Abstract
BACKGROUND: Proteinuria screening is recommended for patients with hypertension to screen for kidney disease and identify those at elevated risk for cardiovascular disease. However, screening rates among hypertensive patients are low. Home testing strategies may be useful in improving proteinuria screening adherence. METHODS: We conducted an individual-level, randomized trial at 55 primary care clinic sites in the Geisinger Health System to evaluate the effectiveness of a strategy using home smartphone urinalysis test (Dip.io) to complete proteinuria screening in previously unscreened non-diabetic patient portal users with hypertension. All patients received an educational letter and a standing urinalysis lab order, and then were randomized to control (usual care) or intervention. Intervention arm participants were invited to complete proteinuria screening with a mailed home smartphone urinalysis test. Co-primary outcomes were completion of proteinuria screening and number of albuminuria cases (albumin/creatinine ratio [ACR] ≥ 30 mg/g or protein/creatinine ratio ≥ 150 mg/g) at the end of 3 months. We also evaluated patient satisfaction with the home test, and compliance with recommendations for patients with newly detected albuminuria. RESULTS: A total of 999 patients were randomized to intervention or control. Out of 499 patients assigned to the intervention arm, 253 were reached by phone, and 69/97 (71.1%) consented patients completed the home test. Overall, the intervention increased proteinuria screening completion (28.9% vs. 18.0%; p < 0.001) with no effect on the number of albuminuria cases (4 vs. 4) although only 6/57 (10.5%) patients with trace or 1+ urine dipstick protein had a follow-up quantitative test. Among the 55 patients who completed a survey after the home test, 89% preferred testing at home rather than the physician's office. CONCLUSIONS: A strategy using a home urinalysis smartphone test increased proteinuria screening rates in previously unscreened patients with hypertension and may be useful in increasing rates of proteinuria screening compliance. Future studies should evaluate use of home testing kits to screen for and confirm albuminuria, and determine whether improving early detection of kidney disease can improve future kidney health. TRIAL REGISTRATION: Clinical Trial Registry: NCT03470701 (First posted 3/20/2018) https://clinicaltrials.gov/ct2/show/NCT03470701 . This study was retrospectively registered.