IMPROVE AKI Cluster-Randomized Trial

Not Applicable

Completed

Conditions: Acute Kidney Injury

Interventions: Behavioral: AKI Prevention Toolkit
Behavioral: Technical Assistance (TA)
Behavioral: Virtual Learning Collaborative (VLC)
Behavioral: Automated Surveillance Reporting (ASR)

Registration Number: NCT03556293

Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description: The investigators propose to test the implementation of evidence-based preventive interventions through a Virtual Learning Collaborative (VLC) with and without the novel use Automated Surveillance Reporting (ASR) intervention to change clinical practice and improve patient safety in common diagnostic procedures. Over 2 million people in the United States undergo diagnostic or interventional cardiac catheterization each year. Acute kidney injury (AKI), a patient safety metric set by the National Quality Forum, occurs in up to 14% of all patients following a procedure and up to 50% in patients with pre-existing chronic kidney disease (CKD), making AKI the most prevalent adverse event. Patients developing AKI have an increased risk of serious adverse events. There are widely accepted interventions to prevent AKI in patients undergoing cardiac catheterization. Our research team has demonstrated AKI can be prevented in 28% of patients with CKD through a large regional pilot. Our team has already developed ASR techniques for AKI nationally within the Veterans' Administration. Based on our own preliminary studies, the investigators hypothesize the incorporation of an automated plug-in ASR toolkit to provide near-realtime feedback to front-line care teams will significantly augment both VLC and Technical Assistance (TA) interventions in implementation trials. Our objective is to conduct a national randomized clinical trial testing the use of VLC or TA with or without a plug-in ASR toolkit to determine if ASR significantly improves outcomes for patients undergoing procedures with contrast dye to overcome the inconsistent application of known ways to prevent AKI. The rationale underlying the project is that ASR could prove to be a plug-in vehicle to improve patient endpoints in evidence-based preventive interventions in common diagnostic procedures. The investigators plan to test our hypothesis through the following specific aims in a 2x2 factorial cluster-randomized trial. For all aims, 16 hospitals will be randomized to receive one of the following interventions for 18-months: A) Technical Assistance (TA); B) Technical Assistance with Automated Surveillance Reporting (TA+ASR); C) Virtual Learning Collaborative (VLC) with team-based coaching (VLC); and D) Virtual Learning Collaborative with Automated Surveillance Reporting (VLC+ASR). Specific Aim 1: Compare the efficacy of a VLC and/or ASR compared to TA to reduce the incidence of AKI. Specific Aim 2: Evaluate the sustained efficacy of VLC and/or ASR to reduce the incidence of AKI following the intervention period. The interventions proposed use novel interactive video coaching sessions and ASR as low-cost scalable implementation strategies to prevent a clinical endpoint (AKI). Eighteen hospitals have agreed to participate and be randomized. The investigators expect the impact of a plug-in ASR to augment evidence based preventive interventions and VLC could significantly improve the consistent application of these interventions and implementation trials. In our opinion, our study will open the door to a new paradigm of implementation science seeking to continuously improve health care.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10252

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Virtual Learning Collaborative with ASR	Automated Surveillance Reporting (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).
Virtual Learning Collaborative (No ASR)	AKI Prevention Toolkit	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).
Technical Assistance with ASR	Automated Surveillance Reporting (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.
Technical Assistance with ASR	AKI Prevention Toolkit	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.
Technical Assistance (No ASR)	Technical Assistance (TA)	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
Technical Assistance with ASR	Technical Assistance (TA)	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.
Virtual Learning Collaborative with ASR	Virtual Learning Collaborative (VLC)	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).
Technical Assistance (No ASR)	AKI Prevention Toolkit	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
Virtual Learning Collaborative (No ASR)	Virtual Learning Collaborative (VLC)	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).
Virtual Learning Collaborative with ASR	AKI Prevention Toolkit	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).

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury	within 48-hours of the procedure or within 7-days for in-patients, or onset of dialysis within 7-days	Number of Participants with Acute Kidney Injury

Secondary Outcome Measures