The VICTORY Trial: Virtual, Innovative, Postsurgical Care To Optimize Return Home for Older People With frailtY
VICTORY
Virtual, Innovative, Postsurgical Care To Optimize Return Home for Older People With frailtY: the VICTORY Randomized Trial
1 other identifier
interventional
1,000
1 country
1
Brief Summary
Canadian hospitals continue to struggle with severe emergency department and hospital bed capacity shortages. Maximizing bed availability and minimizing emergency department and urgent-centre visits by providing patients with alternative options to care is an important part of the solution. Surgical patients with frailty are at high risk of requiring subsequent acute-hospital care. The VICTORY trial will answer an important question that will inform how to improve care for surgical patients with frailty by determining the effect of virtual care with CloudDX technology compared to standard care to see if it can result in an increase in the number of days alive and at home that older people with frailty experience after planned surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable surgery
Started Jan 2025
Longer than P75 for not_applicable surgery
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2024
CompletedFirst Posted
Study publicly available on registry
July 16, 2024
CompletedStudy Start
First participant enrolled
January 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2030
February 4, 2025
January 1, 2025
3 years
June 24, 2024
January 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of days each patient spends alive and at home following surgery
This validated, patient-centered outcome is calculated as the sum of all days alive within 30-days of surgery minus any days spent in hospital (index or readmission), rehabilitation, or nursing home/long term care centers. Death will be assigned a '-1' value; those surviving 30-days will be assigned an outcome value of their count of days alive and at home
30 days
Other Outcomes (15)
Resource use- Index length of stay
30 days
Resource use- Readmission
30 days, 1 year
Resource use- Readmission length of stay
30 days
- +12 more other outcomes
Study Arms (2)
Virtual Care
EXPERIMENTALIntervention group participants will be enrolled in a PVC program prior to admission, including receipt of a cellular-enabled tablet and Cloud DX remote monitoring equipment. Through Cloud DX remote monitoring technology, intervention group participants will receive the following intervention: remote automated monitoring, frailty-tailored daily symptom survey, Katz Index of Independence in Activities of Daily Living survey, FAM-CAM survey, Virtual RN assessment, medications.
Standard Care
NO INTERVENTIONThe standard care group will receive their post-hospital discharge management in alignment with standard of care at the hospital where they had surgery.
Interventions
Through Cloud DX, intervention group participants will receive: Remote Automated Monitoring: measurement of: blood pressure, heart rate, respiratory rate, oxygen saturation, temperature and weight. Frailty-tailored daily symptom survey: The recovery survey consists of questions related to infection, bleeding, pain, appetite, dehydration, appetite, syncope and falls. The tablet will prompt the participant to complete a Katz Index of Independence in Activities of Daily Living (IADL) survey. The FAM-CAM survey will also be pushed by Cloud DX to be completed. Virtual RN assessment: a virtual RN assessment will be scheduled at a minimum of every 2 days for the first 7 days. The virtual RN will also perform the 4AT Delirium Assessment. Medications: the virtual RN will undertake medication review and reconciliation. In addition, they will provide counselling regarding analgesic support and monitor for drug interactions.
Eligibility Criteria
You may qualify if:
- Age \> 60years
- Diagnosis of frailty (Clinical Frailty Score \>4)
- Elective surgery
- Fluent in English
You may not qualify if:
- Preoperative institutional residence
- Planned postoperative non-home discharge (i.e. rehabilitation or convalescence)
- Patient unable to interact with virtual care and/or technology
- Cognitive impairment preventing ability to provide independent informed consent to surgery and the trial
- Patient lives in an area without cellular or internet service
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ottawa Hospital
Ottawa, Ontario, K1Y1J8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvie Aucoin, MD
The Ottawa Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The VICTORY Trial is a multicenter, innovative clinical trial using an individual patient, parallel-arm randomized controlled trial design of 1,000 older patients living with frailty being discharged from hospital after elective surgery.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2024
First Posted
July 16, 2024
Study Start
January 29, 2025
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
January 31, 2030
Last Updated
February 4, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data.
- Access Criteria
- Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.
Individual participant data, including data dictionaries, will be available. This includes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The Study Protocol, Statistical Analysis Plan and Informed Consent Form will also be made available. Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data. Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.