PROTECT2: Diabetes Care - Eye Exam

Diabetic Retinopathy Clinical Trial

Official title:

PROTECT2: Diabetes Care - Eye Exam

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03094819
• Other study ID #: 09-PLN-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 17, 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2022
• Source: Retinal Care Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4500
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Macular Edema

Intervention

Behavioral:
• Financial Incentive
Participants will receive usual care and a $25 payment if they obtain a confirmed eye examination.
• 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.

Locations

Country	Name	City	State
United States	Dean McGee Eye Institute	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Retinal Care Inc.	Dean A. McGee Eye Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualified eye examination rate	Percent of participants in each study group obtaining a qualified eye examination.	12 months
Secondary	PCP report rate	Percent of eye examinations with a follow-up report sent to the PCP.	12 months
Secondary	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
Secondary	Eye examination barriers	Descriptive analysis of barriers to obtaining an eye examination.	12 months
Secondary	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
Secondary	Eye examination findings	Descriptive analysis of eye examination findings for participants at increased risk for vision-threatening diabetic retinopathy.	12 months
Secondary	Eye examination components	Descriptive analysis of eye examination components for participants at increased risk for vision-threatening diabetic retinopathy.	12 months
Secondary	Eye care costs	Numerical analysis of eye care costs using provider reported and claims data.	12 months
Secondary	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
Secondary	Participant perceptions	Descriptive analysis of participant perceptions of the Retinal Care DR Service.	12 months