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NCT Number: NCT06537453

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Calgary, Alberta, Canada

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About this study

  • 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.

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Care

Other

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

Primary outcomes

  1. the number of days alive out of hospital

    Time frame: Up to 45 days from the date of randomization

    the number of days alive out of hospital

Secondary outcomes

  1. the time as inpatient in hospital

    Time frame: Up to 45 days from the date of randomization

    the time as inpatient in hospital

  2. death

    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.

  3. hospital readmission

    Time frame: Up to 45 days from the date of randomization

    hospital readmission records from health administrative data.

  4. Emergency Department visits

    Time frame: Up to 45 days from the date of randomization

    Emergency Department visit records from health administrative data.

  5. Estimated Glomerular Filtration (eGFR)

    Time frame: At 90 days after the date of randomization

    eGFR

  6. Urine Albumin Creatinine Ration (ACR)

    Time frame: At 90 days after the date of randomization

    ACR laboratory test

  7. total number of physician visits

    Time frame: Up to 45 days from the date of randomization

    total number of physician visits

  8. number of physician visits by specialty

    Time frame: Up to 45 days from the date of randomization

    primary care vs. non-primary care

  9. Changes to medication prescription

    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

  10. laboratory testing

    Time frame: Up to 45 days from the date of randomization

    Number of creatinine/eGFR, electrolytes, and urine protein quantification

  11. patient experience care transition measure

    Time frame: At 45 days after the date of randomization

    Online Survey

  12. Euro Qol- 5 Dimension (EQ5D)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Health services

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2024
Registry last updated
May 14, 2026

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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