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Improving Proteinuria Screening with Mailed Smartphone Urinalysis Testing in Previously Unscreened Patients with Hypertension: a Randomized Controlled Trial

Julia Leddy, Jamie A. Green, Christina Yule, Juliann Molecavage, Josef Coresh, Alex R Chang
doi: https://doi.org/10.1101/536995
Julia Leddy
1Geisinger Health System, Department of Nephrology
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Jamie A. Green
1Geisinger Health System, Department of Nephrology
2Geisinger Health System, Kidney Health Research Institute
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Christina Yule
2Geisinger Health System, Kidney Health Research Institute
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Juliann Molecavage
3Geisinger Health System, Ambulatory Medicine Institute
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Josef Coresh
4Johns Hopkins University, Welch Center for Prevention, Epidemiology and Clinical Research
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Alex R Chang
1Geisinger Health System, Department of Nephrology
2Geisinger Health System, Kidney Health Research Institute
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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 are needed to determine whether improving early detection of kidney disease can improve future kidney health.

Trial Registration Clinical Trial Registry: NCT03470701

https://clinicaltrials.gov/ct2/show/NCT03470701

Footnotes

  • Email Addresses: Julia Leddy jlleddy{at}geisinger.edu, Jamie A. Green jgreen1{at}geisinger.edu, Christina Yule cmyule{at}geisinger.edu, Juliann Molecavage jamolecavage{at}geisinger.edu, Josef Coresh coresh{at}jhu.edu, Alex R Chang chaalex{at}gmail.com

  • List of abbreviations

    ACR
    Albumin/creatinine ratio
    CKD
    chronic kidney disease
    NKF
    National Kidney Foundation
    eGFR
    estimated glomerular filtration rate
    PI
    principal investigator
    MTM
    medication therapy management
    OR
    odds ratio
    CI
    confidence interval
    FDA
    Federal Drug Administration
  • Copyright 
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    Posted February 08, 2019.
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    Improving Proteinuria Screening with Mailed Smartphone Urinalysis Testing in Previously Unscreened Patients with Hypertension: a Randomized Controlled Trial
    Julia Leddy, Jamie A. Green, Christina Yule, Juliann Molecavage, Josef Coresh, Alex R Chang
    bioRxiv 536995; doi: https://doi.org/10.1101/536995
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    Improving Proteinuria Screening with Mailed Smartphone Urinalysis Testing in Previously Unscreened Patients with Hypertension: a Randomized Controlled Trial
    Julia Leddy, Jamie A. Green, Christina Yule, Juliann Molecavage, Josef Coresh, Alex R Chang
    bioRxiv 536995; doi: https://doi.org/10.1101/536995

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