Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery (CONTACT-GRECCAR 21)

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: Readmission; Colorectal Surgery

Treatments: Device: Remote monitoring platform

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06850688

RC22_0452

2024-A01770-47 (Registry Identifier)

Details and patient eligibility

About

The goal of this Clinical Investigation is to evaluate the effectiveness of implementing the discharge protocol of the remote monitoring platform after colorectal surgery in patients at risk of hospital readmission.

Participants will be randomized into either the "30 days of remote monitoring" group or the "conventional discharge" group. The patient returns to the site for their postoperative visit at 30 days and is contacted by phone 90 days after their surgery.

Enrollment: 362 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Man or woman over 18 years old at the time of the J0 visit,
• Patient who has undergone colorectal surgery not managed on an outpatient basis at the investigator center,
• At least one of the following two criteria:
• Anticipated early discharge (within 24 hours following laparoscopic surgery without diversion and within 5 days following surgery by laparotomy with stoma) for a surgery not managed on an outpatient basis in routine practice,
• Estimated risk of hospital readmission greater than 10% according to the nomogram of Tevis et al. [15], adapted to the postoperative context in digestive surgery (>120 points according to this score).
• Patient affiliated with a health insurance plan,
• Patient who has signed the study consent form.

Exclusion Criteria:

• Discharge to a rehabilitation center requested by the patient,
• Condition managed on an outpatient basis in routine practice for this type of patient,
• Patient eligible for home hospitalization services,
• Suicidal or hetero-aggressive risk in a patient living alone at home
• Homeless patient,
• Pregnant or breastfeeding women,
• Patient under legal guardianship, curatorship, or protected legal status,
• Patient already enrolled in an interventional postoperative follow-up study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

362 participants in 2 patient groups

conventional discharge

No Intervention group

Description:

The patients will be discharged from the hospital through standard discharge procedures. They will be seen on Day 30 during their routine postoperative consultation and then contacted by phone on Day 90. All patients will be required to complete a patient diary from Day 0 to the telephone contact on Day 90 in order to record their healthcare utilization during this period.

Remote monitoring plateform

Experimental group

Description:

Patient monitoring via the remote monitoring platform for 30 days after hospital discharge. They will be seen on Day 30 during their routine postoperative consultation and then contacted by phone on Day 90. All patients will be required to complete a patient diary from Day 0 to the telephone contact on Day 90 in order to record their healthcare utilization during this period. The qualitative component includes data collection through semi-structured individual interviews with a sample of patients, as well as data collection through focus groups with a sample of healthcare professionals involved in the system.

Treatment:

Device: Remote monitoring platform