Video-Based AI-Generated Peri-operative Instructions for Mitral Valve Surgery: A Randomized Controlled Trial on Health Outcomes and Patient Experience
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Unplanned Healthcare Utilization events
研究概览
简要总结
- The purpose of this study is to evaluate the impact of a novel, AI-generated, interactive peri-operative video education program on total unplanned healthcare utilization
- The main procedures are questionnaires and watching a video.
- The subject population includes patients who are scheduled for isolated mitral valve repair surgery.
- All study procedures will occur here at Cedars Sinai.
详细描述
This study is a prospective, single center, randomized trial comparing an AI-generated peri-operative video education program to standard of care education (1:1 ratio) in patients undergoing MV repair. The trial will be conducted in Southern California. The primary aim of this study is to evaluate the impact of a novel, AI-generated, interactive peri-operative video education program on total unplanned healthcare utilization, defined as a composite of hospital readmissions, ED visits, and unplanned outpatient visits, among patients undergoing mitral valve (MV) repair compared with standard of care education. The secondary aim is to analyze the association between utilization of this educational program with hospital length of stay (LOS) and patient cardiovascular medication compliance compared to standard of care education. The tertiary aim of this trial is to evaluate a range of patient-centered outcomes (levels of anxiety, satisfaction, and discharge location) following receipt of this educational program compared with standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult patients ≥ 18 years planned for elective, isolated MV repair.
- •Provide Informed consent
排除标准
- •Insufficient computer/smart device knowledge. Children or caregivers can assist, but patients should be able to access their own email or text messages and navigate to the internet to use the provided AI generated educational intervention.
- •Inconsistent access to a smart device with internet connection throughout the study period.
- •Inability to speak, read, and understand English or Spanish
- •Need for any concomitant procedure at the time of MV repair
研究组 & 干预措施
Peri-Operative Standard of Care and Artificial Intelligence Video Education Arm
In this arm, patients will receive AI-generated, interactive, peri-operative video education program in addition to standard of care education
干预措施: Artificial Intelligence Video Education Arm (Other)
Peri-Operative Standard of Care Education only Arm
In this arm, patients will receive the usual Standard of Care Peri-Operative Education
结局指标
主要结局
Number of Unplanned Healthcare Utilization events
时间窗: From randomization to 30 days post-surgery
includes the following events: unplanned (i.e. patient initiated) phone calls, emails, clinic visits, and ED visits.
次要结局
未报告次要终点
研究者
Joanna Chikwe
Professor & Chairman, Department of Cardiac Surgery
Cedars-Sinai Medical Center