Patient Navigation Program for Hearing Loss

(HHARC Trial)

Overseen By Matthew L Bush, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Matthew Bush, MD

Disqualifiers: Under 18

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on helping adults in rural Kentucky who struggle to access hearing tests and treatment. It aims to determine if a community-based program, the Patient Navigation Program for Hearing Health Care, can increase access to necessary hearing tests in these areas. The program guides patients through the process of receiving hearing care at rural clinics. Adults who visit a participating primary care clinic in rural Kentucky and speak English may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to improving hearing care access in rural communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this program is safe for rural adults?

Research has shown that patient navigation programs are generally safe and help people access hearing care more quickly. One study found that a patient navigator, who guides individuals through the healthcare system, significantly reduced the time for people with hearing loss to start receiving help.

No reports of serious side effects have emerged from using a patient navigation program. This approach focuses on improving access to care rather than introducing new medicine or treatment, which means the risks are low since no new drugs or physical treatments are involved. The program simply helps more people obtain the tests and care they need for their hearing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Patient Navigation Program for Hearing Health Care is unique because it focuses on personalized support and guidance for individuals with hearing loss, particularly in rural areas. Unlike traditional treatments that primarily involve hearing aids or clinical assessments, this program helps patients navigate their hearing health care journey, ensuring they access the services they need. Researchers are excited about this approach because it aims to remove barriers to care and improve overall outcomes by providing tailored assistance and resources, making hearing health care more accessible and effective for underserved communities.

What evidence suggests that the Patient Navigation Program for Hearing Health Care is effective for increasing diagnostic hearing tests in rural adults?

Research has shown that patient navigation programs can ease access to hearing health care. In studies on children's hearing loss, these programs have helped more families adhere to recommended care after unusual hearing test results, ensuring more people receive necessary care. One study found that patient navigation can reduce the time between discovering hearing loss and beginning treatment. This trial will pilot test the Patient Navigation Program specifically with adults in rural primary care clinics, potentially simplifying access to hearing tests and follow-up care. Overall, these findings support the effectiveness of patient navigation in improving access to and speed of hearing care. ^{2 3 6 7 8}

Who Is on the Research Team?

Matthew L Bush, M.D.

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This clinical trial is for adults over the age of 18 who live in rural areas and may be experiencing hearing loss. Participants must speak, understand, and read English to join.

Inclusion Criteria

Able to speak, understand, and read English

Exclusion Criteria

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Pilot testing of the Patient Navigation Program with adults in rural primary care clinics

12 months

Follow-up

Participants are monitored for the number of diagnostic audiograms obtained after enrollment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Patient Navigation Program for Hearing Health Care

Trial Overview

The study is testing a community-based patient navigation program designed to help rural adults get diagnostic tests for hearing loss. It aims to see if this program increases the number of people getting tested.

How Is the Trial Designed?

Group I: Rural Clinic Hearing Healthcare Patient Navigation Program Experimental Treatment 1 Intervention

This arm will involve pilot testing of the Patient Navigation Program with adults in rural primary care clinics

Who Is Running the Clinical Trial?

Matthew Bush, MD

Lead Sponsor

Trials

4

Recruited

3,300+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

In a study involving 222 patients, those who received patient navigation (PN) for cancer screening reported significantly higher satisfaction with their overall medical care compared to those who did not receive PN (71.0 vs 66.8).

The results suggest that PN programs can enhance patient satisfaction, particularly for individuals at high risk of not adhering to recommended cancer screening, indicating a potential benefit for improving care quality and equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. Hermann, EA., Ashburner, JM., Atlas, SJ., et al.[2022]

A standardized national training program for patient navigators (PNs) was successfully implemented, attended by 116 PNs from 85 cities, aimed at reducing cancer health disparities for medically underserved populations.

The training showed significant efficacy, with overall improvements in posttest scores compared to pretest scores, particularly among participants with higher education levels or more work experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A national patient navigator training program. Calhoun, EA., Whitley, EM., Esparza, A., et al.[2021]

A study involving 1345 patients with abnormal cancer screenings or cancer diagnoses found a significant correlation between satisfaction with patient navigators and overall satisfaction with cancer-related care, indicating that effective navigation can enhance patient experiences.

