UPTAKE - Virtual Care: Virtual Home Hospital With Remote Monitoring to Reduce Acute Care Hospitalization
NCT Number: NCT06537453
Acronym: UPTAKE-VC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Kidney Injury
Interventions: OTHER: Virtual Care
Sponsor: University of Calgary
Collaborators: Alberta Health services
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 354
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-10
Completion Date: 2026-10-31
Locations: University of Calgary, Calgary, Alberta, T2N 1N4, Canada|University of Alberta, Edmonton, Alberta, T6G 2G3, Canada

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

Primary Outcome Measures: the number of days alive out of hospital, the number of days alive out of hospital, Up to 45 days from the date of randomization
Secondary Outcome Measures: the time as inpatient in hospital, the time as inpatient in hospital, Up to 45 days from the date of randomization|death, death records from health administrative data., from the date of randomization up to 45 days, or date of death from any cause, whichever came first,|hospital readmission, hospital readmission records from health administrative data., Up to 45 days from the date of randomization|Emergency Department visits, Emergency Department visit records from health administrative data., Up to 45 days from the date of randomization|Estimated Glomerular Filtration (eGFR), eGFR, At 90 days after the date of randomization|Urine Albumin Creatinine Ration (ACR), ACR laboratory test, At 90 days after the date of randomization|total number of physician visits, total number of physician visits, Up to 45 days from the date of randomization|number of physician visits by specialty, primary care vs. non-primary care, Up to 45 days from the date of randomization|Changes to medication prescription, 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, Up to 45 days from the date of randomization|laboratory testing, Number of creatinine/eGFR, electrolytes, and urine protein quantification, Up to 45 days from the date of randomization|patient experience care transition measure, Online Survey, At 45 days after the date of randomization|Euro Qol- 5 Dimension (EQ5D), 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, At 45 days after the date of randomization