Ephrem Abebe1, Noll L Campbell2, Daniel O Clark3, Wanzhu Tu4, Jordan R Hill5, Addison B Harrington6, Gracen O'Neal6, Kimberly S Trowbridge6, Christian Vallejo6, Ziyi Yang4, Na Bo4, Alexxus Knight6, Khalid A Alamer7, Allie Carter4, Robin Valenzuela6, Philip Adeoye6, Malaz A Boustani8, Richard J Holden9. 1. Department of Pharmacy Practice, Purdue University College of Pharmacy, West Lafayette, IN, USA; Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA. 2. Department of Pharmacy Practice, Purdue University College of Pharmacy, West Lafayette, IN, USA; Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA; Center for Health Innovation and Implementation Science, Indiana University School of Medicine, Indianapolis, IN, USA; Eskenazi Health, Indianapolis, IN, USA. 3. Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA; Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA. 4. Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA. 5. Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA. 6. Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA. 7. Department of Pharmacy Practice, Purdue University College of Pharmacy, West Lafayette, IN, USA. 8. Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA; Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA; Indiana Clinical and Translational Sciences Institute, Indianapolis, IN, USA; Sandra Eskenazi Center for Brain Care Innovation, Eskenazi Health, Indianapolis, IN, USA. 9. Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA; Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA; Center for Health Innovation and Implementation Science, Indiana University School of Medicine, Indianapolis, IN, USA. Electronic address: rjholden@iu.edu.
Abstract
INTRODUCTION: A growing body of scientific evidence points to the potentially harmful cognitive effects of anticholinergic medications among older adults. Most interventions designed to promote deprescribing of anticholinergics have directly targeted healthcare professionals and have had mixed results. Consumer-facing technologies may provide a unique benefit by empowering patients and can complement existing healthcare professional-centric efforts. METHODS: We initiated a randomized clinical trial to evaluate the effectiveness of a patient-facing mobile application (Brain Safe app) compared to an attention control medication list app in reducing anticholinergic exposure among community-dwelling older adults. Study participants are adults aged 60 years and above, currently using at least one prescribed strong anticholinergic, and receiving primary care. The trial plans to enroll a total of 700 participants, randomly allocated in 1:1 proportion to the two study arms. Participants will have the Brain Safe app (intervention arm) or attention control medication list app (control arm) loaded onto a smartphone (study provided or personal device). All participants will be followed for 12 months and will have data collected at baseline, at 6 months, and 12 months by blinded outcome assessors. The primary outcome of the study is anticholinergic exposure measured as total standard daily dose (TSDD) computed from medication prescription electronic records. Secondary outcomes of the study are cognitive function and health-related quality of life. DISCUSSION: A consumer-facing intervention to promote deprescribing of potentially high-risk medications can be part of a multi-pronged approach to reduce inappropriate medication use among older adult patients. Delivering a deprescribing intervention via a mobile app is a novel approach and may hold great promise to accelerate deployment of medication safety initiatives across diverse patient populations. CLINICAL TRIAL REGISTRATION: Registered at ClinicalTrials.gov on October 10, 2019. Identifier number: NCT04121858.
INTRODUCTION: A growing body of scientific evidence points to the potentially harmful cognitive effects of anticholinergic medications among older adults. Most interventions designed to promote deprescribing of anticholinergics have directly targeted healthcare professionals and have had mixed results. Consumer-facing technologies may provide a unique benefit by empowering patients and can complement existing healthcare professional-centric efforts. METHODS: We initiated a randomized clinical trial to evaluate the effectiveness of a patient-facing mobile application (Brain Safe app) compared to an attention control medication list app in reducing anticholinergic exposure among community-dwelling older adults. Study participants are adults aged 60 years and above, currently using at least one prescribed strong anticholinergic, and receiving primary care. The trial plans to enroll a total of 700 participants, randomly allocated in 1:1 proportion to the two study arms. Participants will have the Brain Safe app (intervention arm) or attention control medication list app (control arm) loaded onto a smartphone (study provided or personal device). All participants will be followed for 12 months and will have data collected at baseline, at 6 months, and 12 months by blinded outcome assessors. The primary outcome of the study is anticholinergic exposure measured as total standard daily dose (TSDD) computed from medication prescription electronic records. Secondary outcomes of the study are cognitive function and health-related quality of life. DISCUSSION: A consumer-facing intervention to promote deprescribing of potentially high-risk medications can be part of a multi-pronged approach to reduce inappropriate medication use among older adult patients. Delivering a deprescribing intervention via a mobile app is a novel approach and may hold great promise to accelerate deployment of medication safety initiatives across diverse patient populations. CLINICAL TRIAL REGISTRATION: Registered at ClinicalTrials.gov on October 10, 2019. Identifier number: NCT04121858.
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