NCT05184894

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

January 17, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 25, 2024

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

December 22, 2021

Results QC Date

September 12, 2024

Last Update Submit

December 3, 2024

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects to Complete the ACT Program

    Total number of subjects to complete the full ACT program intervention

    30 days after hospitalization

Study Arms (2)

AKI in Care Transitions (ACT) Group

EXPERIMENTAL

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.

Behavioral: AKI in Care Transitions (ACT) program

Usual Care Group

NO INTERVENTION

Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will receive standard of care from their inpatient and outpatient care teams.

Interventions

AKI in Care Transitions (ACT) programBEHAVIORAL

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

AKI in Care Transitions (ACT) Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • May HP, Griffin JM, Herges JR, Kashani KB, Kattah AG, Mara KC, McCoy RG, Rule AD, Tinaglia AG, Barreto EF. Comprehensive Acute Kidney Injury Survivor Care: Protocol for the Randomized Acute Kidney Injury in Care Transitions Pilot Trial. JMIR Res Protoc. 2023 May 22;12:e48109. doi: 10.2196/48109.

    PMID: 37213187DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Patient Transfer

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Continuity of Patient CarePatient CareTherapeuticsHospitalizationHealth ServicesHealth Care Facilities Workforce and ServicesPrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Results Point of Contact

Title
Erin Barreto, PharmD, MS
Organization
Mayo Clinic
barreto.erin@mayo.edu
507-284-2511

Study Officials

  • Erin Barreto, PharmD, RPh

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 11, 2022

Study Start

January 17, 2022

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

December 18, 2024

Results First Posted

November 25, 2024

Record last verified: 2024-12

Locations

US(1)