A Step-Wedged Cluster Randomized Registry-Based Multi-Centre Trial to Compare the Efficacy Between the Canadian TAVI Triage Tool and Standard of Care in TAVI Patients in Ontario, Canada
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,060
- 主要终点
- To assess the efficacy of using the CAN3T tool in triage compared to standard care, in TAVI patients, including: reduce wait-time adverse events, improve patient-centred outcomes, and reduce wait-time health care utilization.
研究概览
简要总结
The goal of this trial is to see if a tool that may reduce wait times will reduce bad outcomes in participants on the TAVI waitlist. The main questions it aims to answer are:
- How many deaths, hospitalizations, or urgent TAVI procedures take place while participants wait
- Days alive and out of hospital at 30 days and 12 weeks, total health care costs, and wait times
Researchers will compare usual wait times to see if the tool reduces death, hospitalizations, and urgent procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients referred for TAVI who are 18 years or older at one of 11 TAVI hospitals
排除标准
- •Any inpatient referrals who have an urgent inpatient TAVI on the same admission
- •Any referral during the 1-month transition period
结局指标
主要结局
To assess the efficacy of using the CAN3T tool in triage compared to standard care, in TAVI patients, including: reduce wait-time adverse events, improve patient-centred outcomes, and reduce wait-time health care utilization.
时间窗: From the beginning of enrollment and continuing for 32 months.
Composite of death, all-cause hospitalization or urgent TAVI (in-hospital and unplanned TAVI) on the TAVI waitlist. The waitlist period is defined as period between TAVI referral and first of either death, TAVI procedure or off list.
次要结局
未报告次要终点