Digital Health Strategy for Acute Kidney Injury

(UPTAKE-1 Trial)

Recruiting at 1 trial location

Overseen By Neesh Pannu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Advanced CKD, Dialysis, Transplant, Cirrhosis, others

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

Compensation: Varies

Number of Visits: Unknown

6046 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for individuals who have experienced sudden kidney problems, known as acute kidney injury (AKI), after hospital discharge. Researchers will use digital tools to create personalized care plans, called a risk-guided transition of care intervention, delivered through an integrated digital health strategy. These plans aim to prevent serious health issues like kidney failure or heart attacks. Half of the participants will receive these tailored plans, while the other half will continue with standard care. The trial targets those hospitalized in Alberta with AKI who are at risk of long-term kidney issues.

As an unphased trial, this study offers participants the chance to contribute to innovative care strategies that could enhance recovery and prevent future health complications.

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 study team or your healthcare provider.

What prior data suggests that this digital health strategy is safe for patients with acute kidney injury?

Past studies have shown promise in using digital health methods to care for patients with acute kidney injury (AKI). Research indicates that these methods can create personalized care plans and improve patient outcomes without significant risks. One study found that digital tools guiding care plans increased recommended care for patients at high risk of chronic kidney disease (CKD) after hospital discharge. This suggests that the digital health approach is generally well-received.

While specific data on side effects related to this digital health method is unavailable, similar strategies have been used without major safety concerns. Since the trial uses existing digital tools to customize care plans, it is unlikely to introduce new risks. The trial does not test a new drug or invasive treatment but focuses on improving care through personalized plans, which are usually safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel digital health strategy for managing acute kidney injury (AKI). Unlike standard care, which typically involves hospital discharge with general follow-up recommendations, this approach uses a risk-guided transition of care. It leverages a risk prediction model combined with a patient's medical profile to create personalized care plans. These plans are integrated into electronic health records, potentially leading to more tailored and effective management from hospital to home, particularly for patients at varying risk levels. This personalized approach could improve outcomes by ensuring that care is specifically aligned with each patient's needs.

What evidence suggests that this digital health strategy is effective for acute kidney injury?

This trial will compare a risk-guided transition of care intervention, delivered through an integrated digital health strategy, with usual care for patients with acute kidney injury (AKI). Research has shown that a targeted approach for patients with AKI can improve their care after hospital discharge. One study found that this approach increased the use of recommended care for those at high risk of long-term kidney issues. Digital tools assist by identifying patients who might face complications, ensuring they receive personalized care plans. This method aims to reduce the chances of serious health problems like kidney failure, heart attacks, and strokes. The strategy could enhance patients' health and experiences as they transition from hospital to home. ^{1 2 3 4 6}

Who Is on the Research Team?

Neesh Pannu

Principal Investigator

University of Alberta

Matthew James

Principal Investigator

University of Calgary

Tyrone Harrison

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for adults over 18 in Alberta hospitals who've had a sudden loss of kidney function (acute kidney injury or AKI) and are at risk of future health issues. They must be hospitalized where the AHS electronic health record system is used.

Inclusion Criteria

(all of)

I am currently hospitalized where AHS electronic health records are used.

I have been diagnosed with acute kidney injury stages 1 to 3.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a tailored post-discharge care plan based on their risk of long-term complications after AKI

2 years

Regular follow-ups integrated within the electronic health record

Follow-up

Participants are monitored for safety and effectiveness after discharge, including kidney function and cardiovascular events

2 years

Regular monitoring through electronic health records and periodic surveys

Patient Experience Assessment

Patient experience is assessed using a survey administered 3 months post-discharge

3 months post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• Risk-guided transition of care intervention delivered through an integrated digital health strategy

Trial Overview

The study tests a personalized care plan based on patients' risk levels after an AKI event, using digital tools within Alberta's healthcare EHR. Participants will either receive this tailored plan or standard care, determined randomly.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The proposed experimental intervention will incorporate our risk prediction model which will be used in combination with a patients medical profile to guide the hospital to home transition of care for low, medium and high-risk groups of patients. Patients will receive transition of care plans that are tailored to their medical profile and embedded within standardized discharge pathways within the electronic health record

Group II: Usual Care Active Control 1 Intervention

The usual care group will not receive the risk-guided transition of intervention and will receive standard hospital discharge care in accordance with local health system standards (Alberta Health Services), with recommendations for kidney function, proteinuria and laboratory testing at 90 days after discharge.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Published Research Related to This Trial

The ACT program, designed for post-acute kidney injury (AKI) care, aims to improve follow-up and health outcomes by embedding care in primary clinics, and is currently being tested for feasibility and acceptability in a pilot trial with 34 participants.

