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Demonstrate that the IPREA3 program (Study: Impact of Multicomponent Intervention to Reduce Perceived Discomforts of the patients in intensive care) reducing discomforts perceived by the patients of intensive care, implemented at the level of the whole intensive care unit, reduce the incidence of the depressive symptoms one year after intensive care exit.
AQVAR is a study of type not exposed presentations, study ancillary of controlled study, multicentric with randomization to cluster, the study IPREA3, for which a financing was already obtained within the framework of the Hospital National Clinical Program of Research on 2012, current study, the inclusions of which began on October 1st, 2014 after the obtaining of all the necessary authorizations. To date, more than 4300 patients were included in the study IPREA3 within 34 departments or intensive care units participating on approval. All the patients included in the study AQVAR will be patients included before in the study IPREA3 and which a complete questionnaire IPREA3 of measure of the discomforts collected by all the patients of intensive care will be available.
The AQVAR study leans on the original current research IPREA3 which consists of the evaluation of a program with multiple components of reduction of the discomforts collected by the patients of including in intensive care:
The innovative character is also brought by the research for the association between conditions of hospitalization in intensive care according to the perception of the patient and very remote quality of life of the hospitalization in intensive care , as well as by the evaluation of a method of primary prevention of the psychiatric morbidity post-intensive care.
The individual profits waited for the patient hospitalized in an intensive care unit having implemented the program of reduction of the discomforts IPREA3 are the improvement of its conditions of hospitalization during its whole stay in intensive care, such as the patient perceives them at the exit of intensive care, then remote, a reduction of the risk of arisen a state of post-traumatic stress, anxious and/or depressive symptoms, and cognitive dysfunctions. This reduction of the psychiatric morbidity should lead to an improvement of its quality of life bound to the health, but also to the recourse to the consultations in an emergency department or to the new hospitalizations.
The expected main collective profits are a better description of the post-traumatic states of stress consecutive to a hospitalization in intensive care, as well as an understanding of mechanisms and risk factors of arisen this psychiatric morbidity.
If the study AQVAR allows to show the tested hypothesis, it will be an additional, decisive argument, to implement in all the intensive care units a program with multiple components of type IPREA3 of reduction of the received discomforts, requiring the commitment of all the healthcare professionals, whose feasibility is in the course of demonstration, and which must be integrated into the projects of department and establishment.
The additional expected collective profits concern two other populations:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients exposed | Patients exposed will be estimated in the study IPREA3 corresponding to surviving individuals of a hospitalization in intensive care in a department having set up the program of reduction of the discomforts collected by the patients of intensive care during a minimal period of 5 months. The program is so defined as factor of exposure and supposed protector of development of anxio-depressive disorders.These patients will have been included in the study IPREA3 in 17 centers of the interventional group of the study IPREA3 during the months of April, 2015 and October, 2015, and in 17 centers of the group control some study IPREA3 during October 2015 |
| |
| patients non exposed | The patients "not exposed" in the supposed factor protector of development of anxio-depressive disorders will be constituted by the patients estimated in the study IPREA3 corresponding to surviving individuals of a hospitalization in intensive care in a department having never operated the program of reduction of the discomforts collected by the patients of intensive care. These patients will have been included in the study IPREA3 in 17 centers of the group control some study IPREA3 during October 2014 and April, 2015 and in 17 centers of the interventional group during October 2014 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| experimental | Other | corresponding to surviving individuals of a hospitalization in intensive care in a department having set up the program of reduction of the discomforts collected by the patients of intensive care during a minimal period of 5 months. The program is so defined as factor of exposure and supposed protector of development of anxio-depressive disorders.These patients will have been included in the study IPREA3 in 17 centers of the interventional group of the study IPREA3 during the months of April, 2015 and October, 2015 |
| Measure | Description | Time Frame |
|---|---|---|
| Improve the reduction of depressive symptoms | A score 8 (maximal score of 21) allows to hold the presence of clinically significant depressive symptoms. | up to 52 weeks of the hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Score of the sub-scale A of the questionnaire HAD-S ( Hospital and Anxiety Depression Scale) | Allowing to estimate the presence of anxious symptoms. Score of the sub-scale A of the questionnaire HAD-S one year after the exit of intensive care allowing to estimate the presence of anxious symptoms. A score 8 (maximal score of 21) allows to hold the presence of clinically significant anxious symptoms. The scale HAD contains 14 highly-rated items from 0 to 3. Seven questions relate to the anxiety ( total A) and seven others in the depressive dimension (total D), so allowing the obtaining of two scores, the maximal note of wich for each of them is 21. |
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Inclusion Criteria:
The same criteria of the IPREA3 study
Exclusion Criteria:
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All the patients included in the study AQVAR will be patients included before in the study IPREA3 for whom the IPREA3 questionnary of measure of the discomforts collected by the patients will be informed (available score for each of the items establishing the questionnaire IPREA3). The inclusion of the patients in the study AQVAR will be made the day of the intensive care exit.
