Clinical trial NCT02590172: Evaluation of the Methods and Effectiveness of Care for Eligible Medical and Surgical Patients on Admission in Continuous Monitoring Units
Official title: Evaluation of the Methods and Effectiveness of Care for Eligible Medical and Surgical Patients on Admission in Continuous Monitoring Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Units Continuous Monitoring (USC)
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be one of the selected schools and hospitals among those with a USC.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

Adult patients (age\> = 18 years) hospitalized in a facility selected during the investigation period:

or in one of the three evaluated healthcare pathways: 1 / out patient surgery postoperative period; 2 / downstream of hospital emergencies; 3 / downstream resuscitation (excluding return home and external transfer), it is recognized or not USC.

USC is present during the investigation period. Patient who read the Circular.

Exclusion Criteria:

* opposition to the data collection

Primary outcomes:
measure: hospital Mortality
timeFrame: seven days
Secondary outcomes:
measure: Score ASIC
timeFrame: seven days
measure: typology of admitted patients
timeFrame: seven days
measure: hospital stay duration
timeFrame: seven days
measure: numbers of serious adverse events
timeFrame: seven days
measure: Readmission and death rates
timeFrame: seven days
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôptal Saint Antoine
Study officials:
affiliation: Assistance publique hopitaux de Paris - APHP
name: Beaussier Marc, PHD
role: PRINCIPAL_INVESTIGATOR
References: