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Improving Post Discharge Care After Acute Kidney Injury (AFTER AKI)

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ClinicalTrials.gov Identifier: NCT02915575
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : January 31, 2023
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Study Description
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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..

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Other: Risk guided follow-up Other: Usual Care Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Advancing Community Care and Access to Follow-up After Acute Kidney Injury Hospitalization
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Control Arm (usual care)
Participants will be discharged as per usual ward discharge protocols.
 Other: Usual Care
Participants will be discharged as per usual ward discharge protocols.
Risk guided follow-up
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
 Other: Risk guided follow-up
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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients develop Chronic kidney disease after Acute kidney injury [ Time Frame: 90 days ]
    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 :
  1. Proportion of patients completed the lab and seen by PCP [ Time Frame: 90 days ]
    Participant discharged from the hospital will be given lab requisition, to be drawn within 90 days

  2. check eGFR [ Time Frame: one year ]
    Participant will have their eGFR check at one year

  3. Hospitalization [ Time Frame: one year ]
    Proportion of patients hospitalized for AKI or renal specific condition

  4. Feasibility [ Time Frame: one year ]
    Proportion of eligible patients recruited in the study


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915575


Contacts
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Contact: Nancy Ruholl 780-492-3887 nruholl@ualberta.ca
Contact: Esther Ekpe, PhD 780-492-3302 ekpeadew@ualberta.ca

Locations
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Canada, Alberta
Foothills Hospital Recruiting
Calgary, Alberta, Canada
Contact: Coralea Bignell    (403) 944-9882    Coralea.Bignell@albertahealthservices.ca   
Contact: Meha Bhatt    403-210-3991    Meha.Bhatt@albertahealthservices.ca   
University of Alberta hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Neesh Pannu, MD University of Alberta
Principal Investigator: Matthew James, MD Foothills Medical Centre
More Information
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02915575    
Other Study ID Numbers: Pro00067815
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases