Browsing by Author "Harrington, Addison B."

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    Deprescribing anticholinergics to preserve brain health: reducing the risk of dementia through deprescribing (R2D2): study protocol for a randomized clinical trial
    (Springer Nature, 2024-11-22) Campbell, Noll L.; Holden, Richard J.; Gao, Sujuan; Unverzagt, Frederick W.; Lane, Kathleen A.; Carter, Allie; Harrington, Addison B.; Manoharan, Sneha; Manoharan, Neha; Rosenthal, Danielle L.; Pitts, Christopher; Pelkey, Kathryn; Papineau, Emily; Lauck, David M.; Keshk, Noha; Alamer, Khalid; Khalil, Hussein; Boustani, Malaz A.; Psychiatry, School of Medicine
    Background: Older adults commonly experience chronic medical conditions and are at risk of cognitive impairment as a result of age, chronic comorbidity, and medications prescribed to manage multiple chronic conditions. Anticholinergic medications are common treatments for chronic conditions and have been repeatedly associated with poor cognitive outcomes, including delirium and dementia, in epidemiologic studies. However, no study has definitively evaluated the causal relationship between anticholinergics and cognition in a randomized controlled trial design. Utilizing our prior experience in deprescribing anticholinergic medications in various clinical environments, we designed an outpatient deprescribing intervention to prospectively test the potential causal relationship between anticholinergics and cognition in primary care older adults. Methods: This cluster randomized clinical trial will be conducted to evaluate the impact of an anticholinergic deprescribing intervention compared to usual care on outcomes of cognition and safety in primary care older adults. Participants will include those aged 65 years and over, receiving primary care in the greater Indianapolis area, using a strong anticholinergic within the last 2 weeks or with evidence of high-risk exposure in the past year. Those excluded will have a diagnosis of Alzheimer's disease or related dementia, or serious mental illness. The trial plans to enroll 344 participants who will be cluster-randomized at the level of primary care physician to avoid contamination. Participants will complete outcome assessments every 6 months up to 2 years by blinded outcome assessors. The primary outcome of the study is a composite measure of cognition that includes domains assessing executive cognitive function, language, and memory. Secondary outcomes include patient-reported measures of pain intensity, depression, anxiety, sleep disturbance, and health-related quality of life. Discussion: The R2D2 trial will be the largest and longest prospective randomized trial testing the impact of an anticholinergic-specific deprescribing intervention on cognition in primary care older adults. Results could influence deprescribing methodology and provide new insight on the relationship between anticholinergics and cognition.
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    Going Remote: Demonstration and Evaluation of Remote Technology Delivery and Usability Assessment with Older Adults
    (JMIR, 2021-03) Hill, Jordan R.; Harrington, Addison B.; Adeoye, Philip; Campbell, Noll L.; Holden, Richard J.; Medicine, School of Medicine
    Background: The COVID-19 pandemic necessitated “going remote” with the delivery, support, and assessment of a study intervention targeting older adults enrolled in a clinical trial. While remotely delivering and assessing technology is not new, there are few methods available in the literature that are proven to be effective with diverse populations, and none for older adults specifically. Older adults comprise a diverse population, including in terms of their experience with and access to technology, making this a challenging endeavor. Objective: Our objective was to remotely deliver and conduct usability testing for a mobile health (mHealth) technology intervention for older adult participants enrolled in a clinical trial of the technology. This paper describes the methodology used, its successes, and its limitations. Methods: We developed a conceptual model for remote operations, called the Framework for Agile and Remote Operations (FAR Ops), that combined the general requirements for spaceflight operations with Agile project management processes to quickly respond to this challenge. Using this framework, we iteratively created care packages that differed in their contents based on participant needs and were sent to study participants to deliver the study intervention—a medication management app—and assess its usability. Usability data were collected using the System Usability Scale (SUS) and a novel usability questionnaire developed to collect more in-depth data. Results: In the first 6 months of the project, we successfully delivered 21 care packages. We successfully designed and deployed a minimum viable product in less than 6 weeks, generally maintained a 2-week sprint cycle, and achieved a 40% to 50% return rate for both usability assessment instruments. We hypothesize that lack of engagement due to the pandemic and our use of asynchronous communication channels contributed to the return rate of usability assessments being lower than desired. We also provide general recommendations for performing remote usability testing with diverse populations based on the results of our work, including implementing screen sharing capabilities when possible, and determining participant preference for phone or email communications. Conclusions: The FAR Ops model allowed our team to adopt remote operations for our mHealth trial in response to interruptions from the COVID-19 pandemic. This approach can be useful for other research or practice-based projects under similar circumstances or to improve efficiency, cost, effectiveness, and participant diversity in general. In addition to offering a replicable approach, this paper tells the often-untold story of practical challenges faced by mHealth projects and practical strategies used to address them.
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    Reducing Anticholinergic Medication Exposure among Older Adults using Consumer Technology: Protocol for a Randomized Clinical Trial
    (Elsevier, 2021) Abebe, Ephrem; Campbell, Noll L.; Clark, Daniel O.; Tu, Wanzhu; Hill, Jordan R.; Harrington, Addison B.; O’Neal, Gracen; Trowbridge, Kimberly S.; Vallejo, Christian; Yang, Ziyi; Bo, Na; Knight, Alexxus; Alamer, Khalid A.; Carter, Allie; Valenzuela, Robin; Adeoye, Philip; Boustani, Malaz A.; Holden, Richard J.; Medicine, School of Medicine
    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.