Examining the Impact of Physician Influence on Hearing Aid User Satisfaction and Retention

NCT ID: NCT02842905


Title
Examining the Impact of Physician Influence on Hearing Aid User Satisfaction and Retention
Purpose
Most of us will experience some degree of hearing loss as we get older. Hearing loss can be due to genetics, trauma, infections, exposure to loud sounds, toxins or ageing. It can affect one or both ears and without treatment causes difficulty with following conversations in the home or workplace. Individuals with hearing loss can seek treatment from either an audiologist or a physician. An audiologist specializes in identifying, diagnosing, treating and monitoring disorders of the auditory and vestibular system portions of the ear. Audiologists are trained to diagnose and treat hearing loss and tinnitus problems. They also dispense, and fit hearing aids. Physicians do not provide or fit hearing aids directly, however they diagnose hearing loss and can recommend hearing aids amongst other treatments for hearing loss. It is undecided whether consulting with a physician in addition to an audiologist will improve the acceptability of hearing aids to potential users compared to consulting with an audiologist alone. The purpose of this study is to determine whether physician involvement (in addition to an audiologist) in the hearing aid fitting process will benefit patients. The study utilizes questionnaires to assess satisfaction and benefit from hearing aid fittings. Furthermore, participants decision to keep the purchased hearing aids will be recorded. The study will take place in the clinics of family doctors, Otolaryngology (Ear) surgeons and audiologists. A hearing aid suitable for the needs of the participant will be fitted by an audiologist. In the first 21days after the fitting, participants will attend follow-up visits with the audiologists for adjustments to the hearing aids to best meet their specific listening needs. After 21 days, eligible participants will be allocated to either the Control or Test groups. During Phase II the participants will have a follow-up visit with an audiologist (Control group) or their referring physician (Test group). During this visit participants in both groups will be asked to describe the change in their hearing performance related to the use of hearing aids. The study involvement time for each participant will extend over a period of 90 days. At the study's end visit, participants will be asked to complete a questionnaire. The time taken to fit a hearing aid varies depending on the individual needs of the patient. It is estimated that at most 10 visits will be required over 90 days to complete the hearing aid fitting and study processes. These visits will be of 30 minutes duration on average, except for the initial and final visits which lasts for 45 minutes. A patient will spend a maximum of 330 minutes to complete the hearing aid fitting process, but only 25 minutes of this time will be specifically related to the study. Each participant is under no obligation to retain the hearing aid if s/he is not satisfied with the hearing device, nor will any of the study investigators pressurise the participants to retain the hearing device. The study is not intended to provide participants with hearing aids, but rather to determine the benefit derived from hearing aids and consultations with health professionals.
Details
Description of study design This study seeks to determine if additional patient benefit is derived from involving the referring physician in the hearing aid fitting process using the Client Oriented Scale of Improvement (COSI) process. The COSI process is a well-known methodology that consists of two consecutive phases: Phase I is completed by the client with the Audiologist either at the time of initial hearing aid fitting or within 21 days thereafter. The patient is asked to list any specific listening environment/situations in which he/she would like to improve his/her hearing with the assistance of wearing hearing aids; Phase II occurs within days 22 to 76 from the day the hearing aid device is fitted and is also normally completed by the patient and the Audiologist. In this phase, the patient indicates any degree of change in the specific listening environment/situations he/she had previously listed (wearing the hearing aid). Two methods will be used for study purposes to assess patient satisfaction with hearing aid use 77 to 90 days post fitting: (1) the validated SADL questionnaire described previously will be completed by the patient and (2) the number of hearing aids returned up to 90 days post initial fitting will be recorded. The study will consist of two groups: a control group and a test group. Both groups will undergo Phase I of the COSI process with the fitting Audiologist. Patients in the control group will undergo Phase II of the COSI process as part of their follow up with the audiologist, whereas those in the test group will complete Phase II of the COSI process in a scheduled visit with their referring physician before further follow-up with the audiologist. Participants will be recruited from the investigating audiologists' clinics in Vancouver. The study involvement time for each participant will extend over a period of 90 days. Routine Clinical Practice A complete hearing aid fitting takes place over the course of several clinic visits each on average 30-45 minutes in duration. These include the initial hearing test and consultation, actual fitting, and any subsequent post-fitting adjustments. During hearing evaluation and post-fitting follow-up sessions, a COSI questionnaire is used by audiologists as part of routine clinical practice to guide optimal hearing aid adjustment to meet the patient's listening needs. Time schedule The time taken to fit a hearing aid varies depending on the needs of the patient. Very often clients over the age of 55 have problems with dexterity, memory and other health impairments that extend the length of individual consultations. Some patients require more clinic consultations than others. Anecdotally it is estimated that the maximal number of visits required to complete the hearing aid fitting process is 10 visits over 90 days. These visits on average will be of 30 minutes in duration except for the initial and final visits which lasts for 45 minutes. A patient will spend a maximum of 330 minutes to complete the hearing aid fitting process of which 25 minutes will be related to study specific procedures. Subjects Patients referred by General practitioners or Otolaryngologists for hearing aid fittings to the offices of two Audiologists who meet the inclusion criteria will be provided with details of the study including a participant information and consent form at their initial evaluation. Study Procedures Recruitment Patients who satisfy the inclusion criteria will be invited to participate in the study and complete a study consent form. Allocation Consenting patients will be assigned a study ID and randomized into the Control or Test group using a table of random numbers. Intervention Process Consenting patients will be randomised using a random number table to have a post-fitting visit between days 21 to 60 after the initial hearing aid fitting with an Audiologist (Control group) or the referring Physician (Test Group). At this visit the audiologist or physician will document the degree of hearing change in specific listening environment/situations as a result of hearing aid use by following the COSI questionnaire. This visit will be for a maximum of 30 minutes. A follow-up visit of this nature is part of routine clinical practice for the participating audiologist. The physician visit is the novel study intervention after which the patient returns for all subsequent follow-ups with the hearing aid fitting audiologist in keeping with routine clinical practice. Patient data to be collected Demographics: • age, sex Clinical data: • degree of hearing loss Data Analysis The primary indicator of patient satisfaction will be the scored 15-item SADL questionnaire. The Statistical Program for the Social Sciences will be used to undertake a t-test or ANOVA comparison of the mean total SADL questionnaire scores in the Control and Test groups. The secondary outcome measure hearing aid returns, will be assessed by Chi-squared tests of the proportion of returned hearing aids returned in both groups.
Conditions
Hearing Loss
Keywords
Source
University of British Columbia
Sponsors
University of British Columbia, NexGen Hearing
Status
Not yet recruiting
Acronym
Last Updated
21 Jul 2016
URL
Official Link
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