Patient Navigator Intervention for Vision Impairment or Blindness

(NYCES Trial)

Overseen By Lisa A. Hark, PhD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Terminal illness, Dementia, others

Compensation: Varies

Number of Visits: 1

10000 Participants Needed

Trial Summary

What is the purpose of this trial?

Dr. Lisa A. Hark (PI and Study Chair) and an interdisciplinary team have designed the New York City Eye Study (NYCES) to promote eye and vision health by conducting eye health screenings in adults age 21+ (PAR-23-009/NOT-EY-22-004).

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 using patient navigators for vision impairment or blindness?

Research suggests that targeting interventions to improve patient activation (involvement in their own care) can lead to better adherence to treatment and improved outcomes for individuals with vision loss. Additionally, having full-time nurses in schools significantly increased follow-up care for vision problems, indicating that dedicated support can enhance treatment adherence and outcomes. ^{1 2 3 4 5}

Is the Patient Navigator Intervention safe for humans?

The research does not provide specific safety data for the Patient Navigator Intervention, but it is generally used to help people access healthcare services and manage their care, which suggests it is safe for humans. ^{1 6 7 8 9}

How does the Patient Navigator Intervention for Vision Impairment or Blindness differ from other treatments?

The Patient Navigator Intervention is unique because it uses trained individuals to help patients with vision impairment or blindness navigate the healthcare system, addressing barriers to care and improving treatment adherence, which is not typically a focus of standard treatments for vision loss. ^{1 6 10 11 12}

Research Team

Lisa A. Hark

Principal Investigator

Columbia University Department of Ophthalmology

Eligibility Criteria

The NYC Eye Study is for adults aged 21+ living independently in certain affordable housing areas. It's aimed at those with eye conditions like blindness, cataract, diabetic retinopathy, and glaucoma. People with terminal illnesses or unable to consent due to dementia cannot participate.

Inclusion Criteria

I am 21 years old or older.

This criterion means that the participant must be living on their own in a housing area that is not too expensive.

Exclusion Criteria

I am unable to understand and give consent for treatment due to dementia.

You have a terminal illness and are expected to live less than 1 year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Intervention

Participants in the Intervention Arm receive ongoing support from patient navigators for follow-up eye care over a 1-year period.

1 year

Usual Care

Participants in the Usual Care Arm receive automated appointment reminders for follow-up eye exams over a 1-year period.

1 year

Follow-up

Participants are monitored for adherence to follow-up eye care appointments.

1 year

Treatment Details

Interventions

• Intervention Using Patient Navigators
• Usual Care Without Patient Navigators

Trial Overview This study tests whether using patient navigators can improve eye health compared to usual care without them. Patient navigators are people who help guide patients through the healthcare system to ensure they receive appropriate care.

Participant Groups

Group I: Arm 1: Intervention Using Patient Navigators Active Control 1 Intervention

Consented participants referred to ophthalmology from the 9 developments randomized to the Intervention Arm will receive ongoing support from patient navigators to assist with all aspects of follow-up eye care at either Columbia Harkness Eye Institute or Harlem Hospital Ophthalmology, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.

Group II: Arm 2: Usual Care + Automated Appointment Reminders Placebo Group 1 Intervention

Consented participants referred from the 5 developments randomized to the Usual Care Arm +Automated Appointment Reminders who are referred to an ophthalmologist for a follow-up eye exam will only be scheduled for their initial appointment at either Columbia Harkness Eye Institute or Harlem Hospital Ophthalmology. They will not receive enhanced support. Scheduling this initial appointment will allow tracking of adherence. Arm 2 represents a realistic choice available for participants following screening over a 1-year period.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Findings from Research

Modifications to the family navigation (FN) strategy significantly improved recruitment for the study, with a reduction in the number of families refusing or being excluded from participation (from 19.5% to 4.8% and 43.6% to 0%, respectively).

In the second pilot RCT, families were more likely to complete the diagnostic assessment and reported greater satisfaction with clinical care, with FN showing a continued benefit over usual care in increasing the likelihood of completing assessments (hazard ratio of 2.57).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Family Navigation for Children With Autism: A Comparison of Two Pilot Randomized Controlled Trials. Feinberg, E., Kuhn, J., Eilenberg, JS., et al.[2022]

In a study involving 10,521 participants with abnormal cancer screenings and 2,105 with cancer diagnoses, patient navigation significantly improved the timeliness of diagnostic resolution and treatment initiation after 90 days, with adjusted hazard ratios of 1.51 and 1.43, respectively.

The effectiveness of patient navigation was particularly notable in centers where there were greater delays in follow-up care, suggesting that this intervention is especially beneficial for populations at risk of being lost to follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of patient navigation on timely cancer care: the Patient Navigation Research Program. Freund, KM., Battaglia, TA., Calhoun, E., et al.[2022]

The use of patient navigators (PNs) significantly reduced healthcare costs for high-risk patients aged 60 and older, with total costs dropping from $7,640 to $5,676 within 180 days post-discharge.

While the PN intervention showed cost savings for older patients, it did not significantly impact costs for those under 60, suggesting that PNs may be particularly beneficial for older adults in transitional care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Impact of a Postdischarge Community Health Worker Intervention on Health Care Costs in a Safety-Net System. Galbraith, AA., Meyers, DJ., Ross-Degnan, D., et al.[2019]

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]

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]

References

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

Activation in individuals with vision loss. [2021]

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

Geographic Information Systems Mapping of Diabetic Retinopathy in an Ocular Telemedicine Network. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Does government assistance improve utilization of eye care services by low-income individuals? [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Increasing Screening Follow-Up for Vulnerable Children: A Partnership with School Nurses. [2019]

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

Economic evaluation of blind rehabilitation for veterans with macular diseases in the Department of Veterans Affairs. [2008]

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

Factors Influencing the Implementation of Patient Navigation Programs for Adults with Complex Needs: A Scoping Review of the Literature. [2023]

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

Improving Family Navigation for Children With Autism: A Comparison of Two Pilot Randomized Controlled Trials. [2022]

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

Impact of patient navigation on timely cancer care: the Patient Navigation Research Program. [2022]

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

Long-Term Impact of a Postdischarge Community Health Worker Intervention on Health Care Costs in a Safety-Net System. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

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

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

Patient navigators for people with chronic disease: A systematic review. [2023]

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

A national patient navigator training program. [2021]