Congenital Hearing LossCHHIRPNCT03875339
Communities Helping the Hearing of Infants by Reaching Parents
A study testing Navigator Guidance in people with Congenital Hearing Loss, run by Matthew Bush, MD at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Hearing Loss
- What is being tested?
- Navigator Guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,699 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jan 2021to 8 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Children and parents live outside Kentucky or who will be moving out of Kentucky within the first three months of life.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kentucky
Lexington, Kentucky, 40536
Office for Children with Special Health Care Needs
Louisville, Kentucky, 40222
About this study
Official title: Communities Helping the Hearing of Infants by Reaching Parents: The CHHIRP Navigator Trial
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.
Read the 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) (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.
- Conditions
- Congenital Hearing Loss
- Being tested
- Navigator Guidance
- Keywords
- Infant Hearing Screening, Patient Navigator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigator GuidanceBehavioural
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 group | Role | What they receive |
|---|---|---|
| Navigator Arm | Active comparator | Examination of adherence to follow-up with a navigator. Receives: Behavioral: Navigator Guidance |
| Non-Intervention Arm | No intervention | Examination of adherence to follow-up without a navigator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1)
This outcome is the number of participants who do not follow-up at an OCSHCN Clinic for diagnostic audiologic testing after a failed newborn hearing screening from the date of randomization to 3 months after birth.
Measured: 3 months. (This is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start13 Jan 2021
- Primary completion8 Sep 2023
- Study completion8 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment via Stepped Wedge Trial Design
- Masking
- None (open label)
- Enrolment
- 2,699 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Bush, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Matthew Bush, MD, University of Kentucky
- Investigators
- Matthew L Bush, MD, PhD, Principal investigator, Associate Professor, Vice Chair of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875339
- Sponsor's protocol ID
- 47997 2019
- Other IDs
- 1R01DC017770-01
- Acronym
- CHHIRP
- Status last verified
- Jan 2025
- First submitted
- 8 Mar 2019
- Last updated
- 14 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35440449
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communities Helping the Hearing of Infants by Reaching Parents: The CHHIRP Navigator Trial
- ClinicalTrials.gov ID
- NCT03875339
- Acronym / sponsor ID
- CHHIRP / 47997 2019
- Conditions
- Congenital Hearing Loss
- Keywords
- Infant Hearing Screening, Patient Navigator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,699 participants (actual)
- Lead sponsor
- Matthew Bush, MDUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 8 Sep 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Posted 14 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) (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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment via Stepped Wedge Trial Design
| Arm | Type | Receives |
|---|---|---|
| Navigator Arm | Active comparator | Behavioral: Navigator GuidanceExamination of adherence to follow-up with a navigator. |
| Non-Intervention Arm | No intervention | –Examination of adherence to follow-up without a navigator. |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Children and parents live outside Kentucky or who will be moving out of Kentucky within the first three months of life.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigator GuidanceUse of a dedicated Navigator to determine if follow-up and compliance rates can be improved for those infants initially demonstrating an abnormal hearing result. | Behavioural | Navigator Arm |
Primary outcome
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 at an OCSHCN Clinic for diagnostic audiologic testing after a failed newborn hearing screening from the date of randomization to 3 months after birth.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35440449Bush 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew L Bush, MD, PhD principal investigator
Associate Professor, Vice Chair of Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigator Guidance in people with Congenital Hearing Loss, run by Matthew Bush, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03875339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.