ClinicalTrials.gg
Not yet recruitingNCT07431931Updated May 12, 2026

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

An interventional study of Electronic Health Record alert in Referral and Consultation, Glomerulonephritis and Hematuria, sponsored by Geisinger Clinic. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Geisinger Clinic · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Referral and Consultation
  • Glomerulonephritis
  • Hematuria
  • Proteinuria
  • Kidney Disease

Keywords

  • Hematuria; Proteinuria; Albuminuria; Glomerulonephritis; Clinical Decision Support; EHR Alert; Referral; Nephrology
03

In context

Glomerulonephritis

115 studies on the registry are indexed under Glomerulonephritis; 32 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 50 across 87 interventional studies indexed under Glomerulonephritis.

Browse Glomerulonephritis studies →

Lead sponsor

Geisinger Clinic is the lead sponsor of 127 studies on the registry; 17 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 \< 15 mL/min/1.73m2, or kidney transplantation) at any time during the baseline
  • Patients receiving palliative care at any time during the baseline
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,200 participants (estimated)

Study arms

  • Experimental
    Patients randomized to have PCP receive EHR Alert

    Other: Electronic Health Record alert

  • No intervention
    Patients receiving usual care

    Patient will receive usual care

Interventions

  • OtherElectronic 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.

06

What researchers measure

Primary outcomes

  1. Referral to Nephrology

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

    Time frame: Within One month of index PCP visit

Other outcomes

  1. 3-6 month Nephrology referral

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

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

  2. Nephrology referral completion

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

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

  3. Time to referral to nephrology

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

    Time frame: Within 12 months of index PCP visit

  4. 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

    Time frame: Within 6 months of index PCP visit

  5. Repeat urinalysis

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

    Time frame: Within 6 months of index PCP visit

  6. Time from PCP referral to scheduled nephrology visit

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

    Time frame: Within 12 months of index PCP visit

  7. 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

    Time frame: Within 12 months of index PCP visit

  8. Proportion diagnosed with glomerulonephritis

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

    Time frame: Within 12 months of index PCP visit

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided — We will consider sharing data upon reasonable request, pending data use agreements.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2026
First posted
Feb 25, 2026
StartEst.
Nov 2026
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
May 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07431931
Lead sponsor
Geisinger Clinic
Collaborators
Novartis
Responsible party
Sponsor
First posted
Feb 25, 2026
Start date
Nov 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
May 12, 2026

Study contacts

Alexander Chang, MD
Contact
achang@geisinger.edu
570-214-3156

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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