Communities Helping the Hearing of Infants by Reaching Parents

NCT03875339 | Completed Results DMC

• 2 other identifiers: 47997 20191R01DC017770-01
• Study Type: interventional
• Target: 2,699
• Locations: 1 country
• Sites: 2

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.

Conditions

Congenital Hearing Loss

Keywords

Infant Hearing Screening; Patient Navigator

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Study Arms (2)

Navigator Arm

ACTIVE COMPARATOR

Examination of adherence to follow-up with a navigator.

Behavioral: Navigator Guidance

Non-Intervention Arm

NO INTERVENTION

Examination of adherence to follow-up without a navigator.

Interventions

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.

Navigator Arm

Eligibility Criteria

• Age: Up to 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Matthew Bush, MD: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Office for Children with Special Health Care Needs

Louisville, Kentucky, 40222, United States

Location

Related Publications (1)

• Bush M, Hatfield M, Schuh M, Balasuriya B, Mahairas A, Jacobs J, Studts C, Westgate P, Schoenberg N, Shinn J, Creel L. Communities Helping the Hearing of Infants by Reaching Parents (CHHIRP) through patient navigation: a hybrid implementation effectiveness stepped wedge trial protocol. BMJ Open. 2022 Apr 19;12(4):e054548. doi: 10.1136/bmjopen-2021-054548.

  PMID: 35440449 DERIVED

Results Point of Contact

• Title: Dr. Matthew L. Bush, Professor and Chair of Otolaryngology- Head and Neck Surgery
• Organization: University of Kentucky

matthew.bush@uky.edu

(859)218-2139

Study Officials

• Matthew L Bush, MD, PhD

  Associate Professor, Vice Chair of Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Parallel Assignment via Stepped Wedge Trial Design

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 14, 2019
• Study Start: January 13, 2021
• Primary Completion: September 8, 2023
• Study Completion: September 8, 2023
• Last Updated: February 14, 2025
• Results First Posted: February 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
• Access Criteria: De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.

Locations

US (2)