Clinical trial NCT02915575: Improving Post Discharge Care After Acute Kidney Injury
Official title: Advancing Community Care and Access to Follow-up After Acute Kidney Injury Hospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Proportion of patients develop Chronic kidney disease after Acute kidney injury
timeFrame: 90 days
Secondary outcomes:
measure: Proportion of patients completed the lab and seen by PCP
timeFrame: 90 days
measure: check eGFR
timeFrame: one year
measure: Hospitalization
timeFrame: one year
measure: Feasibility
timeFrame: one year
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Neesh Pannu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Foothills Medical Centre
name: Matthew James, MD
role: PRINCIPAL_INVESTIGATOR
References: