Acute Kidney Injury In Care Transitions (ACT): Pragmatic Clinical Trial

Обзор

The purpose of this study is to determine the effect of a multidisciplinary intervention at care transitions for acute kidney injury survivors on patient-centered outcomes.

Вмешательства

• Поведенческое Acute Kidney Injury in Care Transitions (ACT)
  Clinicians will assign risk-individualized kidney health care prior to hospital discharge for acute kidney injury survivors. Low risk acute kidney injury survivors will receive education prior to hospital discharge, moderate risk acute kidney injury survivors will receive a referral to primary care for laboratory and clinical follow-up within approximately 14-days including a medication review by a pharmacist, and high risk acute kidney injury survivors will be referred to nephrologist-directed
• Поведенческое Usual Care
  Physicians and nurse practitioners will provide standard of care education, labs, and clinical follow-up after discharge.

Первичные конечные точки

• Hospital-Free Days [Срок оценки: 90 days, 180 days, 1 year]

Вторичные конечные точки (12)

• Unplanned hospital readmissions or acute care contact or death [Срок оценки: 90-days, 180-days, 1 year]
• Death [Срок оценки: 90-days, 180-days, 1-year]
• AKI recurrence [Срок оценки: 90 days, 180 days, 1 year]
• Major Adverse Kidney Event [Срок оценки: 90-, 180- days]
• Change in Estimated Glomerular Filtration Rate (eGFR) from preadmission baseline [Срок оценки: 90 days, 180 days, 1 year]
• Chronic kidney disease (CKD) [Срок оценки: 90 days, 180 days, 1 year]
• End-stage kidney disease (ESKD) [Срок оценки: 90 days, 180 days, 1 year]
• Kidney transplantation [Срок оценки: 90 days, 180 days, 1 year]
• Major adverse cardiovascular event [Срок оценки: 90-days, 180-days, 1 year]
• Provider and laboratory follow-up [Срок оценки: 30-days, 90-days, 180-days]
• Post-discharge serum creatinine evaluation [Срок оценки: time to first, 30-days, 90-days, 180-days]
• Post-discharge urine protein evaluation [Срок оценки: time to first, 30-days, 90-days, 180-days]

Критерии участия

Критерии включения

• Clinician subjects

• Hospital clinicians including physicians and advanced practice providers employed by Mayo Clinic and practicing at one of the four study sites
• Provide care for hospitalized patients with stage 2 or stage 3 acute kidney injury (AKI) who are expected to be discharged home and are not receiving dialysis
• Patient subjects:

• Adults ≥18 years old
• Meet KDIGO consensus criteria for stage 2 (moderate) or 3 (severe) AKI
• Residence within the study catchment area (southern Minnesota, northern Iowa, or western Wisconsin)

Критерии исключения

• Clinician subjects: Physicians and advanced practice providers who:

• Care exclusively for pediatric patients (<18 years)
• Care exclusively for patients on palliative care
• Patient subjects

• Discharged to hospice care
• Require outpatient dialysis at discharge
• Are admitted from or expected to be discharged to a skilled nursing facility
• Dementia Diagnosis
• Have undergone solid organ transplant within the past 100 days
• Decline authorization for use of their medical records for research

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

Открытое

Основная цель

Профилактика

Центры проведения

США · 3 центра

• Mayo Clinic Health System-Mankato — Mankato
• Mayo Clinic in Rochester — Rochester
• Mayo Clinic Health System-Eau Claire Clinic — Eau Claire

Идентификаторы

NCT: NCT07670520 · 25-009970 · 1R01DK145433-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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