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

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals who may be unaware of having high blood pressure (hypertension) or glaucoma. The study will test whether patient navigators, who provide support through text messages, can help participants attend health appointments and learn more about these conditions. Participants will be divided into two groups: one receiving text message support (Intervention Using Patient Navigators) and one without it (Usual Care Without Patient Navigators). This trial suits those aged 40 and older who live in affordable housing and have a cell phone capable of texting. As an unphased trial, it offers a unique opportunity to contribute to research that may enhance healthcare support systems.

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 intervention using patient navigators is safe?

Research has shown that patient navigator programs have been safely used in various healthcare settings. For example, one study found that a virtual patient navigation program led to fewer hospital visits compared to regular care, indicating that these programs are generally well-received.

Although specific safety data for the navigator program in this trial is not available, these programs typically help people understand and navigate the healthcare system. They focus on providing support and information, not on administering medication or performing medical procedures, which usually makes them low-risk. Overall, existing evidence suggests these programs are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to support people with vision impairment or blindness through the use of patient navigators. Unlike typical care where patients might only get initial appointment scheduling, this approach offers ongoing text message support for managing follow-up appointments and educating patients about conditions like hypertension and glaucoma. This personalized, continuous assistance could improve adherence to treatment plans and empower patients with valuable health knowledge, which is a big step forward compared to standard care options.

What evidence suggests that this trial's treatments could be effective for vision impairment or blindness?

Research has shown that patient navigators can significantly assist people with visual impairments in maintaining their eye exam schedules. For instance, the NYC-SIGHT Study found that these navigators increased the number of patients attending follow-up eye exams after community screenings. In this trial, participants in the Virtual Automated Navigator Intervention arm will receive text messaging support for scheduling and attending appointments, along with education about hypertension and/or glaucoma. Another study highlighted that patient navigator programs effectively overcome obstacles patients face, facilitating access to necessary care. These findings suggest that patient navigators play a crucial role in managing vision health, particularly for those at risk of glaucoma, a condition that can damage the optic nerve. Meanwhile, participants in the Usual Care arm will only have their initial appointments scheduled without additional support. ^{1 4 6 7 8}

Who Is on the Research Team?

Lisa A. Hark

Principal Investigator

Columbia University Department of Ophthalmology

Are You a Good Fit for This Trial?

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

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

I am 21 years old or older.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Arm 1: Virtual Automated Navigator Intervention with Health Education Active Control 1 Intervention

Consented participants referred for follow-up to in-office appointments from the 10 NYCHA developments randomized to the Virtual Automated Navigator Intervention with Health Education Arm will receive text messaging support with all aspects of follow-up appointments at either Columbia University Irving Medical Center or Harlem Hospital, specifically appointment scheduling and education about hypertension and/or glaucoma/suspect over a 1 year period.

Group II: Arm 2: Usual Care Active Control 1 Intervention

Consented participants referred for follow-up to in-office appointments from the 4 NYCHA developments randomized to the Usual Care Arm will only be scheduled for their initial appointments at either Columbia University Irving Medical Center or Harlem Hospital. 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+

Published Research Related to This Trial

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]

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]

Citations

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Patient Navigator Intervention for Vision Impairment or ...

What data supports the effectiveness of the treatment using patient navigators for vision impairment or blindness? Research suggests that targeting ...

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pmc.ncbi.nlm.nih.gov/articles/PMC10804762/

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Patient Navigators Improve In-Office Eye Exam Adherence ...

Patient Navigators Improve In-Office Eye Exam Adherence After Community Eye Screenings in a Randomized Clinical Trial: NYC-SIGHT Study.

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Two Billion Live with Vision Impairment -- Can AI Help ...

He highlights age-related macular degeneration (AMD) as a leading cause of blindness, with ~25% of Europeans over 60 showing early signs and ~ ...

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Patient Navigator Intervention for Diabetic Retinopathy

Evidence-based treatment for Diabetic retinopathy (DR) established 30 years ago decreases the likelihood of blindness by 50%. Outcomes are even better now with ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6991284/

Effect of a Virtual Patient Navigation Program on Behavioral ...

In this randomized clinical trial, there were fewer admissions on days when the navigation program was available (55.1%) vs on days with usual care (63.1%).

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Navigation Training for Persons With Visual Disability Through ...

This study aims to (1) establish a novel virtual reality (VR) environment to test the efficacy of ETAs in complex urban environments for a simulated visual ...