Diabetic Retinopathy Screening in Private Practice

The Feasibility of Screening for Diabetic Retinopathy in Private Practice Hong Kong

Introduction: Diabetic mellitus (DM) is a prevalent disease in Hong Kong (HK) and diabetic retinopathy (DR) is one of the most common complications of DM. Screening for DR is a cost-effective method to identify patients who are at risk of vision loss so that timely treatment can be provided to patients. In Hong Kong, the Hospital Authority has recently set up screening services (RAMP) in the government outpatient clinics and all DM patients attending these clinics will be screened at least once every two years and some every six months, according to their individual risks. However, those diabetic patients who attend the private sector for their primary care may not have access to this service.

Aim: This study from the University of Hong Kong aims to determine the characteristics of a sustainable approach to setting up an effective and quality-controlled screening service for DR in the private primary care sector of Hong Kong and to estimate the potential benefit to be gained in terms of impact on avoidable vision loss, costs of care and potential for further development of this model in chronic disease care.

Methods:A screening centre is being set up and a randomised study carried out in which screening will be offered at three different fee levels to subjects recruited by their general practitioner (GP). The following data will be collected (a) willingness to attend screening at the different fee levels (b) screening findings in terms of DR and other eye diseases (c) risk factors and other characteristics of those screened and unscreened. The information will allow us to estimate the level of fee which best combines effectiveness with sustainability in the longer term.

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Other: Free screening group; Other: Pay screening group ($150); Other: Pay screening group ($300)

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Department of Ophthalmology, The University of Hong Kong, Hong Kong

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients diagnosed to have diabetic mellitus
• Able to give informed consent

Exclusion Criteria:

• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Free screening group; Subjects in this group receive free diabetic retinopathy screening.	Other: Free screening group; The intervention provide Diabetic Retinopathy screening without charging a fee.
Active Comparator: Pay screening group ($150); Subjects in this group receiving diabetic retinopathy screening will be charged HK$150.	Other: Pay screening group ($150); The intervention is charging HK$150 for the Diabetic Retinopathy screening.
Active Comparator: Pay screening group ($300); Subjects in this group receiving diabetic retinopathy screening will be charged HK$300.	Other: Pay screening group ($300); The intervention is charging HK$300 for the Diabetic Retinopathy screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The overall, & at different fee level, uptake (as a percentage of participants) of screening from those at-risk patients who attend private GP's	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants with diabetes who are only under the care of a private GP, or also attend specialist service, and have had access to DR screening	one year
Prevalence of DR (overall, and for sight-threatening diabetic retinopathy) among diabetic patients in private primary care	one year

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Jonathan Cheuk Hung Chan, MBBS, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 13, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Screening; Diabetic Retinopathy; Fee for screening; Private practice
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: 12133951

Plan for Individual participant data (IPD)

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