Telehealth After Stroke Care Pilot Randomized Trial of Home Blood Pressure Telemonitoring in an Underserved Setting.

BACKGROUND: Hypertension is the most important modifiable stroke risk factor, but blood pressure (BP) remains poorly controlled after stroke, especially among Black and Hispanic patients. We tested the feasibility of TASC (Telehealth After Stroke Care), a post-acute stroke care model integrating nurse-supported home BP telemonitoring, tailored infographics, and multidisciplinary team video visits. METHODS: Acute stroke patients with hypertension were randomized at discharge to usual care or usual care with TASC. Usual care patients received video visits with primary care and stroke. TASC included a tablet and monitor to wirelessly transmit BP data to the electronic health record, with telenursing support, tailored infographics to explain BP readings, and pharmacist visits. Outcomes assessment was blinded. Feasibility outcomes included recruitment, randomization, adherence, and retention. Systolic BP from baseline to 3 months after discharge was evaluated using generalized linear modeling. RESULTS: Fifty patients (64±14 years; 36% women' 44% Hispanic, 32% Black, 54% ≤high school education, 30% private insurance), and 75% of all eligible were enrolled over 6.3 months. Baseline systolic BP was similar in both (TASC n=25, 140±19 mm Hg; usual care n=25, 142±19 mm Hg). At 3 months, adherence to video visits (91% versus 75%, P=0.14) and retention (84% versus 64%, P=0.11) were higher with TASC. Home systolic BP declined by 16±19 mm Hg from baseline in TASC and increased by 3±24 mm Hg in usual care (P=0.01). Among Black patients, systolic BP control (<130 mm Hg) improved from 40% to 100% with TASC versus 14% to 29%, and among Hispanic patients, from 23% to 62% with TASC, versus 33% to 17% in usual care. CONCLUSIONS: Enhancing post-acute stroke care with home BP telemonitoring is feasible to improve hypertension in an underserved setting and should be tested in a definitive randomized clinical trial. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04640519.

Leveraging electronic health record data for clinical trial planning by assessing eligibility criteria's impact on patient count and safety.

OBJECTIVE: To present an approach on using electronic health record (EHR) data that assesses how different eligibility criteria, either individually or in combination, can impact patient count and safety (exemplified by all-cause hospitalization risk) and further assist with criteria selection for prospective clinical trials. MATERIALS AND METHODS: Trials in three disease domains - relapsed/refractory (r/r) lymphoma/leukemia; hepatitis C virus (HCV); stages 3 and 4 chronic kidney disease (CKD) - were analyzed as case studies for this approach. For each disease domain, criteria were identified and all criteria combinations were used to create EHR cohorts. Per combination, two values were derived: (1) number of eligible patients meeting the selected criteria; (2) hospitalization risk, measured as the hazard ratio between those that qualified and those that did not. From these values, k-means clustering was applied to derive which criteria combinations maximized patient counts but minimized hospitalization risk. RESULTS: Criteria combinations that reduced hospitalization risk without substantial reductions on patient counts were as follows: for r/r lymphoma/leukemia (23 trials; 9 criteria; 623 patients), applying no infection and adequate absolute neutrophil count while forgoing no prior malignancy; for HCV (15; 7; 751), applying no human immunodeficiency virus and no hepatocellular carcinoma while forgoing no decompensated liver disease/cirrhosis; for CKD (10; 9; 23893), applying no congestive heart failure. CONCLUSIONS: Within each disease domain, the more drastic effects were generally driven by a few criteria. Similar criteria across different disease domains introduce different changes. Although results are contingent on the trial sample and the EHR data used, this approach demonstrates how EHR data can inform the impact on safety and available patients when exploring different criteria combinations for designing clinical trials.

Protocol for randomized personalized trial for stress management compared to standard of care.

Stress is a significant public health burden in the United States, with most Americans reporting unhealthy levels of stress. Stress management techniques include various evidence-based treatments shown to be effective but with heterogeneous treatment responses, indicating a lack of uniform benefits for all individuals. Designed to assess a participant's response to a specific intervention, personalized (N-of-1) trials provide guidance for which treatment (s) work (s) best for the individual. Prior studies examining the effects of mindfulness meditation, yoga, and walking for stress reduction found all three interventions to be associated with significant reductions in self-reported measures of stress. Delivering these treatments using a personalized trial approach has the potential to assist clinicians in identifying the best stress management techniques for individuals with persistently high stress while fostering treatment decisions that consider their personal condition/barriers. This trial will evaluate a personalized approach compared to standard of care for three interventions (guided mindfulness meditation; guided yoga; and guided brisk walking) to manage perceived stress. Participants will respond to daily surveys and wear a Fitbit device for 18 weeks. After a 2-week baseline period, participants in the personalized trial groups will receive 12 weeks of interventions in randomized order, while participants in the standard-of-care group will have access to all interventions for self-directed stress management. After intervention, all participants will undergo 2 weeks of observation, followed by two additional weeks of the stress management intervention of their choosing while continuing outcome measurement. At study completion, all participants will be sent a satisfaction survey. The primary analysis will compare perceived stress levels between the personalized and standard of care arms. The results of this trial will provide further support for the use of personalized designs for managing stress. Clinical Trial Registration: clinicaltrials.gov, NCT05408832. Protocol version: 9/14/2022, 21-0968-MRB.