Improving Mental and Physical Health and Decreasing Hospital Readmission After Pancreatectomy Through Enhanced Patient and Caregiver Education and Engagement
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Efficacy of the SAFECARE at Home program as measured by readmission rate
研究概览
简要总结
The study of readmission is in its infancy in the surgical world, and there are no prospective studies, to the investigators' knowledge, evaluating the efficacy of interventions on preventing readmission following pancreatectomy. Undoubtedly, patients and their caregivers will play a key role in any useful intervention to reduce readmission. Therefore, the investigators' approach is to target perioperative education and engagement of patients and their caregivers in the postoperative recovery of pancreatectomy patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Scheduled for major pancreatectomy (i.e., pancreaticoduodenectomy, total pancreatectomy, or a distal pancreatectomy).
- •At least 18 years of age.
- •Able to read and understand English (the SAFECARE at Home program is only implemented in English)
- •Has internet access.
- •Knowledge of the internet and how to use web-based programs.
- •Not pregnant or breastfeeding.
- •Able to understand and willing to sign an IRB-approved written informed consent document.
排除标准
- 未提供
结局指标
主要结局
Efficacy of the SAFECARE at Home program as measured by readmission rate
时间窗: 30 days
-The investigators hypothesize that the SAFECARE at HOME program intervention will reduce readmission by half (i.e. from 22% to 11%). The investigators will include a total of 225 evaluable patients in the study, randomized in a 2:1 ratio (i.e. 2 patients in the SAFECARE arm for every 1 patient in the standard of care arm). The designed sample size will allow 80% at a 1-sided alpha=0.1 to detect a 50% decrease in 30-day readmission.
次要结局
- Effect of the SAFECARE at Home program as measured by the number of follow-up visits(Through 30 day post-discharge)
- Comparison of quality of life between SAFECARE at Home patients and patients who received standard post-operative care and education as measured by SF-36(Up to 6 months post-discharge)