The COPE-AKI study is a randomized, pragmatic, parallel-arm trial comparing a multimodal intervention to usual care on hospital-free days through 90 days of study follow up. The primary study hypothesis is that patients randomized to the intervention will have increased odds of more hospital-free days through 90 days (primary clinical) compared to those randomized to usual care. Key secondary hypotheses will investigate the impact of the intervention on rates of major adverse kidney events, rates of recurrent AKI, and changes in patient-reported outcomes. Participants (N=2145) will be allocated 1:1 to the intervention or usual care using a web-based system to maintain allocation concealment using stratified randomization with randomly permuted blocks. Randomization will be stratified by clinical site.
Aged ≥ 18 years
Kidney Disease Improving Global Outcomes (KDIGO) Stage 2/3 AKI with evidence of persistent AKI (defined as meeting Stage 2+ AKI for 2 consecutive days with serum creatinine concentration measurements >12 hours apart)
AKI due to primary glomerulonephritis, renal vasculitis, or thrombotic microangiopathy
Baseline estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m2
Previous kidney transplant recipient
On chronic dialysis
Parallel
Study Physician/Advance Practice Provider
Other interventionThe nephrologist and/or nephrology-associated advanced practice provider (APP) at each site will lead the intervention team for the duration of the study. The study physicians will fulfil two main roles: (a) Provide supervision to the rest of the study team and (b) conduct a discharge assessment to triage and make recommendations for follow-up care.
Nurse Navigator
Other interventionThe nurse navigator will be the primary contact for the participants assigned to the intervention group for the study. The navigator will obtain contact information, information about the patient's usual care providers and pharmacy, review medications, show the participant how to use the home blood pressure machine and scales and arrange for follow-up visits. The role of the nurse navigator will be to monitor the participant's medical condition; facilitate scheduling of needed medical follow-up including both routine (pre-scheduled) and ad hoc (urgent or emergency); enhance adherence with prescribed medical care and follow-up appointments; and serve as a resource to the patient to answer questions about their AKI-related management, facilitate medical and associated care and provide enhanced psychosocial support.
Pharmacist
Other interventionThe pharmacist will complete the medication reconciliation and medication regimen review per the predetermined checklist, via telemedicine if agreeable to the patient. The goal of the patient/caregiver-pharmacist interaction is to cover the following: avoidance of nephrotoxins when possible and appropriate, appropriate dosing of renally cleared drugs, review for drug-drug interactions, monitoring appropriate use of chronic medications, medication adherence, monitor for adverse drug reactions, evaluation of non-prescription medication use, medication/disease education and social support.
Patient Education
Other interventionWritten information about kidney disease, nephrotoxins to be avoided and importance/need for follow up with a physician will be provided.
Hospital-Free Days (HFDs) through day 90
Hospital-free days through day 90 defined as 90 minus the number of calendar days in the hospital as either an inpatient or on observation status.
Rate of Major Adverse Kidney Events (MAKE) at 180 days
MAKE-180 composite outcome of death, dialysis and assessment of kidney function defined as: * death within 180 days of index hospital discharge; * need for dialysis at 180 days after index hospital discharge; or * serum creatinine \>2x baseline at 180 days after index hospital discharge
Recurrent Acute Kidney Injury (AKI) Hospitalization at 180 days
Episodes of recurrent AKI during subsequent all-cause hospitalizations will be adjudicated based on hospitalization data, defining recurrent episodes of AKI based on an increase in serum creatinine of \>50% relative to the lowest-known value preceding or including the rehospitalization.
Change from baseline in Global Health-Related Quality of Life (HR-QoL) at 90 days.
HR-QOL will be assessed with the 10-item Patient-Reported Outcomes Measurement Information System (PROMIS) HRQoL measure. The PROMIS Global Health measures assess an individual's physical, mental, and social health. The measures are generic, rather than disease-specific, and often use an "In General" item context as it is intended to globally reflect individuals' assessment of their health. The adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health, which are rescaled into a standardized score (T-score) with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher T-score represents more of the concept being measured. Thus, a person who has T-scores of 60 for the Global Physical Health or Global Mental Health scales is one standard deviation better (more healthy) than the general population.
Change from baseline in AKI-Specific Health-Related Quality of Life (HR-QoL) at 90 days.
AKI-Specific HR-QOL will be assessed with the 6-item Chronic Kidney Disease Quality of Life (CKD-QoL) measure. The CKD-QoL comprehensively represents CKD-specific quality of life and yields a single summary impact score. Norm-based scoring is used (linearly transformed to have a mean of 50 and an SD of 10) in which a higher score indicates worse QOL impact.
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University of Pittsburgh
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
