Communities Helping the Hearing of Infants by Reaching Parents

Study Overview
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Brief Summary
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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.

Detailed Description
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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) 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.

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

Conditions
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Congenital Hearing Loss

Intervention / Treatment
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* Behavioral: Navigator Guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: 1. Children and parents live outside Kentucky or who will be moving out of Kentucky within the first three months of life.

Ages Eligible for Study
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Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment via Stepped Wedge Trial Design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Navigator Arm<br>Examination of adherence to follow-up with a navigator. | Behavioral: Navigator Guidance<br>* 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.<br>|
| No Intervention: Non-Intervention Arm<br>Examination of adherence to follow-up without a navigator. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. (This is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant Hearing Screening, Patient Navigator