NCT07431931

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Nov 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

February 10, 2026

Last Update Submit

February 18, 2026

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 3-6 month Nephrology referral

    Within 3 and 6 months of index PCP visit

  • Nephrology referral completion

    Within 3 and 6 months of index PCP visit

  • Time to referral to nephrology

    Within 12 months of index PCP visit

  • +5 more other outcomes

Study Arms (2)

Patients with PCP receiving EHR Alert

EXPERIMENTAL
Other: Electronic Health Record alert

Patients receiving usual care

NO INTERVENTION

Patient will receive usual care

Interventions

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.

Patients with PCP receiving EHR Alert

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

GlomerulonephritisHematuriaProteinuriaKidney DiseasesAlbuminuria

Condition Hierarchy (Ancestors)

NephritisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrination DisordersHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsUrological ManifestationsSigns and Symptoms

Central Study Contacts

Alexander Chang, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Geisinger primary care providers assigned to the EHR alert intervention will receive an automated alert when conducting a visit with a patient meeting eligibility criteria. 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, 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 25, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations