IMPROVE AKI Cluster-Randomized Trial
IMPROVE-AKI
IMPROVE AKI: A Cluster-Randomized Trial of Team-Based Coaching Interventions to IMPROVE Acute Kidney Injury
2 other identifiers
interventional
10,252
1 country
2
Brief Summary
When a person has an imaging procedure that uses radio-contrast dye, there is a possibility of damage to that person's kidneys, which could result in being on dialysis or early death. The investigators are testing novel coaching and automated tools to help healthcare teams apply approaches that have been shown to prevent damage to kidneys during a cardiac catheterization procedure. The results of our study will help inform health care leaders on how to implement low-cost preventive strategies through team-based coaching and surveillance reporting for kidney injury and other patient safety priorities to every hospital in the United States.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
2 active sites
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
April 30, 2018
CompletedFirst Posted
Study publicly available on registry
June 14, 2018
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedResults Posted
Study results publicly available
March 18, 2025
CompletedMarch 18, 2025
March 1, 2025
3.2 years
April 30, 2018
November 20, 2024
March 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Acute Kidney Injury
Number of Participants with Acute Kidney Injury
within 48-hours of the procedure or within 7-days for in-patients, or onset of dialysis within 7-days
Study Arms (4)
Technical Assistance (No ASR)
ACTIVE COMPARATORTechnical Assistance (TA). Intervention: TA will be offered to the 4 teams randomized to the TA condition without automated surveillance reporting and will receive the AKI Prevention Toolkit plus monthly technical calls independently
Virtual Learning Collaborative (No ASR)
ACTIVE COMPARATORVirtual Learning Collaborative (VLC). Intervention: The VLC will be offered to 4 teams without automated surveillance reportingand will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator \[CAC\] and Systems Redesign).
Technical Assistance with ASR
ACTIVE COMPARATORTechnical Assistance (TA). Intervention: TA will be offered to the 4 teams randomized to the TA condition with automated surveillance reporting (ASR) and will receive the AKI Prevention Toolkit plus monthly technical calls independently and monthly ASR dashboard.
Virtual Learning Collaborative with ASR
ACTIVE COMPARATORVirtual Learning Collaborative (VLC). Intervention: The VLC will be offered to 4 teams with automated surveillance reporting (ASR) and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites with the and monthly ASR dashboard. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator \[CAC\] and Systems Redesign).
Interventions
AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies.
Technical Assistance (TA). Intervention: TA will be offered to the 8 teams randomized to the TA condition and will receive the AKI Prevention Toolkit plus monthly technical calls independently. TA arms will include TA with and without automated surveillance reporting (ASR).
Virtual Learning Collaborative (VLC). Intervention: The VLC will be offered to 8 teams and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator \[CAC\] and Systems Redesign). VLC arms will include VLC with and without automated surveillance reporting (ASR).
Automated Surveillance Reporting (ASR). Intervention: The ASR will be offered to 8 teams. In addition to either TA or VLC, ASR teams will receive automated monthly reports in the form of an dashboard focused on AKI outcome and preventative measures overtime. The ASR report will be customized to each team and each individual operator and linked to their national VA-CART registry.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dartmouth-Hitchcock Medical Centerlead
- Vanderbilt Universitycollaborator
- University of Vermontcollaborator
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
Study Sites (2)
Tennesee Valley VA
Nashville, Tennessee, 37212, United States
White River Junction VA
White River Junction, Vermont, 05001, United States
Related Publications (2)
Matheny ME, Carpenter-Song E, Ricket IM, Solomon RJ, Stabler ME, Davis SE, Zubkoff L, Westerman DM, Dorn C, Cox KC, Minter FF, Jneid H, Currier JW, Athar SA, Girotra S, Leung C, Helton TJ, Agarwal A, Vidovich MI, Plomondon ME, Waldo SW, Aschbrenner KA, McKay V, O'Malley AJ, Brown JR. Sustained Improvements After Intervention to Prevent Contrast-Associated Acute Kidney Injury: A Randomized Controlled Trial. J Am Heart Assoc. 2025 May 20;14(10):e038920. doi: 10.1161/JAHA.124.038920. Epub 2025 May 15.
PMID: 40371586DERIVEDBrown JR, Solomon R, Stabler ME, Davis S, Carpenter-Song E, Zubkoff L, Westerman DM, Dorn C, Cox KC, Minter F, Jneid H, Currier JW, Athar SA, Girotra S, Leung C, Helton TJ, Agarwal A, Vidovich MI, Plomondon ME, Waldo SW, Aschbrenner KA, O'Malley AJ, Matheny ME. Team-Based Coaching Intervention to Improve Contrast-Associated Acute Kidney Injury: A Cluster-Randomized Trial. Clin J Am Soc Nephrol. 2023 Mar 1;18(3):315-326. doi: 10.2215/CJN.0000000000000067. Epub 2023 Feb 8.
PMID: 36787125DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jeremiah Brown
- Organization
- Dartmouth College
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremiah R Brown, PhD
Dartmouth College
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Contact PI, Professor
Study Record Dates
First Submitted
April 30, 2018
First Posted
June 14, 2018
Study Start
September 1, 2019
Primary Completion
November 30, 2022
Study Completion
January 31, 2023
Last Updated
March 18, 2025
Results First Posted
March 18, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Immediately following publication and contingent on third party access to VA data and regulations.
- Access Criteria
- contingent on third party access to VA data and regulations
Tools (data, software, libraries, research tools, etc.) will be made available to all researchers in both the private and public sector free or for a nominal charge and with minimal restriction. An analytic program file used to produce the analyses and a de-identified dataset will be made available to third parties within the VA system to conduct confirmatory analyses for the proposed specific aims. All parties must be in compliance with VA regulations and access. All analytic program files (code) and results will be reported in supplementary appendixes for all publications.