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| Name | Affiliation | Role |
|---|---|---|
| Pierre KALFON, PhD | CH CHARTRES | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.H. de Chartres | Chartres | 28018 | France | |||
| CHU Beaujon APHP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17558490 | Result | Griffiths J, Fortune G, Barber V, Young JD. The prevalence of post traumatic stress disorder in survivors of ICU treatment: a systematic review. Intensive Care Med. 2007 Sep;33(9):1506-18. doi: 10.1007/s00134-007-0730-z. Epub 2007 Jun 9. | |
| 24401069 | Result | Pandharipande PP, Girard TD, Ely EW. Long-term cognitive impairment after critical illness. N Engl J Med. 2014 Jan 9;370(2):185-6. doi: 10.1056/NEJMc1313886. No abstract available. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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The calculation of the number of necessary subjects is realized from the main criterion and bases on the proportion of presenting subjects of the clinically significant depressive symptoms in 1 year of their hospitalization in intensive care, estimated from it under scale D of the score HAD-S.The proposal of the subject waited for the patient presenting this profile was on the works available in particular on the general review of DAVYDOW and AL
|
| control | Other | The patients "not exposed" in the supposed factor protector of development of anxio-depressive disorders will be constituted by the patients estimated in the study IPREA3 corresponding to surviving individuals of a hospitalization in intensive care in a department having never operated the program of reduction of the discomforts collected by the patients of intensive care. These patients will have been included in the study IPREA3 in 17 centers of the group control some study IPREA3 during October 2014 and April, 2015 |
|
| up to 52 weeks of the hospitalization |
| Score IES-R ( impact of Events Scale-Revised) | Allowing to detect a risk of state of post traumatic stress. | up to 52 weeks of the hospitalization |
| Questionnaire EQ-5D | Indicators of quality of life estimated by questionnaires EQ-5D | up to 52 weeks of the hospitalization |
| Describe quality of life | Return home, taken by a professional activity, an existence of a psychiatric or psychological follow up, and a regular consumption of psychotropics | up to 52 weeks of the hospitalization |
| Duration of hospitalization | Informations are in the medical bases statistic of each hospital | Consecutive to the hospitalization in intensive care |
| Clichy |
| 92110 |
| France |
| CH Douai | Douai | 59507 | France |
| CH La Rochelle | La Rochelle | 17022 | France |
| CH Le Puy en Velay | Le Puy-en-Velay | 43000 | France |
| CH Lens | Lens | 62300 | France |
| CHU Edouard Herriot | Lyon | 69003 | France |
| CHU Saint Louis APHP | Paris | 75010 | France |
| CHU Cochin APHP | Paris | 75014 | France |
| CHU NHC | Strasbourg | 67000 | France |
| CHU Hautepierre | Strasbourg | 67100 | France |
| CH Troyes | Troyes | 10000 | France |
| 25083985 | Result | Davydow DS, Hough CL, Zatzick D, Katon WJ. Psychiatric symptoms and acute care service utilization over the course of the year following medical-surgical ICU admission: a longitudinal investigation*. Crit Care Med. 2014 Dec;42(12):2473-81. doi: 10.1097/CCM.0000000000000527. |
| 23369507 | Result | Davydow DS, Zatzick D, Hough CL, Katon WJ. A longitudinal investigation of posttraumatic stress and depressive symptoms over the course of the year following medical-surgical intensive care unit admission. Gen Hosp Psychiatry. 2013 May-Jun;35(3):226-32. doi: 10.1016/j.genhosppsych.2012.12.005. Epub 2013 Jan 28. |
| 20502874 | Result | Kalfon P, Mimoz O, Auquier P, Loundou A, Gauzit R, Lepape A, Laurens J, Garrigues B, Pottecher T, Malledant Y. Development and validation of a questionnaire for quantitative assessment of perceived discomforts in critically ill patients. Intensive Care Med. 2010 Oct;36(10):1751-1758. doi: 10.1007/s00134-010-1902-9. Epub 2010 May 26. |
| 30701294 | Derived | Kalfon P, Alessandrini M, Boucekine M, Renoult S, Geantot MA, Deparis-Dusautois S, Berric A, Collange O, Floccard B, Mimoz O, Julien A, Robert R, Audibert J, Renault A, Follin A, Thevenin D, Revel N, Venot M, Patrigeon RG, Signouret T, Fromentin M, Sharshar T, Vigne C, Pottecher J, Levrat Q, Sossou A, Garrouste-Orgeas M, Quenot JP, Boulle C, Azoulay E, Baumstarck K, Auquier P; IPREA-AQVAR Study Group. Tailored multicomponent program for discomfort reduction in critically ill patients may decrease post-traumatic stress disorder in general ICU survivors at 1 year. Intensive Care Med. 2019 Feb;45(2):223-235. doi: 10.1007/s00134-018-05511-y. Epub 2019 Jan 30. |