Sustainable Community Clinic Telemedicine-Based Glaucoma Screening
Phase: NA
Conditions: Glaucoma
Sponsor: University of Michigan

Screening and Intervention for Glaucoma and eye Health through Telemedicine- SIGHT 
Formal Title: Sustainable Community Clinic Telemedicine-Based Glaucoma Screening 
 
NCT04274764 
 
Date of IRB Approval: April 29, 2024 
 
 
 

2 
 
Screening and Intervention for Glaucoma and eye Health through Telemedicine- SIGHT 
Formal Title: Sustainable Community Clinic Telemedicine-Based Glaucoma Screening 
 
BACKGROUND AND SIGNIFICANCE 
Glaucoma Epidemiology and Glaucoma Disparities. The prevalence of glaucoma in the 
United States (US) is expected to grow from the current 2.7 million to 4.2 million by 2030. 
Researchers estimate that 50% of people remain undiagnosed, so 2.1 million US citizens 
will remain undiagnosed in 2030 with current screening methods. Health care disparities 
exist with African Americans being three times more likely to have glaucoma, five times 
more likely to have unilateral blindness from glaucoma, and twice as likely to have bilateral 
blindness from glaucoma, compared to Caucasians. The National Academy of Science, 
Engineering & Medicine (NASEM) has recommended a call to action to make eye health a 
population health imperative. One target is to improve eye care for underserved populations 
that include African Americans and people with lower socio-economic status. There is a 
critical need to address disparities in population eye care and to minimize glaucoma-related 
vision loss. 
Programs screening for glaucoma in impoverished communities have identified glaucoma 
and glaucoma suspect cases at much higher rates than within the general population. In 
Philadelphia, Pennsylvania, community-based comprehensive eye exams identified incident 
glaucoma in 17% of those screened and incident glaucoma suspects in 21% of those 
screened. Similarly, in Birmingham, Alabama, community-based comprehensive eye 
examinations identified incident glaucoma in 19% of those screened and incident glaucoma 
suspects in 23% of those screened. This demonstrates the scientific rigor of focusing 
glaucoma screening on populations at high risk of the disease as a critical first step to 
changing the prevalence of un-diagnosed glaucoma and subsequent glaucoma-related vision 
loss. 
We hypothesize that implementing a telemedicine platform will decrease the glaucoma screening 
gap. Telemedicine can take specialty glaucoma services to the locally trusted environment of 
primary care community clinics. Telemedicine involves the electronic communication of medical 
information from one site to another for review by physicians specializing in the conditions being 
assessed.16 Screening patients does not require an in-person specialist encounter, so evidence-
based specialty care becomes accessible in geographically remote areas and does not require 
patient transportation over long distances. Therefore, telemedicine helps overcome logistical and 
psychosocial barriers to care. Patients are accustomed to finding transport to their community 
clinic, and social workers in these clinics can help patients access transportation resources to the 
clinic. Thus, a telemedicine approach can improve access to glaucoma screening, currently 
lacking for these communities. 
 
OBJECTIVE 
Our objective is to overcome a key set of critical barriers to glaucoma care by addressing the 
logistical and psychosocial issues that limit the access of vulnerable populations; by enhancing 

3 
 
and expanding our current partnerships with community clinics: Hope Clinic (Ypsilanti, MI), and 
a federally qualified health center Hamilton Community Health Network (Flint, MI), to enable 
local screening for glaucoma and other potentially blinding diseases among vulnerable 
populations using a telemedicine approach. 
 
SPECIFIC AIM/HYPOTHESIS 
 
Aim 1: (Phase 1- HUM 00173023) Use community-engaged research strategies to overcome 
key logistical and psychosocial barriers to accessing glaucoma care for uninsured and under-
insured adults. To engage communities in glaucoma program development. we will create a 
Community Advisory Board (CAB) to solidify a trusting partnership between the University of 
Michigan, the Hope Clinic, Hamilton Community Health Network. We will conduct semi-
structured interviews with patients and community stakeholders to understand barriers to eye 
care and inform program development and implementation.  
 
Aim 2: (Phase 2- HUM 00169371) Develop a sustainable telemedicine model for glaucoma 
screening and care in community clinics. We hypothesize that a validated Veteran’s Affairs (VA) 
telemedicine glaucoma screening program will identify a higher prevalence of glaucoma in 
primary care community clinics than screening the general population. We will test this 
hypothesis by implementing: (1) an automated technician-lead glaucoma screening with the VA 
protocol in the Hope and Hamilton partner community clinics for approximately 5,800 
participants over 4 years; (2) remote ophthalmologists’ grading of glaucoma screening tests for 
diagnosis and management; (3) a one-month follow-up visit with the technician to deliver low-
cost eyeglasses and to educate and arrange ophthalmology care for participants who screen 
positive for eye disease; and (4) assess a 24-month change in vision and vision-related quality of 
life among participants screened during Year 1. 
 
Aim 3: (Phase 2- HUM 00169371) Integrate personalized glaucoma education and counseling 
during the technician visit and test the behavioral intervention’s impact on adherence to follow-
up care with an ophthalmologist. We hypothesize that personalized eHealth education and 
motivational-interviewing-based counseling will improve adherence to glaucoma follow-up care 
compared to standard education delivered by a trained staff member. We will test our hypothesis 
in a randomized controlled trial with participants (n=400) from Aim 2 who have glaucoma or 
suspected glaucoma. We will make iterative refinements to our existing evidence-based, 
individualized counseling/eHealth glaucoma education program with a focus on adherence to 
follow-up recommendations based on learning in Aim 1. The primary outcome is the proportion 
of participants attending the recommended physician appointments within three months. 
Secondary outcomes include glaucoma knowledge, satisfaction with communication, and 
confidence in asking the ophthalmologist questions. Program economic efficiency will be 
assessed. 
 
METHODS 
 
Aim 1: Use community-engaged research strategies to overcome key logistical and 
psychosocial barriers to accessing glaucoma care for uninsured and under-insured adults 

4 
 
and develop and implement a telemedicine-based glaucoma screening program in the 
community clinics. 
In Aim 1, we will use community-engaged research to understand community-specific barriers to 
glaucoma screening uptake and follow-up glaucoma care. We will use semi-structured interviews 
with key-stakeholders, including patients and providers, to understand how best to implement 
glaucoma screening and follow-up care in community clinics that are both located in cities with 
high rates of poverty. We will obtain informed consent and interview up to 50 people including 
patients with glaucoma, eye care providers, and community clinic staff.  
 
Semi-structured interviews will explore: (1) community-specific barriers to eye care and follow-
up, (2) how a telemedicine glaucoma screening program could be best implemented to meet 
people’s needs, and (3) what educational components would be most salient in motivating people 
to return for glaucoma follow-up care.  
 
We will form a Community Advisory Board (CAB) comprised of leaders from the Hope and 
Hamilton clinics, providers from the clinics, patients from the community and university 
researchers. The board will meet quarterly throughout the grant period to refine, implement, 
analyze, and discuss how to sustain the interventions. Following written informed consent, CAB 
members will be asked to take a brief survey at each meeting. A crosslink file containing survey 
participant names with a study identifier will be kept to correlate member responses over time.   
 
Data Analysis 
 
Qualitative methodology: We will use a semi-structured interview guide to inform the 
conversation. All interviews will be audio-recorded and transcribed verbatim. Transcripts will be 
investigated for major themes by two researchers using grounded theory, which uses inductive 
reasoning to analyze what participants said without coming to the interviews with a pre-
conceived notion as to how the data should be categorized. Key ideas and phrases expressed by 
the participants will be categorized as codes. A code book is then generated as a team. Five 
transcripts will be coded, and inter-coder reliability will be calculated using qualitative software. 
The two coders will then code the transcripts and major themes will be identified. This 
information will inform program development and implementation. 
Aim 2: Develop a sustainable telemedicine model for glaucoma screening and care 
in community clinics. 
 
 
In Aim 2, we will deploy a telemedicine glaucoma screening program in the primary care-
based community clinics. We will offer both free glaucoma screening and a free 
eyeglasses exam.  
Telemedicine-based vision and glaucoma screening  protocols developed and validated by 
the US Veterans Affairs (VA) Medical Center will be used.1 Following the Technology-
Based Eye Care Services (TECS) program, an ophthalmic technician is based permanently 
in a primary care clinic and will operate out of a room containing only essential 
ophthalmology equipment (i.e., no slit lamp). The technician will test the patient’s vision 
using automated processes (e.g. autorefractor, hand-held tonometer, fundus photographs, 

5 
 
and optical coherence tomography). Data will be transmitted via a secure electronic health 
record (EHR) to a remote ophthalmologist. The ophthalmologist will review the data, 
develop an assessment and plan including prescribing eyeglasses and follow up for 
suspected eye diseases, if identified. We will use the secure image storage and reading 
platform at the UM Kellogg Eye Center, to transmit imaging data from community clinic 
sites to the University for images to be assessed.  
 
Research Design 
 
Recruitment: 
Participant selection at Hope & Hamilton clinics 
Inclusion criteria:  
≥18 years of age  
 
Exclusion criteria: 
Significant eye pain (> 8 out of 10)* 
Sudden decrease in vision (within 1 week)* 
Double vision that doesn’t stop when you blink and stops no matter what eye you cover (not 
blurred, but seeing 2 objects* 
Pregnant women 
Prisoners 
Cognitive impairment- unable to give an ocular and social history 
Moving outside of Michigan or driving distance to the clinic within 6 months 
*if any of these symptoms are present, the patient will be directed to the primary care 
physician staffing the clinic 
 
We will focus on recruiting people with diabetes and African Americans over the age of 50. 
We will recruit participants by calling people prior to their scheduled appointments at the 
primary care and dental care clinics. We will describe the study and let them know they can 
participate on the day of their scheduled appointment. Additionally, when the ophthalmic 
technicians’ have availability, they will encourage referrals for diabetic patients seen in 
clinic that day. We will publicize the program in both free clinics using print media to open 
the program to self-referrals. To make the program more widely known in the community, 
we will have information about the program on the clinic websites. 
 
Study staff will become registered clinic volunteers.  This will allow them access to clinic 
space and electronic records.  
 
 
 

6 
 
Consenting non-English reading participants  
For participants that are unable to read English, we will provide them a short form consent 
or full consent in the language they can read and ask them to sign. These participants will 
also be given a written summary/short form in English that has been signed by a study team 
member. A friend or family member (witness) that is fluent in both English and the 
participants language will be present and will translate the short form English consent for 
the participant.  This witness will sign both the English and non- English forms and a copy 
of these signed forms will be given to the participant.  
Consent form signatures  
English summary or long form English consent- signed by a study team member & witness 
Non-English short form or Non-English standard form consent- signed by participant & 
witness 
Participant receives a signed copy of both forms.  Study personnel retains all forms that 
were signed. 
Consent forms available 
Standard informed consents are available in English, Spanish, Albanian and Arabic 
Short forms are available in Chinese, French, Hindi, Korean, Igbo and Tagalog 
 
Baseline screening examination: Screening examinations will take approximately 1 hour. 
The technician will contact UM registration to create a unique UM Medical Record 
Number (MRN) for each patient, which will be linked to their community clinic MRN 
through a secure spreadsheet. Images will be stored using the UM MRN on the secure UM 
ophthalmic imaging platform. If the patient is not currently a clinic patient, creating a 
patient record at Hope is not necessary, although creating a patient account at Hamilton is 
required.  
Ophthalmology Technician Eye Exam:  
(1) Health history 
(2) Vision exam for uncorrected and best- corrected visual acuity (UCVA and BCVA) at 
distance and near 
(3) Contrast sensitivity 
(4) Eyeglass evaluation including inter- pupillary distance 
(5) Eye exam testing including pupillary response, anterior chamber angle assessment by 
penlight, extraocular motility and alignment, and intraocular pressure measurement 
(6) Imaging of the posterior pole by fundus photography and Optical Coherence 
Tomography (OCT)  
Technicians will have a “no dilation” protocol for patients with narrow angles by penlight 
or those with a history of glaucoma, an afferent pupillary defect, or intraocular pressure ≥ 
21 mmHg. Previous community-based screening studies have had no cases of acute angle 

7 
 
closure glaucoma by following these recommendations.  All other patients will be dilated 
prior to photography. Dilated participants will be instructed to return to the clinic if they 
should experience any headache, eye pain, redness or nausea after their examination. If a 
participant returns with any of these complaints, the technician will re-measure intraocular 
pressure. If IOP is elevated by >5mmHg over their pre-dilation measurement and 
>21mmHg, the technician will contact the ophthalmologist on call. Protocols exist for 
potentially urgent situations, including but not limited to: acute vision loss, flashes and 
floaters, severe eye pain, an afferent pupil defect, new onset double vision, or intraocular 
pressure measure ≥32 mmHg. The technicians will also be trained to contact the physician if 
they see abnormal findings on fundus photography, using the TECS training as a guide. 
Upon dilation, fundus photographs and OCT images will be taken. The fundus photography 
protocol will be the validated protocol used for the VA diabetic tele-retinal screening 
program. Four photographs are taken: 1) an external photograph of the eye; 2) an image 
centered on the posterior pole; 3) an image centered on the optic nerve; and 4) an image 
centered on the supero-temporal arcade. Spectral-domain OCT will be used to obtain 
images of the retinal nerve fiber layer and ganglion cell layer of the macula. The UM 
software platform for storing and visualizing ophthalmic images will be utilized. The 
cameras will have software installed that facilitates all images being uploaded automatically 
to the imaging platform under the participant’s UM MRN following HIPAA secure 
standards. 
Baseline Surveys: For surveys, ophthalmic technicians will administer the National Eye 
Institute Visual Function Questionnaire – 9 to patients, which assesses vision-related 
quality of life. Additional surveys will include: Flint Water- questions are related to living 
in Flint during the water crisis, Everyday Discrimination Scale, Perceived Stress Scale, 
UCLA Loneliness Survey, Fall history and Timed Up & Go. They will also administer a 
standardized survey about socio-demographics and health history. Patients will confirm 
their address, phone number, and contacts in case of an emergency. 
Eyeglasses: After the examination, ophthalmic technicians will help participants who need 
correction select free (ReSpectacle.org) or low-cost (ZenniOptical.com) eyeglass frames. 
ReSpectacle.org are donated glasses that have been categorized by exact prescription and 
are viewable on the website. The organization ships the glasses free- of charge. 
Participants may also purchase low cost ($10-$50) glasses on ZenniOptical.com. On this 
website, people can choose the frames. For both options, technicians will place the on-line 
order after the ophthalmologist confirms the eyeglasses prescription remotely, glasses will 
be shipped to the clinic. 
Physician Evaluation: Physician’s evaluation will be via a store-and-forward 
telemedicine technique. This store-and-forward technique, or asynchronous telemedicine, 
involves the electronic transmission of health data to the provider for evaluation and 
management. Physicians will review data received within 1 week. The reading 
ophthalmologist will enter the data into the UM EHR (MiChart). The physician will 
complete one of two letters with the examination results for the participant indicating 
whether the participant has ophthalmic disease or not. A time frame for an in-person 
ophthalmologist examination will be requested if needed. This letter will be sent to the 
patient via mail and the technician and the patient’s PCP (if they have one) via the EHR. 

8 
 
Physician Review Glaucoma Screen: In terms of glaucoma screening, a “positive 
screen” for glaucoma or glaucoma suspect will include the following exam criteria as 
defined by the TECS protocol: 
1) Cup to disc ratio ≥0.7 
2) Intraocular pressure ≥ 21 mm Hg  
3) Disc hemorrhage 
4) Asymmetry of the cup-to-disc ratio by ≥0.2 where the larger cup-to-disc ratio is ≥0.6 
5) Rim thinning or focal notch 
6) Abnormal retinal nerve fiber layer observed on OCT defined as >10 microns difference 
in average retinal nerve fiber layer between the two eyes or the presence of thinning 
(defined as <5% or yellow) in any of the superior or inferior clock hours) 
7) Narrow angles on penlight examination or any other concern for narrow angle 
(complaint of chronic headache or red eye) 
9) Afferent pupillary defect 
10) Patient already on treatment or being followed for glaucoma 
 
Physicians will also evaluate for diabetic retinopathy and macular degeneration using 
validated TECS protocols. If the ophthalmologist identifies an urgent issue such as 
corneal ulcer, optic disc edema, melanoma, tumor, or retinal vascular event (e.g. central or 
branch retinal vein or retinal artery occlusion), the physician will contact the patient by 
phone to arrange immediate care. 
  
Follow-up: The technician will schedule a follow-up visit 4-8 weeks later to give 
participants their eyeglasses and adjust them. Participants that do not need eyeglasses, but 
screen positive for eye disease, will return to review their diagnosis letter and management 
plan and help the patient to schedule an in-person appointment with the ophthalmologist. 
The ophthalmic technician will help the patient arrange follow-up care and provide 
educational material to explain diagnoses of cataract, diabetic retinopathy, macular 
degeneration or glaucoma. (UM Health System Patient Education Clearinghouse at 
https://pteducation.med.umich.edu/kellogg ) If the participant has no need for eyeglasses 
and has no eye disease, the technician will call the participant to cancel the follow-up 
appointment after reviewing the ophthalmologist’s recommendations. During the follow-
up phone call, the satisfaction survey will be administered that would have otherwise been 
administered at the follow-up visit. 
 
Glaucoma or glaucoma suspect: Patients with a diagnosis of glaucoma or glaucoma suspect 
who speak English will be  randomized (1:1) to receive standard care as described above, or a 
60-minute personalized counseling and education program (intervention) about their diagnosis 
and the importance of glaucoma follow-up care in maintaining vision (Aim 3) ). Ocular 
hypertension that is low risk for developing glaucoma within one year and/or the recommended 
follow up time period is one year or more, will not be randomized, the PI will review these cases 
to determine if they should be randomized or not. Randomization will occur in web-based 
randomization system. Both groups will be provided support scheduling their ophthalmologist 
exam and will be asked to complete a brief satisfaction survey. The standard care group will 
receive a reminder call prior to the ophthalmologist exam, while the intervention will receive a 

9 
 
reminder call as well as a 10-15 minute motivational-interviewing based- counseling follow-up 
phone call to remind them of why following up for glaucoma care is important to them and 
trouble-shoot barriers to attending. Further discussion regarding personalized counseling and 
motivational interviewing can be found later in this protocol. All non-English speaking patients 
will not be randomized and will receive standard of care education; the personalized counseling 
is only available in English. We have created a Spanish version of the personalized counseling. 
Spanish speaking participants will not be randomized, all will receive the personalized coaching 
session. A Spanish speaking study coordinator will conduct the Spanish eHealth coaching. All 
subjects participating in the counseling/education encounters will have the option to have their 
sessions be audio-recorded. Additionally, we will ask English and Spanish speaking participants 
to complete a visual field test at this appointment. A visual field test measures peripheral vision 
and is used to review glaucoma patients. This test will take about 20 minutes and there will be no 
charge to the participant or their insurance.  Visual field data will be entered into the REDCap 
database.  
March 2024. Interviews have been completed; no further interviews will be conducted. 
Spanish speaking participants will be asked to participate in a post- coaching semi-
structured interview to identify program components that are helpful/unhelpful and areas 
for improvement. Interviewers will follow the survey interview guide post-coaching 
interview guide and participants will receive a $20 Visa gift card.  Additionally, interviews 
will be recorded, transcribed, and stored on a secure UM server. Qualitative software such 
as Dedoose may be utilized.  
Planned Analysis Results Nov. 14, 2023 
A planned analysis reported no difference in adherence between the intervention (personal 
coaching) and the control (standard education). Therefore, we will no longer randomize 
glaucoma/glaucoma suspect participants and instead ask them to choose which education 
they would like to receive.  
Follow-up surveys: All returning participants will complete a satisfaction survey. The 
intervention group will also be asked to complete; 1) National Eye Institute Glaucoma Eye-
Q test, 2) Satisfaction with Information Scale, 3) Clinician and Group Survey of the 
Consumer Assessment of Healthcare Providers and Systems (CG- CAHPS), 4) Health-Care 
Climate- eye care (HCCQ), 5) Confidence in question asking, which will be assessed with 
the following question “How confident are you in your ability to know what questions to 
ask the ophthalmologist?” and will have responses ranging from 1-10 on a Likert scale 
where 1 is “not confident at all” and 10 is “extremely confident.” 
Follow-up Care with an Ophthalmologist: The ophthalmologists who remotely reviews 
the screening examination data will make recommendations follow-up care. All patients 
who screen positive for ophthalmic disease will be referred to the comprehensive 
ophthalmologist at the Hamilton Clinic, or to the Hope-Kellogg ophthalmology clinic that 
runs every two months on a Saturday. The comprehensive ophthalmologists will either 
provide definitive care or provide a referral for further sub-specialty care. If the patient has 
barriers to accessing sub-specialty care at the Hamilton clinic, social workers and financial 
counselors will be involved to help with logistical barriers. If a patient from Hamilton clinic 

10 
 
has moderate or severe glaucoma, they can be referred to see the glaucoma specialist from 
UM who will have one day of clinic per month at Hamilton Clinic. If a patient from Hope 
requires further specialty consultation or surgery, they will sign up for MSupport, the UM 
charity care program, with the financial counselor available on-site during the Saturday 
clinics. Once a patient receives MSupport, they receive free care and medications at the UM 
for 12 months with the option to renew the services annually with proof of low income. 
Once a patient receives MSupport, they will be scheduled with the appropriate provider at 
the UM. For participants that are glaucoma/glaucoma suspect and seen at Hamilton or the 
Kellogg Eye Center for their follow up exam, these findings and visual field data will be 
collected and entered into the REDCap database.  
One-Year Vision Outcomes: Repeat screenings at one year following the participants 
initial enrollment will take place during the second and third year of the program, where 
phone calls will be made to participants screened in the first or second year of the 
program (regardless if they screened positive or negative for disease) to encourage them 
to return for a second screening. When they return, they will follow the same protocol as 
described for the initial visits with the ophthalmic technician above. Although, One-
Year visit survey data will only include demographics and the VFQ-9 and Falls survey 
which they also completed in their initial enrollment. Participants who were already 
randomized to the clinical trial in Aim 3 will not be re-randomized.  
Two-Year Vision Outcomes: Repeat screenings will take place during the third year of 
the program, where phone calls will be made to all participants screened in the first year 
(regardless if they screened positive or negative for disease) to encourage them to return 
for a second screening. When they return, they will follow the same protocol as 
described for the initial visits with the ophthalmic technician above. Participants who 
were already randomized to the clinical trial in Aim 3 will not be re-randomized. 
Participants that do not return to the clinic for a repeat screening examination, will be 
asked to complete the VFQ-9 survey over the phone when they are contacted.  
One and Two-Year Vision Outcomes: These participants will need to meet the 
inclusion/exclusion criteria listed in section Recruitment Section of this protocol.  
Post Program Participant Interview: We will ask up to 75 participants to participate in a 
post program interview to identify program components that are helpful/unhelpful and areas 
for improvement.  We will randomly contact English speaking participants within our study 
database that agreed to be contacted for future studies. The study consent document 
contains an additional signature section for participants to consent/not consent contact for 
future research. Selected participants will be contacted by phone, or in-person following 
their last appointment. Interviewers will follow the survey interview guide. Interviews will 
be conducted via in-person at the clinics, telephone, or UM Zoom.  Participants will receive 
a $20.00 Visa Gift Card or check by mail or in-person. Additionally, interviews will be 
recorded, transcribed, and stored on a secure UM server. Qualitative software such as 
Dedoose may be utilized. 1/24/2023 English post program interviews have been completed.  
 
Evaluation of “No-show” Appointments: We will evaluate our high (approximately 35%) no-
show and last-minute cancelations rates at this community clinic study (Hope & Hamilton 

11 
 
Community Clinic). The SIGHT study is open to non- clinic patients, therefore, potential 
participants may or may not be clinic patients.  We will only review data of the SIGHT study “no 
shows” and will not include the clinics appointment “no shows”.  When potential participants 
contact the SIGHT team, the team member reviews the recruitment script that describes the 
study. Following this discussion and verification of study eligibility, a medical record number 
(MRN) in MiChart is created for those that do not already have an MRN. The SIGHT study 
baseline appointment is then made within the MiChart system. This process is completed prior to 
consent.  
It may be possible that high no-show rates are associated with lack of convenient transportation. 
By accessing patient information for those that missed appointments, we can investigate the 
logistical barriers of cost and transportation for show versus no-show patients. Associations 
between outcome variable (shows versus no-shows) and demographics, including age, sex, and 
race, zip codes and logistical factors such as cost, travel time, and distance from appointment 
location will be studied graphically (e.g., boxplots and scatterplots) and with appropriate 
inference tools (e.g., t-tests, chi-square tests, regression) where available. This will be completed 
by utilizing the potential participants medical record number access the described variables 
where available. Additionally, when available, reasons given by the potential participant to the 
SIGHT team for “no-shows” and last-minute cancellations will be analyzed.  
Healthcare Effectiveness Data & Information Set (HEDIS) 
HEDIS scores are a standard system to measure patients’ compliance to health care 
treatment/testing for a variety of conditions/diseases. A retinol eye examine is part of the 
diabetes HEDIS score, and this is included with our exam. We would like to review the diabetic 
HEDIS scores at Hamilton Clinic through their database to see if there have been changes 
following the implementation of the SIGHT program. This database is de-identified.  
Recording of Data: The ophthalmic technicians will enter all data from each patient 
encounter into both the UM EHR. The research assistant will then enter the data from the 
EHR into a secure research database, REDCap. Data will be entered into the EHR as a no- 
charge research visit. The ophthalmologist’s letter to the patient with the diagnosis and plan 
will be abstracted from the EHR by the Project Manager and the diagnosis and follow-up 
plan will be entered into REDCap. The Project Manager will also run weekly reports from 
the EHR to assess adherence to follow-up recommendations for study participants and enter 
this data into REDCap.  
Visual Impairment 
We will review participants with visual impairment of Best Corrected Visual Acuity 
(BCVA) less than 20/70 or legally blind BCVA 20/200 or worse in the better seeing eye 
and visual field results with less than 20 degrees in the better seeing eye. We will determine 
if there is any statistical significance between presence of visual impairment and 
demographic data.  Additionally, we will determine the proportion that meet the 
requirements for Michigan Bureau of Services for Blind Persons for participants with 
progressive and non-progressive disease.   
 

12 
 
Pupillary Light Reflex Device Data Collection- Completed 10/2023 
The pupillary light reflex (PLR) is a standard part of every eye examination used by eye 
care professionals to provide critical information about the health and integrity of the visual 
system.  When light is directed at the pupil, stimulated photoreceptors in the retina transmit 
the signal through the optic nerve to the midbrain. The sensory signal is processed in the 
midbrain and the autonomic nervous system via the parasympathetic (pupil constriction) 
and sympathetic (pupil dilation) nerves, coordinating a motor response in both the 
stimulated and unstimulated eye. However, the typical PLR relies on subjective observation 
by examiners and the data collected is imprecise. Consequently, current PLR assessment 
suffers from poor reliability and reproducibility, affecting its utility across care settings 
over time.  
To address these issues, we have developed an inexpensive, binocular, handheld PLR 
system that captures high resolution video imaging and determines pupil constriction 
dynamics with machine vision algorithms. The quantitative PLR system (Q-PLR) is a 
handheld binocular device requiring minimal operator effort and skill that uses machine 
vision algorithms to capture high resolution video images and information about pupil 
constriction dynamics. Using LED light sources and low-light infra-red cameras, the Q-
PLR automatically tracks pupils, and captures static and dynamic pupillary parameters. 
Pupillary measurements are accurate to 0.5mm, or less, and sampled at 30 frames per 
second, which is an appropriate sampling frequency to assess pupillary changes. Unlike the 
pupillometers currently available for clinical use, both pupils are imaged, measured, and 
recorded simultaneously. Assessment of inter-pupillary responses provides additional 
information about the relative integrity of retinal and optic nerve function. While pre-
clinical testing of the prototype system has been reproducible, further testing in real-world 
clinical settings must be performed to assess the robustness of the system. First, further 
testing in real-world clinical settings must be performed to assess the accuracy, reliability, 
and robustness of the system to environmental and operator variability when compared to 
standard pupil exams. Second, the system must demonstrate clinical usefulness for 
clinicians and paraprofessionals using the device. To accomplish these aims, we will collect 
clinical examination data captured as part of the standard eye examination from participants 
in the SIGHT program and compare to Q-PLR image capture. We will additionally obtain 
qualitative feedback from ophthalmic technicians to improve device usability. We will only 
ask English and Spanish speaking participants to take part with this measurement. Data 
collected from the Q-PLR will not be reviewed for participant assessment. There is no 
known risk, the device camera operates like a smart phone.   
Outcomes 
Primary: The primary outcomes will be the number of participants screened and the 
prevalence of glaucoma/glaucoma suspect diagnosis and the cost per case of detected 
disease. 
Secondary: 1a) Prevalence of other eye disease: visual impairment (visual acuity in the 
better seeing eye <20/40) on screening presentation, refractive error, cataract, diabetic 
retinopathy, and age-related macular degeneration. Prevalence will be determined by 
dividing the number of cases of disease on initial screening exam by the total number of 
participants who received screening each year. 1b) Incident disease will be estimated by 

13 
 
assessing the number of new cases of eye disease among the participants screened in the 
first year who returned for repeat screening in the third year. 2) The mean time since last 
eye exam: will be reported for the entire cohort of new patients seen for screening. The 
proportion of patients whose last eye exam was >2 years prior will be calculated for the 
cohort. 3) Vision related quality of life (NEI VFQ 9) will be assessed for all participants. 
The associations of vision related quality of life with eye disease diagnosis and 
demographic variables will be assessed. The 2-year change in vision and vision related 
quality of life will be measured for all participants screened in the first year of the program 
and re-screened in Year 3. 
Sample Size: Approximately 5,000 patients access the Hope Clinic per year and 25,000 
patients access the Hamilton clinic per year. One technician will be assigned full-time to 
Hamilton. The other technician will split time between Hope (60%, Tuesday, Wednesday, 
Thursday) and Hamilton (40%, Monday and Friday) because there is such a higher volume 
of patients to screen at Hamilton and the Hope Clinic is not open on Mondays or Fridays. 
The clinic equipment at Hamilton will be set up to be used by both technicians. A typical 
day for each technician will include 5 screenings and 5 one-month follow-up visits. In the 
first 2 years (48 weeks each) at each site, all screenings will be of new or 1 year follow up 
patients. In the 3rd year, 2 will be new and 3 will be one or two-year re-screening visits. At 
Hope, the technician has capacity for 2448 new screenings and 432 repeat screenings in 4 
years. At Hamilton, the technicians have capacity for 4872 new screenings and 1008 re- 
screenings in 3.5 years. Thus full capacity is 7320 new screenings and 1440 re-screenings. 
Operating at just 80% capacity enrolls over 5,800 patients for new screenings including 
over 1100 with 2-year re-screenings to determine impact on longer term visual acuity and 
visual function. 
Data Analysis 
Primary Outcome Analysis: The primary outcomes will be the number of participants 
screened, the prevalence of glaucoma/glaucoma suspect diagnosis and the cost per case of 
detected disease. related macular degeneration) will be summarized similarly. Based on the 
anticipated sample size (n=5800), the margin of error is at most 1.2 percentage points for 
the overall prevalence (but could be larger for annual and by-site estimates).  
 
Aim 3: Integrate personalized glaucoma education and counseling during the 
technician visit and test the behavior intervention’s impact on adherence to follow-
up care with an ophthalmologist. 
 
Overall strategy and experimental rigor. 
In Aim 3, we will refine and optimize our eHealth-based, personalized education and counseling 
intervention that improves glaucoma medication adherence to also help support people in 
prioritizing returning for glaucoma care. This intervention uses a web-based application to 
generate personalized education materials for patients based on their diagnosis, test results, 
doctor’s recommendations, and barriers to following those recommendations. A glaucoma 
counselor trained in brief, glaucoma-specific motivational interviewing (MI) uses the 

14 
 
individualized content generated from this web- based application to form the basis of her 
conversation with the patient. The glaucoma counselor uses MI- based communication strategies 
– including open-ended questions, reflective listening, and asking permission to give advice – to 
engage the person in identifying their own barriers to participating in glaucoma follow-up care 
and brainstorming their own solutions. All patients who screen positive for a diagnosis of 
glaucoma or glaucoma suspect and are being referred for an in-person examination with an 
ophthalmologist and who speak English will be randomized to receive either A) a 30-minute 
session with help scheduling the follow up appointment with an ophthalmologist and an 
educational hand-out or B) a 60-minute session with help scheduling the follow-up appointment 
with an ophthalmologist and a personalized counseling and education session about glaucoma. 
Spanish speaking participants will not be randomized and will receive personalized counseling 
and education about glaucoma. As of March 2024, Spanish speaking participants will be asked to 
choose eHealth education or standard education.  
Rationale for experimental design.  
Both empowerment theory and self-determination theory form the basis for our health and 
counseling intervention. The World Health Organization describes empowerment as a “process 
through which people gain greater control over decisions and actions affecting their health.” 
Empowerment is particularly important for people who may experience a powerlessness that can 
come with minority status or poverty. To empower people to best manage their eye health, 
people must be supported to develop knowledge and skills about their health condition, coping 
skills for managing emotions that can negatively affect self-management, and motivation to 
attain improved health. Self-determination theory posits that to change a health behavior, people 
must feel autonomously supported and connected to their health care provider, perceive that they 
are competent to engage in the behavior, and be motivated to change their behavior.   
Thus, the two theories provide very similar frameworks for understanding how to help 
people improve their health behaviors. MI is a counseling style consistent with the 
frameworks of self-determination theory and empowerment theory. This counseling 
engages patients by discussing priorities and obstacles to facilitate intrinsic motivation to 
change health behavior. At its base is a belief that an individual must develop a personally 
compelling reason to motivate a change in behavior for that change to happen.  
 
Research design- Intervention 
Block randomization: Subjects will be randomized to one of two treatment arms (standard 
glaucoma education from handouts or personalized education with counseling) in a 1:1 
ratio. The time of randomization is when the patient returns for their follow-up visit with 
the ophthalmic technician. Randomization will occur separately for the two clinics 
(stratification). A variable-block randomization scheme will be used to assure balanced 
assignment to the treatment arms throughout the study.  
Leveraging eHealth to provide personalized glaucoma education and counseling: The web-
based application for personalized glaucoma education has two components woven together 
into a single tool to support the conversation between the patient and the glaucoma 

15 
 
counselor: 1) an electronic health (eHealth) component and 2) a semi-structured, tailored 
interview guide to facilitate an MI-based conversation. The eHealth component provides 
individually tailored disease information and an explanation of a patient’s test results. The 
counselor uses the web-based application on a tablet, to share engaging audio-visual content 
on a screen. The counselor walks a patient through their diagnosis and test results and what 
would happen to their vision if glaucoma goes untreated. The counselor then elicits an 
understanding of what motivates that patient to maintain their vision. The counselor 
explores what unique obstacles the patient has to engaging in follow-up care. The counselor 
then assesses the patient’s motivation to attend the follow-up appointment. The counselor 
and patient create a concrete “action plan” that delineates the short-term plan of the steps 
patient will take to address any identified barriers to follow-up care, which can include 
addressing motivational factors in a subsequent phone visit if a patient is not interested in 
follow-up care. 
Throughout the program, the counselor helps patients put together a list of questions for 
their doctor to prepare for their visit. African-American patients are often less active in 
asking questions of health care providers,63 so supporting question-asking during medical 
visits is a key modifiable patient engagement behavior. Creating a question prompt list for 
patients can improve patients’ information recall after the doctor visit, reduces patients’ 
anxiety about the visit, and improves self-efficacy for question-asking.64 At the end of the 
visit, the counselor will print out a patient’s action plan with their appointment time for the 
ophthalmologist, the list of questions to bring to the appointment, and login information in 
case the patient would like to access the website to view their education plan remotely. 
Between 2-6 weeks after the counseling session, depending on when the glaucoma follow-
up appointment is scheduled, the ophthalmic technician will make at least 3 attempts to 
contact within a 30 day window to schedule a phone call with the patient. During this phone 
call, the technician will remind the patient of when their upcoming appointment is 
scheduled. S/he will assess a patient’s motivation and confidence in attending the visit and 
elicit possible obstacles. S/he will help the patient brainstorm possible solutions to identified 
obstacles and end the conversation by summarizing a new action plan. If needed, the 
counselor can arrange a subsequent phone call before the follow-up appointment to check- 
in about any outstanding problems. Patients will have the counselor’s phone number to call 
if they need additional help. 
Training para-professional staff in brief, glaucoma-specific motivational interviewing: We 
have developed a 2- day training program in brief, glaucoma-specific MI. 65 The program 
focuses on teaching the five core skills of MI: 1) asking open-ended questions; 2) affirming; 
3) reflecting; 4) summarizing; 5) asking permission to provide information and advice.57 
These skills help elicit “change talk,” through which counselors help patients talk 
themselves into changing their usual behavior, which in this case will be to ensure they 
attend their glaucoma follow-up care appointment. The program also teaches the counselor 
how to express empathy, with is the key component that underlies the spirit of MI and 
promotes rapport between the counselor and the patient. 
During the first day of training, counselors are taught to ask open-ended questions, or 
questions that cannot be answered with a “yes” or “no” response. They learn reflective 
listening, or para-phrasing what a person has said to ensure the person knows the counselor 

