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Набор скоро начнётся NCT07431931

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

Без фазы С лечением Referral and Consultation Glomerulonephritis Hematuria Proteinuria

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Electronic Health Record alert.
Кому может быть актуально
Состояния в реестре: Referral and Consultation, Glomerulonephritis, Hematuria, Proteinuria. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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 optio

Первичные конечные точки

  • Referral to Nephrology [Срок оценки: Within One month of index PCP visit]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Скрининг

Центры проведения

США · 1 центр
  • Geisinger Medical Center — Danville

Идентификаторы

NCT: NCT07431931 · HEORUSV201555

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