Clinical trial NCT05182580: Bangladesh PRODUCTIVity in Eyecare Trial
Official title: Assessing the Impact of Using Autonomous Artificial Intelligence (AI) for Pre-screening of Diabetic Retinopathy (DR) and Diabetic Macular Edema on Physician Productivity in Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Diabetic Macular Edema
Lead sponsor: Orbis
Sponsor class: OTHER
Collaborators: name: Digital Diagnostics, Inc.
name: Deep Eye Care Foundation (DECF)
First posted: 2022-01-10
Enrollment: 993
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized (by clinic day) controlled trial.
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the impact of using autonomous artificial intelligence (AI) system for identification of diabetic retinopathy (DR) and diabetic macular edema on productivity of retina specialists in Bangladesh.

Globally, the number of people with diabetes mellitus is increasing. Diabetic retinopathy is a chronic, progressive complication of diabetes mellitus that affects the microvasculature of the retina, which if left untreated can potentially result in vision loss. Early detection and treatment of diabetic retinopathy can prevent potential blindness.

Study Aim: To assess the impact of using autonomous artificial intelligence (AI) system for detection of diabetic retinopathy (DR) and diabetic macular edema on physician productivity in Bangladesh.

Main study question: Will ophthalmologists with clinic days randomized to use autonomous AI DR detection for all persons with diabetes (diagnosed or un-diagnosed) visiting their clinic system have a greater number of examined patients with diabetes (by either AI or clinical exam), and a greater complexity of examined patients on a recognized grading scale, per physician working hour than those randomized not to have autonomous AI screening for their diabetes population?

The investigators anticipate that this study will demonstrate an increase in physician productivity, supporting efficiency for both physicians and patients, while also addressing increased access for DR screening; ultimately, preventing vision loss amongst diabetic patients. The study has the potential to contribute to the evidence base on the benefits of AI for physicians and patients. Additionally, the study has the potential to demonstrate the benefits (and/or challenges) of implementing AI in resource-constrained settings, such as Bangladesh.

Detailed description: Bangladesh PRODUCTIVity in Eyecare (B-PRODUCTIVE) Trial

Study Aim: To assess the impact of using autonomous artificial intelligence (AI) for identification of diabetic retinopathy (DR) and diabetic macular edema on productivity of retina specialists in Bangladesh.

Hypothesis: Autonomous AI increases retina specialist productivity

Main Study Question: Will retina specialists complete a greater number of diabetic eye exams per working hour (including persons reviewed by AI whom the retina specialist does not need to see personally) when they use autonomous AI in a randomized clinical trial?

Design: Cluster-randomized (by clinic day) controlled trial.

Randomization: By clinic day. Each morning the clinic manager will open an opaque envelope, which informs the manager if it is an Intervention (AI) or Control (non-AI) day.

Interventions: All patients in both groups go through the eligibility checklist. If approved, they will be evaluated by autonomous AI. This is done to decrease potential bias (neither patients nor physicians know the group assignment of participants) and concealment (so that neither patients nor doctors can arrange visits on a known "Intervention Day").

Intervention Group: On randomly selected "Intervention" clinic days, if patients screen positive or have insufficient image quality, they continue to the ophthalmologist. If not eligible for autonomous AI, they proceed straight to the ophthalmologist without autonomous AI evaluation. If patients receive a negative result, they do not see the retina specialist, and are referred for a visit at the regular eye clinic (not the retina clinic) in 3 months.

Control Group: On randomly-selected "Control Days," all patients see the ophthalmologist, irrespective of the results of autonomous AI evaluation.

Masking: The retina doctors are masked both patient group assignment (that is, whether autonomous AI was used for pre-screening or not on the particular clinic day) and also masked to the results of the AI on Intervention days. Patients are also masked to group assignment and autonomous AI results.

Eligibility criteria: Inclusion Criteria:

Retina specialists regularly seeing patients with DR

* Routinely examines \>= 20 patients with diabetes without known diabetic retinopathy or diabetic macular edema per week
* Routinely provides laser treatment or intravitreal injections to \>= 3 DR patients/month

Patients

* Diagnosed with type 1 or 2 diabetes
* Presenting visual acuity \>= 6/18 best corrected visual acuity in the better-seeing eye

Exclusion Criteria:

Retina specialists

* Currently using an AI system integrated into their clinical care and/or inability to provide informed consent.

Patients

* Inability to provide informed consent or understand the study; persistent vision loss, blurred vision or floaters; previously diagnosed with diabetic retinopathy or diabetic macular edema; history of laser treatment of the retina or injections into either eye, or any history of retinal surgery; contraindicated for imaging by fundus imaging systems

Primary outcomes:
measure: Number of Completed Care Encounters Among Clinic Patients With Diabetes Per Retina Specialist Clinic Hour
timeFrame: 105 randomized clinic days
measure: Number of Completed Care Encounters Among All Clinic Patients (With and Without Diabetes) Per Retina Specialist Clinic Hour
timeFrame: 105 randomized clinic days
Secondary outcomes:
measure: Specialist Productivity Adjusted for Patient Complexity for Patients With Diabetes
timeFrame: 105 randomized clinic days
measure: Number of Participants Who Were Very Satisfied or Satisfied With Autonomous AI
timeFrame: 105 randomized clinic days
Other outcomes:
Locations:
city: Rangpur
country: Bangladesh
facility: Deep Eye Care Foundation
Study officials:
affiliation: Orbis
name: Nathan Congdon, MD, MPH
role: STUDY_CHAIR
References: