Communities Helping the Hearing of Infants by Reaching Parents (CHHIRP)
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|ClinicalTrials.gov Identifier: NCT03875339|
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2310 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Assignment via Stepped Wedge Trial Design|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03875339
|Contact: Kris P Dyer, BSemail@example.com|
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|Commission for Children with Special Health Care Needs|
|Louisville, Kentucky, United States, 40222|
|Principal Investigator:||Matthew L Bush, MD, PhD||Associate Professor, Vice Chair of Research|