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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients randomized to have PCP receive EHR Alert | Experimental |
| |
| Patients receiving usual care | No Intervention | Patient will receive usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Health Record alert | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 3-6 month Nephrology referral | Proportion of patients with nephrology referral order within 3 and 6 months of index PCP visit | Within 3 and 6 months of index PCP visit |
| Nephrology referral completion | Proportion of patients with completed nephrology appointment within 3 and 6 months of index PCP visit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Chang, MD | Contact | 570-214-3156 | achang@geisinger.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
We will consider sharing data upon reasonable request, pending data use agreements.
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| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D006417 | Hematuria |
| D011507 | Proteinuria |
| D007674 | Kidney Diseases |
| D000419 | Albuminuria |
| ID | Term |
|---|---|
| D009393 | Nephritis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.
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| Within 3 and 6 months of index PCP visit |
| Time to referral to nephrology | Compare the median time to referral between the intervention and usual care group | Within 12 months of index PCP visit |
| 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 | Within 6 months of index PCP visit |
| Repeat urinalysis | Proportion of patients who completed repeat urinalysis and microscopy lab test within 6 months of index PCP visit | Within 6 months of index PCP visit |
| Time from PCP referral to scheduled nephrology visit | Compare time from PCP referral to the date of nephrology appointment during follow up period | Within 12 months of index PCP visit |
| 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 | Within 12 months of index PCP visit |
| Proportion diagnosed with glomerulonephritis | Proportion of patients who were diagnosed with a glomerulonephritis during follow up period | Within 12 months of index PCP visit |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |