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. 2024 Jul 8;14(7):e085898.
doi: 10.1136/bmjopen-2024-085898.

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

David Andrew Dorr  1 , Emma Montgomery  2 , Aisha J Ghumman  3 , LeAnn Michaels  4 , Abigail Rolbiecki  2   5 , Shannon Canfield  2 , Victoria Shaffer  6 , Blake Johnson  4 , Melinda Lockwood  2 , Parijat Ghosh  2 , William Martinez  7 , Richelle Koopman  6 ; COACH Consortium
Collaborators, Affiliations

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

David Andrew Dorr et al. BMJ Open. .

Abstract

Introduction: Hypertension, 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 analysis: The 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 dissemination: The 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 number: NCT06124716.

Keywords: Clinical Trial; Health informatics; Hypertension; Implementation Science; Primary Care; QUALITATIVE RESEARCH.

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Conflict of interest statement

Competing interests: No, there are no competing interests for any author.

Figures

Figure 1
Figure 1
PRagmatic Explanatory Continuum Indicator Summary Tool-2 (PRECIS) diagram.
Figure 2
Figure 2
(A) COACH home page for enhanced arm. (B) COACH home page for control arm. COACH, Collaboration Oriented Approach to Controlling High.
Figure 3
Figure 3
High BP warning (similar for low BP) for both groups. BP, blood pressure.
See this image and copyright information in PMC

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