N/A
N=106
Promoting Early Diagnosis of Congenital Hearing Loss With Patient Navigators
Congenital Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT01917747 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) — 15; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient Navigator (Behavioral); Standard scheduling and follow-up (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Matthew Bush, MD
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) |
15; 8 | — |
| PRIMARY Number of Participants Who do Not Receive Hearing Intervention by Six Months of Age (Aim 2) |
— | — |
| SECONDARY Number of Weeks Between Birth and Date of Diagnostic Audiological Testing (Aim 1) |
7.13; 6.19 | — |
| SECONDARY Number of Weeks Between Date of Hearing Loss Diagnosis and Intervention (Aim 2) |
— | — |
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.
Eligibility Criteria
Inclusion Criteria (Arm 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
- 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.
Exclusion Criteria (Arm 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)
- 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
Inclusion Criteria (Arm 2):
- 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.
Exclusion Criteria (Arm 2):
- 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
Data sourced from ClinicalTrials.gov (NCT01917747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.