This study will evaluate the effectiveness of the ACT program compared to usual care, focusing on patient education, laboratory monitoring, and follow-up within 14 days after discharge, with outcomes assessed over 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Acute Kidney Injury Survivor Care: Protocol for the Randomized Acute Kidney Injury in Care Transitions Pilot Trial. May, HP., Griffin, JM., Herges, JR., et al.[2023]

The implementation of a computerized provider order entry alert system significantly improved the rate of medication modification or discontinuation in patients with acute kidney injury, increasing from 35.2 to 52.6 per 100 events within 24 hours (P < 0.001).

The intervention also led to faster responses in modifying or discontinuing medications, indicating that such alert systems can enhance medication safety during changes in kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A computerized provider order entry intervention for medication safety during acute kidney injury: a quality improvement report. McCoy, AB., Waitman, LR., Gadd, CS., 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]

In a review of discharge communications for 75 patients hospitalized with acute kidney injury (AKI), less than half of the physician discharge summaries and patient instructions included essential information about the presence, cause, or course of AKI, indicating a significant gap in communication.

Discharge communications were more comprehensive for patients with more severe AKI (Stage 3) and those with chronic kidney disease, highlighting the need for improved quality and consistency in discharge instructions to enhance post-hospitalization care for all AKI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital discharge communications during care transitions for patients with acute kidney injury: a cross-sectional study. Greer, RC., Liu, Y., Crews, DC., et al.[2018]

A study involving a 10-person expert panel evaluated 819 clinical scenarios to establish guidelines for post-discharge care for adults recovering from acute kidney injury (AKI), emphasizing the necessity of timely actions like medication reviews and kidney function monitoring.

The panel unanimously agreed that taking no action after discharge is inappropriate, recommending that initial medication reviews and kidney monitoring should occur within 1-2 weeks or 1 month, particularly for high-risk patients such as those with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidance for post-discharge care following acute kidney injury: an appropriateness ratings evaluation. Tsang, JY., Murray, J., Kingdon, E., et al.[2020]

The electronic health record-based intervention did not significantly improve the rate of timely office visits to primary care providers within 7 days after hospital discharge for older adults, with 27.7% in the intervention group and 28.3% in the control group attending visits.

There was no significant difference in the rehospitalization rates within 30 days after discharge between the intervention group (18.8%) and the control group (19.9%), indicating that the intervention did not effectively reduce the risk of rehospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An electronic health record-based intervention to increase follow-up office visits and decrease rehospitalization in older adults. Gurwitz, JH., Field, TS., Ogarek, J., et al.[2022]

A review of 43 studies on digital systems for managing acute kidney injury (AKI) found that most interventions effectively used real-time serum creatinine levels to improve early recognition and risk prediction at the individual clinician level, but broader system-level applications were rare.

Despite the clear benefits of real-time data for individual patient care, there is limited evidence of improved outcomes at the organizational level, highlighting the need for better system design and interoperability to fully realize the potential of learning healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scoping review exploring the impact of digital systems on processes and outcomes in the care management of acute kidney injury and progress towards establishing learning healthcare systems. Chew, CKT., Hogan, H., Jani, Y.[2021]

Patients with chronic kidney disease (CKD) often experience poor care coordination during transitions between different healthcare settings, which can lead to negative health outcomes.

The article highlights the importance of using technology-based interventions to improve integrated care and facilitate smoother transitions for CKD patients, addressing gaps in communication and information exchange among providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Evidence: Using Technology to Improve Integrated Care Coordination. Feldner, K., Davey, H.[2023]

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Digital Health Strategy for Acute Kidney Injury

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The main outcome was AKI within 7 days of cardiac catheterization among all participants and those with preexisting chronic kidney disease. In ...

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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 ...