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

NARecruitingINTERVENTIONAL
Enrollment

2,145

Participants

Timeline

Start Date

September 5, 2023

Primary Completion Date

June 5, 2026

Study Completion Date

March 5, 2027

Conditions
Acute Kidney Injury
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.

Trial Locations (9)

21201

RECRUITING

University of Maryland, Baltimore

21287

RECRUITING

Johns Hopkins University, Baltimore

33331

RECRUITING

Cleveland Clinic Weston Hospital, Weston

35233

RECRUITING

University of Alabama at Birmingham, Birmingham

37232

RECRUITING

Vanderbilt University, Nashville

44109

RECRUITING

MetroHealth, Cleveland

44195

RECRUITING

Cleveland Clinic Foundation, Cleveland

06510

RECRUITING

Yale University, New Haven

37212-2637

RECRUITING

Nashville VA Medical Center, Nashville

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

University of Pittsburgh

OTHER