NCT Number: NCT03564314
Acute kidney injury (AKI) is common and costly complication of major surgery. AKI can lead to prolonged hospitalization and a higher likelihood of dialysis, chronic kidney disease and death. However, AKI can be reversed when recognized early, by ensuring that patients receive adequate fluids and medications that worsen kidney function or cause toxicity are avoided or appropriately prescribed. Past research suggests that AKI in surgical settings can be missed early in its onset, leading to delayed intervention and progression to more severe stages. The purpose of this project is to implement clinical decision support for early recognition and management of AKI on surgical units in Alberta hospitals, and to determine whether the initiative leads to improvements in the quality of care for AKI, length of hospital stay for patients, and costs to the healthcare system.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Foothills Medical Centre, Calgary, Alberta, Canada
Overview: Cluster-randomized stepped-wedge trial to evaluate the impact of implementing a clinical decision support initiative for early recognition and management of hospital-acquired AKI.
Study Population: Adult patients hospitalized on surgical units in Alberta who develop acute kidney injury will be eligible if not already receiving dialysis.
Intervention: The multidimensional clinical decision support intervention consists of: (1) electronic and non-computerized tools for early recognition of AKI, (2) educational program for clinical staff, (3) decision support resources and guidance for the management of AKI and consultation with specialists.
Study Design: Using a stepped-wedge design, eight general and vascular surgery unit clusters in Calgary (Foothills Medical Centre, Peter Lougheed Centre) and Edmonton (University of Alberta Hospital, Grey Nuns Community Hospital), Alberta will be randomly ordered to be sequentially introduced to the clinical decision support intervention. The pre-implementation period will include all patients admitted to the participating hospital units in the year before the random timing of introduction of the initiative on each participating unit. The post-implementation study cohort will include patients admitted in the year after the random timing of introduction of the initiative on each unit. Analysis of processes of care and outcomes will focus on patients on these units who develop AKI during the pre- and post-implementation time periods (i.e. are eligible to receive care under the AKI decision support initiative). Additionally, health care providers (e.g. physicians, nursing staff, pharmacists) who have direct experience with the clinical decision support tools and processes will be invited to participate in the surveys and interviews pre- and post-implementation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical units will receive a multidimensional clinical decision support intervention consisting of: (1) electronic and non-computerized tools to alert for early recognition of AKI, (2) educational program for physicians and nursing staff, (3) decision support tools with guidance on fluid therapies, medication management, investigations for AKI, and consultation with specialists.
Time frame: From date of AKI onset to discharge from hospital, assessed up to 30 days
Incidence of progression of AKI to higher AKI stage (including progression to dialysis or death)
Time frame: From date of AKI onset to discharge from hospital, assessed up to 30 days
Mean length of hospital stay from acute kidney injury to discharge
Time frame: Duration of index hospital admission, assessed up to 30 days
Mean total health care costs of hospital care during the index admission
Time frame: From AKI onset up to 48 hours following AKI onset
Time from AKI onset to clinical response with fluid or medication management intervention
Time frame: Within 48 hours following AKI onset
New or modified intravenous fluid or diuretic order
Time frame: Within 48 hours following AKI onset
Dose modification or suspension or a medication that may cause AKI or that is cleared by the kidney
Time frame: Within 7 days of AKI onset
Consultation with nephrology or general internal medicine
Time frame: From most recent baseline eGFR measurement prior to AKI onset to eGFR measurement closest to 3 months after AKI onset
The difference in eGFR from baseline to 3 months after development of AKI
Time frame: Within 30 days of AKI onset
All cause mortality
University of Calgary
Other
Acronym: SUPPORT AKI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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