Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02590172 |
| Other study ID # |
NI14008 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 13, 2019 |
| Est. completion date |
December 11, 2020 |
Study information
| Verified date |
August 2023 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In France, Intensive Medicine is carried out in three types of structures: intensive care
units, intensive care unit and units Continuous Monitoring (USC). Created in the 90s as
intermediate structures between conventional care units and intensive care units, these units
are assigned to the care of patients whose conditions and treatment are fear the occurrence
of one or more critical failures requiring to be monitored, or whose condition, at the end of
one or more critical failure is too severe or unstable to allow a return to a classical
inpatient unit.
Thus, USC represent a milestone in the journey of patients whose condition is critical:
patients from the emergency services, patients in the immediate postoperative period, coming
out of intensive care patients, or finally in conventional hospitalization patients whose
condition s 'worse. The creation of the USC is not subject to authorization but must be
contractualized between the hospital and the Regional Health Agency (ARS) because it is
resource intensive. Organizations and their operating modes are guided by the recommendations
of the French Society of Anesthesia and Intensive Care (SFAR), and the Society of French
Language Resuscitation (SRLF) published in 2005.The US establishment has a beneficial effect
on the quality of care and the care pathway of patients at risk shown by the reduction in
morbidity and mortality, the rate of admission and / or USC readmission of length of stay and
hospital stay costs.
It is possible to objectify provided first establish an inventory on the activity of these
units and the patient base supported. To judge the benefit of the assumption by the USC, it
is necessary to assess the adequacy of patients managed with an updated specification and
defined by a group of experts.
Description:
4600 adult patients will be enrolled in the study with the primary objective to quantify in
terms of mortality reduction, "the benefit" of using USC on the effectiveness of the
treatment and patient care pathway that present Medical eligibility criteria to supervision
USC.
The methodology of the study is organized into 5 phases:
- Development of candidate criteria that justify the presence in USC and validation by a
panel of experts according to the Delphi method
- Selection of a representative sample of 100 institutions with USC stratified by major
regions (North, Ile-de-France, Southeast, Southwest), the activity of the USC (number
admissions / year), method of financing the establishment, presence or absence of an
operating theater.
- Observational Cohort study, prospective, multicenter. In each selected center will be
collected the data during consecutive patients 1-2 weeks depending on the activity
centers on USC sectors, post-operative, post-resuscitation and post emergency. Data
collection will be done on the ground and from Medicalization Programme of Information
Systems extraction . An external quality control will be organized on 10% of stays.
- Determination of eligibility for hospitalization USC will be conducted by a group of
professionals representing different companies analysis in pairs and independently
stays.
- Modelling and economic evaluation: development and validation of the score (ASIC
Activity Score for Intermediate Care) and medico-economic analysis.