16 
 
is hearing and understanding what they say. They learn to use affirmations to praise actions 
people are taking towards improving their health and vision. They learn to use the elicit-
provide-elicit technique to give information. This involves assessing people’s knowledge 
prior to giving information, asking permission to give new information or advice, and then 
following up by eliciting the person’s response to the new information in order to evaluate 
their understanding. This non-directive way of giving advice and information supports 
people’s autonomy. During the second day of training, counselors are taught how to make 
complex reflections.  
Complex reflections are statements that para-phrase what a person has said and adds 
significant meaning to help make a person think about the implications of their statement. 
Counselors learn how to promote change talk and develop an action plan to adhere to 
follow-up care recommendations. 
 
Role playing is used to develop these skills using a video collection of glaucoma patients 
explaining their reasons for not engaging in their glaucoma management. The training 
consists of approximately 35% didactic material and 65% role-playing and interactive 
learning. 
Primary outcome: The primary outcome will be adherence to the recommended follow-up 
appointment with the ophthalmologist within 6 months due to availability in scheduling 
these appointments. Six-month adherence will be used as the endpoint for all participants. 
Adherence in each treatment group will be calculated as the proportion of patients who 
attended the initial scheduled follow-up visit with an ophthalmologist as recommended after 
being diagnosed with glaucoma or glaucoma suspect on screening exam, dividing by the 
total number of patients diagnosed with glaucoma or glaucoma suspect during the screening 
exam and scheduled for follow-up with an ophthalmologist. This objective outcome 
variable will be assessed through record review by the study coordinator who is masked to 
the treatment allocation. 
Maintaining Fidelity to Treatment Allocation: All counseling/education encounters will be 
audio-recorded. A study therapist and MI trainer, will assess a random sample of 10% of 
encounters (n=40) for fidelity to MI-based counseling. She will be masked to treatment 
allocation though the personalized counseling sessions will be longer than standard 
education. She will assess each encounter according to the modified One Pass71 grading 
system, a rubric with 17 items that assesses fidelity to MI counseling techniques. Each item 
is scored on a Likert scale from 1 to 7 and a passing score is set at a mean of 5. Counselors 
should not be using motivational interviewing-based counseling in the control group and 
therefore should have an average One Pass score <5 for these participants. 
Data Analysis 
Primary outcome: The primary outcome (attendance to follow-up appointment with a 
glaucoma specialist within three months) will be summarized with frequencies and 
percentages by intervention and control groups, overall and stratified by site. 
 
Data Sharing 

17 
 
Participant data will be combined and shared with the Westat Corporation, a data analysis 
service, working with the CDC. Data will contain no PHI.  
 
DATA AND SAFETY MONITORING PLAN 
Dr. Musch will lead the study team in quarterly review of study recruitment, adverse 
events, and compliance with the protocol. These quarterly reports will also be reviewed at 
CAB meetings. Dr. Musch will work with Ms. Niziol to prepare monthly reports of 
recruitment, retention, and adverse events for the entire team. Any physical, social, 
economic, or psychological harm attributable to participation in the research study, if 
serious, will be reported to the IRB within 7 days. Any non-serious adverse events will be 
reported with scheduled continuing review to the IRB. Examples of possible adverse events 
include injury occurring during a study visit, breach of confidentiality, or auto accident on 
the way to or from the study visit. Any unrelated deaths while in the study will be reported 
to the IRB with scheduled continuing review. 
The proposed tele-health protocols for glaucoma screening have been developed, validated 
and approved by the Veterans Affairs Hospital and those guidelines will be followed for 
triaging any urgent disease identified through screening. If a person requires urgent or 
emergent ophthalmic care at Hamilton Clinic, the ophthalmologist at Hamilton will be 
paged and will take responsibility for ensuring that the patient receives appropriate care. If a 
person at Hamilton Clinic needs urgent surgical glaucoma care, the ophthalmologist will 
page a study team Ophthalmologist who will contact UM staff to help arrange 
transportation for the patient to the Kellogg Eye Center. If a person requires urgent or 
emergent attention at Hope Clinic, the Hope medical director, the physician providing care 
at Hope during this time and Dr. Newman-Casey will be paged and take responsibility for 
ensuring the patient receives appropriate care. If a patient needs urgent surgical glaucoma 
care, Hope Clinic staff will help Dr. Newman-Casey arrange transportation for the patient to 
the Kellogg Eye Center for care. 
 
RESEARCH SHARING AND DATA MANAGEMENT PLAN 
Data entered in REDCap will be identified only through a participant ID number. The 
participant ID numbers will be linked to patient identifiers in a single Excel document that 
is password protected and accessible only to members of the study team. It will be kept on a 
HIPAA secure, encrypted file sharing service, M+Box or UM server, provided by the 
University of Michigan. Using REDCap for data entry by its nature makes data easier to 
share by coding data using common terminologies and data elements. The REDCap 
database elements will be archived and stored on HIPAA secure, low-cost storage 
(MiStorage) at the University of Michigan.