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NCT Number: NCT07670520

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

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.

Recruiting

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Health System-Mankato, Mankato, Minnesota, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute Kidney Injury in Care Transitions (ACT)

Behavioral

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 care including remote monitoring program (RPM) where available and aligned with the patients goals/values/preferences for up to 90 days after discharge for the highest risk patients.

Usual Care

Behavioral

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

Primary outcomes

  1. Hospital-Free Days

    Time frame: 90 days, 180 days, 1 year

    Hospital-free days is defined as the total number of days a patient is alive and out of the hospital within the specified time frame.

Secondary outcomes

  1. Unplanned hospital readmissions or acute care contact or death

    Time frame: 90-days, 180-days, 1 year

    Composite of unplanned hospital readmissions or care contact (emergency department visit or observation) or death

  2. Death

    Time frame: 90-days, 180-days, 1-year

    Death after discharge

  3. AKI recurrence

    Time frame: 90 days, 180 days, 1 year

    Total number of patients to experience a recurrence of acute kidney injury after discharge.

  4. Major Adverse Kidney Event

    Time frame: 90-, 180- days

    Composite of death, dialysis, or persistent kidney dysfunction described as a 30% decline in eGFR from baseline

  5. Change in Estimated Glomerular Filtration Rate (eGFR) from preadmission baseline

    Time frame: 90 days, 180 days, 1 year

    eGFRcreatinine will be estimated from available serum creatinines checked in routine clinical practice at the study time points, and absolute and relative change in eGFR in milliliters per minute per 1.73m2 will be determined.

  6. Chronic kidney disease (CKD)

    Time frame: 90 days, 180 days, 1 year

    Total number of patients with new or worsening chronic kidney disease (CKD) post discharge

  7. End-stage kidney disease (ESKD)

    Time frame: 90 days, 180 days, 1 year

    Total number of patients with end-stage kidney disease (ESKD) post discharge

  8. Kidney transplantation

    Time frame: 90 days, 180 days, 1 year

    Total number of patients that require kidney transplantation post discharge

  9. Major adverse cardiovascular event

    Time frame: 90-days, 180-days, 1 year

    Incidence of major adverse cardiovascular event

  10. Provider and laboratory follow-up

    Time frame: 30-days, 90-days, 180-days

    Cumulative incidence of provider (PCP or nephrologist) and laboratory (serum creatinine and urine protein analysis) follow-up

  11. Post-discharge serum creatinine evaluation

    Time frame: time to first, 30-days, 90-days, 180-days

    Assessment of serum creatinine in the post-discharge interval

  12. Post-discharge urine protein evaluation

    Time frame: time to first, 30-days, 90-days, 180-days

    Assessment of urine protein in the post-discharge interval

  13. Primary care follow-up

    Time frame: time to first, 30-days, 90-days, 180-days

    Occurrence of a completed primary care encounter after discharge

  14. Nephrology follow-up

    Time frame: time to first, 30-days, 90-days, 180-days

    Occurrence of completed nephrology follow-up during the post-discharge interval

  15. Pharmacist follow-up

    Time frame: time to first, 30-days, 90-days, 180-days

    Occurrence of a completed pharmacist encounter in the post-discharge interval

  16. Guideline concordant care

    Time frame: 90 days, 180 days, 1 year

    Occurrence of provider and laboratory and initiation of renin-angiotensin system inhibitors, sodium-glucose cotransporter-2 inhibitors, or glucagon-like peptide-1 agonists in CKD.

  17. Engaged in remote monitoring program (RPM) program

    Time frame: 30 days, 90 days

    Total number of patients who submitted one or more sets of vitals/symptoms through the supplied technology or completed one of the scheduled laboratory assessments as part of the remote monitoring program (RPM)

Other outcomes

  1. Proteinuria

    Time frame: 90 days, 180 days, 1 year

    Binary classification of proteinuria in patients with laboratory data available from the scheduled follow-up time

  2. Excess days in acute care

    Time frame: 90 days, 180 days, 1 year

    Total days a patient spends in any acute care setting in the time interval after discharge, compared to what is expected for similar patients. Includes unplanned readmissions, observation stays, and emergency department visits.

  3. Hierarchical composite outcome

    Time frame: 90 days, 180 days, 1 year

    • Death (y/n)
    • KRT initiation after discharge (y/n)
    • Hospital-free days
    • Unplanned ED/outpatient visit (y/n)
    • Change in eGFR

Study contacts

Contact information is provided by the study sponsor or research team.

Mitchell C. Strand

CONTACT

[email protected]

507-293-0952

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: ACT

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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