Recruiting

Multimodal Intervention

Sponsor:

University of Pittsburgh

Code:

NCT05805709

Conditions

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Study Physician/Advance Practice Provider

Nurse Navigator

Pharmacist

Patient Education

Study Details

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.

Conditions

Acute Kidney Injury

Study ID

NCT05805709

Start date

Sep 5, 2023

Status verified date

Jul, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Aged ≥ 18 years
2. 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)

Exclusion Criteria:

1. AKI due to primary glomerulonephritis, renal vasculitis, or thrombotic microangiopathy
2. Diagnosis of end-stage kidney disease (ESKD) at the time of admission, defined as:

1. Baseline estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m2
2. Previous kidney transplant recipient
3. On chronic dialysis
3. Acute urinary obstruction with rapid kidney function improvement following relief of obstruction
4. Index hospitalization involving nephrectomy
5. Index hospitalization involving solid organ transplant or stem cell/bone marrow transplant
6. Continued dialysis dependence at time of discharge
7. Previous (within 6 months) or new referral to a nephrologist for care specifically for:

1. Previous or new diagnosis of glomerulonephritis
2. Primary electrolyte imbalance disorders unrelated to AKI (e.g., syndrome of inappropriate antidiuretic hormone secretion, Bartter syndrome)
3. Active treatment for acute interstitial nephritis
8. Non-kidney end-organ failure:

1. Class IV congestive heart failure
2. Decompensated cirrhosis with Model For End-Stage Liver Disease (MELD) > 30 or those with a diagnosis of hepatorenal syndrome by the clinical teams
3. End-stage pulmonary disease (advanced stage chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
9. Metastatic malignancy or malignancy requiring active treatment (chemotherapy, immunotherapy), such as multiple myeloma
10. Primary goal of care is palliation: life expectancy <6 months
11. Pregnancy
12. Vulnerable populations

1. Persons incarcerated
2. Persons institutionalized
13. Inability to provide informed consent

a. Impaired cognition as demonstrated by the Brief Confusion Assessment Method (bCAM)
14. Concurrent enrollment in a separate greater than minimal risk interventional trial
15. Inability to participate in either in-person or remote visits

a. Inability to participate as determined by the research team at time of discharge based on disposition (vs uniform decision across site about exclusion based on SNF)
16. Discharge to long-term acute care facility or other hospital-based location

Study Design

Enrollment

2145 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

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.

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.

Patient Education

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Susan J Copelli, MSHI

412-245-0803sju1@pitt.edu

Kaleab Abebe, PhD

kza3@pitt.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Principal Investigator:

Javier Neyra, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Angela V Castro, MD

angela.victoria-castro@yale.edu

Principal Investigator:

Francis Wilson, MD

Cleveland Clinic Weston Hospital

Recruiting

Weston, Florida, United States, 33331

Contacts

Laura Duarte

DUARTEL2@ccf.org

Principal Investigator:

Scott Cohen, MD

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Tramanh Phan, MD

TPhan@som.umaryland.edu

Principal Investigator:

Matthew Weir, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Pam Corona, MD

pamelacorona@jhmi.edu

Principal Investigator:

Chirag Parikh, MD PhD

MetroHealth

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Kyra Jancik

KJancik@metrohealth.org

Principal Investigator:

Edward Horwitz, MD

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

Emilio Poggio, MD

Nashville VA Medical Center

Recruiting

Nashville, Tennessee, United States, 37212-2637

Contacts

Jasiu Latocha

john.latocha@vumc.org

Principal Investigator:

Eddie Siew, MD

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Ethan Kefauver, BS

ethan.kefauver@vumc.org

Principal Investigator:

Edward Siew, MD

More Information

Sponsor

University of Pittsburgh

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • acute kidney injury
  • process of care
  • acute renal failure
  • kidney failure
  • kidney damage
  • pragmatic
  • nurse navigator
  • pharmacist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-07-06.