Implementation of a pragmatic randomized trial of screening for chronic kidney disease to improve care among non-diabetic hypertensive veterans

Carmen A Peralta, Martin Frigaard, Anna D Rubinsky, Leticia Rolon, Lowell Lo, Santhi Voora, Karen Seal, Delphine Tuot, Shirley Chao, Kimberly Lui, Phillip Chiao, Neil Powe, Michael Shlipak, Carmen A Peralta, Martin Frigaard, Anna D Rubinsky, Leticia Rolon, Lowell Lo, Santhi Voora, Karen Seal, Delphine Tuot, Shirley Chao, Kimberly Lui, Phillip Chiao, Neil Powe, Michael Shlipak

Abstract

Background: Whether screening for chronic kidney disease (CKD) can improve the care of persons at high risk for complications remains uncertain. We describe the design and early implementation experience of a pilot, cluster-randomized pragmatic trial to evaluate the feasibility, implementation, and effectiveness of a "triple marker" CKD screening program (creatinine, cystatin C and albumin to creatinine ratio) for improving care among hypertensive veterans seen in primary care at one Veterans Administration Hospital.

Methods/design: Non-diabetic hypertensive veterans age 18-80 without known CKD were randomized in clusters determined by primary care provider (unit of randomization) into three arms. Usual care will be compared with two incrementally intensified treatment strategies: (1) screen for CKD followed by patient and provider education or (2) screen-educate plus a clinical pharmacist-led CKD and BP management program. The primary clinical outcome is systolic blood pressure (BP) change from baseline. Secondary clinical outcome is BP control. The primary process outcomes is triple marker screening (across three arms), and secondary process outcomes include use of inhibitors of the renin-angiotensin system (ACE/ARB) overall and in persons with albuminuria, CKD recognition by PCP, use of non-steroidal anti-inflammatory drugs (NSAIDs) and NSAID education by PCP. The design uses the Veterans Health Administration electronic health record (EHR) to identify participants, deliver the interventions and ascertain study outcomes. Assessment of the program implementation will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Study duration is 12 months.

Results: A total of 1,819 patients have been randomized within 41 provider clusters. The median age (interquartile range) is 68 years (61-72), and 99% of participants are male. Approximately 16% are Black, and 5% Hispanic. In the first 6 months of the trial, 434 triple marker screening tests have been ordered, and 217(50%) have been tested. A total of 48 new CKD cases have been identified among those tested, for a preliminary yield of 22%.

Conclusion: We have successfully implemented a pragmatic protocol that uses the EHR to identify and characterize eligible participants, deliver the intervention, and ascertain study outcomes with high rates of participation by providers and patients. Results from this study can guide design of pragmatic trials in the field of CKD.

Trial registration: NCT01978951 ; Date or Registration: 1/17/2014.

Trial registration: ClinicalTrials.gov NCT01978951 NCT02059408.

Keywords: Blood pressure; Chronic kidney disease; Hypertension; Screening.

Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
Consort diagram for patient inclusion

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