2145 Participants Needed

Patient-centered Care for Acute Kidney Injury

(COPE-AKI Trial)

Recruiting at 8 trial locations
BP
KA
Overseen ByKaleab Abebe, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The research suggests that interventions like computerized alerts and medication safety systems can improve patient safety by reducing errors and improving care for acute kidney injury, indicating a focus on safety in these approaches.12345

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?

KA

Kaleab Abebe, PhD

Principal Investigator

Univerisity of Pittsburgh

LF

Linda Fried, MD

Principal Investigator

University of Pittsburgh

PP

Paul Palevsky, MD

Principal Investigator

University of Pittsburgh

SK

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

I have stage 2 or 3 kidney injury that has lasted for more than 2 days.

Exclusion Criteria

You have trouble thinking clearly, as shown by a test called the Brief Confusion Assessment Method (bCAM).
Vulnerable populations:
Concurrent enrollment in a separate greater than minimal risk interventional trial
See 26 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multimodal process-of-care intervention or usual care, including study physician oversight, nurse navigator involvement, and pharmacist-led medication reconciliation

90 days
Regular follow-up visits as per study protocol

Follow-up

Participants are monitored for hospital-free days and major adverse kidney events, with assessments of patient-reported outcomes

180 days
Follow-up visits at 90 and 180 days

Long-term Follow-up

Participants are monitored for long-term outcomes including recurrent AKI and quality of life measures

365 days

What Are the Treatments Tested in This Trial?

Interventions

  • Multimodal Intervention
Trial Overview This study compares a special care package including a doctor/advanced provider team-up, nurse navigator support, pharmacist involvement and patient education against the usual care given to AKI patients. The goal is to see if this approach increases the number of days patients stay out of the hospital after discharge.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Multimodal Process of Care InterventionExperimental Treatment4 Interventions
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

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

Collaborator

Trials
2,513
Recruited
4,366,000+

Published Research Related to This Trial

Current research on acute kidney injury (AKI) primarily focuses on diagnosis and treatment outcomes, with limited attention given to the quality of care provided to patients.
To improve patient outcomes, it is essential to evaluate the processes of care delivery for AKI using quality improvement metrics that assess both care processes and outcomes.
Does Your Program Know Its AKI and CRRT Epidemiology? The Case for a Dashboard.Mottes, TA.[2020]
Follow-up care after acute kidney injury (AKI) in the ICU is currently inadequate, highlighting the need for standardized processes to improve patient outcomes, as suggested by both retrospective studies and some prospective trials.
Initiating or resuming renin-angiotensin-aldosterone agents may enhance recovery after AKI, but caution is needed due to potential risks of adverse events, especially if these medications are restarted too soon.
Individualized acute kidney injury after care.Koyner, JL., Haines, RW., Bouchard, J.[2022]
In a study involving ICU patients, an educational intervention called the 'Save the Kidney' (STK) bundle did not significantly reduce the primary outcome of mortality, renal replacement therapy, or progression of acute kidney injury (AKI) compared to usual care, with 33% of patients in the STK group experiencing these outcomes versus 29% in the control group.
While the STK intervention showed a lower rate of renal replacement therapy (1.6% vs. 3.6%), it did not lead to a significant overall improvement in patient outcomes, indicating that simply educating healthcare providers may not be enough to prevent AKI progression in critically ill patients.
Bundled care in acute kidney injury in critically ill patients, a before-after educational intervention study.Koeze, J., van der Horst, ICC., Wiersema, R., et al.[2021]

Citations

Does Your Program Know Its AKI and CRRT Epidemiology? The Case for a Dashboard. [2020]
Individualized acute kidney injury after care. [2022]
Bundled care in acute kidney injury in critically ill patients, a before-after educational intervention study. [2021]
[Acute kidney injury - status of biomarkers in perioperative and critically ill patients]. [2017]
Critical Care Nephrology: A Multidisciplinary Approach. [2017]
Mixed methods evaluation of a computerised audit and feedback dashboard to improve patient safety through targeting acute kidney injury (AKI) in primary care. [2023]
A trial of in-hospital, electronic alerts for acute kidney injury: design and rationale. [2022]
A system to improve medication safety in the setting of acute kidney injury: initial provider response. [2016]
Decreasing Rates of Acute Kidney Injury After Percutaneous Coronary Interventions Through Education and Standardized Order Sets in a Large Tertiary Teaching Center. [2021]
The Quality of Discharge Summaries After Acute Kidney Injury. [2023]
Integrative literature review of evidence-based patient-centred care guidelines. [2021]
[Contribution of a multimorbidity person-centered care strategy to the Comprehensive Family and Community Healthcare Model in Chile]. [2023]
What are the effective elements in patient-centered and multimorbidity care? A scoping review. [2018]
14.United Statespubmed.ncbi.nlm.nih.gov
Patient-Centered and Family-Centered Care in the Intensive Care Unit. [2023]
15.United Statespubmed.ncbi.nlm.nih.gov
Measuring Patients' Perceptions of Health Care Encounters: Examining the Factor Structure of the Revised Patient Perception of Patient-Centeredness (PPPC-R) Questionnaire. [2022]
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