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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07431931
Enrollment
1200
Registered
2026-02-25
Start date
2026-11-01
Completion date
2027-12-01
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

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.

Sponsors

Geisinger Clinic
Lead SponsorOTHER
Novartis
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Geisinger primary care providers will receive an automated alert when conducting a visit with a patient randomized to the EHR alert intervention. 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Referral to NephrologyWithin One month of index PCP visitProportion of adult patients with high-risk features for glomerulonephritis with a nephrology referral order

Countries

United States

Contacts

CONTACTAlexander Chang, MD
achang@geisinger.edu570-214-3156

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026