Navigator Guidance for Hearing Loss

(CHHIRP Trial)

Recruiting at 1 trial location

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Matthew Bush, MD

Disqualifiers: Living outside Kentucky, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2699 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the treatment Navigator Guidance for Hearing Loss?

The study on early pediatric hearing detection showed that patient navigation can improve adherence to follow-up audiological testing, suggesting that similar navigator guidance could be effective in managing hearing loss by ensuring patients receive necessary care. ^{1 2 3 4 5}

How is the Navigator Guidance treatment for hearing loss different from other treatments?

Navigator Guidance for hearing loss is unique because it focuses on providing personalized guidance and support, which may not be a standard part of other treatments for hearing loss. This approach can help patients navigate their condition more effectively, potentially improving outcomes by addressing individual needs and preferences. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial tests whether using a guide can help families of children with hearing loss get medical tests and keep appointments. The guide educates families about hearing loss, offers emotional support, and ensures they receive necessary care. The goal is to improve the scheduling of tests and increase appointment attendance.

Research Team

Matthew L Bush, MD, PhD

Principal Investigator

Associate Professor, Vice Chair of Research

Eligibility Criteria

This trial is for infants who failed a hearing screening in one or both ears before leaving the hospital after birth, and are referred for follow-up tests at specific clinics. It's also for parents who speak English or can use phone interpreting services. Families must live in Kentucky and not plan to move within three months.

Inclusion Criteria

The baby did not pass a hearing test before leaving the hospital after birth.

Infant was referred for follow-up diagnostic testing at one of the 10 participating CCSHCN clinics

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard of Care

Participants receive the standard of care before the introduction of patient navigation

6 months

Patient Navigation

Patient navigation is introduced to improve adherence to follow-up appointments and expand parental knowledge

6 months

Follow-up

Participants are monitored for adherence to follow-up appointments and diagnostic testing

3 months

Treatment Details

Interventions

• Navigator Guidance

Trial Overview The study is testing whether having a patient navigator - someone to support, educate, and guide families - helps children with congenital hearing loss get their necessary hearing tests faster, improves appointment attendance, and increases parental knowledge about the condition.

Participant Groups

Group I: Navigator Arm Active Control 1 Intervention

Examination of adherence to follow-up with a navigator.

Group II: Non-Intervention Arm Active Control 1 Intervention

Examination of adherence to follow-up without a navigator.

Who Is Running the Clinical Trial?

Matthew Bush, MD

Lead Sponsor

Trials

4

Recruited

3,300+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Make the right noises caring for hearing-impaired patients. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Promotion of early pediatric hearing detection through patient navigation: A randomized controlled clinical trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Reducing Postoperative Call Volume Through Verbal Preoperative Education. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

How successful is the fitting of digital hearing aids? Implications for the allocation of resources within national health systems. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Hearing Impairment and the Amelioration of Avoidable Medical Error: A Cross-Sectional Survey. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

Abnormal cochleovestibular anatomy and imaging: Lack of consistency across quality of images, sequences obtained, and official reports. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Newborns at risk of sensorineural hearing loss in low-income countries. [2009]

8. England pubmed.ncbi.nlm.nih.gov

Imaging in 28 children with cochlear nerve aplasia. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Hearing assessment in infants and children: recommendations beyond neonatal screening. [2009]

10. England pubmed.ncbi.nlm.nih.gov

Clinical Practice Guideline: Sudden Hearing Loss (Update). [2020]