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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03875339
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : May 9, 2019
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Matthew Bush, MD, University of Kentucky

Brief 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.

Condition or disease Intervention/treatment Phase
Congenital Hearing Loss Behavioral: Navigator Guidance Not Applicable

Detailed 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) 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment via Stepped Wedge Trial Design
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Communities Helping the Hearing of Infants by Reaching Parents: The CHHIRP Navigator Trial
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Navigator Arm
Examination of adherence to follow-up with a navigator.
Behavioral: 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.

No Intervention: Non-Intervention Arm
Examination of adherence to follow-up without a navigator.

Primary Outcome Measures :
  1. Number of participants who do not receive diagnostic audiological testing (Aim 1) [ Time Frame: 3 months. (This is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.) ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 Spanish

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03875339

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Contact: Kris P Dyer, BS 859-218-2167

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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Commission for Children with Special Health Care Needs
Louisville, Kentucky, United States, 40222
Sponsors and Collaborators
University of Kentucky
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institutes of Health (NIH)
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Principal Investigator: Matthew L Bush, MD, PhD Associate Professor, Vice Chair of Research

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Responsible Party: Matthew Bush, MD, Assistant Professor, University of Kentucky Identifier: NCT03875339     History of Changes
Other Study ID Numbers: 47997 2019
1R01DC017770-01 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matthew Bush, MD, University of Kentucky:
Infant Hearing Screening
Patient Navigator

Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms