Communities Helping the Hearing of Infants by Reaching Parents

Congenital Hearing Loss Clinical Trial

— CHHIRP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03875339
• Other study ID #: 47997 2019
• Secondary ID: 1R01DC017770-01
• Status: Completed
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: September 8, 2023

Study information

• Verified date: February 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: September 8, 2023
• Est. primary completion date: September 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Hearing Loss
• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky
United States	Office 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. (This is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.)