A Multicomponent Intervention to Improve Blood Pressure Management in Chronic Kidney Disease: A Protocol for a Pragmatic Clinical Trial

Abstract BackgroundChronic kidney disease is common, leads to end stage renal disease, and is a major risk factor for cardiovascular disease. Although both chronic kidney disease and hypertension, the main risk factor for disease progression, are not difficult to diagnose, both often go unrecognized by primary care providers. It has yet to be determined whether a multicomponent intervention that leverages electronic health records and behavioral economic principles can improve diagnosis, treatment, and control of hypertension in chronic kidney disease. MethodsThe aim of this pragmatic, cluster-randomized controlled trial is to evaluate a clinical decision support system based in behavioral economic and user-centered design principles that will: 1) synthesize existing laboratory tests, medication orders, and vital sign data; 2) increase recognition of chronic kidney disease, 3) increase recognition of uncontrolled hypertension in chronic kidney disease patients, and 4) deliver evidence-based chronic kidney disease and hypertension management recommendations. The intervention has been designed and piloted. The primary endpoint is the change in mean systolic blood pressure between baseline and 6 months compared across arms. We will use an effectiveness-implementation hybrid trial type 2 design and the RE-AIM framework to guide evaluation of process and outcome measures. Patients with two prior eGFR 16-59 mL/min/1.73m2 separated by 90 days or two prior UACR >30mg/g, one SBP >140 mmHg within the 2 years preceding the enrollment visit, and SBP >140 mmHg at enrollment will be included; patients with a most recent eGFR ≤ 20 or 2 previous eGFRs within 2 years separated by at least 90 days ≤ 15 will be excluded. Rao-Scott chi-square tests and GEE z-tests will be used. We calculated that 497 evaluable patients per arm and an average of 6 patients per provider would provide over 80% power to detect an average 3 mmHg SBP decrease in the intervention arm. Discussionhe proposed study, if successful, would be the first to improve hypertension in chronic kidney disease patients through a multicomponent intervention that incorporates clinical decision support and behavioral methods. Trial RegistrationClinicalTrials.gov identifier: NCT03679247. Registered September 20, 2018, https://clinicaltrials.gov/ct2/show/NCT03679247?term=Samal&draw=2&rank=1.