Improve the Quality of Life After a Hospitalization in Critical Care

Depression Clinical Trial

— AQVAR  

Official title:

Improve the Quality of Life After a Hospitalization in Critical Care Thanks to a Program of Prevention of Discomforts Perceived by the Patients of Critical Care Base on Targeted Measures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762409
• Other study ID #: PREPS-15-15-0183
• Status: Completed
• Phase: N/A
• First received: April 18, 2016
• Last updated: July 20, 2017
• Start date: October 1, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: August 2016
• Source: Centre Hospitalier of Chartres
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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:

1. The preliminary identification of a binomial doctor-nurse of local coordinating experts of the program IPREA3

2. A systematic measure of the discomforts collected by means of the questionnaire IPREA administered the day of the exit.

3. An immediate return of the scores of discomfort in every nursing administering the questionnaire IPREA

4. The implementation of measures targeted by reduction of the discomforts, based on the analysis of the results appropriate to the intensive care unit.

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:

• The close relations of the patients hospitalized in intensive care, according to the hypothesis of an interaction between the quality of life of the patients after the intensive care and that of their susceptible close relations they too to develop a state of post-traumatic stress after the hospitalization in intensive care.

• The health workers practicing in intensive care, among which the job satisfaction, and possibly the level risks of professional exhaustion, should be improved by the membership in a department applying the program, federative, of reduction of the discomforts in intensive care, applied by the whole team specialized in intensive care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1006
• Est. completion date: December 31, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

The same criteria of the IPREA3 study

• Taken out alive of intensive care

• Hospitalization in intensive care extending at least over three calendar days.

Exclusion Criteria:

• Deaths in intensive care

• Age 18-year-old inferior

• Under guardianship patient

• Incompatible situation with the administration of the IPREA questionnaire at the exit of intensive care: presence of neuropsychic disorders, language barrier, transfer under mechanical ventilation, taken out of intensive care in urgency

• Patient refused to participate in the study IPREA3

• Patient refused to participate in the study AQVAR

Related Conditions & MeSH terms

• Depression
• Depression Symptoms
• Depressive Disorder

Intervention

Other:
• experimental
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
• control
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

Locations

Country	Name	City	State
France	C.H. de Chartres	Chartres
France	CHU Beaujon APHP	Clichy
France	CH Douai	Douai
France	CH La Rochelle	La Rochelle
France	CH Le Puy en Velay	Le Puy en Velay
France	CH Lens	Lens
France	CHU Edouard Herriot	Lyon
France	CHU Cochin APHP	Paris
France	CHU Saint Louis APHP	Paris
France	CHU Hautepierre	Strasbourg
France	CHU NHC	Strasbourg
France	CH Troyes	Troyes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier of Chartres

Country where clinical trial is conducted

France, 

References & Publications (5)

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/CC — View Citation

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. d — View Citation

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. Epub 2007 Jun 9. Review. — View Citation

Kalfon P, Mimoz O, Auquier P, Loundou A, Gauzit R, Lepape A, Laurens J, Garrigues B, Pottecher T, Mallédant Y. Development and validation of a questionnaire for quantitative assessment of perceived discomforts in critically ill patients. Intensive Care Me — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	up to 52 weeks of the hospitalization
Secondary	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
Secondary	Questionnaire EQ-5D	Indicators of quality of life estimated by questionnaires EQ-5D	up to 52 weeks of the hospitalization
Secondary	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
Secondary	Duration of hospitalization	Informations are in the medical bases statistic of each hospital	Consecutive to the hospitalization in intensive care