Patient-centered Care for Acute Kidney Injury

(COPE-AKI Trial)

Recruiting at 8 trial locations

Overseen By Susan J Copelli, MSHI

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: End-stage kidney disease, Non-kidney end-organ failure, Metastatic malignancy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 90

Duration: 90 days

2145 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for people with severe acute kidney injury (AKI) by comparing a special intervention, the Multimodal Intervention, against usual care. The intervention includes a study doctor, a nurse for guidance and education, and a pharmacist to review medications. Researchers seek to determine if this approach results in more days out of the hospital and better kidney health. Suitable candidates are adults who have experienced stage 2 or 3 AKI for at least two days without quick improvement. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies for AKI.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the approach tested in the COPE-AKI study is generally safe for patients. This approach includes several components: doctors oversee care, nurses educate about kidney disease, and pharmacists review medications. While specific side effects are not listed, the study ensures the approach is both safe and effective. Since the study does not test a new drug or invasive procedure, the risk of harmful side effects is likely low. This type of care aims to improve kidney health without causing additional issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the multimodal intervention for acute kidney injury because it offers a comprehensive approach that current treatments typically don't include. Unlike standard care, which primarily focuses on medication management and follow-up, this intervention combines physician oversight, nurse navigation, and pharmacist-led medication review. The nurse navigator plays a crucial role in educating patients about kidney disease and coordinating their care, potentially leading to better outcomes. Additionally, the inclusion of a pharmacist to review and reconcile medications ensures that patients avoid harmful drug interactions, which is a unique feature compared to usual care. This integrated approach aims to improve patient recovery and long-term kidney health by addressing multiple aspects of care simultaneously.

What evidence suggests that this multimodal intervention is effective for acute kidney injury?

Research has shown that combining different treatments can improve recovery after acute kidney injury (AKI). In this trial, participants in the Multimodal Process of Care Intervention arm will receive a comprehensive approach involving study physician oversight, nurse navigator support, and pharmacist-led medication review. One study found that care bundles, similar to these combined treatments, reduced the need for dialysis. This suggests that collaboration among doctors, nurses, and pharmacists can manage AKI more effectively. By focusing on follow-up care, education, and medication review, these treatments aim to prevent further kidney problems and enhance recovery. Early results are promising, indicating better patient outcomes and fewer complications. ^{1 4 6 7 8}

Who Is on the Research Team?

Kaleab Abebe, PhD

Principal Investigator

Univerisity of Pittsburgh

Paul Palevsky, MD

Principal Investigator

University of Pittsburgh

Linda Fried, 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

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

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?

Group I: Multimodal Process of Care Intervention Experimental Treatment 4 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 Care Active Control 1 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.

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

The revised Patient Perception of Patient-Centeredness (PPPC-R) questionnaire, tested on 381 patients in Ontario, Canada, successfully identified a 3-factor model that effectively measures patient-centered care, demonstrating good statistical fit and validity.

While the PPPC-R aligns with the Patient-Centered Clinical Method (PCCM) framework, it reflects the patient's actual experience of care rather than a direct correspondence, highlighting the importance of patient perspectives in evaluating healthcare quality.

NCBI (Pubmed)

pubmed.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. Ryan, BL., Brown, JB., Tremblay, PF., et al.[2022]

The review identified three key factors that facilitate patient-centred care in acute healthcare settings: effective patient care practices, educational initiatives for both staff and patients, and supportive organizational policies.

Implementing these evidence-based guidelines can enhance the quality of care by promoting better communication, family involvement, and interdisciplinary collaboration among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative literature review of evidence-based patient-centred care guidelines. Jardien-Baboo, S., van Rooyen, DRM., Ricks, EJ., et al.[2021]

A scoping review of 98 studies identified key elements of patient-centered interventions that can improve health outcomes for patients with multimorbidity, emphasizing the importance of supporting patient self-management and decision-making processes.

The review suggests that integrating patient-oriented approaches, interdisciplinary teamwork, and training for healthcare providers can significantly enhance care for individuals with multiple chronic conditions, leading to better health management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the effective elements in patient-centered and multimorbidity care? A scoping review. Poitras, ME., Maltais, ME., Bestard-Denommé, L., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Acute kidney injury (AKI) significantly increases the risk of complications and mortality in ICU patients, highlighting the need for a multidisciplinary care approach that includes nephrologists and intensivists.

Implementing a nephrology rapid response team and using AKI biomarkers for early diagnosis and intervention can improve patient outcomes, reduce the progression to chronic kidney disease (CKD), and enhance renal recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical Care Nephrology: A Multidisciplinary Approach. Rizo-Topete, L., Ronco, C.[2017]

The quality of discharge summaries for patients who survived acute kidney injury (AKI) is generally low, with a median score of only 4 out of 9, indicating that many important elements of care are often omitted.

Factors such as higher baseline creatinine levels, intrarenal causes of AKI, and increased severity of AKI are associated with better quality discharge summaries, highlighting areas for improvement in communication and care transitions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Quality of Discharge Summaries After Acute Kidney Injury. Giles, C., Novakovic, M., Hopman, W., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized acute kidney injury after care. Koyner, JL., Haines, RW., Bouchard, J.[2022]

Acute kidney injury (AKI) can negatively affect both short- and long-term health outcomes, even if patients appear to fully recover based on serum creatinine levels, highlighting the importance of timely intervention.

