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Strategy for Uptake of Processes for Recognizing and Responding to Acute Kidney Injury (SUPPORT AKI)

Primary Purpose

Acute Kidney Injury

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SUPPORT AKI Clinical Decision Support
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Kidney Injury focused on measuring Acute kidney injury, Major surgery, Clinical decision support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peter Lougheed Centre
  • Foothills Medical Centre
  • University of Alberta Hospital
  • Grey Nuns Community Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SUPPORT AKI Clinical Decision Support

Control

Arm Description

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.

Usual care provided to patients with AKI on surgical units.

Outcomes

Primary Outcome Measures

Progression of AKI
Incidence of progression of AKI to higher AKI stage (including progression to dialysis or death)

Secondary Outcome Measures

Length of AKI hospital stay, days
Mean length of hospital stay from acute kidney injury to discharge
Resource use for AKI
Mean total health care costs of hospital care during the index admission
Time to initial response to AKI
Time from AKI onset to clinical response with fluid or medication management intervention
Volume intervention (change in fluid or diuretic order) for AKI
New or modified intravenous fluid or diuretic order
Adverse medication exposure
Dose modification or suspension or a medication that may cause AKI or that is cleared by the kidney
Medical consultation for AKI
Consultation with nephrology or general internal medicine
Change in estimated Glomerular Filtration Rate (eGFR)
The difference in eGFR from baseline to 3 months after development of AKI
Mortality
All cause mortality

Full Information

First Posted
May 25, 2018
Last Updated
May 3, 2021
Sponsor
University of Calgary
Collaborators
Alberta Health services, University of Alberta, Covenant Health
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1. Study Identification

Unique Protocol Identification Number
NCT03564314
Brief Title
Strategy for Uptake of Processes for Recognizing and Responding to Acute Kidney Injury
Acronym
SUPPORT AKI
Official Title
Strategy for Uptake of Processes for Recognizing and Responding to Acute Kidney Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 13, 2017 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
Alberta Health services, University of Alberta, Covenant Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Acute kidney injury, Major surgery, Clinical decision support

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1206 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SUPPORT AKI Clinical Decision Support
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care provided to patients with AKI on surgical units.
Intervention Type
Other
Intervention Name(s)
SUPPORT AKI Clinical Decision Support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression of AKI
Description
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
Secondary Outcome Measure Information:
Title
Length of AKI hospital stay, days
Description
Mean length of hospital stay from acute kidney injury to discharge
Time Frame
From date of AKI onset to discharge from hospital, assessed up to 30 days
Title
Resource use for AKI
Description
Mean total health care costs of hospital care during the index admission
Time Frame
Duration of index hospital admission, assessed up to 30 days
Title
Time to initial response to AKI
Description
Time from AKI onset to clinical response with fluid or medication management intervention
Time Frame
From AKI onset up to 48 hours following AKI onset
Title
Volume intervention (change in fluid or diuretic order) for AKI
Description
New or modified intravenous fluid or diuretic order
Time Frame
Within 48 hours following AKI onset
Title
Adverse medication exposure
Description
Dose modification or suspension or a medication that may cause AKI or that is cleared by the kidney
Time Frame
Within 48 hours following AKI onset
Title
Medical consultation for AKI
Description
Consultation with nephrology or general internal medicine
Time Frame
Within 7 days of AKI onset
Title
Change in estimated Glomerular Filtration Rate (eGFR)
Description
The difference in eGFR from baseline to 3 months after development of AKI
Time Frame
From most recent baseline eGFR measurement prior to AKI onset to eGFR measurement closest to 3 months after AKI onset
Title
Mortality
Description
All cause mortality
Time Frame
Within 30 days of AKI onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew T James, MD, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peter Lougheed Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y6J4
Country
Canada
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B7
Country
Canada
Facility Name
Grey Nuns Community Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L5X8
Country
Canada

12. IPD Sharing Statement

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

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