Units Continuous Monitoring (USC)UNISURCNCT02590172
Evaluation of the Methods and Effectiveness of Care for Eligible Medical and Surgical Patients on Admission in Continuous Monitoring Units
An observational study of Units Continuous Monitoring (USC), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Units Continuous Monitoring (USC)
- How many people
- 501 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2019to 11 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be one of the selected schools and hospitals among those with a USC.
Who may be able to join
- 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.
Who cannot join
- opposition to the data collection
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Units Continuous Monitoring (USC)
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital Mortality
Quantify in terms of mortality reduction, "the benefit" of using USC on the effectiveness of the treatment and patient care pathway with existing medical eligibility criteria to supervision USC
Measured: seven days
Secondary outcomes (5)
Score ASIC
Develop a score justifying the eligibility of patients USC: ASIC score for Intermediate Care Activity Score
Measured: seven days
typology of admitted patients
Describe the organization and activity of USC in France by representative sampling.
Measured: seven days
hospital stay duration
Measured: seven days
numbers of serious adverse events
Measured: seven days
Readmission and death rates
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study start13 Feb 2019
- Primary completion11 Dec 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Units Continuous Monitoring (USC)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beaussier Marc, PHD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590172
- Sponsor's protocol ID
- NI14008
- Acronym
- UNISURC
- Status last verified
- Aug 2023
- First submitted
- 27 Oct 2015
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37487677
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Methods and Effectiveness of Care for Eligible Medical and Surgical Patients on Admission in Continuous Monitoring Units
- ClinicalTrials.gov ID
- NCT02590172
- Acronym / sponsor ID
- UNISURC / NI14008
- Conditions
- Units Continuous Monitoring (USC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be one of the selected schools and hospitals among those with a USC.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- opposition to the data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hospital Mortality
Time frame: seven days
Quantify in terms of mortality reduction, "the benefit" of using USC on the effectiveness of the treatment and patient care pathway with existing medical eligibility criteria to supervision USC
5 secondary outcomes
Score ASIC
Time frame: seven days
typology of admitted patients
Time frame: seven days
hospital stay duration
Time frame: seven days
numbers of serious adverse events
Time frame: seven days
Readmission and death rates
Time frame: seven days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Derived from this study: PubMed 37487677Misset 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beaussier Marc, PHD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Units Continuous Monitoring (USC), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospital Mortality (time frame: seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02590172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.