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临床试验/NCT07431931
NCT07431931尚未招募不适用

Optimizing Referral Pathways for Patients With Hematuria and Moderate-Severe Proteinuria - Phase 2: A Quality Improvement Project

Geisinger Clinic1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2026年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,200
试验地点
1
主要终点
Referral to Nephrology

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Patients receiving usual care

No Intervention

Patient will receive usual care

结局指标

主要结局

Referral to Nephrology

时间窗: Within One month of index PCP visit

Proportion of adult patients with high-risk features for glomerulonephritis with a nephrology referral order

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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