Virtual, Innovative, Postsurgical Care To Optimize Return Home for Older People With frailtY: the VICTORY Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Number of days each patient spends alive and at home following surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 60years
- •Diagnosis of frailty (Clinical Frailty Score >4)
- •Elective surgery
- •Fluent in English
排除标准
- •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
结局指标
主要结局
Number of days each patient spends alive and at home following surgery
时间窗: 30 days
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
次要结局
未报告次要终点