Acute Kidney Injury In Care Transitions (ACT): Pragmatic Clinical Trial
ACT
2 other identifiers
interventional
2,260
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2026
CompletedFirst Submitted
Initial submission to the registry
June 19, 2026
CompletedFirst Posted
Study publicly available on registry
June 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
June 26, 2026
June 1, 2026
4 years
June 19, 2026
June 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
Unplanned hospital readmissions or acute care contact or death
90-days, 180-days, 1 year
Death
90-days, 180-days, 1-year
AKI recurrence
90 days, 180 days, 1 year
Major Adverse Kidney Event
90-, 180- days
Change in Estimated Glomerular Filtration Rate (eGFR) from preadmission baseline
90 days, 180 days, 1 year
- +12 more secondary outcomes
Other Outcomes (3)
Proteinuria
90 days, 180 days, 1 year
Excess days in acute care
90 days, 180 days, 1 year
Hierarchical composite outcome
90 days, 180 days, 1 year
Study Arms (2)
Acute Kidney Injury in Care Transitions (ACT) Intervention
EXPERIMENTALPhysicians 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.
Usual Care
ACTIVE COMPARATORPhysicians and nurse practitioners randomized to the usual care group will provide standard of care education, labs, and clinical follow-up after discharge.
Interventions
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.
Physicians and nurse practitioners will provide standard of care education, labs, and clinical follow-up after discharge.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Mayo Clinic Health System-Mankato
Mankato, Minnesota, 56001, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54703, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin F. Barreto, Pharm.D., Ph.D.
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 19, 2026
First Posted
June 26, 2026
Study Start
April 16, 2026
Primary Completion (Estimated)
March 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
June 26, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 5 years post primary completion date
- 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.
Data from this study may be requested from other researchers five years after the completion of the primary endpoint by contacting the principal investigator.