A Pilot Project to Assess the Impact of Diabetes Education During Ophthalmology Visits (LionsDMed)

Providing Diabetes Services in the Lions Eye Clinic: a Pilot Project to Assess the Impact of Diabetes Education During Ophthalmology Visits

The overarching purpose of this project is to provide diabetes education to the diverse patient population at the Lions Eye Clinic, a resident-run ophthalmology practice at California Pacific Medical Center. Because of high clinic volume in a teaching environment, our patients often experience long wait times. The goal of this program is to utilize this wait time for diabetes education, a much-needed corollary to the eye care that patients receive at our clinic.

This pilot project will investigate the impact of a program like this in our patient population. Specifically, the investigators are investigating whether diabetes education delivered in an ophthalmology setting enhances patient understanding of diabetes (via knowledge surveys) and/or leads to improved blood glucose control (via hemoglobin A1c). This is a 6-month study that runs through April 2015, and looks at the impact of an interactive diabetes education iPad app +/- in-person sessions with a diabetes educator. A subset of patients who meet with a diabetes educator will also be shown their own retinal images (compared to a normal retina).

Study Overview

• Status: Completed
• Conditions: Diabetes Complications; Diabetic Retinopathy
• Intervention / Treatment: Behavioral: iPad app; Behavioral: Educator sessions; Behavioral: Retinal photos

• Study Type: Observational
• Enrollment (Actual): 36

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

• Sampling Method: Non-Probability Sample

Study Population

The proposed subjects are diabetic patients already approved to be seen in the Lions Eye Clinic, specifically for dilated eye exam by a retinal specialist. This is a high-risk population with advanced disease and often with limited preexisting knowledge about diabetes, thus providing the motivation for these educational interventions.

Description

Inclusion Criteria:

• Type 1 or Type 2 diabetes (as defined by evident systemic findings OR recent hemoglobin A1c OR patient report, as specific blood sugar data and knowledge of particular medications are often limited in this population)
• Age 18-75
• Able and willing to provide informed consent
• Speak English, Spanish, or any other language for which a translator is present

Exclusion Criteria:

• Advanced visual acuity loss in both eyes which prevents adequate use of educational tools
• Pregnant women, elderly patients (>75 years old), children and adolescents (17 or younger)
• Non-English/Spanish speakers for whom a translator is not present

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
iPad app; This group will have unlimited access to educational iPad app while waiting for ophthalmology visits.	Behavioral: iPad app; Provided by the Patient Education Institute, the "X-plain" iPad app includes modules on healthy eating for diabetics, eye complications, foot care, and others.
Educator sessions; This group will have unlimited access to educational iPad app AND at least one appointment with a certified diabetes educator or registered dietitian while waiting for ophthalmology visits.	Behavioral: iPad app; Provided by the Patient Education Institute, the "X-plain" iPad app includes modules on healthy eating for diabetics, eye complications, foot care, and others.; Behavioral: Educator sessions; A certified diabetes educator and/or registered dietitian will meet with patients for 30-60 minutes prior to their ophthalmology visits, when scheduling permits.
Educator sessions + retinal photos; This group will have same access as "iPad app + education sessions" and in addition will be able to briefly review their own retinal photos (compared to normal retina) with a resident ophthalmologist during timeline of pilot program.	Behavioral: iPad app; Provided by the Patient Education Institute, the "X-plain" iPad app includes modules on healthy eating for diabetics, eye complications, foot care, and others.; Behavioral: Educator sessions; A certified diabetes educator and/or registered dietitian will meet with patients for 30-60 minutes prior to their ophthalmology visits, when scheduling permits.; Behavioral: Retinal photos; A resident ophthalmologist will spend approximately 5 minutes showing patient their own retinal photos, compared to a normal retina, and explaining the pathology present (if applicable).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Patient Knowledge about Diabetes at 3 months (via multiple-choice surveys)	Objective assessment of patient knowledge about diabetes using 13 multiple-choice questions	Participants will be re-surveyed at their next follow-up eye appointment, an expected average of 3 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Hemoglobin A1c at 3 months	Provides estimate of patient's average blood sugar over past three months	Participants will have repeat lab drawn at their next follow-up eye appointment, an expected average of 3 months post-intervention
Patient Satisfaction / Motivation / Subjective Improvement in Knowledge (brief surveys)	Brief 3-4 question surveys to assess patient satisfaction with services offered, motivation to manage their disease process, and subjective improvement in knowledge after using educational services	1 day
Change from Baseline in Patient Knowledge about Diabetes Immediately after using Educational Services (via multiple-choice surveys)	Objective assessment of patient knowledge about diabetes using 13 multiple-choice questions	1 day

Collaborators and Investigators

• Sponsor: California Pacific Medical Center Research Institute
• Collaborators: Pacific Vision Foundation
• Investigators: Study Director: Samuel J Reiter, MD, Resident Ophthalmologist, CPMC; Principal Investigator: Taliva Martin, MD, CPMC Ophthalmologist, Residency Program Director

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 31, 2014
• First Submitted That Met QC Criteria: January 6, 2015
• First Posted (Estimate): January 8, 2015

Study Record Updates

• Last Update Posted (Estimate): July 27, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Retinal Diseases; Diabetes Mellitus; Diabetic Retinopathy; Diabetes Complications
• Other Study ID Numbers: Diabetes Ed at Lions Eye