A Multifaceted Implementation Strategy to Increase Out-of-Office Blood Pressure Monitoring: The EMBRACE Cluster Randomized Clinical Trial.

Importance: Few primary care patients complete guideline-recommended out-of-office blood pressure (BP) monitoring prior to having hypertension diagnosed. Objective: To evaluate the effectiveness of a behavioral theory-informed, multifaceted implementation strategy on out-of-office BP monitoring (ambulatory BP monitoring [ABPM] or home BP monitoring [HBPM]) among patients with new hypertension. Design, Setting, and Participants: This 2-group, pre-post cluster randomized trial was conducted within a primary care network of 8 practices (4 intervention practices with 99 clinicians; 4 control practices with 55 clinicians) and 1186 patients (857 intervention; 329 control) with at least 1 visit with elevated office BP and no prior hypertension diagnosis between October 2016 and September 2017 (preimplementation period) or between April 2018 and March 2019 (postimplementation period). Data were analyzed from February to July 2023. Interventions: Usual care (control group) or a multifaceted implementation strategy consisting of an accessible ABPM service; electronic health record (EHR) tools to facilitate test ordering; clinician education, reminders, and feedback relevant to out-of-office BP monitoring; nurse training on HBPM; and patient information handouts. Main Outcomes and Measures: The primary outcome was patient completion of out-of-office BP monitoring within 6 months of an eligible visit. Secondary outcomes included clinician ordering of out-of-office BP monitoring. Blinded assessors extracted outcomes from the EHR. Results: A total of 1186 patients (857 intervention; 329 control) were included, with a mean (SD) age of 54 (16) years; 808 (68%) were female, and 549 (48%) were Spanish speaking; among those with race and ethnicity documented, 123 (10%) were Black or African American, and 368 (31%) were Hispanic. Among intervention practices, the percentage of visits resulting in completed out-of-office BP monitoring increased from 0.6% (0% ABPM; 0.6% HBPM) to 5.7% (3.7% ABPM; 2.0% HBPM) between the preimplementation and postimplementation periods (P = .009). Among control practices, the percentage of visits resulting in completed out-of-office BP monitoring changed from 5.4% (0% ABPM; 5.4% HBPM) to 4.3% (0% ABPM; 4.3% HBPM) during the corresponding period (P = .94). The ratio of relative risks (RRs) of out-of-office BP monitoring in the postimplementation vs preimplementation periods for intervention vs control practices was 10.5 (95% CI, 1.9-58.0; P = .01). The ratio of RRs of out-of-office BP monitoring being ordered was 2.2 (95% CI, 0.8-6.3; P = .12). Conclusions and Relevance: This study found that a theory-informed implementation strategy that included access to ABPM modestly increased out-of-office BP monitoring among patients with elevated office BP but no hypertension diagnosis. Trial Registration: ClinicalTrials.gov Identifier: NCT03480217.