PROTECT2: Diabetes Care - Eye Exam

The primary objective of this study is to compare the qualified eye examination rate in two groups of patients with diabetes receiving a new intervention, with the rate in a control group of patients with diabetes receiving usual care only.

Secondary objectives are to:

• Improve our understanding of the barriers to obtaining eye examinations;
• Evaluate the communication between eye care providers (ECP) and referring primary care providers (PCP), as determined by rates of follow-up reports sent and received;
• Characterize eye examinations provided to patients with diabetes;
• Explore the relationships between systemic variables known to affect the severity of diabetic retinopathy and the patient's risk of vision-threatening diabetic retinopathy.

Design and Primary Endpoint

• The pilot study is a single cohort prospective study to gather pilot data and finalize operational details of the main study.
• The main study is a prospective randomized controlled multi-center three group clinical trial. The primary endpoint is the percentage of participants in each study group obtaining a qualified eye examination within 12 months of their enrollment in the study.

Interventions and Duration

Eligible patients will be randomized to one of three groups in a 1:1:2 ratio.

• Group 1. Participants randomized to Group 1 will be the control group. They will be observed while they receive usual eye care without any study intervention.
• Financial Incentive. Participants randomized to the Financial Incentive group will be offered a financial incentive in conjunction with their usual eye care. They will receive usual care and a $25 payment if they obtain a confirmed eye examination.
• Retinal Care DR Service. Participants randomized to the Retinal Care DR Service group will receive: (1) point of care risk assessment for vision- threatening diabetic retinopathy, (2) retinal specialist interpretation of their risk assessment data, and (3) care coordination designed to improve the eye examination rate for patients with diabetes at increased risk for vision- threatening diabetic retinopathy.

All participants, regardless of their group, will be in the study for about one year.

Sample Size and Population Patients meeting the inclusion and exclusion criteria will be recruited at up to four (4) study sites until the sample size of 4,500 participants is enrolled. This includes up to 500 patients at each site in the pilot study, and weighted randomization in the main study to ensure enrollment of approximately 500 patients in the Retinal Care DR Service group at each site to evaluate the operational characteristics of the Retinal Care DR Service in populations representative of those anticipated in commercial use.