Patient Navigator Intervention for Vision Impairment or Blindness

(NYCES Trial)

LA
Overseen ByLisa A. Hark, PhD, MBA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
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 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.12345

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.14678

Who Is on the Research Team?

LA

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?
2Treatment groups
Active Control
Group I: Arm 1: Virtual Automated Navigator Intervention with Health EducationActive Control1 Intervention
Group II: Arm 2: Usual CareActive Control1 Intervention

Find a Clinic Near You

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

Citations

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 ...
Effect of a Patient Navigator Program to Address Barriers ...Patients with visual impairment may especially benefit from a patient navigation program. Visual impairment and blindness are associated with increased ...
A comprehensive review of navigation systems for visually ...This review explores the evolutionary trajectory of navigation assistance tools tailored for the visually impaired, spanning from traditional aids like white ...
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.
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 ~ ...
Patient Navigator Intervention for Diabetic RetinopathyEvidence-based treatment for Diabetic retinopathy (DR) established 30 years ago decreases the likelihood of blindness by 50%. Outcomes are even better now with ...
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%).
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 ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security