Communities Helping the Hearing of Infants by Reaching Parents

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.

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Key information

Conditions

Congenital Hearing Loss

Age range

Up to 99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky, Lexington, Kentucky, United States

About this study

For Specific Arm 1:

The investigators will (1) use a stepped-wedge trial design to deliver patient navigation (PN) sequentially in 10 state-funded Kentucky Commission for Children with Special Healthcare Needs (CCSHCN) (also referred to as the Office for Children with Special Healthcare needs or OCSHCN) clinics randomized to cross from usual care to PN in steps of 6-month intervals over the project period. Prior to initiation of PN at each clinic, the control condition will be the standard of care. The overall effectiveness of PN will be tested by comparing non-adherence rates during the PN condition to those during the standard of care condition. Simultaneously, the investigators will (2) assess preliminary implementation outcomes (i.e., acceptability, adoption, recruitment/retention, and fidelity) as well as multilevel factors influencing implementation of PN in each clinic.

For Specific Arm 2:

Patient navigators will not be used for all subjects at participating clinics.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for parent-infant dyads:

Infant failed a hearing screening in one or both ears before postnatal hospital discharge
Infant was referred for follow-up diagnostic testing at one of the 10 participating CCSHCN clinics.
Parent able to speak either English or another language using Cyracom phone interpreting services.

Exclusion criteria

Children and parents live outside Kentucky or who will be moving out of Kentucky within the first three months of life.

Treatment and study plan

Navigator Guidance

Behavioral

Use of a dedicated Navigator to determine if follow-up and compliance rates can be improved for those infants initially demonstrating an abnormal hearing result.

Primary outcomes

Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1)

Time frame: 3 months. (This is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.)

This outcome is the number of participants who do not follow-up at an OCSHCN Clinic for diagnostic audiologic testing after a failed newborn hearing screening from the date of randomization to 3 months after birth.

Sponsors and collaborators

Lead sponsor

Matthew Bush, MD

Other

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institutes of Health (NIH)

Registry information

Official study title

Communities Helping the Hearing of Infants by Reaching Parents: The CHHIRP Navigator Trial

Acronym: CHHIRP

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Mar 14, 2019
Registry last updated: Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed