Skip to content

A Study of Acute Kidney Injury in Care Transitions

AKI in Care Transitions (ACT) Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05184894
Enrollment
50
Registered
2022-01-11
Start date
2022-01-17
Completion date
2023-10-31
Last updated
2024-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Brief summary

This research is being done to develop materials and processes that will help facilitate education and kidney care coordination for AKI survivors.

Interventions

BEHAVIORALAKI in Care Transitions (ACT) program

Multicomponent transitional support bundle that includes consultation from nurse educators before discharge to deliver kidney health education and coordination of appointments post-discharge.

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- Participants will be recruited from those identified by a developed electronic health record list of patients with stage III AKI (severe) during a hospitalization based on serum creatinine rise or urine output decline from Olmsted County.

Exclusion criteria

* Dementia. * Non-English speaking. * Expected to be dismissed to a skilled nursing facility or hospice at discharge. * Expected to need dialysis at discharge. * Primary Care Transitions Program enrollment. * Transplant recipients within 100 days of transplant. * Can only have one time enrollment.

Design outcomes

Primary

MeasureTime frameDescription
Number of Subjects to Complete the ACT Program30 days after hospitalizationTotal number of subjects to complete the full ACT program intervention

Countries

United States

Participant flow

Recruitment details

Eligible patients were identified using an electronic health record (EHR)- embedded list of adults (≥18 years) hospitalized at Mayo Clinic in Rochester from January 2022 to July 2023 who met stage 3 AKI criteria based on serum creatinine rise or urine output decline during a hospitalization and had a local address. Candidate participants were approached within 48-72 hours of discharge to obtain written informed consent and randomized 1:1 to the ACT intervention or usual care.

Participants by arm

ArmCount
AKI in Care Transitions (ACT) Group
Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will participate in the ACT program which provides standardized education and assists with coordination of follow up care after hospital stay. AKI in Care Transitions (ACT) program: Multicomponent transitional support bundle that includes consultation from nurse educators before discharge to deliver kidney health education and coordination of appointments post-discharge.
25
Usual Care Group
Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will receive standard of care from their inpatient and outpatient care teams.
25
Total50

Baseline characteristics

CharacteristicAKI in Care Transitions (ACT) GroupUsual Care GroupTotal
Age, Continuous63 years66 years65 years
AKI Recovery stage at discharge
Recovered (back to baseline) or stage 0 recovery (serum creatinine < 1.5x baseline)
17 Participants13 Participants30 Participants
AKI Recovery stage at discharge
Stage 1 recovery (1.5-1.9x baseline)
3 Participants5 Participants8 Participants
AKI Recovery stage at discharge
Stage 2 recovery (2.0-2.9x baseline)
3 Participants3 Participants6 Participants
AKI Recovery stage at discharge
Stage 3 recovery (3x baseline or >= 4 mg/dL)
2 Participants4 Participants6 Participants
Discharge eGFR31 mL/min/1.73m^227 mL/min/1.73m^230 mL/min/1.73m^2
Preadmission baseline eGFR63 mL/min/1.73m^261 mL/min/1.73m^262 mL/min/1.73m^2
Race/Ethnicity, Customized
Race/Ethnicity
Non-Hispanic Caucasian
23 Participants20 Participants43 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Other or Unknown Race/Ethnicity
2 Participants5 Participants7 Participants
Sex: Female, Male
Female
8 Participants7 Participants15 Participants
Sex: Female, Male
Male
17 Participants18 Participants35 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 251 / 25
other
Total, other adverse events
0 / 250 / 25
serious
Total, serious adverse events
0 / 250 / 25

Outcome results

Primary

Number of Subjects to Complete the ACT Program

Total number of subjects to complete the full ACT program intervention

Time frame: 30 days after hospitalization

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
AKI in Care Transitions (ACT) GroupNumber of Subjects to Complete the ACT Program22 Participants

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026