UPTAKE - Virtual Care: Virtual Home Hospital With Remote Monitoring to Reduce Acute Care Hospitalization
- Conditions
- Acute Kidney Injury
- Interventions
- Other: Virtual Care
- Registration Number
- NCT06537453
- Lead Sponsor
- University of Calgary
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 354
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual Care Virtual Care Participants will receive virtual care through Virtual Home Hospital programs in Alberta for their hospital to home transition of care.
- Primary Outcome Measures
Name Time Method the number of days alive out of hospital Up to 45 days from the date of randomization the number of days alive out of hospital
- Secondary Outcome Measures
Name Time Method Estimated Glomerular Filtration (eGFR) At 90 days after the date of randomization eGFR
patient experience care transition measure At 45 days after the date of randomization Online Survey
Emergency Department visits Up to 45 days from the date of randomization Emergency Department visit records from health administrative data.
number of physician visits by specialty Up to 45 days from the date of randomization primary care vs. non-primary care
the time as inpatient in hospital Up to 45 days from the date of randomization the time as inpatient in hospital
death 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.
total number of physician visits Up to 45 days from the date of randomization total number of physician visits
hospital readmission Up to 45 days from the date of randomization hospital readmission records from health administrative data.
Urine Albumin Creatinine Ration (ACR) At 90 days after the date of randomization ACR laboratory test
Changes to medication prescription 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
laboratory testing Up to 45 days from the date of randomization Number of creatinine/eGFR, electrolytes, and urine protein quantification
Euro Qol- 5 Dimension (EQ5D) 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
Trial Locations
- Locations (2)
University of Calgary
🇨🇦Calgary, Alberta, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada