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

Trial Summary

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 data supports the effectiveness of the treatment Patient Navigation Program for Hearing Health Care?

Patient navigation programs have been shown to improve access to care and satisfaction among patients in other areas, like cancer screening and treatment, by helping them overcome barriers and navigate complex healthcare systems. This suggests that similar benefits might be seen in hearing health care, as the program aims to provide personalized support and improve access to necessary services. ^{1 2 3 4 5}

How does the Patient Navigation Program for Hearing Loss differ from other treatments for hearing loss?

The Patient Navigation Program for Hearing Loss is unique because it focuses on providing personalized support and guidance to help patients navigate the healthcare system, similar to its use in cancer care. Unlike traditional treatments that directly address hearing loss, this program aims to overcome barriers to care and ensure continuity of care, making it a novel approach in managing hearing loss. ^{1 2 3 6 7}

What is the purpose of this trial?

Adult hearing loss in is the third most common chronic health condition in the United States. Adults living in rural areas face a higher risk of experiencing hearing loss, and more difficulty receiving testing and treatment than adults in urban settings. 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 study aims to answer is: -Can the number of rural adults receiving diagnostic hearing tests be increased?

Research Team

Matthew L Bush, M.D.

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

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

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Experiences of cancer patients in a patient navigation program: a qualitative systematic review. [2019]

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

A national patient navigator training program. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Patient navigation (PN) support to timely access to radiotherapy in the Brazilian public health system. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of system navigation programs linking primary care with community-based health and social services: a systematic review. [2023]

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

Satisfaction with cancer care among underserved racial-ethnic minorities and lower-income patients receiving patient navigation. [2022]

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

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