Factors such as having an abnormal colorectal cancer screening and being older or from a minority racial-ethnic background were linked to higher satisfaction levels, suggesting that tailored navigation support may help address disparities in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction with cancer care among underserved racial-ethnic minorities and lower-income patients receiving patient navigation. Jean-Pierre, P., Cheng, Y., Wells, KJ., et al.[2022]

Patient navigation programs significantly enhance the experiences of adult cancer patients by providing emotional and logistical support, helping to reduce feelings of isolation during treatment.

Navigators play a crucial role in empowering patients through knowledge and practical assistance, ensuring continuity of care and alignment between patient needs and treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of cancer patients in a patient navigation program: a qualitative systematic review. Tan, CH., Wilson, S., McConigley, R.[2019]

Patient navigation can significantly improve access to care and support for vulnerable cancer patients, particularly those with low income, low education, and multiple health issues, as shown by recent analyses of the Patient Navigation Research Program.

To be most effective, patient navigation programs should be tailored to address the specific challenges faced by these high-risk populations, requiring careful planning and integration into existing healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of evidence-based patient navigation programs. Freund, KM.[2017]

Patient navigation (PN) significantly reduced the time from biopsy to the start of radiotherapy (RT) in cancer patients in Brazil, decreasing the median time from 108 days to 74 days, which highlights its efficacy in improving access to timely treatment.

The PN program also shortened various time frames related to the treatment process, including referral to RT and the time from the first consultation to the end of RT, demonstrating its potential as a cost-effective solution to enhance cancer care in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation (PN) support to timely access to radiotherapy in the Brazilian public health system. Vieira, CM., Diniz, PHC., Dizon, DS., et al.[2023]

Team-based system navigation models may lead to slightly better health service utilization compared to usual care, based on evidence from three low-bias studies.

Lay person-led and health professional-led navigation models appear to enhance patient experiences with the quality of care, although the overall impact on patient health outcomes remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of system navigation programs linking primary care with community-based health and social services: a systematic review. Teggart, K., Neil-Sztramko, SE., Nadarajah, A., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5669046/

Promotion of Early Pediatric Hearing Detection Through ...

Patient navigation decreases non-adherence rates following abnormal infant hearing screening and improves knowledge of follow-up recommendations.

2.

pubs.asha.org

pubs.asha.org/doi/10.1044/2025_JSLHR-24-00284

Prioritizing Hearing: Patient and Provider Perspectives on ...

This study aims to explore experiences of hearing loss, identify factors that impact access, and assess the potential acceptability of a patient navigation ...

3.

aao-hnsfjournals.onlinelibrary.wiley.com

aao-hnsfjournals.onlinelibrary.wiley.com/doi/abs/10.1002/ohn.1369

Impact of Patient Navigation on Time to Intervention for Deaf ...

This study evaluated the impact of a patient navigator on time to intervention for pediatric hearing loss. Study Design. Pre-post cohort study.

4.

reporter.nih.gov

reporter.nih.gov/project-details/10273379

Hearing Healthcare Assessment in Rural Communities ...

The goal of this study is to assess the utilization of hearing healthcare among rural adults through RHCs with the R21 phase of the program and then develop a ...

5.

pubs.asha.org

pubs.asha.org/doi/abs/10.1044/2025_JSLHR-24-00284?af=R

Patient and Provider Perspectives on Rural Hearing Health ...

This study aims to explore experiences of hearing loss, identify factors that impact access, and assess the potential acceptability of a patient navigation ...

6.

withpower.com

withpower.com/trial/phase-hearing-loss-6-2023-005ce

Patient Navigation Program for Hearing Loss (HHARC Trial)

The goal of this clinical trial is to develop and test a community-based hearing healthcare patient navigation program in rural Kentucky. The main question this ...

7.

researchgate.net

researchgate.net/publication/394312743_Impact_of_Patient_Navigation_on_Time_to_Intervention_for_Deaf_and_Hard-of-Hearing_Children

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 ...

8.

bmjopen.bmj.com

bmjopen.bmj.com/content/12/4/e054548

Communities Helping the Hearing of Infants by Reaching ...

A strength of this study is the investigation of patient navigation intervention delivered within public-funded healthcare system for hearing healthcare, which ...