Trials / Not Yet Recruiting
Not Yet RecruitingNCT07431931
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,200 (estimated)
- Sponsor
- Geisinger Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. Geisinger primary care providers caring for participating patients will be randomized in equal proportion to 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-11-01
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2026-02-25
- Last updated
- 2026-02-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07431931. Inclusion in this directory is not an endorsement.