Patient-centered Care for Acute Kidney Injury
(COPE-AKI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the multimodal intervention for acute kidney injury safe for humans?
How is the Multimodal Intervention treatment for Acute Kidney Injury different from other treatments?
The Multimodal Intervention for Acute Kidney Injury is unique because it focuses on patient-centered care, which means it tailors the treatment to the individual needs and preferences of the patient, rather than following a one-size-fits-all approach. This treatment is not just about medication but involves a comprehensive approach that may include various therapies and support systems to improve overall patient outcomes.678910
What data supports the effectiveness of the treatment Multimodal Intervention for Acute Kidney Injury?
Research suggests that a multidisciplinary approach, which is part of multimodal interventions, can improve outcomes for patients with acute kidney injury (AKI) by ensuring early diagnosis and timely intervention. Additionally, educational interventions and personalized care have been shown to improve patient outcomes in similar settings.1112131415
Who Is on the Research Team?
Kaleab Abebe, PhD
Principal Investigator
Univerisity of Pittsburgh
Linda Fried, MD
Principal Investigator
University of Pittsburgh
Paul Palevsky, MD
Principal Investigator
University of Pittsburgh
Sandy Kane-Gill, PharmD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
The COPE-AKI trial is for adults over 18 with severe acute kidney injury (AKI) that's lasted at least two days. It's not for those with certain types of kidney diseases, end-stage kidney disease, serious lung or liver conditions, life expectancy under six months, pregnancy, cognitive impairment preventing consent, or if they're in another high-risk study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a multimodal process-of-care intervention or usual care, including study physician oversight, nurse navigator involvement, and pharmacist-led medication reconciliation
Follow-up
Participants are monitored for hospital-free days and major adverse kidney events, with assessments of patient-reported outcomes
Long-term Follow-up
Participants are monitored for long-term outcomes including recurrent AKI and quality of life measures
What Are the Treatments Tested in This Trial?
Interventions
- Multimodal Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator