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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old

Hospitalized at site using AHS EHR

Acute Kidney Injury (Stage 1-3) identified in hospital per KDIGO guideline criteria

Disqualifiers

Pre-hospitalization advanced CKD: eGFR<30 mL/min/1.73m2

Pre-hospitalization dialysis

Very low risk (<1% risk) of advanced CKD

Non-Alberta resident

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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

Treatment groups

6,046 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

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)

Time frame
2 years after discharge

Secondary outcomes

1

Secondary Clinical Outcomes-Death

Death from any cause within 2 years of discharge

Time frame
2 years of discharge
2

Safety Outcomes- Hyperkalemia

Serum potassium ≥ 6.0 mEq/L on outpatient lab testing within one year of discharge

Time frame
within 1 year of discharge
3

Safety Outcomes-Hospitalization for Kidney Disease Ambulatory Care Specific Condition

Hospitalization for a Kidney Disease Ambulatory Care Specific Condition (Congestive Heart Failure, Volume Overload, Hyperkalemia, or Hypertensive Emergency) within one year after discharge (based on ICD-10 coding algorithms)

Time frame
within 1 year of discharge
4

Safety Outcomes-All Cause Hospitalization or ED Visit

All-cause hospitalization or ED visits within 30 and 90 days of discharge

Time frame
30 and 90 days of discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Alberta Health services

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

University of Calgary

Collaborator