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

Overview

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.

Interventions

• Behavioral 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
• Behavioral Usual Care
  Physicians and nurse practitioners will provide standard of care education, labs, and clinical follow-up after discharge.

Primary outcome measures

• Hospital-Free Days [Time frame: 90 days, 180 days, 1 year]

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 3 centers

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

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