Virtual Care
OtherParticipants will go through Virtual hospital programs following the processes established by these programs in Alberta.
NCT Number: NCT06537453
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
University of Calgary, Calgary, Alberta, Canada
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will go through Virtual hospital programs following the processes established by these programs in Alberta.
Time frame: Up to 45 days from the date of randomization
the number of days alive out of hospital
Time frame: Up to 45 days from the date of randomization
the time as inpatient in hospital
Time frame: from the date of randomization up to 45 days, or date of death from any cause, whichever came first,
death records from health administrative data.
Time frame: Up to 45 days from the date of randomization
hospital readmission records from health administrative data.
Time frame: Up to 45 days from the date of randomization
Emergency Department visit records from health administrative data.
Time frame: At 90 days after the date of randomization
eGFR
Time frame: At 90 days after the date of randomization
ACR laboratory test
Time frame: Up to 45 days from the date of randomization
total number of physician visits
Time frame: Up to 45 days from the date of randomization
primary care vs. non-primary care
Time frame: Up to 45 days from the date of randomization
Changes 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
Time frame: Up to 45 days from the date of randomization
Number of creatinine/eGFR, electrolytes, and urine protein quantification
Time frame: At 45 days after the date of randomization
Online Survey
Time frame: At 45 days after the date of randomization
Online 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
Contact information is provided by the study sponsor or research team.
University of Calgary
Other
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
Acronym: UPTAKE-VC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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