Clinical trial NCT03094819: PROTECT2: Diabetes Care - Eye Exam
Official title: PROTECT2: Diabetes Care - Eye Exam
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Retinopathy
Diabetic Macular Edema
Lead sponsor: Retinal Care Inc.
Sponsor class: INDUSTRY
Collaborators: name: Dean A. McGee Eye Institute
First posted: 2017-03-29
Enrollment: 4500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed diabetes using the criteria documented in the 2016 Physician Quality Reporting System (PQRS) Measure Specifications Manual for Claims and Registry Reporting of Individual Measures.
2. 18 through 75 years of age
3. Have a PCP appointment scheduled within 90 days of the date of medical record review.

Exclusion Criteria:

1. Patients not diagnosed with diabetes
2. History of photosensitive epilepsy
3. Inability or unwillingness of the participant to give verbal or written informed consent.

Primary outcomes:
measure: Qualified eye examination rate
timeFrame: 12 months
Secondary outcomes:
measure: PCP report rate
timeFrame: 12 months
measure: PCP medical record rate
timeFrame: 12 months
measure: Eye examination barriers
timeFrame: 12 months
measure: Increased risk group eye examination rate
timeFrame: 12 months
measure: Eye examination findings
timeFrame: 12 months
measure: Eye examination components
timeFrame: 12 months
measure: Eye care costs
timeFrame: 12 months
measure: Risk correlations
timeFrame: 12 months
measure: Participant perceptions
timeFrame: 12 months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Dean McGee Eye Institute
state: Oklahoma
Study officials:
affiliation: Dean McGee Eye Institute / University of Oklahoma Health Sciences Center
name: Ronald M Kingsley, MD
role: PRINCIPAL_INVESTIGATOR
References: