Risk guided follow-up
OtherParticipant 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
NCT Number: NCT02915575
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..
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Foothills Hospital, Calgary, Alberta, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Participants will be discharged as per usual ward discharge protocols.
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
Time frame: 90 days
Participant discharged from the hospital will be given lab requisition, to be drawn within 90 days
Time frame: one year
Participant will have their eGFR check at one year
Time frame: one year
Proportion of patients hospitalized for AKI or renal specific condition
Time frame: one year
Proportion of eligible patients recruited in the study
University of Alberta
Other
Advancing Community Care and Access to Follow-up After Acute Kidney Injury Hospitalization
Acronym: AFTER AKI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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