Contemporary clinical trials · 2025
Addressing sleep apnea post-stroke and transient ischemic attack (ASAP) clinical trial design features: Inclusion of usual care control sites and electronic health record data validation.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Bravata Dawn M, Myers Laura J, Perkins Anthony J, Sexson Ali E, Daggy Joanne K, Taylor Stanley E, Burrone Laura, Koo Brian B, Miech Edward J, Rattray Nicholas A, Story K Maya, Waddell Kimberly, Ding Qinglan, Sico Jason J
Аннотация
BACKGROUND: Addressing Sleep Apnea Post-Stroke and TIA (ASAP) evaluated a quality improvement (QI) intervention to increase sleep apnea testing among patients with ischemic stroke or transient ischemic attack (TIA). We describe ASAP methods highlighting two features: inclusion of usual care control sites and validation of electronic health record (EHR) data.
METHODS: ASAP was a stepped-wedge cluster-randomized clinical trial at N = 6 intervention sites augmented with N = 30 control sites to evaluate the effectiveness, implementation, sustainability, and business case of a quality improvement intervention to increase sleep apnea testing among stroke/TIA patients. The study period included the COVID-19 pandemic and an international device recall. EHR data were compared with chart review for cerebrovascular diagnosis, sleep study eligibility, sleep study receipt, and patient characteristics. EHR data accuracy (ACC) was assessed as: (true positives + true negatives)/(true positives + false positives + true negatives + false negatives).
RESULTS: During the baseline period (May 2019-February 2021), the average 30-day diagnostic rate was 2.0 % (implementation sites) and 1.3 % (control sites). Among N = 1658 implementation site patients, the index event was stroke in 78.7 %. EHR data accuracy was high for cerebrovascular diagnoses (ACC 0.918-0.953), sleep study receipt (ACC 0.949), and patient characteristics (0.898-0.996). EHR data accuracy was lower for sleep study eligibility (ACC 0.850).
CONCLUSIONS: The addition of control sites to stepped-wedge trials allows for intervention evaluation within the context of potential temporal trends influencing outcomes. EHR data can be used to evaluate sleep apnea diagnostic testing after ischemic stroke or TIA. Trial registration ClinicalTrials.govNCT04322162 Date of trial registration: 04/02/2020.
METHODS: ASAP was a stepped-wedge cluster-randomized clinical trial at N = 6 intervention sites augmented with N = 30 control sites to evaluate the effectiveness, implementation, sustainability, and business case of a quality improvement intervention to increase sleep apnea testing among stroke/TIA patients. The study period included the COVID-19 pandemic and an international device recall. EHR data were compared with chart review for cerebrovascular diagnosis, sleep study eligibility, sleep study receipt, and patient characteristics. EHR data accuracy (ACC) was assessed as: (true positives + true negatives)/(true positives + false positives + true negatives + false negatives).
RESULTS: During the baseline period (May 2019-February 2021), the average 30-day diagnostic rate was 2.0 % (implementation sites) and 1.3 % (control sites). Among N = 1658 implementation site patients, the index event was stroke in 78.7 %. EHR data accuracy was high for cerebrovascular diagnoses (ACC 0.918-0.953), sleep study receipt (ACC 0.949), and patient characteristics (0.898-0.996). EHR data accuracy was lower for sleep study eligibility (ACC 0.850).
CONCLUSIONS: The addition of control sites to stepped-wedge trials allows for intervention evaluation within the context of potential temporal trends influencing outcomes. EHR data can be used to evaluate sleep apnea diagnostic testing after ischemic stroke or TIA. Trial registration ClinicalTrials.govNCT04322162 Date of trial registration: 04/02/2020.