NCT03875339

Communities Helping the Hearing of Infants by Reaching Parents

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,699 (actual)
• Sponsor: Matthew Bush, MD · Academic / Other
• Sex: All
• Age: 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Congenital Hearing Loss

Interventions

Type	Name	Description
BEHAVIORAL	Navigator Guidance	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.

Timeline

• Start date: 2021-01-13
• Primary completion: 2023-09-08
• Completion: 2023-09-08
• First posted: 2019-03-14
• Last updated: 2025-02-14
• Results posted: 2025-02-14

Locations

2 sites across 1 country: United States