Clinical trial NCT06503198: The VICTORY Trial: Virtual, Innovative, Postsurgical Care To Optimize Return Home for Older People With frailtY
Official title: Virtual, Innovative, Postsurgical Care To Optimize Return Home for Older People With frailtY: the VICTORY Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Frailty
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individual patient, parallel-arm randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed description: Background: Each year, \>130,000 older Canadians living with frailty have major, inpatient surgery. The presence of frailty, a multidimensional state of vulnerability, is strongly associated with adverse outcomes. Compared to similar patients without frailty, surgical patients with frailty experience a 2- to 5-fold adjusted increase in the odds of mortality, complications, patient-reported disability, length of stay, readmissions and non-home discharge. However, despite the growing number of patients with frailty presenting for surgery each year, a recent systematic review from our team demonstrates that there are no evidence-based, frailty-specific interventions available to drive improvements in outcomes for this vulnerable population. A promising intervention to support independence and maintain older people at home after surgery is Virtual Recovery After Surgery (VRAS), an innovative multidisciplinary program that has been providing post-discharge remote monitoring and virtual care for surgical patients since 2021. Patients receive virtual care from the VRAS nursing and anesthesiologist team following surgical discharge, facilitated by Cloud DX software and monitoring equipment. Based on our team's joint expertise in frailty and Postoperative Virtual Care (PVC), the investigators have identified: 1) a crucial gap in care expressed by older patients with frailty (the need for support and continuity of care via telehealth resources to support transition of care to their homes), and 2) an intervention that could directly fill this gap (frailty tailored PVC).

Overarching Aim: The objective of the VICTORY Trial is to determine 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 in the 30 days after planned surgery. A secondary aim is to estimate the probability that enrollment in a frailty-tailored PVC program will reduce healthcare resource use and improve patient-reported outcomes and safety.

Methods:

Design, setting and participants: 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.

People ≥60 years old with frailty having elective surgery will be included.

Intervention: Patients randomized to the PVC program will be monitored at home by virtual nurses for at least 7 days after hospital discharge. Participants will be provided with a hospital-to-home kit that contains the following technologies: tablet computer (with stand), wrist-based blood pressure cuff (for blood pressure, pulse and breathing rate), finger worn pulse oximeter (for measuring oxygen levels), thermometer (for temperature) and weigh scale (to monitor weight). Monitoring will include video visits with a nurse on post-discharge days 1, 3, 5 and 7 and every other day until post-discharge day 14 if needed. Patients will be asked to complete a daily survey that will include questions about any symptoms they may be experiencing, their independence/dependence with activities of daily living, and their experience with the PVC program. Depending on the patient's recovery (including the assessments and surveys described), patients may receive information electronically on how to manage certain challenges (i.e., confusion, not eating enough), their care may be escalated to a physician, or they may be instructed to come to the hospital.

Outcomes and sample size: The primary outcome is the number of days that each patient spends alive and at home following surgery. Secondary outcomes are: resource use (index length of stay, readmission, total hospital days, emergency department visits, time to first acute hospital care, cost of care), patient-centered outcomes (delirium (4AT), quality of life (EQ- 5D-5L), pain interference (PROMIS), satisfaction (likelihood to recommend), goal attainment, and overall quality of transitional care received), safety (medication issues, incidence of post-discharge falls).

Based on trial simulations, the investigators estimate that the most likely number of participants required will be 1000 (500 per arm), which is adequate to achieve at least 90% power to declare superiority (defined as probability of any benefit = 99% (P(Odds Ratio (OR)\>1) = 99%) when the effect size, expressed as an OR from a cumulative logistic model, is 1.5 and the control group number of days alive at home within 30 days is 16.

Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives.

Expected outcomes: The VICTORY Trial will: 1) advance the practice of PVC using evidence-based, frailty-tailored approaches; 2) evaluate this frailty-tailored PVC intervention in direct partnership with patients; and 3) produce robust, potentially practice-changing research using innovative clinical trial methodologies that will inform implementation.

Eligibility criteria: Inclusion Criteria:

1. Age \> 60years
2. Diagnosis of frailty (Clinical Frailty Score \>4)
3. Elective surgery
4. Fluent in English

Exclusion Criteria:

1. Preoperative institutional residence
2. Planned postoperative non-home discharge (i.e. rehabilitation or convalescence)
3. Patient unable to interact with virtual care and/or technology
4. Cognitive impairment preventing ability to provide independent informed consent to surgery and the trial
5. Patient lives in an area without cellular or internet service

Primary outcomes:
measure: Number of days each patient spends alive and at home following surgery
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
measure: Resource use- Index length of stay
timeFrame: 30 days
measure: Resource use- Readmission
timeFrame: 30 days, 1 year
measure: Resource use- Readmission length of stay
timeFrame: 30 days
measure: Resource use- 30-day total hospital days
timeFrame: 30 days
measure: Resource use- Number of Emergency Department visits
timeFrame: 30 days, 1 year
measure: Resource use- Time to first acute hospital care
timeFrame: 30 days
measure: Resource use- Costs of care
timeFrame: 30 days, 1 year
measure: Patient-centered- Delirium (4AT)
timeFrame: Days 1 and 3 post-discharge
measure: Overall quality of transitional care received
timeFrame: 30 days
measure: Quality of life (EQ- 5D-5L)
timeFrame: 30 days, 90 days
measure: Pain interference (PROMIS)
timeFrame: 30 days, 90 days
measure: Satisfaction (Likelihood to Recommend)
timeFrame: 30 days
measure: Personalized goal attainment
timeFrame: 30 days, 90 days
measure: Safety- Incidence of post-discharge falls
timeFrame: 30 days
measure: Safety- Medication issues using the Treatment Satisfaction Questionnaire for Medications (TSQM) scale
timeFrame: Day of discharge from program post-surgery (assessed up to day 6)
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Sylvie Aucoin, MD
role: PRINCIPAL_INVESTIGATOR
References: