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Clinical Trials/NCT02915575
NCT02915575CompletedNot Applicable

Advancing Community Care and Access to Follow-up After Acute Kidney Injury Hospitalization

University of Alberta2 sites in 1 country155 target enrollmentStarted: March 19, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
155
Locations
2
Primary Endpoint
Proportion of patients develop Chronic kidney disease after Acute kidney injury

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Control Arm (usual care)

Other

Participants will be discharged as per usual ward discharge protocols.

Intervention: Usual Care (Other)

Risk guided follow-up

Other

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: Risk guided follow-up (Other)

Outcomes

Primary Outcomes

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 Outcomes

  • Feasibility(one year)
  • Proportion of patients completed the lab and seen by PCP(90 days)
  • check eGFR(one year)
  • Hospitalization(one year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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