Improving Post Discharge Care After Acute Kidney Injury (AFTER AKI)
Primary Purpose
Acute Kidney Injury
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Risk guided follow-up
Usual Care
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Injury
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 yrs
- At least a doubling of serum creatinine during hospitalization (including need for dialysis)
- Have a primary care physician (PCP)
- No nephrologist follow up arranged after hospital discharge
Exclusion Criteria:
- Baseline GFR<30ml/min/1.73m2(CKD-EPI) or requiring chronic dialysis on admission
- Renal transplant recipients
- Poor prognosis not expected to survive > 6 months
- Residence at a nursing home facility
Sites / Locations
- Foothills HospitalRecruiting
- University of Alberta hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Control Arm (usual care)
Risk guided follow-up
Arm Description
Participants will be discharged as per usual ward discharge protocols.
Participant will be stratified for risk of CKD in three groups: Low (<1% risk of CKD), medium (1-10 % risk of CKD) and high (≥10 % risk of CKD). Specific follow-up will be guided by risk status
Outcomes
Primary Outcome Measures
Proportion of patients develop Chronic kidney disease after Acute kidney injury
The primary (process based) outcome of this trial is the proportion of patients with CKD meeting all three quality of care indicators (statin use, ACEi/ARB use in those with proteinuria (ACR>30mg/mmol) or diabetes, nephrologist visit if sustained eGFR<30ml/min/1.73m2) within 90 days of hospital
Secondary Outcome Measures
Proportion of patients completed the lab and seen by PCP
Participant discharged from the hospital will be given lab requisition, to be drawn within 90 days
check eGFR
Participant will have their eGFR check at one year
Hospitalization
Proportion of patients hospitalized for AKI or renal specific condition
Feasibility
Proportion of eligible patients recruited in the study
Full Information
NCT ID
NCT02915575
First Posted
September 22, 2016
Last Updated
January 30, 2023
Sponsor
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT02915575
Brief Title
Improving Post Discharge Care After Acute Kidney Injury
Acronym
AFTER AKI
Official Title
Advancing Community Care and Access to Follow-up After Acute Kidney Injury Hospitalization
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
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
The purpose of this trial is to test the clinical benefit and feasibility of structured risk based post discharge care for hospital acquired Acute kidney injury survivors.This is a Pragmatic randomized controlled trial. It will be conducted at 2 hospitals in Alberta. 166 participants will be enrolled in this Randomized controlled trial..
Detailed Description
Research Objective:
To evaluate the impact of risk based decision support on processes of care for high-risk patients following discharge after hospitalization with Acute Kidney injury.
Experimental Strategy- rationale and considerations:
International guidelines for Chronic Kidney disease diagnosis and management provide a stage-based management approach to reduce the risk of adverse cardiovascular and renal outcomes based on estimated glomerular filtration rate (eGFR) and proteinuria. Identified key quality indicators for CKD care include the use of statins in CKD patients greater than age 50, or with diabetes or cardiovascular disease, use of ACEi (angiotensin-converting enzyme inhibitor) and ARB (angiotensin receptor blocker) in patients with proteinuria and referral to nephrology care with a sustained eGFR <30/ml/min/1.73m2. patients at low risk of CKD can be effectively managed by primary care given appropriate support. Study investigator will evaluate the identification of CKD by providing lab requisitions to all study participants. Those in the medium and high risk groups for CKD based on our risk index will be further guided to either a primary care web-based CKD care pathway which helps Primary care Physicians identify, treat and refer CKD patients using best practices, or nephrology care, respectively. Transitional care interventions have been shown to be effective preventing readmission in chronic conditions such as heart failure. Specialist care delivery often through multidisciplinary clinics has been found to improve prescription of proven efficacious medications and outcomes in a number of chronic disease settings including heart failure, Myocardial infarction,asthma and CKD. As there is no specific intervention for treating Acute kidney injury ensuring high adherence to CKD care in affected individuals is a feasible, sustainable strategy.
