The COPE-AKI study is a randomized, pragmatic, parallel-arm kidney trial conducted to find out if an "enhanced care" team approach can improve a participant’s outcome after hospitalization with acute kidney injury (AKI) through 90 days of study follow up. The primary study hypothesis is that participants 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 participant 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.

The primary study objective is hospital-free days through 90 days of follow up, defined as 90 minus the number of calendar days in the hospital as either an inpatient or on observation status, based on the determination made by the corresponding hospital.

Key secondary objectives include rates of Major Adverse Kidney Events (MAKE) (measured at 90, 180, and 365 days), rates of recurrent AKI (90, 180, and 365 days), and four participant reported outcomes: global health-related quality of life, AKI-specific health-related quality of life, provider interactions, and social support (30, 90, 180, and 365 days).

The primary outcome measure is computed as hospital-free days through day 90, and is defined as 90 minus the number of calendar days in the hospital as either an inpatient or on observation status.

Secondary outcome measures are as follows:

• Rate of MAKE at 180 days
• Recurrent AKI hospitalization at 180 days
• Change from baseline in global health-related quality of life (HR-QoL) at 180 days
• Change from baseline in AKI-specific health-related quality of life (HR-QoL) at 180 days
• Change from baseline in interactions with providers at 180 days
• Change from baseline in social support at 180 days

Inclusion criteria:

• Age ≥ 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
• Diagnosis of end-stage kidney disease (ESKD) at the time of admission, defined as:
• Baseline estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m2
• Previous kidney transplant recipient
• On chronic dialysis
• Acute urinary obstruction with rapid kidney function improvement following relief of obstruction
• Index hospitalization involving nephrectomy
• Index hospitalization involving solid organ transplant or stem cell/bone marrow transplant
• Continued dialysis dependence at time of discharge
• Previous (within 6 months) or new referral to a nephrologist for care specifically for:
• Previous or new diagnosis of glomerulonephritis
• Primary electrolyte imbalance disorders unrelated to AKI (e.g., syndrome of inappropriate antidiuretic hormone secretion, Bartter syndrome)
• Active treatment for acute interstitial nephritis
• Non-kidney end-organ failure:
• Class IV congestive heart failure
• Decompensated cirrhosis with Model for End-Stage Liver Disease (MELD) > 30 or those with a diagnosis of hepatorenal syndrome by the clinical teams
• End-stage pulmonary disease (advanced stage chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
• Metastatic malignancy or malignancy requiring active treatment (chemotherapy, immunotherapy), such as multiple myeloma
• Primary goal of care is palliation: life expectancy < 6 months
• Pregnancy
• Vulnerable populations
• Persons incarcerated
• Persons institutionalized
• Inability to provide informed consent
• Impaired cognition as demonstrated by the Brief Confusion Assessment Method (bCAM)
• Concurrent enrollment in a separate greater than minimal risk interventional trial
• Inability to participate in either in-person or remote visits
• Inability to participate as determined by the research team at time of discharge based on disposition (versus uniform decision across site about exclusion based on skilled nursing facility)
• Discharge to long-term acute care facility or other hospital-based location

The study is ongoing.