Randomized controlled trial of an education-based intervention to improve medication adherence: Design considerations in the medication adherence in glaucoma to improve care study.
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2021-06
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Abstract
Background
Glaucoma treatment requires patients to follow daily, often times complex, eye drop regimens, but adherence is poor for many patients, putting them at risk for irreversible vision loss. A comprehensive approach is needed to address the challenges in the self-management of glaucoma. The purpose of this study is to improve glaucoma medication adherence in Veterans with medically treated glaucoma using an education-based intervention.Methods/design
This study is a single-site randomized controlled trial enrolling 200 Veterans and their companions, if companions are involved in their care. It has two arms: an intervention group and a control group. Participants in the intervention group receive an educational session with a non-physician interventionist and are provided with an AdhereTech smart bottle with the reminder functions activated. The control group is designed as an attention control such that they have a session on general eye health and are provided with a smart bottle but without the reminder functions activated. The primary outcome is the proportion of prescribed doses taken on schedule over 6 months following randomization according to the smart bottle. Secondary outcomes include intensification of glaucoma treatment, cost of intervention delivery, and cost-effectiveness of the intervention over 12 months.Discussion
The education-based intervention that we are testing is comprehensive in scope, to encompass a variety of barriers to adherence that glaucoma patients encounter, but personalized to address issues facing individual patients. Particular attention was given to feasibility in the real-world setting, as the high throughput of patients and lack of reimbursement for educational encounters in ophthalmology would limit implementation of a resource-intensive intervention.Type
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Rosdahl, Jullia A, Aaron M Hein, Hayden B Bosworth, Sandra Woolson, Maren Olsen, Miriam Kirshner, Anna Hung, Kelly W Muir, et al. (2021). Randomized controlled trial of an education-based intervention to improve medication adherence: Design considerations in the medication adherence in glaucoma to improve care study. Clinical trials (London, England), 18(3). pp. 343–350. 10.1177/1740774520988291 Retrieved from https://hdl.handle.net/10161/29638.
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Scholars@Duke
Jullia Ann Rosdahl
I am a glaucoma specialist at the Duke Eye Center.
My passions are teaching, caring for patients and doctors, and saving retinal ganglion cells.
My research interests include patient education and adherence, medical and surgical education, OCT imaging for glaucoma, and physician wellness.
Maren Karine Olsen
Health services research, longitudinal data methods, missing data methods
Anna Hung
Anna Hung, PharmD, PhD, MS is a pharmacist and health services researcher interested in payer and patient decision making related to pharmacy benefits. Previously, she collaborated with the Defense Health Agency to evaluate the budgetary impact of their antidiabetic drug formulary changes. She has also worked with a variety of managed care organizations to assess their drug utilization and clinical management programs. Her methodological research interests include health care cost evaluations, quasi-experimental study designs, and stated preference research.
Dr. Hung received her Doctor of Pharmacy, Master of Science, and Doctor of Philosophy from the University of Maryland. Her PhD is in pharmaceutical health services research, with concentrations in pharmacoeconomics, comparative effectiveness research, and patient-centered outcomes research. Prior to joining the Department of Population Health Sciences, she completed a post-doctoral fellowship at the Duke Clinical Research Institute and served as Co-Chief Fellow.
Kelly Walton Muir
Kelly W. Muir, MD, specializes in the medical and surgical management of glaucoma, cataracts and general eye disease. Her research focuses on optimizing the quality of care that glaucoma patients receive by improving patient education materials, studying patient and physician communication, and developing a novel eye drop bottle that makes it easier for patients to administer their glaucoma drops. Her research has been funded by the American Glaucoma Society, the National Eye Institute, and the Veterans Health Administration. Dr. Muir also teaches medical students, residents, and fellows about glaucoma and other ophthalmologic conditions. Dr. Muir is fellowship-trained, board-certified and a member of the American Academy of Ophthalmology and American Glaucoma Society.
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