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

NCT ID: NCT03564314

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-13

Study Completion Date

2020-12-31

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.

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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SUPPORT AKI Clinical Decision Support

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.

Group Type EXPERIMENTAL

SUPPORT AKI Clinical Decision Support

Intervention Type OTHER

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.

Control

Usual care provided to patients with AKI on surgical units.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SUPPORT AKI Clinical Decision Support

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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberta Health services

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role collaborator

Covenant Health, Canada

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew T James, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Peter Lougheed Centre

Calgary, Alberta, Canada

Site Status

Foothills Medical Centre

Calgary, Alberta, Canada

Site Status

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

Grey Nuns Community Hospital

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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REB14-1531

Identifier Type: -

Identifier Source: org_study_id