Promoting Early Diagnosis of Congenital Hearing Loss With Patient Navigators

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.

Study Overview

• Status: Completed
• Conditions: Congenital Hearing Loss
• Intervention / Treatment: Behavioral: Standard scheduling and follow-up; Behavioral: Patient Navigator

Detailed Description

Parents of children who fail infant hearing screening at birth at the University of Kentucky or other hospitals in the area that are receiving follow up diagnostic testing at UK Audiology or the Commission for Children with Special Health Care Needs will be enrolled in the first part of the study and randomized into either a patient navigator group or the standard practice group. We will compare the failure to follow-up for testing rates between groups. Of those enrolled subjects, the age of the children when they obtain diagnostic testing will be assessed and compared between the patient navigator group and the standard practice group. This arm will further quantify the effect of the navigator on diagnostic testing timing.

The second arm strives to continue and build upon the first assessment by evaluating hearing follow up in children up to six months of age who are diagnosed with hearing loss. Parents of children born at the University of Kentucky and at other hospitals who are following up as outpatients at UK who are diagnosed with hearing loss will be approached for enrollment. Parents of children in this arm of the study that did not participate in Arm 1 or did participate in Arm 1 but that were randomized to the control group are randomized from the age of enrollment until one year old to a patient navigator group or standard practice group. Parents of children that participated in Arm 1 that were randomized to patient navigation that enroll in Arm 2 will not be randomized and will continue to receive patient navigation. This group of subjects will be assessed to find what follow up is conducted once the child is diagnosed with hearing loss. As in the first arm, the navigator group will have regular phone follow ups with the patient navigator and the standard practice group will not have contact. Both groups will be given or mailed questionnaires, asking them about where they obtained services for the child with regard to hearing follow up and intervention. This will assess the effect of a navigator on parental education and support, timing of diagnostic services, and implementation of interventions with regard to pediatric hearing loss.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
    • Louisville, Kentucky, United States, 40222
      • Commission for Children with Special Health Care Needs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria (Arm 1):

1. 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
2. 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
3. Parents who are willing to be contacted by study coordinators and/or navigator to monitor progress and testing outcomes
4. 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.

Exclusion Criteria (Arm 1):

1. 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)
2. 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)
3. Parents of wards of the state and cases of adoption will be excluded

Inclusion Criteria (Arm 2):

1. 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.
2. Parents who are willing to be contacted by study coordinators and/or navigator to monitor progress and testing outcomes
3. 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.

Exclusion Criteria (Arm 2):

1. 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)
2. 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)
3. Parents of wards of the state and cases of adoption will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard scheduling and follow-up; 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; 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.
Experimental: Patient Navigator Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Weeks Between Birth and Date of Diagnostic Audiological Testing (Aim 1)	This outcome is the timing of diagnostic audiological testing after failed newborn hearing screening from the date of randomization until the date of first documented diagnostic audiological testing, assessed up to 12 months after birth.	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)	This outcome is the timing of hearing loss intervention from the date of hearing loss diagnosis until the date of documented hearing loss intervention, assessed up to 12 months.	From the date of hearing loss diagnosis until up to one year

Collaborators and Investigators

• Sponsor: Matthew Bush, MD
• Collaborators: National Institutes of Health (NIH); National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Matthew L Bush, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: August 2, 2013
• First Submitted That Met QC Criteria: August 6, 2013
• First Posted (Estimate): August 7, 2013

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Patient Navigator; Infant hearing screening
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: MLB-001-KL2TR000116; KL2TR000116 (U.S. NIH Grant/Contract); K23DC014074 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No