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

Nantes University Hospital362 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

362

Conditions

Colorectal Surgery Readmission

Interventions

EPOCA Intelligence Information System is a remote monitoring plateform. The medical device is used as a SaaS platform with restricted access for healthcare professionals. Patients and their families interact with the medical device via notifications and secure links, upon request. The medical device integrates the use of other medical devices such as oximeters, blood pressure monitors, glucometers, bracelets, etc., which are connected and whose use is also governed by their user manuals and training. Patient is monitoring via the remote monitoring platform for 30 days after hospital discharge

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (14)

CHU Angers

Angers, France

RECRUITING

Clinique Tivoli- Ducos

Bordeaux, France

RECRUITING

CHU Grenoble

Grenoble, France

RECRUITING

Centre Hospitalier Lyon-Sud

Lyon, France

RECRUITING

CHU Timone - Assistance publique-Hôpitaux de Marseille

Marseille, France

RECRUITING

Hôpital Nord - Assistance publique- Hôpitaux de Marseille

Marseille, France

RECRUITING

Institut Paoli Calmettes

Marseille, France

NOT_YET_RECRUITING

CHU Nantes

Nantes, France

RECRUITING

Hôpital de Bicêtre - Assistance Publique Hôpitaux de Paris

Paris, France

RECRUITING

Hôpital Saint Antoine - Assistance publique - Hôpitaux de Paris

Paris, France

RECRUITING

...and 4 more locations

Outcomes

Primary Outcomes

Hospitalization days

Cumulative duration of hospitalization days up to 90 days after the index surgery

Time frame: 90 days

Secondary Outcomes

Unplanned hospital readmission

Rate of unplanned hospital readmissions with emergency department visits at 90 days

Time frame: 90 days

Difference between the initial hospital discharge date and the hospital readmission date

Difference between the initial hospital discharge date and the hospital readmission date (for readmitted patients)

Time frame: 90 days

Unplanned consultations

Rate of unplanned consultations at 90 days

Time frame: 90 days

Postoperative morbidity

Number of patients presenting a complication out of the total number of patients

Time frame: 90 days

Severe postoperative morbidity

Severe postoperative morbidity at 90 days (Clavien-Dindo classification levels 3 and 4)

Time frame: 90 days

Visual Analog Scale at Day 3 for preoperative inclusions

Visual Analog Scale at Day 3 for preoperative inclusions. Visual Analog Scale is self-assessment scale (in cm) ranging from 0 (no pain) to 10 (maximum imaginable pain).

Time frame: Day 3

Visual Analog Scale at Day 5 for preoperative inclusions

Visual Analog Scale at Day 5 for preoperative inclusions. Visual Analog Scale is self-assessment scale (in cm) ranging from 0 (no pain) to 10 (maximum imaginable pain).

Time frame: Day 5

Rate of postoperative ileus at Day 3 for preoperative inclusions

Time frame: Day 3

Rate of postoperative ileus at Day 5 for preoperative inclusions

Time frame: Day 5

Return to Professional activities

Date of return to professional activities within 90 days

Time frame: 90 days

Quality of life questionnaires "Medical Outcomes Study 36-item Short-Form Health Survey"

Quality of life questionnaires"Medical Outcomes Study 36-item Short-Form Health Survey" (SF-36) at 30 days. It consists of 36 questions. Each question is assessed using a Likert scale with 3, 5, or 6 possible response levels. The 8 dimensions also allow for the calculation of two quality-of-life scores: the Physical Composite Score and the Mental Composite Score. The higher the score, the greater the capacity.

Time frame: 30 days

Quality of life questionnaires "Medical Outcomes Study 36-item Short-Form Health Survey"

Quality of life questionnaires "Medical Outcomes Study 36-item Short-Form Health Survey " (SF-36) at 90 days. It consists of 36 questions. Each question is assessed using a Likert scale with 3, 5, or 6 possible response levels. The 8 dimensions also allow for the calculation of two quality-of-life scores: the Physical Composite Score and the Mental Composite Score. The higher the score, the greater the capacity.

Time frame: 90 days

Quality of life questionnaires EQ-5D

Quality of life questionnaires EQ-5D at 30 days. The questionnaire 5-level EQ-5D version consists of 5 response items indicating an increasing severity of problems in the relevant dimension and a visual analog scale ranging from 0 to 100, assessing overall health status.

Time frame: 30 days

Quality of life questionnaires EQ-5D

Quality of life questionnaires EQ-5D at 90 days. The questionnaire 5-level EQ-5D version consists of 5 response items indicating an increasing severity of problems in the relevant dimension and a visual analog scale ranging from 0 to 100, assessing overall health status.

Time frame: 90 days

Total cost of the care pathway over 90 days

Costs will be estimated based on hospital stays (initial and any rehospitalizations), outpatient healthcare consumption (limited to medical consultations), and the remote monitoring platform

Time frame: 90 days

Patient satisfaction

Likert scale at 30 days to assess the level of patient satisfaction. This questionnaire consists of 3 items (statements) for which the respondent will express their degree of agreement or disagreement. Each statement will be associated with an integer number from 1 to 5 for the quantitative analysis of the data. The final score on this scale will therefore range between 3 and 15.

Time frame: 30 days

Number of days between surgery and the resumption of both gaseous and fecal transit within 90 days

Time frame: 90 days

Number of patients maintained at home but discontinuing the use of the remote monitoring platform system before the end of follow-up

Time frame: 90 days

The reason for patients remaining at home after discontinuing the use of the remote monitoring platform system before the end of the follow-up

Number of patients maintained at home but discontinuing the use of the remote monitoring platform system before the end of follow-up, along with the reasons

Time frame: 90 days

Number of patients managed with the remote monitoring platform system

Number of patients managed with the remote monitoring platform system from the day the discharge criteria were met

Time frame: 90 days

Duration of use of remote monitoring plateform

Number of days between returning home with the remote monitoring platform system and the end of follow-up by the remote moinitoring platform

Time frame: 90 days

Characteristics of the care provided by the remote monitoring platform system

Characteristics of care provided through the remote monitoring platform system, according to the guidelines

Time frame: 90 days

Focus groups

Analysis of data collected through focus groups with professionals involved in the system

Time frame: 90 days

Patient and caregiver verbatims

Qualitative aspect : Analysis of patient and caregiver verbatims. Evaluation of the patient's and their caregiver's adherence to the system. The collection and analysis of the experiences of thirty families (one patient + one caregiver) will be conducted using two data collection tools : the diary and the semi-structured interview.

Time frame: 90 days

Patient verbatims on the post-operative experience

Qualitative aspect : Analysis of patient verbatims on the post-operative experience. Understanding of the patient's experience, including their feelings and anxiety during the postoperative period. The collection and analysis of the experiences of thirty families (one patient + one caregiver) will be conducted using two data collection tools : the diary and the semi-structured interview.

Time frame: 90 days

Healthcare professionals' verbatims

Qualitative aspect : Analysis of healthcare professionals' verbatims. Exploring the social, economic, and geographical inequalities in the use of outpatient and/or early hospital discharge. The experience of healthcare professionals will be collected during four focus groups and will help determine the conditions for the implementation and dissemination of the remote monitoring platform system beyond the partner centers and for other health situations.

Time frame: 90 days

Medical-economic endpoint

Medical-economic endpoint : Incremental cost-utility ratio (cost per QALY, Quality-Adjusted Life-Year).

Time frame: 90 days

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

Overview

Conditions

Interventions

Eligibility

Locations (14)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts