Health TrialsbyHealthPanel

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

ConditionsReferral and ConsultationGlomerulonephritisHematuriaProteinuriaKidney Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeisinger Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Electronic Health Record alert

    Other 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, 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.

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: Patients randomized to have PCP receive EHR AlertExperimental treatment 1 intervention
Group B: Patients receiving usual careNo intervention 0 interventions

Trial outcomes

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

Secondary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Geisinger Clinic

Lead sponsor

Novartis

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: