Clinical trial NCT03564314: Strategy for Uptake of Processes for Recognizing and Responding to Acute Kidney Injury
Official title: Strategy for Uptake of Processes for Recognizing and Responding to Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Acute kidney injury
Major surgery
Clinical decision support
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Health services
name: University of Alberta
name: Covenant Health, Canada
First posted: 2018-06-20
Enrollment: 2135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression of AKI
timeFrame: From date of AKI onset to discharge from hospital, assessed up to 30 days
Secondary outcomes:
measure: Length of AKI hospital stay, days
timeFrame: From date of AKI onset to discharge from hospital, assessed up to 30 days
measure: Resource use for AKI
timeFrame: Duration of index hospital admission, assessed up to 30 days
measure: Time to initial response to AKI
timeFrame: From AKI onset up to 48 hours following AKI onset
measure: Volume intervention (change in fluid or diuretic order) for AKI
timeFrame: Within 48 hours following AKI onset
measure: Adverse medication exposure
timeFrame: Within 48 hours following AKI onset
measure: Medical consultation for AKI
timeFrame: Within 7 days of AKI onset
measure: Change in estimated Glomerular Filtration Rate (eGFR)
timeFrame: From most recent baseline eGFR measurement prior to AKI onset to eGFR measurement closest to 3 months after AKI onset
measure: Mortality
timeFrame: Within 30 days of AKI onset
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
Study officials:
affiliation: Associate Professor
name: Matthew T James, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: