Clinical trial NCT05806645: UPTAKE: Using Personalized Risk and Digital Tools to Guide Transitions Following Acute Kidney Events
Official title: UPTAKE: Using Personalized Risk and Digital Tools to Guide Transitions Following Acute Kidney Events- A Pragmatic Randomized Controlled Trial in Connect Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Health services
name: Canadian Institutes of Health Research (CIHR)
name: University of Calgary
First posted: 2023-04-10
Enrollment: 6046
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Acute kidney injury (AKI) is common in hospitalized patients and associated with poor long-term outcomes including kidney failure, cardiovascular (CV) events, and death, with highest risk in older adults. The transition of hospitalized patients with AKI to home is challenging, with many care gaps. Identifying those at highest risk of adverse post-discharge outcomes and delivering interventions to reduce the risk of progressive kidney and CV disease via appropriate, acceptable, and efficient intervention strategies are needed. Our team has developed and externally validated a risk prediction model for hospitalized adults with AKI, which can estimate the risk of advanced chronic kidney disease (eGFR\<30mL/min/1.73m2 or kidney failure). The investigators used this risk model to guide follow-up in a pilot trial for AKI survivors within Alberta (ClinicalTrials.gov: NCT02915575). The investigators have found that a risk-guided strategy to follow-up is a feasible approach to close gaps in care; however, larger studies are required to evaluate broader implementation, and impact on patient-centered outcomes, costs, and sustainability in a real-world setting. Alberta Health Services (AHS) has implemented a new province-wide clinical information system which provides a unique opportunity to use digital health technology to design and evaluate a risk-guided hospital-to-home transition of care intervention that builds upon previous work.

OBJECTIVES AND METHODS:

1. To co-develop a risk-guided intervention with patients, clinicians, and health system decision-makers to improve personalized transitions of care between hospital and home for survivors of AKI. The investigators will use a participatory research approach that engages patients and care providers to co-design an evidence-guided, experience-based intervention for AKI transitions in care. Qualitative methods will be used to identify and prioritize transition interventions aligned with patient risk of adverse post-discharge outcomes.
2. To a) identify key service delivery supports required to integrate the AKI hospital to home transition of care intervention and b) establish usability and acceptability of the intervention within the electronic health record. With the support of the AHS and existing hospital to home transition initiatives, the investigators will work with key health system partners to integrate developed AKI transition of care intervention within the EHR. The investigators will use a mixed methods approach to identify barriers and enablers to implementation and establish usability and acceptability of the intervention.
3. To evaluate the effectiveness of this intervention in a pragmatic clinical trial that will measure implementation success and impact on patient experience, outcomes, and costs. Using the EHR, hospitalized adults with AKI at increased risk of adverse long-term outcomes will be randomized to the risk-guided transition intervention or usual care. The risk-guided arm will receive the interventions identified in Objective 1 tailored based on their clinical profile and risk of CKD from the prediction model. The primary outcome of the trial is the two-year risk of a composite of death, kidney failure, or major CV event. 6,046 patients are required to detect a 15% relative risk reduction of the primary outcome, with 90% power. Effects on patient experience, processes of care, implementation, and costs will also be evaluated.

Eligibility criteria: Inclusion Criteria:

(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

Exclusion Criteria:

(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)

Primary outcomes:
measure: Primary effectiveness outcome
timeFrame: 2 years after discharge
Secondary outcomes:
measure: Secondary Clinical Outcomes-Death
timeFrame: 2 years of discharge
measure: Safety Outcomes- Hyperkalemia
timeFrame: within 1 year of discharge
measure: Safety Outcomes-Hospitalization for Kidney Disease Ambulatory Care Specific Condition
timeFrame: within 1 year of discharge
measure: Safety Outcomes-All Cause Hospitalization or ED Visit
timeFrame: 30 and 90 days of discharge
measure: Secondary Clinical Outcomes-Kidney Failure
timeFrame: within 2 years of discharge
measure: Secondary Clinical Outcomes-Hospitalization for CV Events
timeFrame: Within 2 years of hospital discharge
measure: Patient Experience
timeFrame: 3 months post discharge
measure: Implementation Outcomes
timeFrame: 2 or 4 weeks of discharge
measure: Process of Care Outcomes
timeFrame: within 2 or 4 weeks or 90 days of discharge
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Neesh Pannu
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Matthew James
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Tyrone Harrison
role: PRINCIPAL_INVESTIGATOR
References: