Patient-centered Care for Acute Kidney Injury
(COPE-AKI Trial)
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Pittsburgh
Disqualifiers: End-stage kidney disease, Non-kidney end-organ failure, Metastatic malignancy, Pregnancy, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
1112131415Eligibility Criteria
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 am 18 years old or older.
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
+26 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Multimodal Process of Care InterventionExperimental Treatment4 Interventions
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.
Group II: Usual CareActive Control1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland Clinic Weston HospitalWeston, FL
Johns Hopkins UniversityBaltimore, MD
Cleveland Clinic FoundationCleveland, OH
Nashville VA Medical CenterNashville, TN
More Trial Locations
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Who Is Running the Clinical Trial?
University of PittsburghLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Does Your Program Know Its AKI and CRRT Epidemiology? The Case for a Dashboard. [2020]Current acute kidney injury (AKI) literature focuses on diagnosis, treatment, and outcomes. While little literature exists studying the quality of care delivered to patients with AKI. However, improving outcomes for patients is dependent on the specifics of the delivered care (i.e., the who, what, when, and how). Therefore, it is necessary to direct attention to process measures to assess the relationship between care and outcomes. The application of quality improvement science to the care of AKI, uses a series of metrics encompassing both processes and outcomes to better understand, evaluate, and ensure the delivery high quality care.
Individualized acute kidney injury after care. [2022]The aim of this study was to summarize the current evidence around the impact of individualizing patient care following an episode of acute kidney injury (AKI) in the ICU.
Bundled care in acute kidney injury in critically ill patients, a before-after educational intervention study. [2021]Acute kidney injury (AKI) often occurs in critically ill patients. AKI is associated with mortality and morbidity. Interventions focusing on the reduction of AKI are suggested by the Kidney Disease: Improving Global Outcomes guideline. We hypothesized that these educational interventions would improve outcome in patients admitted to the Intensive Care Unit (ICU).
[Acute kidney injury - status of biomarkers in perioperative and critically ill patients]. [2017]Acute kidney injury (AKI) impairs short- and long-term prognosis of affected patients even in case of apparantly mild course and 'full' recovery as measured by follow-up serum creatinine concentrations. Late or none intervention worsens prognosis. However, there are modifiable factors potentially contributing to preserved long-term renal function. Effective treatment is multifactorial and includes identification and reversal of AKI etiology and generation of a (micro)environment for optimal renal recovery. Available treatment options for AKI in perioperative and critically ill patients will be discussed in the setting of novel kidney biomarkers.
Critical Care Nephrology: A Multidisciplinary Approach. [2017]Acute kidney injury (AKI) is a serious medical condition affecting millions of people. Patients in intensive care unit (ICU) who develop AKI have increased morbidity and mortality, prolonged length of stay in ICU and hospital and increased costs, especially when they require renal replacement therapy. In the latter case, morbidity and mortality increase further. In order to meet the needs of the critically ill patients, a multidisciplinary care team is required, combining the efforts of physicians and nurses from different disciplines as well as nephrologists and intensivists. A personalized patient management is strongly recommended as proposed by the recent criteria of precision medicine. Early identification of patients at risk and timely intervention in case of AKI diagnosis can be obtained by integrating the role of nephrologist in the ICU practice. An innovative model of organization by introducing the nephrology rapid response team is advocated to manage critically ill patients with kidney problems in order to make early diagnosis and interventions, to reduce progression toward CKD and improve renal recovery. The routine adoption of AKI biomarkers together with such a collegial teamwork may represent the pathway toward success.
Mixed methods evaluation of a computerised audit and feedback dashboard to improve patient safety through targeting acute kidney injury (AKI) in primary care. [2023]Reducing the harms associated with acute kidney injury (AKI) requires addressing a wide range of patient safety issues, including polypharmacy and transitions of care, particularly for vulnerable patient groups. Computerised audit and feedback can transform the way healthcare organisations measure, analyse and learn from quality and safety data across different care settings, potentially improving patient safety.
