Communities Helping the Hearing of Infants by Reaching Parents

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2699 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-13

Study Completion Date

2023-09-08

Brief Summary

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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.

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Detailed Description

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For Specific Arm 1:

The investigators will (1) use a stepped-wedge trial design to deliver patient navigation (PN) sequentially in 10 state-funded Kentucky Commission for Children with Special Healthcare Needs (CCSHCN) (also referred to as the Office for Children with Special Healthcare needs or OCSHCN) clinics randomized to cross from usual care to PN in steps of 6-month intervals over the project period. Prior to initiation of PN at each clinic, the control condition will be the standard of care. The overall effectiveness of PN will be tested by comparing non-adherence rates during the PN condition to those during the standard of care condition. Simultaneously, the investigators will (2) assess preliminary implementation outcomes (i.e., acceptability, adoption, recruitment/retention, and fidelity) as well as multilevel factors influencing implementation of PN in each clinic.

For Specific Arm 2:

Patient navigators will not be used for all subjects at participating clinics.

Conditions

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Congenital Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment via Stepped Wedge Trial Design

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Navigator Arm

Examination of adherence to follow-up with a navigator.

Group Type ACTIVE_COMPARATOR

Navigator Guidance

Intervention Type 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.

Non-Intervention Arm

Examination of adherence to follow-up without a navigator.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Navigator Guidance

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Infant failed a hearing screening in one or both ears before postnatal hospital discharge
2. Infant was referred for follow-up diagnostic testing at one of the 10 participating CCSHCN clinics.
3. Parent able to speak either English or another language using Cyracom phone interpreting services.