CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 106 enrolled
Drug / intervention
Patient Navigator +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01917747
NCT01917747N/ACompleted

Promoting Early Diagnosis of Congenital Hearing Loss With Patient Navigators

Matthew Bush, MD·interventional·Posted Aug 7, 2013·Updated Mar 31, 2020

In Brief

A clinical study evaluating Patient Navigator and Standard scheduling and follow-up for Congenital Hearing Loss. Completed, enrolled 106 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 7, 2013
Enrollment StartJan 1, 2014
Primary CompletionSep 30, 2018
Study CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 12.9 years ago

Interventions

Patient Navigatorbehavioral

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.

Standard scheduling and follow-upbehavioral

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.