Navigator Guidance for Hearing Loss

(CHHIRP Trial)

No longer recruiting at 1 trial location
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Matthew Bush, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help families with infants who have failed a hearing test receive care more quickly. It examines whether a patient navigator—a person who offers guidance and support—can expedite the testing process, ensure families adhere to appointment schedules, and educate parents about hearing loss. The trial includes two groups: one with a patient navigator and one without. Families with an infant who didn't pass a hearing screening at birth and require further testing at specific clinics in Kentucky may be suitable for this trial. As an unphased trial, it offers families the chance to contribute to research that may enhance care processes for infants with hearing loss.

Will I have to stop taking my current medications?

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

What prior data suggests that this method is safe for children with hearing loss?

Research has shown that using a patient navigator to assist families of children with hearing loss is safe. Studies have found that patient navigators significantly help by ensuring families attend medical tests and appointments on time. They also provide support and information to parents, making it easier to understand their child's hearing loss.

No reports of negative effects from using patient navigators have emerged. Their role primarily involves supporting and guiding families through the healthcare process, without involving any medical procedures or medications. This suggests that the approach is well-received and poses no risk to participants.12345

Why are researchers excited about this trial?

Researchers are excited about the Navigator Guidance for hearing loss because it introduces a personalized approach to managing the condition. Unlike standard treatments that primarily focus on medical or technological solutions, Navigator Guidance uses a human touch—guiding patients through their follow-up care with the help of a dedicated navigator. This approach aims to improve adherence to follow-up appointments, which is crucial for effective hearing loss management. By potentially increasing patient engagement and compliance, Navigator Guidance could enhance overall treatment outcomes, offering a fresh perspective on hearing health care.

What evidence suggests that this method is effective for improving pediatric hearing loss care?

This trial will compare the effectiveness of using a patient navigator versus no intervention for children with hearing loss. Research has shown that a patient navigator can greatly assist children with hearing loss. Studies have found that a patient navigator shortens the time it takes for children to receive necessary hearing tests after a problem is identified. This approach also increases the likelihood that families will keep their appointments. In one study, using a patient navigator reduced the time from discovering hearing loss to starting educational support and medical treatments. In short, patient navigators help families understand and manage their child's hearing condition better, leading to faster and more reliable care.12567

Who Is on the Research Team?

ML

Matthew L Bush, MD, PhD

Principal Investigator

Associate Professor, Vice Chair of Research

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Navigator ArmActive Control1 Intervention
Group II: Non-Intervention ArmActive Control1 Intervention

Find a Clinic Near You

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+

Citations

Navigator Guidance for Hearing Loss (CHHIRP Trial)This approach can help patients navigate their condition more effectively, potentially improving outcomes by addressing individual needs and preferences.
Promotion of Early Pediatric Hearing Detection Through ...To assess the efficacy of a patient navigator intervention to decrease non-adherence to obtain audiological testing following failed screening, ...
Promoting Early Diagnosis of Congenital Hearing Loss ...The hypothesis of this study is that a patient navigator will hasten the timing of pediatric audiological testing, improve compliance with scheduled ...
Impact of Patient Navigation on Time to Intervention for ...Conclusions A patient navigator significantly decreased the time from hearing loss identification to educational intervention and medical ...
Outcomes for Hearing Health InterventionsData from a clinical convenience sample of 5,808 patients at Stanford Ear Institute revealed that many patients have significant challenges on the Quick Speech- ...
Promoting Early Diagnosis of Congenital Hearing Loss ...The hypothesis of this study is that a patient navigator will hasten the timing of pediatric audiological testing, improve compliance with scheduled ...
Clinical Trials and Outcome Measures in Adults With ...Recent systematic reviews of clinical trials reveal a dearth of high quality evidence in almost all areas of hearing health practice.
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