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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Behavioral: Acute Kidney Injury in Care Transitions (ACT); Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 2260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mitchell C. Strand; Phone Number: 507-293-0952; Email: strand.mitchell@mayo.edu

Study Locations

• United States
  • Minnesota
    • Mankato, Minnesota, United States, 56001
      • Not yet recruiting
      • Mayo Clinic Health System-Mankato
      • Contact: Mitchell C. Strand; Phone Number: 507-293-0952
      • Principal Investigator: Jing Miao, M.D., Ph.D.
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Mitchell C. Strand; Phone Number: 507-293-0952
      • Principal Investigator: Erin F. Barreto, Pharm.D., Ph.D.
  • Wisconsin
    • Eau Claire, Wisconsin, United States, 54703
      • Not yet recruiting
      • Mayo Clinic Health System-Eau Claire Clinic
      • Contact: Mitchell C. Strand; Phone Number: 507-293-0952
      • Principal Investigator: Suhail B Shuja, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acute Kidney Injury in Care Transitions (ACT) Intervention; Physicians and nurse practitioners randomized to the ACT intervention group will be provided access to augmented kidney care support for acute kidney injury patients prior to hospital discharge, individualized according to post-discharge risk.	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 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.
Active Comparator: Usual Care; Physicians and nurse practitioners randomized to the usual care group will provide standard of care education, labs, and clinical follow-up after discharge.	Behavioral: Usual Care; Physicians and nurse practitioners will provide standard of care education, labs, and clinical follow-up after discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital-Free Days	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.	90 days, 180 days, 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unplanned hospital readmissions or acute care contact or death	Composite of unplanned hospital readmissions or care contact (emergency department visit or observation) or death	90-days, 180-days, 1 year
Death	Death after discharge	90-days, 180-days, 1-year
AKI recurrence	Total number of patients to experience a recurrence of acute kidney injury after discharge.	90 days, 180 days, 1 year
Major Adverse Kidney Event	Composite of death, dialysis, or persistent kidney dysfunction described as a 30% decline in eGFR from baseline	90-, 180- days
Change in Estimated Glomerular Filtration Rate (eGFR) from preadmission baseline	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.	90 days, 180 days, 1 year
Chronic kidney disease (CKD)	Total number of patients with new or worsening chronic kidney disease (CKD) post discharge	90 days, 180 days, 1 year
End-stage kidney disease (ESKD)	Total number of patients with end-stage kidney disease (ESKD) post discharge	90 days, 180 days, 1 year
Kidney transplantation	Total number of patients that require kidney transplantation post discharge	90 days, 180 days, 1 year
Major adverse cardiovascular event	Incidence of major adverse cardiovascular event	90-days, 180-days, 1 year
Provider and laboratory follow-up	Cumulative incidence of provider (PCP or nephrologist) and laboratory (serum creatinine and urine protein analysis) follow-up	30-days, 90-days, 180-days
Post-discharge serum creatinine evaluation	Assessment of serum creatinine in the post-discharge interval	time to first, 30-days, 90-days, 180-days
Post-discharge urine protein evaluation	Assessment of urine protein in the post-discharge interval	time to first, 30-days, 90-days, 180-days
Primary care follow-up	Occurrence of a completed primary care encounter after discharge	time to first, 30-days, 90-days, 180-days
Nephrology follow-up	Occurrence of completed nephrology follow-up during the post-discharge interval	time to first, 30-days, 90-days, 180-days
Pharmacist follow-up	Occurrence of a completed pharmacist encounter in the post-discharge interval	time to first, 30-days, 90-days, 180-days
Guideline concordant care	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.	90 days, 180 days, 1 year
Engaged in remote monitoring program (RPM) program	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)	30 days, 90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proteinuria	Binary classification of proteinuria in patients with laboratory data available from the scheduled follow-up time	90 days, 180 days, 1 year
Excess days in acute care	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.	90 days, 180 days, 1 year
Hierarchical composite outcome	Death (y/n); KRT initiation after discharge (y/n); Hospital-free days; Unplanned ED/outpatient visit (y/n); Change in eGFR	90 days, 180 days, 1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Erin F. Barreto, Pharm.D., Ph.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: June 19, 2026
• First Submitted That Met QC Criteria: June 19, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 19, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Health Services Administration; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Continuity of Patient Care; Patient Care Management; Comprehensive Health Care; Primary Health Care; Hospitalization; Patient Transfer
• Other Study ID Numbers: 25-009970; 1R01DK145433-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from this study may be requested from other researchers five years after the completion of the primary endpoint by contacting the principal investigator.
• IPD Sharing Time Frame: 5 years post primary completion date
• IPD Sharing Access Criteria: Data will be made available to researchers whose research proposal is approved by the principal investigator in addition to approval by the researcher's local site ethics review committee (such as an IRB) and an executed data use agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No