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| Name | Class |
|---|---|
| Alberta Innovates Health Solutions | OTHER |
| Alberta Health services | OTHER |
| University of Alberta | OTHER |
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Diagnostic and therapeutic cardiac catheterization procedures are important interventions to reduce the risk of death, avoid future cardiovascular events, and improve quality of life of people with heart disease. However, exposure to the radiocontrast dyes required for these procedures can lead to contrast-induced acute kidney injury (CI-AKI); a common and costly complication. There are accurate ways to identify patients at increased risk of this complication and strategies to prevent CI-AKI. This involves ensuring that patients who are at risk have procedures done with the minimum amount of X-ray contrast dye required, and that they receive optimal intravenous fluids at the time of the procedure.
This study will evaluate the implementation of a strategy where computerized decision support tools are used to help doctors identify patients at risk of CI-AKI, as well as make decisions about how much contrast dye to use and how much intravenous fluid to provide to patients who are identified at risk of CI-AKI in cardiac catheterization.
Overview: Randomized stepped-wedge trial to evaluate the impact of implementing a computerized decision support strategy that incorporates CI-AKI risk prediction and calculation of safe contrast dye limits and intravenous fluid recommendations.
Study Population: Adult patients undergoing diagnostic or interventional coronary angiography procedures will be eligible if not already receiving dialysis. Patients receiving emergency primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction will be excluded.
Intervention: Multivariable clinical risk prediction model to estimate risk of CI-AKI and safe contrast limits for patients above the median (>5%) predicted risk of CI-AKI. Intravenous fluids recommendations based on weight and left-ventricular end-diastolic pressure will also be provided for patients identified above the median risk of CI-AKI.
The National Cardiovascular Data Registry (NCDR) Cath-PCI Registry AKI risk model will be used to estimated the predicted risk of CI-AKI, and safe contrast limits will be estimated using the ePRISM, Acute Kidney Injury Model with Contrast Sensitivities and Dialysis Risk (Health Outcomes Sciences) software, incorporated within the Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease (APPROACH) Cardiac Catheterization software.
Study Design: Using a stepped-wedge design, clusters of cardiologists who perform diagnostic or therapeutic cardiac catheterization in each centre will be randomized to be introduced to the intervention at sequential time points spaced over 20 months. At each step, cardiologists who have not yet been randomized will serve as controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Cardiologists will receive computerized clinical decision support information for CI-AKI prevention for patients identified above the median (> 5%) risk of AKI based on the NCDR risk prediction model for CI-AKI. |
|
| Control | Other | Usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Other | Computerized clinical decision support intervention. This intervention consists of 2 decision support components for CI-AKI prevention:
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Kidney Injury | >26 micromol/L or 50% increase in serum creatinine | Within 4 days after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Procedural Hospital Bed Days | Number of days in hospital including length of stay plus readmissions up to 30 days after procedure | Thirty days after procedure |
| Death | Total mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Total direct health care costs | Total direct health care costs | One year after procedure |
| Cost per quality-adjusted life year | Total direct health care costs per quality adjusted life year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew T James, MD PhD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | Canada | |||
| Royal Alexandra Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25516439 | Background | Tsai TT, Patel UD, Chang TI, Kennedy KF, Masoudi FA, Matheny ME, Kosiborod M, Amin AP, Weintraub WS, Curtis JP, Messenger JC, Rumsfeld JS, Spertus JA. Validated contemporary risk model of acute kidney injury in patients undergoing percutaneous coronary interventions: insights from the National Cardiovascular Data Registry Cath-PCI Registry. J Am Heart Assoc. 2014 Dec;3(6):e001380. doi: 10.1161/JAHA.114.001380. | |
| 28678988 |
| Label | URL |
|---|---|
| Health Outcomes Sciences | View source |
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Due to Alberta privacy regulations, unable to share data
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D003324 | Coronary Artery Disease |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| Control | Other | Usual procedural care provided by cardiologist without introduction of the computerized clinical decision support information. |
|
| One year after procedure |
| Change in eGFR | Change in eGFR at one year fro pre-procedural baseline (estimated using CKD-EPI equation) | One year after procedure |
| Cardiac Events | Hospital admission for angina, myocardial infarction, heart failure, or unplanned revascularization procedure (excluding staged procedures) | One year after procedure |
| Kidney Events | Hospital admission for acute kidney injury or dialysis | On year after procedure |
| End-stage Kidney Disease | Kidney failure requiring dialysis, kidney transplantation, or conservative management of kidney failure with eGFR<15 mL/min/1.73m2 | One year after procedure |
| Generic Quality of Life | EQ-5D | One year after procedure |
| Cardiovascular-specific quality of life | Seattle Angina Questionnaire | One year after procedure |
| Contrast Volume | Volume of contrast used for each case | Day of procedure |
| Intravenous Fluid | Volume of intravenous fluids used for each case | Day of procedure |
| One year after procedure |
| Edmonton |
| Alberta |
| Canada |
| University of Alberta Hospital | Edmonton | Alberta | Canada |
| Background |
| Amin AP, Bach RG, Caruso ML, Kennedy KF, Spertus JA. Association of Variation in Contrast Volume With Acute Kidney Injury in Patients Undergoing Percutaneous Coronary Intervention. JAMA Cardiol. 2017 Sep 1;2(9):1007-1012. doi: 10.1001/jamacardio.2017.2156. |
| 28545621 | Background | Allen DW, Ma B, Leung KC, Graham MM, Pannu N, Traboulsi M, Goodhart D, Knudtson ML, James MT. Risk Prediction Models for Contrast-Induced Acute Kidney Injury Accompanying Cardiac Catheterization: Systematic Review and Meta-analysis. Can J Cardiol. 2017 Jun;33(6):724-736. doi: 10.1016/j.cjca.2017.01.018. Epub 2017 Feb 1. |
| 36066520 | Derived | James MT, Har BJ, Tyrrell BD, Faris PD, Tan Z, Spertus JA, Wilton SB, Ghali WA, Knudtson ML, Sajobi TT, Pannu NI, Klarenbach SW, Graham MM. 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. doi: 10.1001/jama.2022.13382. |
| 31472811 | Derived | James MT, Har BJ, Tyrrell BD, Ma B, Faris P, Sajobi TT, Allen DW, Spertus JA, Wilton SB, Pannu N, Klarenbach SW, Graham MM. 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. doi: 10.1016/j.cjca.2019.06.002. Epub 2019 Jun 7. |
| Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease | View source |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |