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

Acute Kidney Injury Clinical Trial

— UPTAKE-1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05806645
• Other study ID #: UPTAKE Pro00128939
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2, 2024
• Est. completion date: September 2028

Study information

• Verified date: October 2023
• Source: University of Alberta
• Contact: Neesh Pannu
• Phone: 780 492 8519
• Email: npannu[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 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: 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6046
• Est. completion date: September 2028
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Alberta Health services, Canadian Institutes of Health Research (CIHR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary Clinical Outcomes-Death	Major adverse kidney or CV events at 1 year, defined as death	1 year
Secondary	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	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	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
Secondary	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
Secondary	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