Study protocol: Collaboration Oriented Approach to Controlling High blood pressure (COACH) in adults – a randomised controlled trial

Abstract

IntroductionHypertension, the clinical condition of persistent high blood pressure (BP), is preventable yet remains a significant contributor to poor cardiovascular outcomes. Digital self-management support tools can increase patient self-care behaviours to improve BP. We created a patient-facing and provider-facing clinical decision support (CDS) application, called the Collaboration Oriented Approach to Controlling High BP (COACH), to integrate home BP data, guideline recommendations and patient-centred goals with primary care workflows. We leverage social cognitive theory principles to support enhanced engagement, shared decision-making and self-management support. This study aims to measure the effectiveness of the COACH intervention and evaluate its adoption as part of BP management.Methods and analysisThe study design is a multisite, two-arm hybrid type III implementation randomised controlled trial set within primary care practices across three health systems. Randomised participants are adults with high BP for whom home BP monitoring is indicated. The intervention arm will receive COACH, a digital web-based intervention with effectively enhanced alerts and displays intended to drive engagement with BP lowering; the control arm will receive COACH without the alerts and a simple display. Outcome measures include BP lowering (primary) and self-efficacy (secondary). Implementation preplanning and postevaluation use the Consolidated Framework for Implementation Research and Reach-Effectiveness-Adoption-Implementation-Maintenance metrics with iterative cycles for qualitative integration into the trial and its quantitative evaluation. The trial analysis includes logistic regression and constrained longitudinal data analysis.Ethics and disseminationThe trial is approved under a single IRB through the University of Missouri-Columbia, #2091483. Dissemination of the intervention specifications and results will be through open-source mechanisms.Trial registration numberNCT06124716.