Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02390245|
Recruitment Status : Active, not recruiting
First Posted : March 17, 2015
Last Update Posted : October 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma Glaucoma Suspect Diabetic Retinopathy Ocular Hypertension Cataract Branch Retinal Vein Occlusion Branch Retinal Arterial Occlusion Central Retinal Vein Occlusion Central Retinal Artery Occlusion Epi-retinal Membrane Macular Degeneration Drusen Loss of Vision||Other: Use of patient navigation and social worker||Not Applicable|
The project will be divided into following parts:
- Phase 1 will consist of recruiting approximately 900 patients from primary care offices and federally qualified health centers across Philadelphia and Chester counties. Using telemedicine, we will detect eye disease at Visit 1, followed by a comprehensive eye exam by a glaucoma specialist in the primary care setting to confirm the diagnosis (Visit 2). Based on preliminary data, 50% of patients will have abnormal optic nerve and/or macular images. The predictive accuracy of the optic nerve images to detect glaucoma, glaucoma suspect and other eye diseases as confirmed by the comprehensive eye exam will be evaluated.
- Phase 2 will involve consenting, enrolling, and randomizing 343 patients to either the usual care group (n=171) or the enhanced intervention group (n=172) and scheduling follow-up eye exams with a local, general ophthalmologist in an office-based setting (Visit 3). The enhanced intervention will consist of using patient navigators and a social worker to reduce barriers to follow-up eye care.
- Phase 3 will involve following patients for proximal (1-2 months) and distal (3 years) follow-up care appointments (Visits 3-8) with a local ophthalmologist. Adherence to follow-up recommendations for eye care will be the primary outcome measure. A comprehensive cost study to estimate the intervention costs and cost-effectiveness of detecting eye diseases and vision impairment in a high-risk population will also be conducted. Protocols, materials, and results will be disseminated to other organizations, stakeholders and communities in order to expand detection of glaucoma, other eye diseases, and visual impairment, and to further refine these approaches.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||375 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: Enhanced Intervention Group
Use of patient navigation and social worker: Patients randomized to Group 1 will be referred to a general ophthalmologist close to the current health center or PCP office where they received the undilated eye exam. Prior to all follow-up visits, patients in the enhanced group who have scheduled an appointment will receive a personal phone call reminding them to attend. These patients will receive any necessary interpretation services and educational materials.
Other: Use of patient navigation and social worker
This arm will include phoning patients to schedule appointments; confirming appointments by mailings, emails and/or text messaging; arranging transportation through Customized Community Transportation (CCT) and Philadelphia Paratransit Service; and scheduling trained medical interpreters.
No Intervention: Usual care group
Patients randomized to Group 2 will be recommended to follow-up for eye care with a local ophthalmologist. These patients will be scheduled for their initial follow-up visit based on the recommendations of our study physicians so the research team is able to track outcomes. Group 2 represents a realistic choice currently available for patients. Practice patterns will vary depending on the resources, staff time, and services available within each local ophthalmology practice.
- To estimate the positive predictive value (PPV) of the teleophthalmology intervention for diagnosing of glaucoma [ Time Frame: 15 months ]We hypothesize that the diagnosis of glaucoma and glaucoma suspect using undilated optic disc images, tonometry pressure results, and medical history will predict the comprehensive eye exam diagnosis. That is, we will calculate the proportion of patients diagnosed with glaucoma or glaucoma suspect whose diagnosis was confirmed at Visit 2 with an exact two-sided binomial confidence interval. We will conclude that the telemedicine intervention has good performance if the lower bound of the confidence interval is above 80%
- Attendance at recommended follow-up visits (Visit 4 and later) [ Time Frame: 5 years ]
Since the expected number of appointments will differ based on diagnosis and disease severity, which may change over time, attendance will be summarized annually.
For each year under observation, an expected number of visits will be determined based on the recommended follow-up at the first visit for that year. For purposes of this calculation, attendance at appointments within 13 months of the first visit will be assessed. We recognized that follow-up recommendations will vary for each patient depending on eye pressure control, medication adherence, disease severity, and surgery/laser appointments. Therefore, the research team, in conjunction with Dr. Blecher and the CDC, will plan and develop definitions of adherence for patients during Visits 3-8
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390245
|United States, Pennsylvania|
|Wills Eye Glaucoma Service|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||L. J Katz, MD||Wills Eye Hospital|
|Principal Investigator:||Lisa A Hark, PhD||Wills Eye Hospital|
|Principal Investigator:||Julia A Haller, MD||Wills Eye Hospital|