Strategy for Uptake of Processes for Recognizing and Responding to Acute Kidney Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Strategy for Uptake of Processes for Recognizing and Responding to Acute Kidney Injury

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Other: SUPPORT AKI Clinical Decision Support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (18 years of age and older) who develop hospital-acquired acute kidney injury on identified general and vascular surgery units in Alberta Exclusion Criteria: Hospitalized on non-surgical units Receiving dialysis prior to admission on surgery unit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SUPPORT AKI Clinical Decision Support<br>Multidimensional clinical decision support intervention consisting of education and tools to support early recognition and management of AKI, including guidance on fluid therapies, medication management, investigation, and consultation with specialists. | Other: SUPPORT AKI Clinical Decision Support<br>* 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.<br>|
| No Intervention: Control<br>Usual care provided to patients with AKI on surgical units. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of AKI | Incidence of progression of AKI to higher AKI stage (including progression to dialysis or death) | From date of AKI onset to discharge from hospital, assessed up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of AKI hospital stay, days | Mean length of hospital stay from acute kidney injury to discharge | From date of AKI onset to discharge from hospital, assessed up to 30 days | 
| Resource use for AKI | Mean total health care costs of hospital care during the index admission | Duration of index hospital admission, assessed up to 30 days | 
| Time to initial response to AKI | Time from AKI onset to clinical response with fluid or medication management intervention | From AKI onset up to 48 hours following AKI onset | 
| Volume intervention (change in fluid or diuretic order) for AKI | New or modified intravenous fluid or diuretic order | Within 48 hours following AKI onset | 
| Adverse medication exposure | Dose modification or suspension or a medication that may cause AKI or that is cleared by the kidney | Within 48 hours following AKI onset | 
| Medical consultation for AKI | Consultation with nephrology or general internal medicine | Within 7 days of AKI onset | 
| Change in estimated Glomerular Filtration Rate (eGFR) | The difference in eGFR from baseline to 3 months after development of AKI | From most recent baseline eGFR measurement prior to AKI onset to eGFR measurement closest to 3 months after AKI onset | 
| Mortality | All cause mortality | Within 30 days of AKI onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute kidney injury, Major surgery, Clinical decision support