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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 : April 16, 2019
Sponsor:
Collaborators:
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

Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE March 14, 2019
Last Update Posted Date April 16, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03875339 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Communities Helping the Hearing of Infants by Reaching Parents
Official Title  ICMJE Communities Helping the Hearing of Infants by Reaching Parents: The CHHIRP Navigator Trial
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment via Stepped Wedge Trial Design
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Congenital Hearing Loss
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: Navigator Arm
    Examination of adherence to follow-up with a navigator.
    Intervention: Behavioral: Navigator Guidance
  • No Intervention: Non-Intervention Arm
    Examination of adherence to follow-up without a navigator.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2019)
2310
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2024
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kris P Dyer, BS 859-218-2167 kris.dyer@uky.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03875339
Other Study ID Numbers  ICMJE 47997 2019
1R01DC017770-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Undecided
Responsible Party Matthew Bush, MD, University of Kentucky
Study Sponsor  ICMJE University of Kentucky
Collaborators  ICMJE
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Matthew L Bush, MD, PhD Associate Professor, Vice Chair of Research
PRS Account University of Kentucky
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP