Evaluation of the Methods and Effectiveness of Care for Eligible Medical and Surgical Patients on Admission in Continuous Monitoring Units

NCT ID: NCT02590172

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

501 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-13

Study Completion Date

2020-12-11

Brief Summary

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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

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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.

Conditions

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Units Continuous Monitoring (USC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beaussier Marc, PHD

Role: PRINCIPAL_INVESTIGATOR

Assistance publique hopitaux de Paris - APHP

Locations

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Hôptal Saint Antoine

Paris, , France

Site Status

Countries

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France

References

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Misset B, Aegerter P, Boulkedid R, Alberti C, Baillard C, Guidet B, Beaussier M. Construction of reference criteria to admit patients to intermediate care units in France: a Delphi survey of intensivists, anaesthesiologists and emergency medicine practitioners (first part of the UNISURC project). BMJ Open. 2023 Jul 24;13(7):e072836. doi: 10.1136/bmjopen-2023-072836.

Reference Type DERIVED
PMID: 37487677 (View on PubMed)

Other Identifiers

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NI14008

Identifier Type: -

Identifier Source: org_study_id

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