[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07431931":3,"trial-entities:NCT07431931":81,"trial-summary:NCT07431931":85},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":39,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":47,"healthy_volunteers":15,"eligibility_criteria":48,"std_ages":59,"locations":62,"central_contacts":72,"overall_officials":78,"references":79,"see_also_links":80},"NCT07431931","HEORUSV201555","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","NOT_YET_RECRUITING","2027-12","2026-05","2026-05-12","2026-11","Geisinger Clinic","OTHER",false,"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.\n\nExploratory outcomes will include:\n\n* Comparing patient demographics (i.e. age, sex, insurance status, race), clinical (i.e. BMI, blood pressure, creatinine, eGFR, protein\u002Furine 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).\n* Proportion referred to nephrology within 3 and 6 months of index PCP visit.\n* Proportion with completed nephrology appointment within 3 and 6 months of index PCP visit\n* Median time to nephrology referral\n* Proportion of patients with dipstick hematuria and concomitant proteinuria (2+ or 3+) who underwent quantitative albumin or protein testing (albumin\u002Fcreatinine ratio or protein\u002Fcreatinine ratio or 24-hour urine albumin or protein) within 6 months of index PCP visit\n* 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\n* Median time from referral to nephrology visit\n* Assess implementation outcomes of the electronic alert intervention: Acceptability; Adoption; Appropriateness; Implementation Costs; Feasibility; Fidelity; Penetration; Sustainability\n\nAnalyses 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.",[19,20,21,22,23],"Referral and Consultation","Glomerulonephritis","Hematuria","Proteinuria","Kidney Disease",[25],"Hematuria; Proteinuria; Albuminuria; Glomerulonephritis; Clinical Decision Support; EHR Alert; Referral; Nephrology","INTERVENTIONAL","SCREENING",[29],"NA",{"count":31,"type":32},1200,"ESTIMATED",[34],{"type":14,"name":35,"description":36,"armGroupLabels":37},"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.",[38],"Patients randomized to have PCP receive EHR Alert",[40],{"measure":41,"description":42,"timeFrame":43},"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",[],"ALL","18 Years",null,{"inclusion":49,"exclusion":53,"raw_text":58},[50,51,52],"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\u002Fg or PCR ≥500 mg\u002Fg) collected within 12 months of index date.",[54,55,56,57],"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\u002For kidney failure (dialysis or eGFR \\\u003C 15 mL\u002Fmin\u002F1.73m2, or kidney transplantation) at any time during the baseline","Patients receiving palliative care at any time during the baseline","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* 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)\n* 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\u002Fg or PCR ≥500 mg\u002Fg) collected within 12 months of index date.\n\nExclusion Criteria:\n\n* Patients with a nephrologist appointment in the last 12 months before the index date\n* Patients with a prior appointment with a nephrologist within the last 2 years before the positive urinalysis test for hematuria (1+ or greater)\n* Patients with a history of glomerulonephritis and\u002For kidney failure (dialysis or eGFR \\\u003C 15 mL\u002Fmin\u002F1.73m2, or kidney transplantation) at any time during the baseline\n* Patients receiving palliative care at any time during the baseline",[60,61],"ADULT","OLDER_ADULT",[63],{"facility":64,"city":65,"state":66,"zip":67,"country":68,"geoPoint":69},"Geisinger Medical Center","Danville","Pennsylvania","17822","United States",{"lat":70,"lon":71},40.96342,-76.61273,[73],{"name":74,"role":75,"phone":76,"email":77},"Alexander Chang, MD","CONTACT","570-214-3156","achang@geisinger.edu",[],[],[],{"nct_id":4,"conditions":82,"biomarkers":84},[20,21,83,22],"Nephropathy",[],{"nct_id":4,"found":86,"summary":87,"prompt_version":96},true,{"design":88,"status":89,"heading":6,"summary":90,"follow_up":91,"word_count":92,"commitments":93,"compensation":94,"drugs_mentioned":95},"This is an interventional study planning to enroll 1200 participants. Patients will be randomly assigned to either receive care where their doctor gets an EHR alert or to receive usual care.","completed","This study is looking at how to improve the referral process for adults who have signs of kidney disease, specifically blood (hematuria) and protein (proteinuria) in their urine. Researchers are testing if an alert in the electronic health record (EHR) system helps primary care providers (PCPs) refer patients to a kidney specialist (Nephrology) more often. The EHR alert will show important information about your urine test results and past visits to kidney or urology doctors. The main goal is to see if this alert leads to more referrals to Nephrology within one month of your PCP visit. You could be eligible if you are an adult receiving care from a Geisinger PCP and have these specific urine test results.","The study will look at referrals to Nephrology within one month, and also at 3 and 6 months after your initial PCP visit.",119,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]