A Pragmatic Cluster Randomized Trial of an Electronic Clinical Decision Support System to Improve Chronic Kidney Disease Management in Primary Care: Design, Rationale, and Implementation Experience (Preprint)
Authors: Khoong Elaine C , Karliner Leah , Lo Lowell , Stebbins Marilyn , Robinson Andrew , Pathak Sarita , Santoyo-Olsson Jasmine , Scherzer Rebecca , Peralta Carmen A 
Published: March 2019

BACKGROUND

Chronic kidney disease (CKD) diagnosis is based on laboratory results easily extracted from electronic health records; therefore, CKD identification and management is an ideal area for targeted electronic decision support efforts. Early CKD management frequently occurs in primary care settings where primary care providers (PCPs) may not implement all the best practices to prevent CKD-related complications. Few prior studies have employed randomized trials to assess a CKD electronic clinical decision support system (eCDSS) that provided recommendations to PCPs tailored to each patient based on laboratory results.

OBJECTIVE

To report the trial design and implementation experience of a CKD eCDSS in primary care.

METHODS

This was a three-arm pragmatic, cluster-randomized trial at an academic general internal medicine practice. Eligible patients had two previous estimated-glomerular-filtration-rates by serum creatinine (eGFRCr) <60 mL/min/1.73m2 at least 90 days apart. Randomization occurred at the primary care provider (PCP) level. For patients of PCPs in one of the two intervention arms, the research team ordered triple-marker testing (serum creatinine, serum cystatin-c, urine albumin-creatinine-ratio) at the beginning of the study period, to be completed when acquiring labs for regular clinical care. The eCDSS launched for PCPs and patients in the intervention arms during a regular PCP visit subsequent to completing the triple-marker testing. The eCDSS delivered individualized guidance on cardiovascular risk-reduction, potassium and proteinuria management, and patient education. Patients in the eCDSS+ arm also received a pharmacist phone call to reinforce CKD-related education. The primary clinical outcome is blood pressure (BP) change from baseline at six-months after the end of the trial, and the primary secondary outcome is provider awareness of CKD diagnosis. We also collected process, patient-centered, and implementation outcomes.

RESULTS

A multidisciplinary team (primary care internist, nephrologists, pharmacist, informaticist) designed the eCDSS to integrate into current clinical workflow. All 81 PCPs contacted agreed to participate and were randomized. Of 995 patients initially eligible by eGFRCr, 413 were excluded per protocol and 58 opted out or withdrew, resulting in 524 patient participants (188 Usual Care; 165 eCDSS; 171 eCDSS+). During the 12-month intervention period, 178/336 (53%) of intervention patient participants completed triple-marker labs. Among these, 138 (78%) had a PCP appointment after labs resulted; the eCDSS was opened for 102/138 (74%), with orders/education signed for 83/102 (81%).

CONCLUSIONS

Successful integration of an eCDSS into primary care workflows and high eCDSS utilization rates at eligible visits suggest this tailored electronic approach is feasible and has the potential to improve guideline-concordant CKD care.

CLINICALTRIAL

ClinicalTrials.gov NCT02925962