Construction and Application of a Digital Postoperative Medical Quality Evaluation and Promotion System for Colorectal Cancer Based on the COLORECTUM+ Model
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- RenJi Hospital
- Enrollment
- 236
- Locations
- 1
- Primary Endpoint
- three-month follow-up rate
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Mobile application follow-up (Device)
Outcomes
Primary Outcomes
three-month follow-up rate
Time Frame: 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.
Secondary Outcomes
- 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)