Pragmatic randomized, controlled trial of patient navigators and enhanced personal health records in CKD

Abstract

Background and objectives Patient navigators and enhanced personal health records improve the quality of health care delivered in other disease states. We aimed to develop a navigator program for patients with CKD and an electronic health record–based enhanced personal health record to disseminate CKD stage–specific goals of care and education. We also conducted a pragmatic randomized clinical trial to compare the effect of a navigator programfor patientswith CKDwith enhanced personal health record and compare their combination compared with usual care among patients with CKD stage 3b/4. Design, setting, participants, &measurements Two hundred and nine patients fromsix outpatient clinics (in both primary care and nephrology settings) were randomized in a 2×2 factorial design into four-study groups: (1) enhanced personal health record only, (2) patient navigator only, (3) both, and (4) usual care (control) group. Primary outcome measure was the change in eGFR over a 2-year follow-up period. Secondary outcome measures included acquisition of appropriate CKD-related laboratory measures, specialty referrals, and hospitalization rates. ResultsMedian age of the study populationwas 68 years old, and 75%werewhite.At study entry, 54%of patients were followedbynephrologists, and88%wereonrenin-angiotensinsystemblockers.After a 2-year follow-up, rate of decline in eGFR was similar across the four groups (P=0.19). Measurements of CKD-related laboratory parameters were not significantly different among the groups. Furthermore, referral for dialysis education and vascular access placement, emergency room visits, and hospitalization rates were not statistically significant different between the groups. Conclusions We successfully developed a patient navigator program and an enhanced personal health record for the CKD population. However, there were no differences in eGFR decline and other outcomes among the study groups. Larger and long-term studies along with cost-effectiveness analyses are needed to evaluate the role of patient navigators and patient education through an enhanced personal health record in those with CKD.