Communities Helping the Hearing of Infants by Reaching Parents (CHHIRP)

Matthew Bush, MD

Status: Completed

Conditions: Congenital Hearing Loss

Treatments: Behavioral: Navigator Guidance

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03875339

47997 2019

1R01DC017770-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,699 patients

Sex: All

Ages: Under 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Inclusion criteria for parent-infant dyads:

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.

Exclusion criteria

1. Children and parents live outside Kentucky or who will be moving out of Kentucky within the first three months of life.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,699 participants in 2 patient groups

Navigator Arm

Active Comparator group

Description:

Examination of adherence to follow-up with a navigator.

Treatment:

Behavioral: Navigator Guidance

Non-Intervention Arm

No Intervention group

Description:

Examination of adherence to follow-up without a navigator.