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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01917747
Other study ID # MLB-001-KL2TR000116
Secondary ID KL2TR000116K23DC
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2014
Est. completion date January 1, 2020

Study information

Verified date March 2020
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hearing loss is the most common sensory congenital disorder and this condition is diagnosable and treatable. Children that are born with hearing loss have to undergo several hearing tests to diagnose the condition and many families are delayed in receiving this testing or never obtain the needed testing. This research employs a new method for helping children with hearing loss receive timely care by using a patient navigator, who is someone who teaches and provides emotional/social support for the families of these children. The hypothesis of this study is that a patient navigator will hasten the timing of pediatric audiological testing, improve compliance with scheduled appointments, and expand parental knowledge of pediatric hearing loss.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Patient Navigator
The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed. In the second part of the study, further educational tools are given to parent(s) and discussion of additional follow up mechanisms, including community hearing services and types of interventions for pediatric hearing loss is imparted.
Standard scheduling and follow-up
The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling or rescheduling of the hearing test, as is standard practice.

Locations

Country Name City State
United States University of Kentucky Lexington Kentucky
United States Commission for Children with Special Health Care Needs Louisville Kentucky

Sponsors (3)

Lead Sponsor Collaborator
Matthew Bush, MD National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) This outcome is the number of participants who do not follow-up for diagnostic audiologic testing after a failed newborn hearing screening from the date of randomization to 3 months after birth. 3 months after birth
Primary Number of Participants Who do Not Receive Hearing Intervention by Six Months of Age (Aim 2) This outcome is the number of participants who do not follow-up for therapeutic audiological intervention after a diagnosis of infant hearing loss is made from the date of randomization to 6 months after birth. From the date of hearing loss diagnosis up to 6 months after birth
Secondary Number of Weeks Between Birth and Date of Diagnostic Audiological Testing (Aim 1) This outcome is the timing of diagnostic audiological testing after failed newborn hearing screening from the date of randomization until the date of first documented diagnostic audiological testing, assessed up to 12 months after birth. From date of randomization to first audiological diagnostic test up to 12 months of age
Secondary Number of Weeks Between Date of Hearing Loss Diagnosis and Intervention (Aim 2) This outcome is the timing of hearing loss intervention from the date of hearing loss diagnosis until the date of documented hearing loss intervention, assessed up to 12 months. From the date of hearing loss diagnosis until up to one year
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