Caring for OutPatiEnts After Acute Kidney Injury (COPE-AKI) Trial Comparing a Multimodal Process-of-Care Intervention to Usual Care

What this Trial Is About

Researchers are studying patients with acute kidney injury (AKI) to compare a new multimodal intervention with usual care. This trial aims to see if the intervention increases the number of days patients spend outside the hospital within 90 days after discharge. It also looks at whether the intervention lowers serious kidney complications, reduces repeat AKI episodes, and improves patient-reported health outcomes. The study will include 2,145 participants who are randomly assigned to one of the two groups, with randomization organized by clinical site. The study intervention combines three key elements: physician oversight with follow-up care recommendations at hospital discharge, support from a nurse navigator who educates patients and coordinates care, and a pharmacist-led review of medications to avoid kidney-harmful drugs and ensure proper dosing. Participants in the usual care group receive written information about kidney disease and the importance of follow-up but do not get additional support from the study team. Both groups will be followed up for 90 days to assess outcomes. During the trial, participants will have scheduled follow-up visits where researchers will collect data on hospital-free days as the main outcome. Secondary outcomes include rates of major adverse kidney events and recurrent AKI up to 180 days, along with assessments of quality of life, provider interactions, and social support up to 365 days. The study includes monitoring through patient questionnaires and clinical evaluations. Participants are expected to be involved for at least 90 days, with some outcomes tracked for up to one year after enrollment.

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