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

• ClinicalTrials.gov Identifier: NCT03564314
• Recruitment Status: Active, not recruiting
• First Posted: June 20, 2018
• Last Update Posted: May 5, 2021
• Sponsor: University of Calgary
• Collaborators: Alberta Health services; University of Alberta; Covenant Health
• Information provided by (Responsible Party): University of Calgary

Tracking Information

• First Submitted Date: May 25, 2018
• First Posted Date: June 20, 2018
• Last Update Posted Date: May 5, 2021
• Actual Study Start Date: March 13, 2017
• Actual Primary Completion Date: January 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 8, 2018)

Progression of AKI [ 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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 20, 2018)

• Length of AKI hospital stay, days [ 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
• Resource use for AKI [ 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 to initial response to AKI [ 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
• Volume intervention (change in fluid or diuretic order) for AKI [ Time Frame: Within 48 hours following AKI onset ]
  New or modified intravenous fluid or diuretic order
• Adverse medication exposure [ 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
• Medical consultation for AKI [ Time Frame: Within 7 days of AKI onset ]
  Consultation with nephrology or general internal medicine
• Change in estimated Glomerular Filtration Rate (eGFR) [ 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
• Mortality [ Time Frame: Within 30 days of AKI onset ]
  All cause mortality

Original Secondary Outcome Measures (submitted: June 8, 2018)

• Length of AKI hospital stay, days [ 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
• Resource use for AKI [ Time Frame: Duration of index hospital admission, asssessed up to 30 days ]
  Mean total health care costs of hospital care during the index admission
• Time to initial response to AKI [ 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
• Volume intervention (change in fluid or diuretic order) for AKI [ Time Frame: Within 48 hours following AKI onset ]
  New or modified intravenous fluid or diuretic order
• Adverse medication exposure [ 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
• Medical consultation for AKI [ Time Frame: Within 7 days of AKI onset ]
  Consultation with nephrology or general internal medicine
• Change in estimated Glomerular Filtration Rate (eGFR) [ 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
• Mortality [ Time Frame: Within 30 days of AKI onset ]
  All cause mortality

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Acute Kidney Injury

Intervention

Other: 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.

Study Arms

• Experimental: 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.
  Intervention: Other: SUPPORT AKI Clinical Decision Support
• No Intervention: Control
  Usual care provided to patients with AKI on surgical units.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: June 8, 2018): 1206
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2021
• Actual Primary Completion Date: January 31, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03564314
• Other Study ID Numbers: REB14-1531
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Calgary
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Calgary
• Original Study Sponsor: Same as current

Collaborators

• Alberta Health services
• University of Alberta
• Covenant Health

Investigators

• Principal Investigator: Matthew T James, MD, PhD; Associate Professor

• PRS Account: University of Calgary
• Verification Date: May 2021