RecruitingNot ApplicableNCT05805709

A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial

Caring for OutPatiEnts After Acute Kidney Injury (COPE-AKI) Trial

Sponsor

University of Pittsburgh

Enrollment

2,145 participants

Start Date

Sep 5, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Kidney Injury

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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)

Exclusion Criteria29

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/1.73m2
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
a. 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
a. Inability to participate as determined by the research team at time of discharge based on disposition (vs uniform decision across site about exclusion based on SNF)
Discharge to long-term acute care facility or other hospital-based location

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Interventions

OTHERStudy Physician/Advance Practice Provider

The 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.

OTHERNurse Navigator

The 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.

OTHERPharmacist

The 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.

OTHERPatient Education

Written information about kidney disease, nephrotoxins to be avoided and importance/need for follow up with a physician will be provided.