Communities Helping the Hearing of Infants by Reaching Parents (CHHIRP)
Primary Purpose
Congenital Hearing Loss
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Navigator Guidance
Sponsored by
About this trial
This is an interventional prevention trial for Congenital Hearing Loss focused on measuring Infant Hearing Screening, Patient Navigator
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria for parent-infant dyads:
- Infant failed a hearing screening in one or both ears before postnatal hospital discharge
- Infant was referred for follow-up diagnostic testing at one of the 10 participating CCSHCN clinics.
- 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.
Sites / Locations
- University of Kentucky
- Office for Children with Special Health Care Needs
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Navigator Arm
Non-Intervention Arm
Arm Description
Examination of adherence to follow-up with a navigator.
Examination of adherence to follow-up without a navigator.
Outcomes
Primary Outcome Measures
Number of participants who do not receive diagnostic audiological testing (Aim 1)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03875339
First Posted
March 8, 2019
Last Updated
March 14, 2023
Sponsor
Matthew Bush, MD
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT03875339
Brief Title
Communities Helping the Hearing of Infants by Reaching Parents
Acronym
CHHIRP
Official Title
Communities Helping the Hearing of Infants by Reaching Parents: The CHHIRP Navigator Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matthew Bush, MD
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Hearing Loss
Keywords
Infant Hearing Screening, Patient Navigator
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment via Stepped Wedge Trial Design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Navigator Arm
Arm Type
Active Comparator
Arm Description
Examination of adherence to follow-up with a navigator.
Arm Title
Non-Intervention Arm
Arm Type
No Intervention
Arm Description
Examination of adherence to follow-up without a navigator.
Intervention Type
Behavioral
Intervention Name(s)
Navigator Guidance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants who do not receive diagnostic audiological testing (Aim 1)
Description
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.
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.)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria for parent-infant dyads:
Infant failed a hearing screening in one or both ears before postnatal hospital discharge
Infant was referred for follow-up diagnostic testing at one of the 10 participating CCSHCN clinics.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew L Bush, MD, PhD
Organizational Affiliation
Associate Professor, Vice Chair of Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Office for Children with Special Health Care Needs
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40222
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
IPD Sharing Time Frame
De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
IPD Sharing Access Criteria
De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
Citations:
PubMed Identifier
35440449
Citation
Bush M, Hatfield M, Schuh M, Balasuriya B, Mahairas A, Jacobs J, Studts C, Westgate P, Schoenberg N, Shinn J, Creel L. Communities Helping the Hearing of Infants by Reaching Parents (CHHIRP) through patient navigation: a hybrid implementation effectiveness stepped wedge trial protocol. BMJ Open. 2022 Apr 19;12(4):e054548. doi: 10.1136/bmjopen-2021-054548.
Results Reference
derived
Learn more about this trial
Communities Helping the Hearing of Infants by Reaching Parents
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