The VICTORY Trial: Virtual, Innovative, Postsurgical Care To Optimize Return Home for Older People With frailtY
NCT Number: NCT06503198
Acronym: VICTORY
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgery|Frailty
Interventions: BEHAVIORAL: Virtual care
Sponsor: Ottawa Hospital Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2030-01-31

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.

Primary Outcome Measures: 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 Outcome Measures: Resource use- Index length of stay, Count of days from date of surgery to hospital discharge will be documented, 30 days|Resource use- Readmission, Any acute care hospitalization after index hospital discharge and within 30-days and 365-days of surgery will be documented, 30 days, 1 year|Resource use- Readmission length of stay, Sum of total counts of days from start of new acute care admission to discharge where the New admissions occurring within 30 days of index surgery will be documented, 30 days|Resource use- 30-day total hospital days, Count of all days spent in an acute care hospital from surgery to 30-days after surgery will be documented, 30 days|Resource use- Number of Emergency Department visits, Count of Emergency Department visits occurring between index surgery and 30-days and 365-days after surgery will be documented, 30 days, 1 year|Resource use- Time to first acute hospital care, Count of days from index surgical admission discharge to first Emergency Department visit or readmission will be documented, 30 days|Resource use- Costs of care, For Ontario patients, standardized case costing methods will be used to estimate total health system costs from date of surgery to 30-days and 365-days after surgery, 30 days, 1 year|Patient-centered- Delirium (4AT), Captured using the UltraBrief, a separate delirium screening tool from the 4AT Confusion Assessment Methods utilized as part of the intervention delirium screening. A score of 4 or more suggests delirium but is not diagnostic. A score of 1-3 suggests cognitive impairment and more detailed cognitive testing and informant history-taking may be indicated. A score of 0 does not definitively exclude delirium or cognitive impairment: more detailed testing may be needed depending on the clinical context., Days 1 and 3 post-discharge|Overall quality of transitional care received, Using the Ideal Transitions in Care (ITC) Framework, which has 10 domains to consider to ensure safe transitions of care. Number of domains will be reported., 30 days|Quality of life (EQ- 5D-5L), This is a well-validated instrument with Canadian valuation statistics and national implementation used to measure health-related quality of life after surgery and to inform incremental cost per quality-adjusted life year gained. Participants are asked to select one answer under each domain (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Responses range from having no problems with a particular domain to being unable to engage in that particular domain. Participants are asked to identify on a scale of 0-100 how good or bad their health is on that given day (0 being worst health they can imagine, 100 being best health they can imagine)., 30 days, 90 days|Pain interference (PROMIS), The 6-item Short Form 6b V1.0 will be used to capture interference of pain. Item-levels are scored numerically for an individual's response to each question. Higher scores means more of the concept being measured. The lowest raw score is 6 and the highest raw score is 30., 30 days, 90 days|Satisfaction (Likelihood to Recommend), Patients will complete the 'Likelihood to recommend' question, reflecting on a 10-point scale their likelihood to recommend their postoperative transitional care experience, 30 days|Personalized goal attainment, A method of evaluating the extent to which patient's individual goals are achieved in the course of an intervention, previously used in rehabilitation studies for older adults with frailty, using an 11-point Likert scale; this outcome directly aligns with the 5th geriatric 'M' (matters most) where participants report the most important benefit from surgery and rate the achievement of the goal on a scale from worse than before surgery to much better than I expected after surgery, 30 days, 90 days|Safety- Incidence of post-discharge falls, Falls post-discharge, 30 days|Safety- Medication issues using the Treatment Satisfaction Questionnaire for Medications (TSQM) scale, The virtual registered nurse will undertake medication review and reconciliation on day 1 and day of discharge from program. In addition, they will provide counselling regarding analgesic support and monitor for drug interactions. Questions from the TSQM scale will be administered. The degree to which medication side effects affected overall satisfaction will be reported on a scale from extremely satisfied to not at all. How satisfied or dissatisfied the participant is with the medications will be reported on a scale from very satisfied to very dissatisfied., Day of discharge from program post-surgery (assessed up to day 6)