Socioeconomic FactorsPRECAREANCT03607019
Social Deprivation Features in Intensive Care Unit Patients
An observational study of Socioeconomic Factors, run by Centre Hospitalier de Saint-Denis at 9 sites in France.
Trial summary
Socioeconomic inequalities are increasingly recognised as an important public health issue, and it is now well established that patients with socioeconomic deprivation (SED) features demonstrate higher mortality and morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Socioeconomic Factors
- How many people
- 234 participants
- Where
- 9 sitesFrance
- Study dates
- 5 Mar 2018to 30 Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients admitted to one of the participating ICUs during the study period
Who may be able to join
- Age ≥ 18 years
- Admission to one of the participating intensive care units
Who cannot join
- None
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Centre Hospitalier Universitaire Ambroise Paré
Boulogne-Billancourt, 92104
Centre Hospitalier Universitaire Louis Mourier
Colombes, 92701
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, 91106
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94010
Grand Hopital de l'Est Francilien
Jossigny, 77600
Groupe Hospitalier Nord-Essone
Longjumeau, 91160
Centre Hospitalier Intercommunal André Grégoire
Montreuil, 93100
Centre Hospitalier Universitaire Lariboisière
Paris, 75010
Centre Hospitalier de Saint-Denis
Saint-Denis, 93200
About this study
Official title: Epidemiology and Prognostic Impact of Social Deprivation Features in Intensive Care Unit Patients
Socioeconomic inequalities are increasingly recognised as an important public health issue, and it is now well established that patients with socioeconomic deprivation (SED) features demonstrate higher mortality and morbidity. The epidemiology and impact of SED on the specific population of ICU patients has been insufficiently investigated.
In this prospective multicenter study of patients admitted to 9 ICUs of the Paris area, the investigators aim to explore the epidemiology of SED features, and its impact on mortality and length of stay.
- Conditions
- Socioeconomic Factors
- Keywords
- Intensive care, Critical care, Poverty, inequalities
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
30-day mortality
Measured: 30 days
Secondary outcomes (3)
ICU length of stay
ICU length of stay
Measured: up to 12 weeks
Hospital length of stay
Hospital length of stay
Measured: up to 12 weeks
ICU mortality
ICU mortality
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start5 Mar 2018
- Primary completion15 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Socioeconomic FactorsStudies of the same condition, open and under way.
- 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
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne de Montmollin, MD, Principal investigator, Centre Hospitalier de Saint-DenisMorgan Benais, MD, Study chair, Centre Hospitalier de Saint-DenisDaniel Da Silva, MD, Study chair, Centre Hospitalier de Saint-Denis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607019
- Sponsor's protocol ID
- 2017-A01272-51
- Acronym
- PRECAREA
- Status last verified
- Mar 2022
- First submitted
- 13 Jul 2018
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marmot M, Allen J, Bell R, Bloomer E, Goldblatt P; Consortium for the European Review of Social Determinants of Health and the Health Divide. WHO European review of social determinants of health and the health divide. Lancet. 2012 Sep 15;380(9846):1011-29. doi: 10.1016/S0140-6736(12)61228-8. Epub 2012 Sep 8.
PubMed 22964159Welch CA, Harrison DA, Hutchings A, Rowan K. The association between deprivation and hospital mortality for admissions to critical care units in England. J Crit Care. 2010 Sep;25(3):382-90. doi: 10.1016/j.jcrc.2009.11.003. Epub 2010 Jan 15.
PubMed 20074907Zager S, Mendu ML, Chang D, Bazick HS, Braun AB, Gibbons FK, Christopher KB. Neighborhood poverty rate and mortality in patients receiving critical care in the academic medical center setting. Chest. 2011 Jun;139(6):1368-1379. doi: 10.1378/chest.10-2594. Epub 2011 Mar 31.
PubMed 21454401Latour J, Lopez V, Rodriguez M, Nolasco A, Alvarez-Dardet C. Inequalities in health in intensive care patients. J Clin Epidemiol. 1991;44(9):889-94. doi: 10.1016/0895-4356(91)90051-a.
PubMed 1890431Bein T, Hackner K, Zou T, Schultes S, Bosch T, Schlitt HJ, Graf BM, Olden M, Leitzmann M. Socioeconomic status, severity of disease and level of family members' care in adult surgical intensive care patients: the prospective ECSSTASI study. Intensive Care Med. 2012 Apr;38(4):612-9. doi: 10.1007/s00134-012-2463-x. Epub 2012 Jan 25.
PubMed 22273749Bige N, Hejblum G, Baudel JL, Carron A, Chevalier S, Pichereau C, Maury E, Guidet B. Homeless Patients in the ICU: An Observational Propensity-Matched Cohort Study. Crit Care Med. 2015 Jun;43(6):1246-54. doi: 10.1097/CCM.0000000000000944.
PubMed 25793435
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Prognostic Impact of Social Deprivation Features in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT03607019
- Acronym / sponsor ID
- PRECAREA / 2017-A01272-51
- Conditions
- Socioeconomic Factors
- Keywords
- Intensive care, Critical care, Poverty, inequalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 31 Jul 2018 (actual)
- 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.
Socioeconomic inequalities are increasingly recognised as an important public health issue, and it is now well established that patients with socioeconomic deprivation (SED) features demonstrate higher mortality and morbidity. The epidemiology and impact of SED on the specific population of ICU patients has been insufficiently investigated.
In this prospective multicenter study of patients admitted to 9 ICUs of the Paris area, the investigators aim to explore the epidemiology of SED features, and its impact on mortality and length of stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients admitted to one of the participating ICUs during the study period
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Admission to one of the participating intensive care units
Key exclusion criteria (1 listed)
- None
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
30-day mortality
Time frame: 30 days
30-day mortality
3 secondary outcomes
ICU length of stay
Time frame: up to 12 weeks
Hospital length of stay
Time frame: up to 12 weeks
ICU mortality
Time frame: up to 12 weeks
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 31 May 2022.
- Background: PubMed 22964159Marmot M, Allen J, Bell R, Bloomer E, Goldblatt P; Consortium for the European Review of Social Determinants of Health and the Health Divide. WHO European review of social determinants of health and the health divide. Lancet. 2012 Sep 15;380(9846):1011-29. doi: 10.1016/S0140-6736(12)61228-8. Epub 2012 Sep 8.
- Background: PubMed 20074907Welch CA, Harrison DA, Hutchings A, Rowan K. The association between deprivation and hospital mortality for admissions to critical care units in England. J Crit Care. 2010 Sep;25(3):382-90. doi: 10.1016/j.jcrc.2009.11.003. Epub 2010 Jan 15.
- Background: PubMed 21454401Zager S, Mendu ML, Chang D, Bazick HS, Braun AB, Gibbons FK, Christopher KB. Neighborhood poverty rate and mortality in patients receiving critical care in the academic medical center setting. Chest. 2011 Jun;139(6):1368-1379. doi: 10.1378/chest.10-2594. Epub 2011 Mar 31.
- Background: PubMed 1890431Latour J, Lopez V, Rodriguez M, Nolasco A, Alvarez-Dardet C. Inequalities in health in intensive care patients. J Clin Epidemiol. 1991;44(9):889-94. doi: 10.1016/0895-4356(91)90051-a.
- Background: PubMed 22273749Bein T, Hackner K, Zou T, Schultes S, Bosch T, Schlitt HJ, Graf BM, Olden M, Leitzmann M. Socioeconomic status, severity of disease and level of family members' care in adult surgical intensive care patients: the prospective ECSSTASI study. Intensive Care Med. 2012 Apr;38(4):612-9. doi: 10.1007/s00134-012-2463-x. Epub 2012 Jan 25.
- Background: PubMed 25793435Bige N, Hejblum G, Baudel JL, Carron A, Chevalier S, Pichereau C, Maury E, Guidet B. Homeless Patients in the ICU: An Observational Propensity-Matched Cohort Study. Crit Care Med. 2015 Jun;43(6):1246-54. doi: 10.1097/CCM.0000000000000944.
- Individual participant dataSharing planned: No
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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.
Etienne de Montmollin, MD principal investigator
Centre Hospitalier de Saint-Denis
Morgan Benais, MD study chair
Centre Hospitalier de Saint-Denis
Daniel Da Silva, MD study chair
Centre Hospitalier de Saint-Denis
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Socioeconomic Factors, run by Centre Hospitalier de Saint-Denis at 9 sites 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 2 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 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
30-day mortality (time frame: 30 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 NCT03607019, which also lists 6 linked publications.
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 31 May 2022.