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UPTAKE - Virtual Care: Virtual Home Hospital With Remote Monitoring to Reduce Acute Care Hospitalization

Using Personalized Risk and Digital Tools to Guide Transitions Following Acute Kidney Events - Virtual Care: Virtual Home Hospital With Remote Monitoring to Reduce Acute Care Hospitalization

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06537453
Acronym
UPTAKE-VC
Enrollment
354
Registered
2024-08-05
Start date
2024-08-10
Completion date
2026-10-31
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Brief summary

Method: Randomized Controlled Trial Study Duration: 3 Years Study Centre(s) University of Calgary and University of Alberta Objectives: To fill care gaps by implementing strategies to reduce length of hospital stay, readmission rates, and improve long-term outcomes after Acute Kidney Injury (AKI). Number of Participants: Three Hundred and fifty four (n=354) Diagnosis and Main Inclusion Criteria: Hospitalized adults with AKI at high risk of hospital readmission or death Study Intervention: Multi-component Digital Health Solutions, including: 1. Computerized Clinical Decision Support (CDS) and 2. Virtual Care Delivered through Hospital at Home (VC) Duration of administration: Determined by the Patient's clinical team Reference therapy: Usual Care Statistical Analyses: Descriptive Analysis, Regression

Detailed description

1. Background and Rationale Acute kidney injury (AKI) is a common and serious complication in hospitals. A major care gap for survivors of AKI is the fragmentation of care that exists as they transition from the hospital to their home. This contributes to a high risk of adverse long-term outcomes, including prolonged hospitalization, high rates of readmission, cardiovascular events, infections, progression to chronic kidney disease (CKD), kidney failure requiring dialysis, and death. To address this challenge, the investigators are implementing multi-component digital health solutions including Computerized Clinical Decision Support (CDS) and Digital Remote Patient Monitoring (dRPM) through Virtual Care (VC) programs in Alberta to reduce length of hospital stay and readmission rates and improve long-term outcomes after AKI. Evidence of the effectiveness of the two digital health solutions is available from Alberta and international clinical trials. Our team previously implemented a computerized CDS intervention for AKI risk assessment and prevention and achieved improved AKI prevention and reduced AKI incidence after cardiac procedures across the province. The investigators will use a similar approach to identify high risk patients with AKI and provide recommendations to improve the quality of their care, which is well suited to the evolving digital health infrastructure in Alberta. Providing hospital-level care at home through Virtual Care (VC) teams has been shown to reduce mortality and readmission rates. Alberta's VC program have existed in both Edmonton and Calgary since 2018 and have reported lower readmission rates, Emergency Department (ED) visits and use of Emergency Medical Services than observed with usual care. Patients reported that the program helped them regain their independence and function. Alberta's VC programs have implemented dRPM technology, which has been further associated with fewer days in hospital and emergency department visits. Patients reported better quality of care using this technology. The framework for dRPM and complex care planning is already in place in Alberta's Virtual Care programs. The investigators intend to utilize these programs to improve transitions of care through early facilitated discharge and enhanced follow-up of patients with AKI at high risk of hospital readmission, who require frequent monitoring and more intensive care strategies during this vulnerable period of transition in care. 2. Research Question and Objectives * Implement and evaluate a transition of care intervention for patients with AKI. * Integrate digital health solutions that can achieve levels of monitoring and care in a patient's own home that are comparable to acute care, while transitioning care to the community setting. * Reduce the length of hospital stay and risk of hospital readmission for people with AKI. * Improve the long-term outcomes after hospitalization with AKI. 3. Methods The investigators will evaluate implementation initially in a Vanguard phase to establish feasibility and acceptability of the intervention, followed by an evaluation of implementation and effectiveness of the intervention in a larger Multicenter Randomized Controlled Trial (RCT). High risk patients with AKI and a predicted risk of readmission or death ≥20% will be identified using a Best Practice Alert (BPA) in Connect Care and participants will be randomized to care with or without virtual monitoring through the VC programs. All patients will receive the same baseline interventions refined in the Vanguard phase, while the intervention arm will additionally receive VC with dRPM following discharge. High risk patients in the intervention arm will be navigated through the transition of care pathway by a trained nurse navigator. Patients will receive dRPM kits, and biometric data will be automatically uploaded to the web-based monitoring platform and reviewed by the nurse navigator. Patients will receive regular virtual assessments via telephone or videoconferencing (via the tablet) after in-patient discharge. Blood tests will be drawn at home by community paramedics as deemed necessary by the clinical team to assess kidney function and monitor for complications of AKI. Should concerns be identified that warrant in-person assessment, paramedic care teams will be sent for assessment and/or intervention. Upon completion of the intervention patients will be assessed for readiness to move to the subacute arms of the program and return to their primary care provider. If ongoing nephrologist or other specialist care is required, the nurse navigator will ensure appropriate follow up is arranged.

Interventions

Participants will go through Virtual hospital programs following the processes established by these programs in Alberta.

Sponsors

University of Calgary
Lead SponsorOTHER
Alberta Health services
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Participants will be randomized in either arm, will be coded such that the outcome assessor is blinded to the arm assignment of the participant.

Intervention model description

One group will receive the Virtual Care Intervention through Virtual Home Hospitals and other group will receive Usual Care.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years old. * AKI identified in hospital using Kidney Disease Improving Global Outcomes (KDIGO) criteria17. * Hospitalization \> 48 hours. * LACE (L= Length patient Stay in the hospital, A= Acuity of Admission of patient in the hospital, C= Comorbidity and E= Emergency Visit.) Score 12 or higher. * Meets all inclusion criteria of Virtual Home Hospital programs of Calgary and Edmonton zones.

Exclusion criteria

* Non-Alberta residents. * Resides outside the catchment areas for the Calgary and Edmonton Virtual Home Hospital programs. * C1 or C2 goals of care. * Hospitalization \> 30 days. * Will be discharged to long-term care. * Kidney failure receiving dialysis. * Already admitted in Virtual Home Hospital Program

Design outcomes

Primary

MeasureTime frameDescription
the number of days alive out of hospitalUp to 45 days from the date of randomizationthe number of days alive out of hospital

Secondary

MeasureTime frameDescription
the time as inpatient in hospitalUp to 45 days from the date of randomizationthe time as inpatient in hospital
deathfrom the date of randomization up to 45 days, or date of death from any cause, whichever came first,death records from health administrative data.
hospital readmissionUp to 45 days from the date of randomizationhospital readmission records from health administrative data.
Emergency Department visitsUp to 45 days from the date of randomizationEmergency Department visit records from health administrative data.
Estimated Glomerular Filtration (eGFR)At 90 days after the date of randomizationeGFR
Urine Albumin Creatinine Ration (ACR)At 90 days after the date of randomizationACR laboratory test
total number of physician visitsUp to 45 days from the date of randomizationtotal number of physician visits
number of physician visits by specialtyUp to 45 days from the date of randomizationprimary care vs. non-primary care
Changes to medication prescriptionUp to 45 days from the date of randomizationChanges to medication prescription (including starting, stopping, or dose adjustment) of an Angiotensin-Converting Enzyme Inhibitors (ACEI)/Angiotensin receptor blockers (ARB), diuretic, SGLT2 inhibitor, or NSAID or administration of IV fluid
laboratory testingUp to 45 days from the date of randomizationNumber of creatinine/eGFR, electrolytes, and urine protein quantification
patient experience care transition measureAt 45 days after the date of randomizationOnline Survey
Euro Qol- 5 Dimension (EQ5D)At 45 days after the date of randomizationOnline Survey to assess quality of life mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" to "extreme problems

Countries

Canada

Contacts

CONTACTDirector
cccr@ucalgary.ca+1 (403) 210. 6730
PRINCIPAL_INVESTIGATORMatthew James, MD

University of Calgary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026