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

Study Overview
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Brief Summary
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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 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, need for dialysis, 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
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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 major adverse kidney and cardiovascular events and death. 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) is currently implementing 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: 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. 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. 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 to estimated risk from the prediction model. The primary outcome of the trial is the one-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.

Official Title
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UPTAKE: Using Personalized Risk and Digital Tools to Guide Transitions Following Acute Kidney Events- A Pragmatic Randomized Controlled Trial in Connect Care

Conditions
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Acute Kidney Injury

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


Participation Criteria
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Eligibility Criteria
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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) Already under nephrologist care (CKD, dialysis, or transplant program care prior to hospital discharge) Pre-hospitalization advanced CKD: eGFR<30 mL/min/1.73m2 Low risk (<1% risk) of death or advanced CKD (based on our CKD risk prediction model51) Non-Alberta resident (without registration for Alberta health care insurance coverage) Palliative goals of care (C1/C2 per AHS framework)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The proposed experimental intervention will incorporate our risk prediction model which will be used to guide the hospital to home transition of care for medium and high-risk groups of patients. Patients will receive transition of care plans that are tailored to their risk and embedded within standardized discharge pathways within the EHR. Documentation of AKI in the discharge summary Consult for medication reconciliation Information about AKI provided to patients through EHR Sick day guidance provided to patients through EHR Kidney function testing done on day of discharge Lab requisition provided for kidney function testing at 3 months for all patients Lab requisition provided for kidney function testing at 1 month for high risk patients Follow-up appointment booked with a study nephrologist within 3 months of discharge for high risk patients If patient known to have CKD prior to admission and meets CKD referral criteria, referral to nephrology | Other: Risk-guided transition of care intervention delivered through an integrated digital health strategy<br>* The proposed experimental intervention will incorporate our risk prediction model which will be used to guide the hospital to home transition of care for medium and high-risk groups of patients. Patients will receive transition of care plans that are tailored to their risk and embedded within standardized discharge pathways within the electronic health record<br>|
| No Intervention: Usual Care<br>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), and additional requisitions for kidney function testing at 90 days. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary effectiveness outcome | The primary outcome of the study is major adverse kidney or CV events at 1 year, defined as the composite of death, kidney failure (receipt of maintenance dialysis 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) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Clinical Outcomes-Death | Major adverse kidney or CV events at 1 year, defined as death | 1 year | 
| Secondary Clinical Outcomes-Kidney Failure | Major adverse kidney or CV events at 1 year, defined as kidney failure (receipt of maintenance dialysis or eGFR < 15 mL/min/1.73m2 for 4 weeks or more) | 1 year | 
| Secondary Clinical Outcomes-Hospitalization for CV Events | Major adverse kidney or CV events at 1 year, defined as hospitalization with a most responsible diagnosis for heart failure, myocardial infarction, or stroke (based on validated ICD-10 coding algorithms) | 1 year | 
| Secondary Clinical Outcomes-All Cause Hospitalization or ED Visit | All-cause hospitalization or ED visits within 30 and 90 days of discharge | 30 and 90 days of discharge | 
| Patient Experience | The Care Transitions Measure (CTM) will be used to assess the hospital to home transition experience from the patient perspective. All 15 items in the CTM-15 use a 4-point scale with responses ranging from Strongly Disagree to Strongly Agree. The items are scored by summing the responses (between 1 and 4) followed by linear transformation to a 0-to-100 range. This score reflects the quality of the care transition with lower scores indicating a poorer quality transition and higher scores indicating a better transition. | 1 year | 
| Implementation and Process of Care Outcomes | The success of implementation of the proposed intervention will be evaluated based on metrics linked to the RE-AIM dimensions of our implementation plan. Implementation outcomes will include the proportion of eligible patients included in the study from each facility and the proportion who received each element of the transition of care intervention according to their risk status. We will evaluate the effect of the intervention on the proportion of patients who receive recommended kidney function monitoring (eGFR, albuminuria) at 30 and 90 days after discharge, guideline-indicated medication use for kidney disease and associated conditions (RAAS blockers, SGLT-2 inhibitors, and statin use), and the proportion of patients with sustained eGFR<30 mL/min/1.73m2 who are referred to nephrology and those that actually receive a nephrology consult within 1 year. | 30 and 90 days after discharge, within 1 year |