Colorectal Surgery, Readmission
Conditions
Keywords
colorectal surgery, remote monitoring platform, Hospital length of stay, Rehospitalization
Brief summary
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.
Interventions
DEVICERemote monitoring platform
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
Sponsors
Nantes University Hospital
EPOCA U&I
Ministry of Health, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * Man or woman over 18 years old at the time of the J0 visit, * Patient who underwent surgery less than 28 days ago, or who is scheduled to undergo colorectal surgery not managed as an outpatient procedure at the investigational center, including resection of at least one colonic or rectal segment and/or an anastomosis involving the colon or rectum, * At least one of the following two criteria: * Anticipated early discharge (within 24 hours following laparoscopic surgery without stoma and without diversion, and within 5 days following laparotomy and/or surgery with stoma and/or rectal surgery) for a procedure that is not usually managed as an outpatient surgery 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization days | 90 days | Cumulative duration of hospitalization days up to 90 days after the index surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned hospital readmission | 90 days | Rate of unplanned hospital readmissions with emergency department visits at 90 days |
| Difference between the initial hospital discharge date and the hospital readmission date | 90 days | Difference between the initial hospital discharge date and the hospital readmission date (for readmitted patients) |
| Unplanned consultations | 90 days | Rate of unplanned consultations at 90 days |
| Severe postoperative morbidity | 90 days | Severe postoperative morbidity at 90 days (Clavien-Dindo classification levels 3 and 4) |
| Visual Analog Scale at Day 3 for preoperative inclusions | Day 3 | 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). |
| Visual Analog Scale at Day 5 for preoperative inclusions | Day 5 | 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). |
| Rate of postoperative ileus at Day 3 for preoperative inclusions | Day 3 | Rate of postoperative ileus at Day 3 for preoperative inclusions |
| Rate of postoperative ileus at Day 5 for preoperative inclusions | Day 5 | Rate of postoperative ileus at Day 5 for preoperative inclusions |
| Postoperative morbidity | 90 days | Number of patients presenting a complication out of the total number of patients |
| Return to Professional activities | 90 days | Date of return to professional activities within 90 days |
| Quality of life questionnaires "Medical Outcomes Study 36-item Short-Form Health Survey" | 30 days | 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. |
| Quality of life questionnaires EQ-5D | 30 days | 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. |
| Total cost of the care pathway over 90 days | 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 |
| Patient satisfaction | 30 days | 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. |
| Number of days between surgery and the resumption of both gaseous and fecal transit within 90 days | 90 days | Number of days between surgery and the resumption of both gaseous and fecal transit within 90 days |
| Number of patients maintained at home but discontinuing the use of the remote monitoring platform system before the end of follow-up | 90 days | Number of patients maintained at home but discontinuing the use of the remote monitoring platform system before the end of follow-up |
| The reason for patients remaining at home after discontinuing the use of the remote monitoring platform system before the end of the follow-up | 90 days | 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 |
| Number of patients managed with the remote monitoring platform system | 90 days | Number of patients managed with the remote monitoring platform system from the day the discharge criteria were met |
| Duration of use of remote monitoring plateform | 90 days | Number of days between returning home with the remote monitoring platform system and the end of follow-up by the remote moinitoring platform |
| Characteristics of the care provided by the remote monitoring platform system | 90 days | Characteristics of care provided through the remote monitoring platform system, according to the guidelines |
| Focus groups | 90 days | Analysis of data collected through focus groups with professionals involved in the system |
| Patient and caregiver verbatims | 90 days | 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. |
| Patient verbatims on the post-operative experience | 90 days | 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. |
| Healthcare professionals' verbatims | 90 days | 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. |
| Medical-economic endpoint | 90 days | Medical-economic endpoint : Incremental cost-utility ratio (cost per QALY, Quality-Adjusted Life-Year). |
Countries
France
Contacts
CONTACTEmilie DUCHALAIS
Outcome results
None listed