Exemplar Trial Overview - Contrast RISK. (15-min video & 22-slide presentation)

• Summary: Contrast-associated acute kidney injury is a common complication of coronary angiography and percutaneous coronary intervention. Dr. Matthew James overviews a stepped-wedge, cluster randomized clinical trial that was conducted in Alberta, Canada to determine whether a multifaceted intervention (composed of educational outreach, clinical decision support, and audit and feedback) could improve AKI prevention practices and reduce the incidence of acute kidney injury in patients undergoing coronary angiography, percutaneous coronary intervention, or both.

James MT, et al. Effect of Clinical Decision Support With Audit and Feedback on Prevention of Acute Kidney Injury in Patients Undergoing Coronary Angiography: A Randomized Clinical Trial. JAMA. 2022 Sep 6;328(9):839-849. Erratum in: JAMA. 2022 Nov 15;328(19):1981. (11-page paper)

• Summary: Publication in JAMA describing the Contrast RISK pragmatic, stepped-wedge, cluster randomized trial in which invasive cardiologists in Alberta, Canada, were randomly assigned to 1 of 8 start dates for the intervention between January 1, 2018 and September 1, 2019. During the intervention period, cardiologists received educational outreach, computerized clinical decision support (on contrast volume and hemodynamic-guided intravenous fluid targets), and audit and feedback. During the control (pre-intervention) period, cardiologists provided usual care and did not receive the intervention; the primary outcome was acute kidney injury.

Exemplar Trial - Contrast RISK. (16-min video & 35-slide presentation)

• Summary: Dr. Matthew James breaks down the pragmatic, stepped-wedge, cluster randomized trial across sections of the curriculum wheel.

James MT, et al. JAMA Visual Abstract. JAMA. 2022 Sep 6;328(9):839-849. (1-page image)

• Summary: An image summarizing the research question, population, locations, interventions, primary outcome, findings, and conclusion of the Contrast RISK trial.

James MT, et al. Clinical Decision Support to Reduce Contrast-Induced Kidney Injury During Cardiac Catheterization: Design of a Randomized Stepped-Wedge Trial. Can J Cardiol. 2019 Sep;35(9):1124-1133. Erratum in: Can J Cardiol. 2022 Mar;38(3):407. (12-page paper)

• Summary: Describes the design of the Contrast-Reducing Injury Sustained by Kidneys (Contrast RISK) study, a pragmatic, stepped-wedge, cluster randomized trial in Alberta, Canada. The initiative aimed to implement a multifaceted intervention - systematically and consistently - to support evidence-based strategies to reduce the incidence of contrast-associated acute kidney injury.

Contrast RISK Project Website (Interdisciplinary Chronic Disease Collaboration, University of Calgary): multi-page website.

• Summary: A central resource for materials related to the trial, including study site-specific protocols and procedures, educational materials for study staff, as well as clinical process-related FAQ documents.

Ma B, et al. Development and Evaluation of an Audit and Feedback Process for Prevention of Acute Kidney Injury During Coronary Angiography and Intervention. CJC Open. 2021 Oct 23;4(3):271-281. (11-page paper)

• Summary: Describes the development of a component of the trial’s intervention, i.e., the audit and feedback process. Reports were developed through an iterative process with interventional cardiologists during the design process and usability testing. It was found that conducting an audit and providing feedback was an understandable and acceptable intervention to help cardiologists improve prevention of contrast-associated acute kidney injury (during coronary angiography or percutaneous coronary intervention).

Gottlieb ER, Mendu M. Clinical Decision Support to Prevent Acute Kidney Injury After Cardiac Catheterization: Moving Beyond Process to Improving Clinical Outcomes. JAMA. 2022 Sep 6;328(9):831-832. Erratum in: JAMA. 2023 Jan 10;329(2):178. (2-page editorial) * An institutional login (e.g., university or research institute e-mail address) is required to access this material.

• Summary: A brief editorial comment on the Contrast RISK trial.

James MT, et al. Contrast RISK (Reducing Injury Sustained by Kidneys). ClinicalTrials.gov identifier: NCT03453996. Updated 2023-11-28. (8-section website)

• Summary: Public registration of the trial (i.e., study overview, contacts and locations, study plan, collaborators and investigators, publications, study record dates).