Trial Outcomes & Findings for Bangladesh PRODUCTIVity in Eyecare Trial (NCT NCT05182580)

Results Overview

Number of completed care encounters among clinic patients with diabetes per retina specialist clinic hour. Numerator is the number of care encounters among patients with diabetes (including persons evaluated by autonomous AI on Intervention Days who are determined not to need to see the retina specialist). The denominator is retina specialist clinic time in hours.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

993 participants

Primary outcome timeframe

105 randomized clinic days

Results posted on

2024-02-06

Participant Flow

The random allocation of each cluster (clinic day) was concealed until clinic staff received an email with this information just before the start of that day's clinic. Medical staff who determined access, specialists and patient participants remained masked to the random assignment of clinic days as control or intervention. Technicians and/or specialists are not considered enrolled. The participant flow details patient participants randomized by clinic day.

Unit of analysis: clinic days

Participant milestones

Participant milestones
Measure	Intervention Group Autonomous AI results are used to evaluate if the participant needs to see the retina specialist (positive result) or not (negative result). Results utilized from autonomous AI diagnostic system for diabetic retinopathy and/or diabetic macular edema: If patients receive a negative result they do not see the retina specialist	Control Group All participants see the retina specialist irrespective of the results of their autonomous AI evaluation.
Overall Study STARTED	494 51	499 54
Overall Study COMPLETED	494 51	499 54
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=494 Participants Autonomous AI results are used to evaluate if the participant needs to see the retina specialist (positive result) or not (negative result). Results utilized from autonomous AI diagnostic system for diabetic retinopathy and/or diabetic macular edema: If patients receive a negative result they do not see the retina specialist	Control Group n=499 Participants All participants see the retina specialist irrespective of the results of their autonomous AI evaluation.	Total n=993 Participants Total of all reporting groups
Age, Customized Age, years	50.8 years STANDARD_DEVIATION 9.70 • n=494 Participants	51.0 years STANDARD_DEVIATION 10.0 • n=499 Participants	50.9 years STANDARD_DEVIATION 9.88 • n=993 Participants
Sex: Female, Male Female	259 Participants n=494 Participants	265 Participants n=499 Participants	524 Participants n=993 Participants
Sex: Female, Male Male	235 Participants n=494 Participants	234 Participants n=499 Participants	469 Participants n=993 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Bangladesh	494 participants n=494 Participants	499 participants n=499 Participants	993 participants n=993 Participants

PRIMARY outcome

Timeframe: 105 randomized clinic days

Population: Completed care encounters among clinic patients with diabetes

Number of completed care encounters among clinic patients with diabetes per retina specialist clinic hour. Numerator is the number of care encounters among patients with diabetes (including persons evaluated by autonomous AI on Intervention Days who are determined not to need to see the retina specialist). The denominator is retina specialist clinic time in hours.

Outcome measures

Outcome measures
Measure	Intervention Group n=1189 care encounters pts with diabetes Autonomous AI results are used to evaluate if the participant needs to see the retina specialist (positive result) or not (negative result). Results utilized from autonomous AI diagnostic system for diabetic retinopathy and/or diabetic macular edema: If patients receive a negative result they do not see the retina specialist	Control Group n=920 care encounters pts with diabetes All participants see the retina specialist irrespective of the results of their autonomous AI evaluation.
Number of Completed Care Encounters Among Clinic Patients With Diabetes Per Retina Specialist Clinic Hour	1.59 care encounters/specialist clinic hour Interval 1.3 to 1.8	1.14 care encounters/specialist clinic hour Interval 1.02 to 1.25

PRIMARY outcome

Timeframe: 105 randomized clinic days

Population: All retina clinic care encounters

Number of completed care encounters among all clinic patients (with and without diabetes) per retina specialist clinic hour. Numerator is the number of completed care encounters (including persons evaluated by autonomous AI on Intervention Days who are determined not to need to see the retina specialist). The denominator is retina specialist clinic working time in hours.

Outcome measures

Outcome measures
Measure	Intervention Group n=3014 all retina clinic care encounters Autonomous AI results are used to evaluate if the participant needs to see the retina specialist (positive result) or not (negative result). Results utilized from autonomous AI diagnostic system for diabetic retinopathy and/or diabetic macular edema: If patients receive a negative result they do not see the retina specialist	Control Group n=2708 all retina clinic care encounters All participants see the retina specialist irrespective of the results of their autonomous AI evaluation.
Number of Completed Care Encounters Among All Clinic Patients (With and Without Diabetes) Per Retina Specialist Clinic Hour	4.05 care encounters/specialist clinic hour Interval 3.66 to 4.43	3.36 care encounters/specialist clinic hour Interval 3.08 to 3.63

SECONDARY outcome

Timeframe: 105 randomized clinic days

Population: This is the same calculation as Outcome 1 but with the addition of adjustment for complexity. (# retina care encounters\*complexity score) / specialist clinic hours

Specialist productivity (care encounters / specialist clinic hour) adjusted for patient complexity for patients with diabetes. The complexity score for each patient participant was calculated by a masked United Kingdom National Health Service grader using the International Grading system, adapted from Wilkinson et al. International Clinical Diabetic Retinopathy and Diabetic Macular Edema Severity Scales (no DED = 0 points, mild non-proliferative DED = 0 points, moderate or severe non-proliferative DED = 1 point, proliferative DED = 3 points and diabetic macular edema = 2 points.) The patient participant complexity score was summed across both eyes. The average complexity score for each arm was calculated. Complexity adjusted specialist productivity was calculated for intervention and control arms by multiplying the respective overall productivity (care encounters per specialist clinic hour) calculation by the respective average complexity score.

Outcome measures

Outcome measures
Measure	Intervention Group n=1189 care encounters pts with diabetes Autonomous AI results are used to evaluate if the participant needs to see the retina specialist (positive result) or not (negative result). Results utilized from autonomous AI diagnostic system for diabetic retinopathy and/or diabetic macular edema: If patients receive a negative result they do not see the retina specialist	Control Group n=920 care encounters pts with diabetes All participants see the retina specialist irrespective of the results of their autonomous AI evaluation.
Specialist Productivity Adjusted for Patient Complexity for Patients With Diabetes	3.15 (exams/clinic hour)*(score on a scale)	1.19 (exams/clinic hour)*(score on a scale)

SECONDARY outcome

Timeframe: 105 randomized clinic days

After the patient participant completed the autonomous AI process, a survey with a 4-point Likert scale ("very satisfied," "satisfied," "dissatisfied," "very dissatisfied") was administered, concerning the participant's satisfaction with interactions with the healthcare team, time to receive examination results, and receiving their diagnosis from the autonomous AI system.

Outcome measures

Outcome measures
Measure	Intervention Group n=494 Participants Autonomous AI results are used to evaluate if the participant needs to see the retina specialist (positive result) or not (negative result). Results utilized from autonomous AI diagnostic system for diabetic retinopathy and/or diabetic macular edema: If patients receive a negative result they do not see the retina specialist	Control Group n=499 Participants All participants see the retina specialist irrespective of the results of their autonomous AI evaluation.
Number of Participants Who Were Very Satisfied or Satisfied With Autonomous AI	493 Participants	499 Participants

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nathan Congdon, Director of Research

Orbis International

Phone: 646-674-5514

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place