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

Trial Summary

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 data supports the effectiveness of the treatment Risk-guided transition of care intervention delivered through an integrated digital health strategy for Acute Kidney Injury?

Research shows that using digital systems, like electronic health records, can improve care for patients with acute kidney injury by enhancing communication and follow-up care, which may reduce hospital readmissions and improve patient outcomes. ^{1 2 3 4 5}

Is the digital health strategy for acute kidney injury safe for humans?

The research articles focus on improving care and communication for acute kidney injury using digital tools, but they do not provide specific safety data for the digital health strategy itself. ^{1 3 4 6 7}

How is the digital health strategy for acute kidney injury treatment different from other treatments?

This treatment is unique because it uses a digital health strategy to guide the transition of care for acute kidney injury patients, focusing on improving communication and coordination between healthcare providers through technology, which is not typically emphasized in standard treatments. ^{1 2 3 4 8}

What is the purpose of this trial?

Nearly one in ten people who are hospitalized in Canada develop a complication with sudden loss of kidney function, called acute kidney injury (AKI). AKI may lead to other severe health problems after discharge home, such as kidney failure requiring dialysis treatment, heart failure, heart attacks, stroke, and even premature death. Discharge from hospital to home can be a difficult transition where there are often gaps in identification, communication, care coordination, education, and planning of care for AKI. The study team will co-design and evaluate a tailored post-discharge care plan that is based on the risk of later kidney problems and uses currently available, yet untapped digital innovation to improve the health and experience of people with AKI. This study will be built into Alberta's new Epic Systems based provincial electronic health record (EHR). The plan is to use digital tools in the EHR to identify all people in Alberta hospitals that have had an AKI event and are at increased risk of long-term complications. Half will randomly be assigned to receive a tailored care plan based on their risk at hospital discharge while the other half will receive care as it is currently provided by their healthcare team. The electronic health system will automatically calculate a patient's risk and report this risk in their chart along with recommendations for care. The study team includes patients, healthcare providers, and health system decision makers needed to co-develop the proposed strategy and introduce the changes needed to deliver this intervention. The investigators will study whether this strategy can reduce health problems that may happen after AKI including death, chronic kidney disease (CKD), kidney failure, heart attacks, and stroke. The investigators will also determine if the approach improves patient experience during the transition from hospital to home. This study has the potential to revolutionize how we care for people that leave hospital after having AKI.

Research Team

Neesh Pannu

Principal Investigator

University of Alberta

Matthew James

Principal Investigator

University of Calgary

Tyrone Harrison

Principal Investigator

University of Calgary

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

An electronic health record-based intervention to increase follow-up office visits and decrease rehospitalization in older adults. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Comprehensive Acute Kidney Injury Survivor Care: Protocol for the Randomized Acute Kidney Injury in Care Transitions Pilot Trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Electronic health record alerts for acute kidney injury: multicenter, randomized clinical trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Hospital discharge communications during care transitions for patients with acute kidney injury: a cross-sectional study. [2018]

5. England 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A computerized provider order entry intervention for medication safety during acute kidney injury: a quality improvement report. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Guidance for post-discharge care following acute kidney injury: an appropriateness ratings evaluation. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Exploring the Evidence: Using Technology to Improve Integrated Care Coordination. [2023]