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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Proteinuria; Glomerulonephritis; Referral and Consultation; Hematuria; Kidney Disease
• Intervention / Treatment: Other: Electronic Health Record alert

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Chang, MD; Phone Number: 570-214-3156; Email: achang@geisinger.edu

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Patients receiving usual care; Patient will receive usual care
Experimental: Patients randomized to have PCP receive EHR Alert	Other: Electronic Health Record alert; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Referral to Nephrology	Proportion of adult patients with high-risk features for glomerulonephritis with a nephrology referral order	Within One month of index PCP visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-6 month Nephrology referral	Proportion of patients with nephrology referral order within 3 and 6 months of index PCP visit	Within 3 and 6 months of index PCP visit
Nephrology referral completion	Proportion of patients with completed nephrology appointment within 3 and 6 months of index PCP visit	Within 3 and 6 months of index PCP visit
Time to referral to nephrology	Compare the median time to referral between the intervention and usual care group	Within 12 months of index PCP visit
Quantitative albuminuria or proteinuria testing	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	Within 6 months of index PCP visit
Repeat urinalysis	Proportion of patients who completed repeat urinalysis and microscopy lab test within 6 months of index PCP visit	Within 6 months of index PCP visit
Time from PCP referral to scheduled nephrology visit	Compare time from PCP referral to the date of nephrology appointment during follow up period	Within 12 months of index PCP visit
Proportion that undergo kidney biopsy and median time to kidney biopsy	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	Within 12 months of index PCP visit
Proportion diagnosed with glomerulonephritis	Proportion of patients who were diagnosed with a glomerulonephritis during follow up period	Within 12 months of index PCP visit

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Collaborators: Novartis

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Hematuria; Proteinuria; Albuminuria; Glomerulonephritis; Clinical Decision Support; EHR Alert; Referral; Nephrology
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urological Manifestations; Hemorrhage; Nephritis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Glomerulonephritis; Kidney Diseases; Proteinuria; Albuminuria; Hematuria
• Other Study ID Numbers: HEORUSV201555

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will consider sharing data upon reasonable request, pending data use agreements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No