Construction and Application of a Digital Postoperative Medical Quality Evaluation and Promotion System for Colorectal Cancer Based on the COLORECTUM+ Model
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- three-month follow-up rate
研究概览
简要总结
This is a single-center, prospective, interventional study. A total of 236 colorectal cancer patients who underwent surgery will be enrolled and followed for 52 weeks. The digital healthcare quality management system, based on the COLORECTUM+ model, will be used for post-treatment quality evaluation and continuous improvement.
Patients will be managed using an Internet+ post-treatment healthcare management platform. The platform integrates AI technology for real-time symptom analysis and alerts. Patients will report symptoms and health data through the platform, which will generate alerts based on symptom severity to guide appropriate interventions. Follow-up assessments will include patient adherence, satisfaction, quality of life, and healthcare utilization.
The study expects to demonstrate that the digital healthcare quality management system improves follow-up rates, enhances patient adherence, reduces unplanned hospital visits, and increases overall patient satisfaction. The findings aim to provide evidence for the implementation of digital management systems in colorectal cancer post-treatment care, potentially leading to improved long-term outcomes for patients.
详细描述
The aim of this study is to evaluate the adherence of postoperative colorectal cancer patients using a digital follow-up platform. The primary endpoint is follow-up rate at 3 months after surgery. The secondary endpoints are: follow-up rate at 6, 9, and 12 months, adherence during 12 months, medication adherence (MMS-4), the number and reasons for alerts triggered by patients, the frequency and reasons for patient-initiated report, quality of life (FACT-C), patient satisfaction (FACIT-TS-PS), the system's usability (SUS), the monitoring rates of imaging exams, colonoscopies, and CEA markers at 3, 6, 9, and 12 months will be analyzed. Differences in clinical outcomes: progression-free survival, overall survival, adverse events, the incidence of complications, hospital admissions (unplanned hospital visit rates, average unplanned hospital stay duration, and potentially preventable emergency visits) are additional outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Over 18 years old.
- •Pathologically confirmed colorectal cancer patients.
- •Underwent surgery at the Colorectal Cancer Diagnosis and Treatment Center, Gastrointestinal Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine.
- •Signed informed consent form.
排除标准
- •Unable to access electronic devices that can connect to the internet or mobile communications.
- •Uncontrolled psychiatric illness.
- •The ECOG score is greater than or equal to
- •Deemed unsuitable for participation by the investigator.
研究组 & 干预措施
experimental group
Colorectal cancer patients enrolled in the 'Internet Plus' post-treatment management platform use the digital medical quality management system based on the 'COLORECTUM+' model for quality evaluation and continuous improvement. The platform integrates AI, using natural language processing and machine learning to analyze patient-reported symptoms, automatically assess severity, and generate alerts. Alerts are classified as yellow, orange, or red. Yellow indicates mild issues with self-care recommendations; consecutive yellow alerts prompt doctor contact within 24 hours. Orange indicates moderate severity, requiring doctor intervention within 24 hours. Red alerts signify serious symptoms or high-risk medication errors, prompting immediate notification of the doctor and emergency team. The system monitors symptom changes and updates alerts to support treatment optimization.
干预措施: Mobile application follow-up (Device)
结局指标
主要结局
three-month follow-up rate
时间窗: At 12 weeks after enrollment.
Our mobile application aims to monitor the three-month follow-up rate for patients, assessing whether they adhere to the follow-up schedule as outlined，providing a streamlined approach to track post-discharge appointments. By utilizing real-time notifications and easy scheduling features, the app encourages patients to attend their follow-up visits, ensuring continuity of care. The application records and analyzes data on scheduled and completed appointments within three months post-discharge, offering insights into adherence rates and identifying factors impacting follow-up compliance. This data-driven approach helps healthcare providers improve patient outcomes and optimize follow-up strategies.
次要结局
- adherance(From enrollment to the end of treatment at 52 weeks, patient adherence will be assessed at each visit.)
- Quality of life(From enrollment to the end of treatment at 52 weeks)
- Average unplanned hospitalization days(The 3rd, 6th, 9th, and 12th months after enrollment)
- Potentially preventable emergency department visits(The 3rd, 6th, 9th, and 12th months after enrollment)
- Number and distribution of alerts(The 3rd, 6th, 9th, and 12th months after enrollment)
- Number and distribution of proactive reports(The 3rd, 6th, 9th, and 12th months after enrollment)
- Patient satisfaction(At the end of patient follow-up)
- System usability of the digital health quality management system(The 3rd and 12th months after enrollment)
- Nutritional status(From enrollment to the end of treatment at 52 weeks)