A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial
Start Date
9/5/2023
Completion Date
11/30/2028
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.
Detailed Description
The primary study hypotheses for the COPE-AKI study are: compared to usual care, patients randomized to a multimodal intervention will have increased odds of more hospital-free days through 90 days (primary) and lower rates of major adverse kidney events (MAKE) at 180 days, lower rates of recurrent AKI at 180 days, and greater improvements in patient-reported outcomes over 90 days (secondary). The primary outcome 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 outcomes include: rates of MAKE (measured at 90, 180, and 365 days), rates of recurrent AKI (90, 180, and 365 days), and 4 patient-report outcomes: global health related quality of life, AKI-specific health related quality of life, provider interactions, and social support (30, 90, 180, 365 days). A multimodal process-of-care intervention that includes 1) study physician oversight and follow up care recommendations at the time of hospital discharge; 2) involvement of a nurse navigator to provide kidney-disease related education, coordinate care, and assess symptoms; and 3) pharmacist-led medication reconciliation and review. Participants in the usual care arm will be provided information about their kidney disease, nephrotoxins to be avoided, and the importance of follow up with a physician will be emphasized.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Study Physician/Advance Practice Provider
Nurse Navigator
Pharmacist
Patient Education
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35233
United States
Yale University
New Haven, Connecticut 06510
United States
Cleveland Clinic Weston Hospital
Weston, Florida 33331
United States
University of Maryland
Baltimore, Maryland 21201
United States
Johns Hopkins University
Baltimore, Maryland 21287
United States
MetroHealth
Cleveland, Ohio 44109
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Nashville VA Medical Center
Nashville, Tennessee 37212-2637
United States
Vanderbilt University
Nashville, Tennessee 37232
United States