Participants The trial population will be comprised of consenting adult patients admitted to general medical or surgical teaching wards at 2 centers, the University of Alberta Hospital in Edmonton and the Foothills Hospital in Calgary.
Randomization
Participants will be randomized to either Control arm or Experimental arm
Control arm (Usual Care): Participants will be discharged as per usual ward discharge protocols. A requisition for follow-up labs (serum creatinine, serum electrolytes, urine albumin/creatinine ratio) to be drawn at 90 days will be given to each participant. Appointments/referrals will be left at the discretion of the care team.
Experimental arm (Risk Guided Follow-up): Participants will be stratified for risk of CKD into three groups: low (<1% risk of CKD), medium (1-10 % risk of CKD) and high (≥10 % risk of CKD) using a risk index developed by the team. Specific follow-up will be guided by risk status.
Analysis Plan:
The primary analysis will follow an intention-to-treat approach. In sensitivity analyses, outcomes based on the predicted risk of CKD will be stratified. Descriptive statistics and bivariate tests of associations will be used as appropriate to evaluate group differences at various time points of follow-up. Associations between key variables and study outcomes will be analyzed using appropriate univariate, multivariate and mixed model multilevel analyses. No interim analyses are planned due to the short duration of the trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Arm (usual care)
Arm Type
Other
Arm Description
Participants will be discharged as per usual ward discharge protocols.
Arm Title
Risk guided follow-up
Arm Type
Other
Arm Description
Participant will be stratified for risk of CKD in three groups: Low (<1% risk of CKD), medium (1-10 % risk of CKD) and high (≥10 % risk of CKD). Specific follow-up will be guided by risk status
Intervention Type
Other
Intervention Name(s)
Risk guided follow-up
Intervention Description
Participant will be stratified for risk of CKD in three groups: Low (<1% risk of CKD), medium (1-10 % risk of CKD) and high (≥10 % risk of CKD). Specific follow-up will be guided by risk status
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Participants will be discharged as per usual ward discharge protocols.
Primary Outcome Measure Information:
Title
Proportion of patients develop Chronic kidney disease after Acute kidney injury
Description
The primary (process based) outcome of this trial is the proportion of patients with CKD meeting all three quality of care indicators (statin use, ACEi/ARB use in those with proteinuria (ACR>30mg/mmol) or diabetes, nephrologist visit if sustained eGFR<30ml/min/1.73m2) within 90 days of hospital
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Proportion of patients completed the lab and seen by PCP
Description
Participant discharged from the hospital will be given lab requisition, to be drawn within 90 days
Time Frame
90 days
Title
check eGFR
Description
Participant will have their eGFR check at one year
Time Frame
one year
Title
Hospitalization
Description
Proportion of patients hospitalized for AKI or renal specific condition
Time Frame
one year
Title
Feasibility
Description
Proportion of eligible patients recruited in the study
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 yrs
At least a doubling of serum creatinine during hospitalization (including need for dialysis)
Have a primary care physician (PCP)
No nephrologist follow up arranged after hospital discharge
Exclusion Criteria:
Baseline GFR<30ml/min/1.73m2(CKD-EPI) or requiring chronic dialysis on admission
Renal transplant recipients
Poor prognosis not expected to survive > 6 months
Residence at a nursing home facility
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Ruholl
Phone
780-492-3887
Email
nruholl@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Ekpe, PhD
Phone
780-492-3302
Email
ekpeadew@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neesh Pannu, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew James, MD
Organizational Affiliation
Foothills Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Hospital
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Coralea Bignell
Phone
(403) 944-9882
Email
Coralea.Bignell@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Meha Bhatt
Phone
403-210-3991
Email
Meha.Bhatt@albertahealthservices.ca
Facility Name
University of Alberta hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Post Discharge Care After Acute Kidney Injury
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