Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537453
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
UPTAKE - Virtual Care Virtual Home Hospital With Remote Monitoring to Reduce Acute Care Hospitalization
Sponsor:
None
Organization:
None
Study Overview
Official 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UPTAKE-VC
Brief Summary:
Method Randomized Controlled Trial Study Duration 3 Years Study Centres 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 n354 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 Patients clinical team Reference therapy Usual Care Statistical Analyses Descriptive Analysis Regression
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 Patients 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 Albertas 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 Albertas 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 Albertas 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 patients 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 andor 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
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 Albertas 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 Albertas 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 Albertas 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 patients 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None