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A Hospital-Wide Open-Label Cluster Crossover Pragmatic Comparative Effectiveness Randomized Trial Comparing Normal Saline to Ringer’s Lactate: Protocol and Statistical Analysis Plan of The FLUID Trial

The design of the FLUID trial is novel because it involves a pragmatic cluster randomized crossover design, a waiver of patient informed consent to include all hospitalized patients, hospital-based randomization, and the use of routinely collected electronic health administrative data for the description of baseline characteristics and all study outcomes.

Julia F Shaw, Yongdong Ouyang, Dean A Fergusson, Tracy McArdle, Claudio Martin, Deborah Cook, Ian D Graham, Steven Hawken, Colin J L McCartney, Kusum Menon, Raphael Saginur, Andrew Seely, Ian Stiell, Alison Fox-Robichaud, Shane English, John Marshall, Kednapa Thavorn, Monica Taljaard, Lauralyn A McIntyre, Canadian Critical Care Trials Group

JMIR Res Protoc 2023;12:e51783

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Behavioral Skills Training for Teaching Safety Skills to Mental Health Clinicians: Protocol for a Pragmatic Randomized Control Trial

Because we are interested in comparing the effectiveness, rather than the efficacy, of the two training methods, we are using a pragmatic randomized controlled trial (RCT) design. The study setting is a large mental health hospital in Ontario, Canada, which delivers inpatient, outpatient, and emergency health care across a wide range of patient populations.

Elizabeth Lin, Mais Malhas, Emmanuel Bratsalis, Kendra Thomson, Rhonda Boateng, Fabienne Hargreaves, Heba Baig, Mary Benisha Benadict, Louis Busch

JMIR Res Protoc 2022;11(12):e39672

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Identifying Caregiver Availability Using Medical Notes With Rule-Based Natural Language Processing: Retrospective Cohort Study

Despite the emergence of NLP in health care [10-14], there is a paucity of work examining the pragmatic collection of caregiver information [9]. Approximately 6 million older adults in the United States live with dementia. This number is expected to double by 2050 [15]. Because of more cognitive and physical limitations, compared with other older adults, people with dementia often have complex care management needs, and their well-being depends on their caregivers [16-19].

Elham Mahmoudi, Wenbo Wu, Cyrus Najarian, James Aikens, Julie Bynum, V G Vinod Vydiswaran

JMIR Aging 2022;5(3):e40241

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A Database of Randomized Trials on the HIV Care Cascade (CASCADE Database): Descriptive Study

pragmatic

Lawrence Mbuagbaw, Diya Jhuti, Gohar Zakaryan, Hussein El-Kechen, Nadia Rehman, Mark Youssef, Michael Cristian Garcia, Vaibhav Arora, Babalwa Zani, Alvin Leenus, Michael Wu, Oluwatoni Makanjuola

JMIR Data 2022;3(1):e36874

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A Behavioral Economics–Electronic Health Record Module to Promote Appropriate Diabetes Management in Older Adults: Protocol for a Pragmatic Cluster Randomized Controlled Trial

Herein, we describe the design of a pragmatic, cluster randomized controlled trial to test the effectiveness of a toolbox of nudges embedded within the EHR and utilizing CDS tools to promote appropriate diabetes management in older adults (Clinical Trials.gov identifier: NCT04181307). Specifically, the behavioral economics–electronic health record (BE-EHR) intervention aims to reduce the overtreatment of older adults with diabetes per the CW guideline.

Hayley M Belli, Andrea B Troxel, Saul B Blecker, Judd Anderman, Christina Wong, Tiffany R Martinez, Devin M Mann