The PROTECT2 pilot study is a single cohort prospective study to gather pilot data and finalize operational details of the main study. The PROTECT2 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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Enrollment
4,500
Participants will receive usual care and a $25 payment if they obtain a confirmed eye examination.
Participants 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.
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States
Qualified eye examination rate
Percent of participants in each study group obtaining a qualified eye examination.
Time frame: 12 months
PCP report rate
Percent of eye examinations with a follow-up report sent to the PCP.
Time frame: 12 months
PCP medical record rate
Percent of eye examinations with a follow-up report sent to the PCP, where the results of the follow-up report are documented in the PCP medical record.
Time frame: 12 months
Eye examination barriers
Descriptive analysis of barriers to obtaining an eye examination.
Time frame: 12 months
Increased risk group eye examination rate
Percent of participants at increased risk for vision-threatening diabetic retinopathy who are subsequently seen by an eye care provider.
Time frame: 12 months
Eye examination findings
Descriptive analysis of eye examination findings for participants at increased risk for vision-threatening diabetic retinopathy.
Time frame: 12 months
Eye examination components
Descriptive analysis of eye examination components for participants at increased risk for vision-threatening diabetic retinopathy.
Time frame: 12 months
Eye care costs
Numerical analysis of eye care costs using provider reported and claims data.
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Time frame: 12 months
Risk correlations
Correlation analysis of systemic variables known to affect the severity of diabetic retinopathy and retinal specialist interpretation of participant's risk assessment data.
Time frame: 12 months
Participant perceptions
Descriptive analysis of participant perceptions of the Retinal Care DR Service.
Time frame: 12 months