Effective management of AKI involves identifying and addressing its causes, as well as creating an optimal environment for kidney recovery, with new kidney biomarkers playing a crucial role in treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Acute kidney injury - status of biomarkers in perioperative and critically ill patients]. Haase-Fielitz, A., Haase, M.[2017]

The implementation of an audit and feedback dashboard targeting acute kidney injury (AKI) in 45 general practices led to significant improvements in medication review (+9.01%) and blood pressure measurement (+5.20%) over six months, indicating enhanced patient safety practices.

Despite some improvements, variable performance was noted for other quality indicators, highlighting the need for better resources and support to fully realize the potential of technology in improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mixed methods evaluation of a computerised audit and feedback dashboard to improve patient safety through targeting acute kidney injury (AKI) in primary care. Tsang, JY., Brown, B., Peek, N., et al.[2023]

A qualitative study involving 67 healthcare professionals highlighted that the Multimorbidity Person-Centered Care Model (MACEP) significantly contributes to the development of key principles in the Comprehensive Family and Community Health Care Model (MAIS).

Participants recognized that the innovations from MACEP facilitate the implementation of Family Health principles, emphasizing the importance of incorporating feedback from both implementers and users to enhance healthcare services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Contribution of a multimorbidity person-centered care strategy to the Comprehensive Family and Community Healthcare Model in Chile]. Martínez, M., Sapag, JC., Zamorano, P., et al.[2023]

The study enrolled 2373 out of a targeted 2400 hospitalized patients to evaluate the effectiveness of an electronic alert system for acute kidney injury, highlighting the feasibility of conducting a randomized controlled trial without individual informed consent due to ethical considerations.

Preliminary data indicated a significant correlation between the severity of acute kidney injury and inpatient mortality, with mortality rates ranging from 6.4% for mild cases to 29% for severe cases, underscoring the importance of early detection and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A trial of in-hospital, electronic alerts for acute kidney injury: design and rationale. Wilson, FP., Reese, PP., Shashaty, MG., et al.[2022]

A clinical decision support system was developed to monitor and alert healthcare providers about potential early-onset acute kidney injury related to nephrotoxic or renally cleared drugs, aiming to reduce dosing errors.

Initial responses from providers indicate that this medication safety intervention may improve patient safety, with potential for future enhancements to further increase its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A system to improve medication safety in the setting of acute kidney injury: initial provider response. McCoy, AB., Peterson, JF., Gadd, CS., et al.[2016]

Patient-centered and family-centered care (PFCC) is essential for high-quality healthcare, especially in the challenging environment of the intensive care unit (ICU).

The article discusses various interventions to enhance PFCC in the ICU, while also addressing the limitations of current practices and suggesting future improvements to better support patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered and Family-Centered Care in the Intensive Care Unit. Secunda, KE., Kruser, JM.[2023]

A large tertiary center implemented a series of interventions, including education and hydration protocols, which led to a significant decrease in post-PCI acute kidney injury (AKI) rates, outperforming national trends.

These interventions included a multidisciplinary education module and a standardized hydration protocol, highlighting the importance of proactive care in reducing AKI complications associated with percutaneous coronary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreasing Rates of Acute Kidney Injury After Percutaneous Coronary Interventions Through Education and Standardized Order Sets in a Large Tertiary Teaching Center. daSilva-deAbreu, A., Gurung, S., Bracamonte-Baran, W., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12465485/

Effect of acute kidney injury care bundles on patient ... Seven studies reported the application of renal replacement therapy after AKI care bundle interventions, with 64 out of 2,774 patients in the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05805709

Study Details | NCT05805709 | A Patient-centered Trial of ... Key secondary outcomes include: rates of MAKE (measured at 90, 180, and 365 days), rates of recurrent AKI (90, 180, and 365 days), and 4 patient-report outcomes ...

3. withpower.com withpower.com/trial/phase-acute-kidney-injury-4-2023-c8227

Patient-centered Care for Acute Kidney Injury 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1532046424000662

Forecasting acute kidney injury and resource utilization in ... Our study revealed the importance and the technicality of applying longitudinal, multimodal modeling to improve early prediction of AKI and CRRT, offering ...

5. academic.oup.com academic.oup.com/jamiaopen/article/8/4/ooaf065/8185567

Artificial intelligence models for predicting acute kidney injury ... This review comprehensively assesses the modeling methods, data utilization strategies, and clinical applicability of AKI prediction models in the ICU

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10980131/

Forecasting Acute Kidney Injury and Resource Utilization in ... Our study revealed the importance and the technicality of applying longitudinal, multimodal modeling to improve early prediction of AKI and CRRT, offering ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2949761224001019

Assessments of Generative Artificial Intelligence as Clinical ... Clinical interventions that prevent or reduce AKI severity include altering medication and contrast administration, treating underlying sepsis, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6061256/

A narrative review of the impact of interventions in acute ... This narrative review discusses reactive interventions and their impact on the progression and severity of AKI, and on mortality from it.