Comprehensive Optimization At-time of Radical Cystectomy Intervention Through Peri-operative Patient Care Program
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 194
- 试验地点
- 2
- 主要终点
- 90 day complication rate
研究概览
简要总结
The proposed study is aimed at a comprehensive optimization at-time of radical cystectomy (COARC) intervention that focuses on patient optimization throughout the perioperative continuum, from the pre-operative setting to the post-operative period, among patients undergoing radical cystectomy for bladder cancer. This multi-modal strategy will focus on three phases of care around surgery: the pre-operative, peri-operative, and post-operative phases. The intervention group will focus on multiple areas of patient optimization including remote patient monitoring for the earlier identification of potential complications. The overall study mission is to decrease complication rates after radical cystectomy using this comprehensive approach.
详细描述
The proposed study includes the following-
Part I: Pre-operative period After randomization, patients in the intervention group will be referred to the Perioperative Optimization of Senior Health (POSH) program where they will undergo nutritional, functional, and global health assessment. The POSH team will refer patients as indicated to nutrition, physical medicine and rehabilitation, and other consultants to optimize their preoperative fitness for surgery.
Patients in the intervention group will also receive a Remote Patient Monitoring (RPM) Ipad from ActiCare Health, which will serve as their remote monitoring device and educational tool. At enrollment, they will be asked to complete an initial steps intake using a pedometer that will be provided to them. They will be asked to input vital signs once per week after receiving the Ipad to become familiar with the platform pre-operatively.
At enrollment, patients in both groups will also be asked to complete a patient reported Bladder Cancer Index questionnaire, a survey that tracks quality of life in patients with bladder cancer.
Part II: Perioperative period Both the intervention and control groups will undergo standard of care Enhanced Recover After Surgery (ERAS) bladder cancer protocol, which is a medication and peri-operative management protocol developed by the anesthesia and urology departments specifically for bladder cancer patients undergoing radical cystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Adults equal to or more than 18 years old
- •Diagnosis of bladder cancer with plan to undergo radical cystectomy
- •Agrees to participate in study procedures
排除标准
- •Patients undergoing cystectomy for diagnosis other than bladder cancer
- •Do not provide informed consent
研究组 & 干预措施
Intervention Arm
Preop intervention Arm Referral to Perioperative Optimization of Senior Health (POSH) Program Remote patient monitoring device orientation, initial intake, and education UTSW ERAS protocol perioperatively Inpatient geriatrics co-management Monitored recovery Post-operative monitoring with Acticare for 90 days Post-op specialist continuity of care
干预措施: Preop Intervention and Monitored Recovery (Other)
Control Arm
Enhanced Recovery After Surgery Usual referral and recovery care as needed Standard follow-up protocol
干预措施: Usual Care (Other)
结局指标
主要结局
90 day complication rate
时间窗: 90 days
Number of occurrences of complications at 90 days in patients in post-operative phase
次要结局
- 30 day complication rate(30 days)
- Readmission rates(90 days)
- Adherence to the intervention(90 days)
- Changes in functional fitness as measured by step count(Baseline, 90 days)
- QOL changes as measured by the Bladder Cancer Index and FACT-Bl-Cys Questionnaire measures(Baseline, 90 days)
研究者
yair lotan
Professor
University of Texas Southwestern Medical Center