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NCT Number: NCT07431931

Optimizing Referral Pathways for Patients With Hematuria and Moderate-Severe Proteinuria

The purpose of the study is to evaluate prospectively the impact of an electronic health record (EHR) alert on primary care providers' (PCP) referral to Nephrology of Geisinger patients with high risk signs (blood and protein in the urine) of glomerulonephritis. This will help quantify the relative effectiveness of EHR alerts on PCPs' referral patterns.

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Key information

About this study

Adult patients receiving care from a Geisinger PCP within 2 years from the start of the study who underwent urinalysis and had high-risk glomerulonephritis features (positive test results for hematuria and proteinuria) will participate in the study. Patients will be randomized 1:1 at the patient level, to intervention arm or usual care arm. The Geisinger primary care provider caring for the participating patient will then, based on the patient's randomization status, receive or not receive one-time EHR alert that will fire during patient clinic visit prompting referral to Nephrology. Index date is the date of the PCP visit during which the EHR alert will fire. The analysis plan will evaluate the potential impact of EHR alert. The primary outcome will be proportion of adult patients with high-risk features for glomerulonephritis with a nephrology referral order within 1 month of the PCP visit.

Exploratory outcomes will include:

  • Comparing patient demographics (i.e. age, sex, insurance status, race), clinical (i.e. BMI, blood pressure, creatinine, eGFR, protein/urine ratio, comorbidities) and PCP practice characteristics (i.e. rural vs. urban, patient volume, nephrology on site vs off site, PCP years of practice, PCP age group, PCP sex, physician vs. advanced practice practitioner).
  • Proportion referred to nephrology within 3 and 6 months of index PCP visit.
  • Proportion with completed nephrology appointment within 3 and 6 months of index PCP visit
  • Median time to nephrology referral
  • Proportion of patients with dipstick hematuria and concomitant proteinuria (2+ or 3+) who underwent quantitative albumin or protein testing (albumin/creatinine ratio or protein/creatinine ratio or 24-hour urine albumin or protein) within 6 months of index PCP visit
  • Proportion of patients who had completed a repeat urinalysis and microscopy lab test within 6 months of index PCP visit between the intervention and usual care group
  • Median time from referral to nephrology visit
  • Assess implementation outcomes of the electronic alert intervention: Acceptability; Adoption; Appropriateness; Implementation Costs; Feasibility; Fidelity; Penetration; Sustainability

Analyses will employ Generalized Linear Mixed Model to evaluate the intervention effect on the primary outcome, after adjusting for patient-level and provider-level characteristics as fixed-effects and allowing for dependencies of patient-level observations within providers by incorporating these as hierarchical random-effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged ≥18 years
  • Patients receiving care from any Geisinger primary care provider (record of an encounter with a Geisinger PCP within the last 2 years from date of survey implementation)
  • Patients with high-risk glomerulonephritis features i.e. positive test results for hematuria (urine dipstick result with blood 1+ or greater) and proteinuria (2+ or 3+ protein on dipstick or ACR≥300 mg/g or PCR ≥500 mg/g) collected within 12 months of index date.

Exclusion criteria

  • Patients with a nephrologist appointment in the last 12 months before the index date
  • Patients with a prior appointment with a nephrologist within the last 2 years before the positive urinalysis test for hematuria (1+ or greater)
  • Patients with a history of glomerulonephritis and/or kidney failure (dialysis or eGFR < 15 mL/min/1.73m2, or kidney transplantation) at any time during the baseline
  • Patients receiving palliative care at any time during the baseline

Treatment and study plan

Electronic Health Record alert

Other

The EHR alert will open upon logging into patient's chart. It will display relevant information about hematuria (dipstick blood), urine microscopy (if available), proteinuria (ACR, PCR, dipstick protein), most recent (if ever) nephrology visit, and most recent (if ever) urology visit. The EHR alert will provide a preselected order button for a nephrology referral with the indication pre-filled out. It will also provide options to order confirmatory urinalysis with microscopy testing and an option to refer to urology. The provider will have an option to deselect the nephrology referral, which will prompt reasons for not ordering the referral: "Not appropriate"; "already seeing a nephrologist"; "palliative care"; "patient refuses"; "Other (document)". The alert will not be a hard-stop in the chart.

Primary outcomes

  1. Referral to Nephrology

    Time frame: Within One month of index PCP visit

    Proportion of adult patients with high-risk features for glomerulonephritis with a nephrology referral order

Other outcomes

  1. 3-6 month Nephrology referral

    Time frame: Within 3 and 6 months of index PCP visit

    Proportion of patients with nephrology referral order within 3 and 6 months of index PCP visit

  2. Nephrology referral completion

    Time frame: Within 3 and 6 months of index PCP visit

    Proportion of patients with completed nephrology appointment within 3 and 6 months of index PCP visit

  3. Time to referral to nephrology

    Time frame: Within 12 months of index PCP visit

    Compare the median time to referral between the intervention and usual care group

  4. Quantitative albuminuria or proteinuria testing

    Time frame: Within 6 months of index PCP visit

    Compare the proportion of patients with dipstick hematuria and concomitant proteinuria (2+ or 3+) who underwent quantitative albuminuria or proteinuria testing (albumin/creatinine ratio or protein/creatinine ratio or 24-hour urine albumin or protein) within 6 months of index PCP visit

  5. Repeat urinalysis

    Time frame: Within 6 months of index PCP visit

    Proportion of patients who completed repeat urinalysis and microscopy lab test within 6 months of index PCP visit

  6. Time from PCP referral to scheduled nephrology visit

    Time frame: Within 12 months of index PCP visit

    Compare time from PCP referral to the date of nephrology appointment during follow up period

  7. Proportion that undergo kidney biopsy and median time to kidney biopsy

    Time frame: Within 12 months of index PCP visit

    Compare the proportion of patients referred to nephrologists who undergo a kidney biopsy and time to kidney biopsy between the intervention and usual care group within 12 months of index PCP visit

  8. Proportion diagnosed with glomerulonephritis

    Time frame: Within 12 months of index PCP visit

    Proportion of patients who were diagnosed with a glomerulonephritis during follow up period

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Chang, MD

CONTACT

[email protected]

570-214-3156

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Collaborators

  • Novartis

Registry information

Official study title

Optimizing Referral Pathways for Patients With Hematuria and Moderate-Severe Proteinuria - Phase 2: A Quality Improvement Project

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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