Multicomponent intervention to improve blood pressure management in chronic kidney disease: a protocol for a pragmatic clinical trial

Abstract

Introduction: The purpose of this study is to incorporate behavioural economic principles and user-centred design principles into a multicomponent intervention for the management of uncontrolled hypertension (HTN) in chronic kidney disease (CKD) in primary care.

Methods and analysis: This is a multicentre, pragmatic, controlled trial cluster-randomised at the clinician level at The Brigham and Women's Practice -Based Research Network of 15 practices. Of 220 total clinicians, 184 were eligible to be enrolled, and the remainder were excluded (residents and clinicians who see urgent care or walk-in patients); no clinicians opted out. The intervention consists of a clinical decision support system based in behavioural economic and user-centred design principles that will: (1) synthesise existing laboratory tests, medication orders and vital sign data; (2) increase recognition of CKD, (3) increase recognition of uncontrolled HTN in CKD patients and (4) deliver evidence-based CKD and HTN management recommendations. The primary endpoint is the change in mean systolic blood pressure between baseline and 6 months compared across arms. We will use the Reach Effectiveness Adoption Implementation Maintenance framework. At the conclusion of this study, we will have: (1) validated an intervention that combines laboratory tests, medication records and clinical information collected by electronic health records to recognise uncontrolled HTN in CKD patients and recommend a course of care, (2) tested the effectiveness of said intervention and (3) collected information about the implementation of the intervention that will aid in dissemination of the intervention to other practice settings.

Ethics and dissemination: The Human Subjects Institutional Review Board at Brigham and Women's Hospital provided an expedited review and approval for this study protocol, and a Data Safety Monitoring Board will ensure the ongoing safety of the trial.

Trial registration number: NCT03679247.

Keywords: chronic renal failure; clinical trials; hypertension; primary care.

Figure 1

Schedule of enrolment, interventions and assessments. *Y, year; Q, quarter.

Figure 2

Example CDS with explanation, clinical information, recommended actions and accountable justification (‘acknowledge reason’). CDS, clinical decision support.

Figure 3

Participant timeline.