UPTAKE: Using Personalized Risk and Digital Tools to Guide Transitions Following Acute Kidney Events

NCT05806645 | Recruiting DMC

• 1 other identifier: UPTAKE Pro00128939
• Study Type: interventional
• Target: 6,046
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Primary effectiveness outcome

  The primary outcome of the study is major adverse kidney or CV events within 2 years after discharge, defined as the composite of death, kidney failure (receipt of maintenance dialysis, kidney transplant or eGFR \< 15 mL/min/1.73m2 for 4 weeks or more), or hospitalization with a most responsible diagnosis for heart failure, myocardial infarction, or stroke (based on validated ICD-10 coding algorithms)

  2 years after discharge

Secondary Outcomes (9)

• Secondary Clinical Outcomes-Death

  2 years of discharge

• Safety Outcomes- Hyperkalemia

  within 1 year of discharge

• Safety Outcomes-Hospitalization for Kidney Disease Ambulatory Care Specific Condition

  within 1 year of discharge

• Safety Outcomes-All Cause Hospitalization or ED Visit

  30 and 90 days of discharge

• Secondary Clinical Outcomes-Kidney Failure

  within 2 years of discharge

Study Arms (2)

Intervention

EXPERIMENTAL

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

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

Usual Care

NO 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.

Interventions

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

Patients will receive transition of care plans that are tailored to their medical profile and risk and embedded within standardized discharge pathways within the EHR- Education and self-management guidance about AKI for patients, Medication guidance based on evidence-based indications for reducing risk of cardiac and kidney outcomes, Recommendations for subsequent laboratory testing of kidney function, proteinuria and electrolytes according to clinical characteristics and risks, Recommendations for timing and nature of PCP follow-up, Information about the patient's AKI and subsequent management provided to PCPs through discharge summary, Recommendations for outpatient Pharmacy follow-up for medication reconciliation and review according to patient risk and medication management gaps, Recommendations for Nephrology referral for high risk patients

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (all of)
• Age ≥ 18 years old
• Hospitalized at site using AHS EHR
• Acute Kidney Injury (Stage 1-3) identified in hospital per KDIGO guideline criteria

You may not qualify if:

• (any of)
• Pre-hospitalization advanced CKD: eGFR\<30 mL/min/1.73m2
• Pre-hospitalization dialysis
• Very low risk (\<1% risk) of advanced CKD
• Non-Alberta resident
• Palliative goals of care
• Enrolled in the UPTAKE VC Trial
• Admitted under a nephrologist at time of discharge
• Dialysis on at least 2 days in the last week prior to discharge
• Receiving apheresis
• Kidney transplant recipient
• Diagnosis of Glomerulonephritis
• Cirrhosis AND complication of cirrhosis in medical history or active problem list (ascites, varices, hepatic encephalopathy, hepatorenal syndrome)

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator
• University of Calgary: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Foothills Medical Centre

Calgary, Alberta, Canada

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, Canada

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Neesh Pannu

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Matthew James

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Tyrone Harrison

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neesh Pannu

CONTACT

780 492 8519; npannu@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a waiver of consent trial, participants will be randomized to an enhanced discharge care pathway vs usual care in the electronic health record.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 10, 2023
• Study Start: February 12, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)