Promoting Early Diagnosis of Congenital Hearing Loss With Patient Navigators

NCT01917747 | Completed Results DMC

• 3 other identifiers: MLB-001-KL2TR000116KL2TR000116K23DC014074
• Study Type: interventional
• Target: 106
• 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 (2)

• 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 after birth

• Number of Participants Who do Not Receive Hearing Intervention by Six Months of Age (Aim 2)

  This outcome is the number of participants who do not follow-up for therapeutic audiological intervention after a diagnosis of infant hearing loss is made from the date of randomization to 6 months after birth.

  From the date of hearing loss diagnosis up to 6 months after birth

Secondary Outcomes (2)

• Number of Weeks Between Birth and Date of Diagnostic Audiological Testing (Aim 1)

  From date of randomization to first audiological diagnostic test up to 12 months of age

• Number of Weeks Between Date of Hearing Loss Diagnosis and Intervention (Aim 2)

  From the date of hearing loss diagnosis until up to one year

Study Arms (2)

Standard scheduling and follow-up

ACTIVE COMPARATOR

The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before and after any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling or rescheduling of the hearing test and any other follow up, as is standard practice.

Behavioral: Standard scheduling and follow-up

Patient Navigator Group

EXPERIMENTAL

The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed.

Behavioral: Patient Navigator

Interventions

Patient Navigator BEHAVIORAL

The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed. In the second part of the study, further educational tools are given to parent(s) and discussion of additional follow up mechanisms, including community hearing services and types of interventions for pediatric hearing loss is imparted.

Patient Navigator Group

Standard scheduling and follow-up BEHAVIORAL

The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling or rescheduling of the hearing test, as is standard practice.

Standard scheduling and follow-up

Eligibility Criteria

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

You may qualify if:

• Parents of children who are born at University of Kentucky Medical Center in the postpartum ward whose children are born after 34 weeks gestation and fail hearing screening in one or both ears
• Parents whose children are receiving follow up testing (due to referral after mandatory newborn hearing screening) at UK Audiology or the Commission for Children with Special Health Care Needs
• Parents who are willing to be contacted by study coordinators and/or navigator to monitor progress and testing outcomes
• Parents who are able to speak English or Spanish as the patient navigator will be speaking one of these languages and this will be the primary means of communication over the phone.

You may not qualify if:

• Parents of newborns who are hospitalized past 30 days after birth or who are born prior to 34 weeks gestation (as this may inherently delay diagnostic work-up)
• Children and parents live outside Kentucky or who will be moving out of Kentucky within the first year of life (they will not be able to be followed closely at our institution)
• Parents of wards of the state and cases of adoption will be excluded
• Children who are 6 months old or less and have been diagnosed with hearing loss in one or both ears through two separate ABR tests.
• Parents who are willing to be contacted by study coordinators and/or navigator to monitor progress and testing outcomes
• Parents who are able to speak English or Spanish as the patient navigator will be speaking one of these languages and this will be the primary means of communication over the phone.
• Parents of newborns who are hospitalized past 30 days after birth or who are born prior to 34 weeks gestation (as this may inherently delay diagnostic work-up)
• Children and parents live outside Kentucky or who will be moving out of Kentucky within the first year of life (they will not be able to be followed closely at our institution)
• Parents of wards of the state and cases of adoption will be excluded

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

Commission for Children with Special Health Care Needs

Louisville, Kentucky, 40222, United States

Location

MeSH Terms

Interventions

Patient Navigation

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Dr. Matthew L. Bush
• Organization: UK Dept. of Otolaryngology Head and Neck Surgery

matthew.bush@uky.edu

859-218-2168

Study Officials

• Matthew L Bush, MD

  University of Kentucky

  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

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 7, 2013
• Study Start: January 1, 2014
• Primary Completion: September 30, 2018
• Study Completion: January 1, 2020
• Last Updated: March 31, 2020
• Results First Posted: December 24, 2019

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)