A trial of in-hospital, electronic alerts for acute kidney injury: design and rationale. [2022]Acute kidney injury is common in hospitalized patients, increases morbidity and mortality, and is under-recognized. To improve provider recognition, we previously developed an electronic alert system for acute kidney injury. To test the hypothesis that this electronic acute kidney injury alert could improve patient outcome, we designed a randomized controlled trial to test the effectiveness of this alert in hospitalized patients. The study design presented several methodologic, ethical, and statistical challenges.
A system to improve medication safety in the setting of acute kidney injury: initial provider response. [2016]Clinical decision support systems can decrease common errors related to inappropriate or excessive dosing for nephrotoxic or renally cleared drugs. We developed a comprehensive medication safety intervention with varying levels of workflow intrusiveness within computerized provider order entry to continuously monitor for and alert providers about early-onset acute kidney injury. Initial provider response to the interventions shows potential success in improving medication safety and suggests future enhancements to increase effectiveness.
Decreasing Rates of Acute Kidney Injury After Percutaneous Coronary Interventions Through Education and Standardized Order Sets in a Large Tertiary Teaching Center. [2021]Acute kidney injury (AKI) is a common complication of percutaneous coronary interventions (PCI), and it is associated with increased morbidity, mortality, and healthcare costs. Post-PCI AKI is a major quality outcome measured by the National Cardiovascular Data Registry for hospitals that perform PCI. We report the experience of a large, tertiary center with high standardized, post-PCI AKI rates in which we implemented multilevel interventions that included: (1) a multidisciplinary education module for all personnel involved in care of patients undergoing cardiac angiography, (2) a standardized electronic medical record based preprocedure hydration protocol order set for patients undergoing cardiac angiography, and (3) a hydration task list to be completed by the care team the evening before the procedure or prior to admission. All this resulted in a constant decrease of the post-PCI AKI rates in remarkable magnitude, significantly stronger than the national tendency, demonstrating a center-specific behavior.
The Quality of Discharge Summaries After Acute Kidney Injury. [2023]Acute kidney injury (AKI) increases the risk of hospital readmission, chronic kidney disease, and death. Therefore, effective communication in discharge summaries is essential for safe transitions of care.
Integrative literature review of evidence-based patient-centred care guidelines. [2021]To summarize what facilitates patient-centred care for adult patients in acute healthcare settings from evidence-based patient-centred care guidelines.
[Contribution of a multimorbidity person-centered care strategy to the Comprehensive Family and Community Healthcare Model in Chile]. [2023]The Multimorbidity Person-Centered Care Model allows to customize care according the needs of each person.
What are the effective elements in patient-centered and multimorbidity care? A scoping review. [2018]Interventions to improve patient-centered care for persons with multimorbidity are in constant growth. To date, the emphasis has been on two separate kinds of interventions, those based on a patient-centered care approach with persons with chronic disease and the other ones created specifically for persons with multimorbidity. Their effectiveness in primary healthcare is well documented. Currently, none of these interventions have synthesized a patient-centered care approach for care for multimorbidity. The objective of this project is to determine the particular elements of patient-centered interventions and interventions for persons with multimorbidity that are associated with positive health-related outcomes for patients.
Patient-Centered and Family-Centered Care in the Intensive Care Unit. [2023]Patient-centered and family-centered care (PFCC) is widely recognized as integral to high-quality health-care delivery. The highly technical nature of critical care puts patients and families at risk of dehumanization and renders the delivery of PFCC in the intensive care unit (ICU) challenging. In this article, we discuss the history and terminology of PFCC, describe interventions to promote PFCC, highlight limitations to the current model, and offer future directions to optimize PFCC in the ICU.
Measuring Patients' Perceptions of Health Care Encounters: Examining the Factor Structure of the Revised Patient Perception of Patient-Centeredness (PPPC-R) Questionnaire. [2022]Given the ongoing desire to make health care more patient-centered and growing evidence supporting the provision of patient-centered care, it is important to have valid tools for measuring patient-centered care. The patient-centered clinical method (PCCM) is a conceptual framework for providing patient-centered care. A revision to the PCCM framework led to a corresponding need to enhance the Patient Perception of Patient-Centeredness (PPPC) questionnaire. The original PPPC was aligned with the components of the PCCM conceptual framework and developed to measure patient-centeredness from the patient's perspective. The purpose of this study was to examine the factor structure of a revised version of the PPPC (ie, PPPC-R).