: Standard of Care
standard of care hearing-aid orientation as provided by clinical audiologist

Detailed Description:

Objectives: Reasons for non-use of hearing aids are varied, but many studies have suggested that a lack of knowledge about how to use and/or take care of the hearing aids is a major factor. This is not surprising given that other healthcare fields have reported that between 40-80% of information provided during a clinical appointment is forgotten by the patient immediately after the appointment and almost half of what is remembered is not correct. The long-term goal of this project is to improve the delivery of information during the hearing-aid orientation, as better delivery of information will result in better hearing-aid handling skills and thus better overall hearing-aid outcomes. To accomplish this goal, we propose to refine and evaluate the effectiveness of three forms of supplemental hearing-aid-orientation tools, each of which was developed using established guidelines for good patient-provider communication

Plan: The purpose of the proposed application is to evaluate the relative effectiveness of four forms of hearing-aid orientation provided to first time hearing-aid users, three of which use some of the aforementioned strategies to enhance the standard of care. The four forms of orientation will be: (1) the standard-of-care hearing-aid orientation; (2) the standard of care plus provision a one-page hearing-aid information guide (HAIG) (3) the standard of care supplemented by an explanation of its content using the talk-back technique to confirm patient understanding; and (4) the standard of care plus provision of a take-home hearing-aid orientation DVD (HAO DVD). The content of the HAIG will be field tested and finalized following input obtained via focus groups with clinical audiologists and first-time hearing aid users.

Methods: For the field testing up to 16 clinical audiologists and 10 new hearing aid user Veterans will be recruited to participate in focus groups during which they will view and then be asked questions about the content of the HAIG. Information learned during these focus groups will then be incorporated into the HAIG , at which time they will be ready for use in the study. For the comparative effectiveness study, up to 468 hearing-impaired Veterans who are about to become first-time hearing-aid users will be enrolled to participate in this investigation. These individuals will be recruited from the Portland VA Medical Center's Audiology and Speech Pathology Service (ASPS). Prior to receiving their hearing aids, subjects will be enrolled in the study at the National Center for Rehabilitative Auditory Research (NCRAR), and will conduct health literacy, manual dexterity and hepatic sensitivity, visual acuity, and learning and memory assessments. They will then attend their hearing aid fitting in the ASPS and will receive standard-of-care hearing-aid orientation. At the end of that appointment, they will be assigned to one of the four arms of the study described above and receive that intervention. Subjects will return to the NCRAR 4-6 weeks after the hearing-aid-fitting appointment to complete the following outcome measures: a knowledge test and a practical test regarding hearing-aid use and care, a measure of self-efficacy, and a measure of hearing-aid outcomes. They also will be interviewed so that we can learn their opinions about the intervention. A subset of the initial 50 participants enrolled into each study arm will attend a second follow-up appointment 6 months after the fitting appointment so we can examine longer-term impacts of the hearing aid orientation interventions.

  Eligibility

Ages Eligible for Study:   50 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants will be Veterans who are receiving hearing aids from the Audiology Clinic at the Portland VAMC and who have had no prior experience using hearing aids. To be included in the study, participants will:

  • Be scheduled to receive a bilateral hearing aid fitting at the Portland VAMC within 4 weeks of study enrollment.
  • Be able to read and converse in English.

Exclusion Criteria:

  • Be younger than 50 years or older than 89 years of age.
  • Have active external ear disease, retrocochlear disease, or a confirmed diagnosis of dynamic cochlear pathology, such as endolymphatic hydrops, Meniere's Disease, sudden hearing loss, or perilymphatic fistula.
  • Have a documented diagnosis of neurological, cognitive, or other mental disorder, such as Alzheimer's disease, schizophrenia, current alcohol or substance abuse, etcetera, as determined by chart review.
  • Have used hearing aids in the past.
  • Have a spouse who routinely uses hearing aids.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01940705

Contacts
Contact: Daniel J McDermott, MA (800) 949-1004 ext 57465 daniel.mcdermott@va.gov

Locations
United States, Oregon
Portland VA Medical Center, Portland, OR Recruiting
Portland, Oregon, United States, 97239
Contact: Daniel J McDermott, MA    (800) 949-1004 ext 57465    daniel.mcdermott@va.gov   
Principal Investigator: M. Samantha Lewis, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: M. Samantha Lewis, PhD Portland VA Medical Center, Portland, OR
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01940705     History of Changes
Other Study ID Numbers: C1260-R, 1 I01 RX001260-01, 3224
Study First Received: September 9, 2013
Last Updated: February 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
hearing aids
counseling
outcomes assessment (health care)
rehabilitation

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014