IMPROVE AKI Cluster-Randomized Trial

Acute Kidney Injury Clinical Trial

— IMPROVE-AKI  

Official title:

IMPROVE AKI: A Cluster-Randomized Trial of Team-Based Coaching Interventions to IMPROVE Acute Kidney Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556293
• Other study ID #: D18114
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 8676
• Est. completion date: January 31, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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.
• 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).
• 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).
• 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.

Locations

Country	Name	City	State
United States	Tennesee Valley VA	Nashville	Tennessee
United States	White River Junction VA	White River Junction	Vermont

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	University of Vermont, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Kidney Injury	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.	within 48-hours of the procedure or within 7-days for in-patients, or onset of dialysis within 7-days
Secondary	Sustainability Measure	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).	12 to 18 months after active interventions