A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial
COPE-AKI
Caring for OutPatiEnts After Acute Kidney Injury (COPE-AKI) Trial
5 other identifiers
interventional
2,145
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2023
CompletedFirst Posted
Study publicly available on registry
April 10, 2023
CompletedStudy Start
First participant enrolled
September 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 5, 2027
September 4, 2025
September 1, 2025
2.8 years
February 23, 2023
September 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital-Free Days (HFDs) through day 90
Hospital-free days through day 90 defined as 90 minus the number of calendar days in the hospital as either an inpatient or on observation status.
90 days
Secondary Outcomes (6)
Rate of Major Adverse Kidney Events (MAKE) at 180 days
180 days
Recurrent Acute Kidney Injury (AKI) Hospitalization at 180 days
180 days
Change from baseline in Global Health-Related Quality of Life (HR-QoL) at 180 days.
180 days
Change from baseline in AKI-Specific Health-Related Quality of Life (HR-QoL) at 180 days.
180 days
Change from baseline in Interactions with Providers at 180 days.
180 days
- +1 more secondary outcomes
Study Arms (2)
Multimodal Process of Care Intervention
EXPERIMENTALA 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.
Usual Care
ACTIVE COMPARATORAfter 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.
Interventions
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.
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.
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.
Written information about kidney disease, nephrotoxins to be avoided and importance/need for follow up with a physician will be provided.
Eligibility Criteria
You may qualify if:
- Aged ≥ 18 years
- Kidney Disease Improving Global Outcomes (KDIGO) Stage 2/3 AKI with evidence of persistent AKI (defined as meeting Stage 2+ AKI for 2 consecutive days with serum creatinine concentration measurements \>12 hours apart)
You may not qualify if:
- AKI due to primary glomerulonephritis, renal vasculitis, or thrombotic microangiopathy
- Diagnosis of end-stage kidney disease (ESKD) at the time of admission, defined as:
- Baseline estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73m2
- Previous kidney transplant recipient
- On chronic dialysis
- Acute urinary obstruction with rapid kidney function improvement following relief of obstruction
- Index hospitalization involving nephrectomy
- Index hospitalization involving solid organ transplant or stem cell/bone marrow transplant
- Continued dialysis dependence at time of discharge
- Previous (within 6 months) or new referral to a nephrologist for care specifically for:
- Previous or new diagnosis of glomerulonephritis
- Primary electrolyte imbalance disorders unrelated to AKI (e.g., syndrome of inappropriate antidiuretic hormone secretion, Bartter syndrome)
- Active treatment for acute interstitial nephritis
- Non-kidney end-organ failure:
- Class IV congestive heart failure
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaleab Abebe, PhD
Univerisity of Pittsburgh
- PRINCIPAL INVESTIGATOR
Linda Fried, MD
University of Pittsburgh
- PRINCIPAL INVESTIGATOR
Paul Palevsky, MD
University of Pittsburgh
- PRINCIPAL INVESTIGATOR
Sandy Kane-Gill, PharmD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants and the clinical care teams (nurse navigator, pharmacist, and study physician) will not be masked due to unblinded nature of the intervention. Research coordinators who carry out screening, enrollment, and study visits at baseline, 3, 6 and 12 months will be masked from participant group assignment. Similarly, study visits performed by research coordinator at baseline (enrollment), 3 months and 12 months will be masked. Similarly, assessment of study endpoints will be blinded to group assignment.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 23, 2023
First Posted
April 10, 2023
Study Start
September 5, 2023
Primary Completion (Estimated)
June 5, 2026
Study Completion (Estimated)
March 5, 2027
Last Updated
September 4, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data collected for this study will be analyzed and stored at the University of Pittsburgh Scientific \& Data Research Center (SDRC). Six months after publication of the primary manuscript or 18 months after study completion, whichever occurs first, the de-identified, archived data will be transmitted to and stored at the NIDDK Central Repository, for use by other researchers including those outside of the study. Permission to transmit data to the NIDDK Central Repository will be included in the informed consent.
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be transmitted to and stored at the University of Pittsburgh Data Coordinating Center (DCC). This will not include the participant's contact or identifying information. Rather, individual participants and their research data will be identified by a unique study identification number. The study data entry and study management systems used by clinical sites and by the DCC research staff will be secured and password protected. At the end of the study, all study databases will be de-identified and archived at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository.