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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Pittsburgh
Study ID
NCT05805709
Status
Recruiting
Apply to this trial

Conditions

  • Acute Kidney Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Study Physician/Advance Practice Provider — OTHER
    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.
  • Nurse Navigator — OTHER
    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.
  • Pharmacist — OTHER
    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.
  • Patient Education — OTHER
    Written information about kidney disease, nephrotoxins to be avoided and importance/need for follow up with a physician will be provided.

Study Details

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.

Key Dates

Start date
Sep 5, 2023
Status verified
Sep 2025
Primary completion
Jun 5, 2026
Completion
Mar 5, 2027

Study Design

Enrollment
2,145 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Multimodal Process of Care Intervention
    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.
  • Active Comparator: Usual Care
    After receiving the same written information about kidney disease, nephrotoxins to be avoided and importance/need for follow up with a physician as individuals randomized to the multimodal intervention arm, participants randomized to the control arm will receive usual care as specified by their treating providers and will not be followed by nurse navigator, pharmacist, or the study team. The only subsequent study-related activities will be the follow-up study visits for ascertainment of endpoints with the research coordinator.

Primary Outcome Measure

Hospital-Free Days (HFDs) through day 90 [ Time Frame: 90 days ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Patricia Busta
Javier Neyra, MD (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06510
Angela V Castro, MD
[email protected]
Francis Wilson, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic Weston HospitalWestonFlorida33331
Laura Duarte
[email protected]
Scott Cohen, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21287
Pam Corona, MD
[email protected]
Chirag Parikh, MD PhD (PRINCIPAL_INVESTIGATOR)
University of MarylandBaltimoreMaryland21201
Tramanh Phan, MD
[email protected]
Matthew Weir, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FoundationClevelandOhio44195
Savannah Gagnon, BS
Emilio Poggio, MD (PRINCIPAL_INVESTIGATOR)
MetroHealthClevelandOhio44109
Edward Horwitz, MD (PRINCIPAL_INVESTIGATOR)
Nashville VA Medical CenterNashvilleTennessee37212-2637
Jasiu Latocha
[email protected]
Eddie Siew, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt UniversityNashvilleTennessee37232
Ethan Kefauver, BS
[email protected]
Edward Siew, MD (PRINCIPAL_INVESTIGATOR)

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