PROTECT2: Diabetes Care - Eye Exam

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Retinopathy; Diabetic Macular Edema
• Intervention / Treatment: Behavioral: Financial Incentive; Behavioral: Retinal Care DR

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.

• Study Type: Interventional
• Enrollment (Anticipated): 4500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104-5065
      • Dean McGee Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: Financial Incentive; Participants will receive usual care and a $25 payment if they obtain a confirmed eye examination.
Experimental: Retinal Care DR; 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.	Behavioral: Retinal Care DR; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualified eye examination rate	Percent of participants in each study group obtaining a qualified eye examination.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCP report rate	Percent of eye examinations with a follow-up report sent to the PCP.	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.	12 months
Eye examination barriers	Descriptive analysis of barriers to obtaining an eye examination.	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.	12 months
Eye examination findings	Descriptive analysis of eye examination findings for participants at increased risk for vision-threatening diabetic retinopathy.	12 months
Eye examination components	Descriptive analysis of eye examination components for participants at increased risk for vision-threatening diabetic retinopathy.	12 months
Eye care costs	Numerical analysis of eye care costs using provider reported and claims data.	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.	12 months
Participant perceptions	Descriptive analysis of participant perceptions of the Retinal Care DR Service.	12 months

Collaborators and Investigators

• Sponsor: Retinal Care Inc.
• Collaborators: Dean A. McGee Eye Institute
• Investigators: Principal Investigator: Ronald M Kingsley, MD, Dean McGee Eye Institute / University of Oklahoma Health Sciences Center

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2016
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 1, 2016
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Diabetic Retinopathy; Macular Edema
• Other Study ID Numbers: 09-PLN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO