IMPROVE AKI Cluster-Randomized Trial (IMPROVE-AKI)
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ClinicalTrials.gov Identifier: NCT03556293 |
Recruitment Status :
Active, not recruiting
First Posted : June 14, 2018
Last Update Posted : February 4, 2022
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Condition or disease | Intervention/treatment | Phase |
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Acute Kidney Injury | Behavioral: AKI Prevention Toolkit Behavioral: Technical Assistance (TA) Behavioral: Virtual Learning Collaborative (VLC) Behavioral: Automated Surveillance Reporting (ASR) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10576 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Intervention Model Description: | 2x2 factorial cluster randomized trial |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | IMPROVE AKI: A Cluster-Randomized Trial of Team-Based Coaching Interventions to IMPROVE Acute Kidney Injury |
Actual Study Start Date : | September 1, 2019 |
Estimated Primary Completion Date : | October 31, 2022 |
Estimated Study Completion Date : | December 31, 2023 |

Arm | Intervention/treatment |
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Active Comparator: Technical Assistance (No ASR)
Technical 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
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Behavioral: AKI Prevention Toolkit
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. Behavioral: Technical Assistance (TA) 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). |
Active Comparator: Virtual Learning Collaborative (No ASR)
Virtual 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).
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Behavioral: AKI Prevention Toolkit
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. Behavioral: Virtual Learning Collaborative (VLC) 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). |
Active Comparator: Technical Assistance with ASR
Technical 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.
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Behavioral: AKI Prevention Toolkit
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. Behavioral: Technical Assistance (TA) 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). Behavioral: 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. |
Active Comparator: Virtual Learning Collaborative with ASR
Virtual 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).
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Behavioral: AKI Prevention Toolkit
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. Behavioral: Virtual Learning Collaborative (VLC) 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). Behavioral: 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. |
- Acute Kidney Injury [ Time Frame: within 48-hours of the procedure or within 7-days for in-patients, or onset of dialysis within 7-days ]AKI defined by ≥0.30 (mg/dL) or ≥50% increase in serum creatinine over baseline within 48-hours of the procedure or within 7-days for in-patients, or onset of dialysis within 7-days.
- Sustainability Measure [ Time Frame: 12 to 18 months after active interventions ]Sustainability Measure: sites will demonstrate sustained implementation if all 3 core interventions are reported to be in place (1. Standardized order sets; 2. IV and Oral Fluids; and 3. Efforts to reduced contrast volume).

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- VA Site Inclusion Criteria: All VA medical centers with a cardiac catheterization laboratory are eligible, and all catheterization operators at a site are included.
- Patient Inclusion Criteria: Among these sites, only patients aged 18 or greater with pre-existing CKD who undergo diagnostic coronary angiography or percutaneous coronary intervention (PCI or angioplasty) will be enrolled in the trial. CKD will be determined by a pre-existing CKD diagnosis in the VA medical record, or by two or more estimated glomerular filtration rates <60 (ml/min/1.73 m2) at least 90-days apart prior to presentation.
Exclusion Criteria:
- Patient Exclusion Criteria: Patients with a history of dialysis (hemodialysis, peritoneal dialysis), under the age of 18, or no evidence of pre-existing CKD will be excluded. Cardiac catheterization (also referred to as coronary angiography) is defined as a procedure in which a catheter is inserted into the femoral or radial artery and is threaded to the cardiac vasculature where radio-contrast dye is administered and a series of x-rays obtained in order to visualize the coronary arterial anatomy. PCI is when a clinical intervention is then performed to address any treatable pathology that is found.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556293
United States, Tennessee | |
Tennesee Valley VA | |
Nashville, Tennessee, United States, 37212 | |
United States, Vermont | |
White River Junction VA | |
White River Junction, Vermont, United States, 05001 |
Principal Investigator: | Jeremiah R Brown, PhD | Dartmouth College |
Responsible Party: | Jeremiah R. Brown, Study Contact PI, Associate Professor, Dartmouth-Hitchcock Medical Center |
ClinicalTrials.gov Identifier: | NCT03556293 |
Other Study ID Numbers: |
D18114 |
First Posted: | June 14, 2018 Key Record Dates |
Last Update Posted: | February 4, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
Supporting Materials: |
Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases |