Electronic Decision Support for Acute Kidney Injury

(MEnD-AKI Trial)

No longer recruiting at 8 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: End stage renal disease, eGFR <15, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new alert system can help doctors better manage drug-associated acute kidney injury (D-AKI) in hospitalized adults. The study tests a multi-hospital electronic decision support tool that sends alerts to doctors, assisting them in adjusting medications to prevent worsening kidney issues. Patients at risk of kidney injury from certain medications and who have a participating doctor might be suitable candidates. Conducted across eight hospitals, the trial compares the new alert system with the standard care alerts already in use. As an unphased trial, it offers patients the chance to contribute to innovative healthcare solutions that could enhance kidney injury management.

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 prior data suggests that this electronic decision support is safe for reducing drug-associated acute kidney injury?

Research shows that the electronic decision support system under testing aims to make medication safer for patients with kidney problems. This system assists doctors and pharmacists in selecting the correct drug doses. Early results suggest that patients generally respond well to this technology.

While the system might not directly improve kidney function, studies indicate it alters how healthcare providers manage patient care. No major reports of harm have emerged from using the system, suggesting that electronic alerts and support are safe for patients.

In summary, current evidence suggests that the electronic decision support system is a safe tool for hospitals. It aids healthcare professionals in making better decisions for patients at risk of kidney damage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care, which typically involves passive alerts for acute kidney injury (AKI), this new approach uses an electronic decision support system to actively identify and manage patients at risk. Researchers are excited about this method because it provides personalized risk profiles and medication management plans, which are delivered directly to physicians by pharmacists. This targeted intervention could lead to better prevention of AKI progression, ultimately improving patient outcomes.

What evidence suggests that this electronic decision support is effective for reducing drug-associated acute kidney injury?

This trial will compare a protocolized stage-based intervention with usual care. Research has shown that electronic decision support systems can enhance medication safety for kidney patients by reducing dosing errors. One study found that alerts for acute kidney injury (AKI) did not directly improve kidney function, but they altered care delivery. Another study in the UK suggested that electronic alerts and care plans might improve outcomes for AKI patients. In this trial, the intervention arm uses an automated alerting system to identify patients at risk of worsening kidney injury due to certain medications, with pharmacists providing recommendations. This approach aims to prevent drug-related acute kidney injury from worsening in hospitalized adults. ^{1 2 3 5 6}

Who Is on the Research Team?

Sandra L Kane-Gill, PharmD, MS

Principal Investigator

University of Pittsburgh

Azra Bihorac, MD, MS

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for non-ICU hospitalized adults at risk of drug-associated acute kidney injury (D-AKI) within the UPMC system. Specific eligibility criteria are not provided, but typically include factors like age, health status, and specific medical conditions related to the study.

Inclusion Criteria

Physician-subject Inclusion: Physicians employed at UPMC hospital systems

Physician-subject Inclusion: Attending physicians of record who care for patients across multiple units outside ICU/ED

Physician-subject Inclusion: Physician cares for 1 or more patient receiving a system alert identifying high-risk for AKI

Exclusion Criteria

Physician-subject Exclusion: Physicians who primarily provide care for transplant (heart, kidney, liver, etc.) patients

Physician-subject Exclusion: Physicians who primarily provide consult services only (dermatology, rehabilitation, etc.)

Physician-subject Exclusion: Physicians of record who only care for ICU or ED patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Protocolized stage-based intervention delivered to the physician by a pharmacist using an automated alerting system

up to 30 days

Ongoing monitoring through EMR alerts

Usual Care

Standard care with Cerner EMR-based AKI passive alert

up to 30 days

Ongoing monitoring through EMR alerts

Follow-up

Participants are monitored for Major Adverse Kidney Events within 30 days of randomization

up to 30 days

What Are the Treatments Tested in This Trial?

Interventions

• Multi-hospital Electronic Decision Support

Trial Overview The trial tests a clinical surveillance system with real-time analytics supporting pharmacist-led interventions aimed at reducing D-AKI progression in patients. It's a randomized controlled trial across eight hospitals where participants receive different levels of alert or intervention.

How Is the Trial Designed?

Group I: Protocolized stage-based intervention Experimental Treatment 2 Interventions

The intervention uses an automated alerting system to identify patients: 1) receiving a high-risk drug or drug combination associated with AKI and at low-risk for progression to either stage 2 AKI or stage 3 AKI (Level A) and 2) patients without AKI or stage 1 AKI receiving a high-risk drug or drug combination associated with AKI and at high risk for progression to either stage 2 AKI or stage 3 AKI, and patients with AKI stage 2 or stage 3 receiving a high-risk drug or drug combination associated with AKI or a medication that requires renal dose adjustment (Level B). This patient specific risk-profile will be coupled with recommendations for medication management and delivered to the physician by a pharmacist for consideration and approval.

Group II: Usual Care Active Control 1 Intervention

A Cerner EMR-based AKI passive alert which is standard of care at UPMC.

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+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+

Published Research Related to This Trial

In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.

The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]

Patients with stage 3 and 4 chronic kidney disease (CKD) are at high risk for adverse drug events (ADEs) due to the kidneys' role in medication clearance, highlighting the need for effective monitoring systems.

Interviews with clinics revealed significant differences in electronic decision support practices and organizational culture, which are crucial factors to consider when implementing electronic drug-disease alerts to reduce ADEs in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the diffusion of innovations theory to assess socio-technical factors in planning the implementation of an electronic health record alert across multiple primary care clinics. Lin, CP., Guirguis-Blake, J., Keppel, GA., et al.[2018]

The implementation of a clinical decision support system (CDSS) significantly improved the response to nephrotoxic drug alerts, with 29% of alerts leading to changes in medication compared to 20% before the system was in place.

The CDSS contributed to a slight increase in the detection of acute kidney injury (AKI) cases, suggesting that real-time alerts can enhance patient safety by promoting more careful drug selection in at-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of drug prescribing in acute kidney injury with a nephrotoxic drug alert system. Arias Pou, P., Aquerreta Gonzalez, I., Idoate García, A., et al.[2022]

In a study of 300 adult patients with chronic kidney disease (CKD), 40.7% experienced adverse drug events (ADEs), highlighting the high prevalence of medication-related complications in this population.

Out of the 159 reported ADEs, 30.2% were deemed preventable, suggesting that the involvement of clinical pharmacists in monitoring medication use could significantly reduce these events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events in hospitalized patients with chronic kidney disease. Hassan, Y., Al-Ramahi, RJ., Aziz, NA., et al.[2022]

In a study involving 6030 adult inpatients with acute kidney injury across six hospitals, electronic health record alerts did not significantly improve patient outcomes related to mortality, dialysis, or progression of kidney injury, with a primary outcome occurrence of 21.3% in the alert group compared to 20.9% in usual care.

Interestingly, in non-teaching hospitals, alerts were associated with worse outcomes, including a higher risk of death, suggesting that the effectiveness of alert systems may vary significantly by hospital type and warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic health record alerts for acute kidney injury: multicenter, randomized clinical trial. Wilson, FP., Martin, M., Yamamoto, Y., et al.[2021]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40850370/

Study protocol for a randomized clinical trial Multi-hospital electronic decision support for drug-associated acute kidney injury (MEnD-AKI): Study protocol for a randomized clinical trial.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06264752?cond=acute%20kidney%20injury&spons=NIDDK&aggFilters=status:not%20rec%20act&viewType=Table&rank=3

Multi-hospital Electronic Decision Support for Drug ... The primary outcome is Major Adverse Kidney Events within 30 days of randomization (MAKE30), defined as defined as a composite of death, new kidney replacement ...

3. withpower.com withpower.com/trial/phase-acute-kidney-injury-1-2024-5a2bf

Electronic Decision Support for Acute Kidney Injury The electronic decision support system is designed to improve medication safety by reducing errors in drug dosing for patients with kidney issues. Initial ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814092

Automated Electronic Alert for the Care and Outcomes of ... Results of this randomized clinical trial showed that the electronic AKI alert did not improve kidney function or other patient-centered outcomes but changed ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10863540/

Impact of electronic AKI alert/care bundle on AKI inpatient ... Outcomes among acute kidney injury (AKI) patients are poor in United Kingdom (UK) hospitals, and electronic alerts and care bundles may improve them.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12070640/

The influence of electronic AKI alert on prognosis of adult ... The primary outcomes were mortality and renal replacement therapy (RRT) rates, Secondary outcomes included hospital length of stay (LoS), AKI ...