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RECRUITING
NCT05805709
NA

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

Sponsor: University of Pittsburgh

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2145

Start Date

2023-09-05

Completion Date

2027-03-05

Last Updated

2025-09-04

Healthy Volunteers

No

Interventions

OTHER

Study 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.

OTHER

Nurse 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.

OTHER

Pharmacist

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.

OTHER

Patient Education

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

Locations (9)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Yale University

New Haven, Connecticut, United States

Cleveland Clinic Weston Hospital

Weston, Florida, United States

University of Maryland

Baltimore, Maryland, United States

Johns Hopkins University

Baltimore, Maryland, United States

MetroHealth

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Nashville VA Medical Center

Nashville, Tennessee, United States

Vanderbilt University

Nashville, Tennessee, United States