Back to resultsA Study of Acute Kidney Injury in Care Transitions
Primary Purpose
Acute Kidney Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AKI in Care Transitions (ACT) program
Sponsored by
About this trial
This is an interventional health services research trial for Acute Kidney Injury
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
AKI in Care Transitions (ACT) Group
Usual Care Group
Arm Description
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.
Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will receive standard of care from their inpatient and outpatient care teams.
Outcomes
Primary Outcome Measures
Number of subjects to complete the ACT program
Total number of subjects to complete the full ACT program intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT05184894
First Posted
December 22, 2021
Last Updated
February 8, 2023
Sponsor
Mayo Clinic
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT05184894
Brief Title
A Study of Acute Kidney Injury in Care Transitions
Official Title
AKI in Care Transitions (ACT) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research is being done to develop materials and processes that will help facilitate education and kidney care coordination for AKI survivors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AKI in Care Transitions (ACT) Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will receive standard of care from their inpatient and outpatient care teams.
Intervention Type
Behavioral
Intervention Name(s)
AKI in Care Transitions (ACT) program
Intervention Description
Multicomponent transitional support bundle that includes consultation from nurse educators before discharge to deliver kidney health education and coordination of appointments post-discharge.
Primary Outcome Measure Information:
Title
Number of subjects to complete the ACT program
Description
Total number of subjects to complete the full ACT program intervention
Time Frame
30 days after hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Barreto, PharmD, RPh
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin F Barreto, PharmD
Phone
507-255-5732
Email
Barreto.Erin@mayo.edu
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of Acute Kidney Injury in Care Transitions
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