Communities Helping the Hearing of Infants by Reaching Parents

Not Applicable

Completed

• Conditions: Congenital Hearing Loss
• Interventions: Behavioral: Navigator Guidance

• Registration Number: NCT03875339
• Lead Sponsor: Matthew Bush, MD

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-14
• Study Start: 2021-01-13
• Primary Completion: 2023-09-08
• Study Completion: 2023-09-08
• Results First Submitted: 2024-08-30
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-01-30
• Results First Posted: 2025-02-14
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2699

Inclusion Criteria

Inclusion criteria for parent-infant dyads:

1. Infant failed a hearing screening in one or both ears before postnatal hospital discharge
2. Infant was referred for follow-up diagnostic testing at one of the 10 participating CCSHCN clinics.
3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigator Arm	Navigator Guidance	Examination of adherence to follow-up with a navigator.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1)	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.

Trial Locations

Locations (2)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Office for Children with Special Health Care Needs; 🇺🇸 Louisville, Kentucky, United States