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Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units (DELIREA)

Primary Purpose

Delirium

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bundle
Standard Paramedical and Medical practices
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring Delirium, Reanimation, Conversational hypnosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent signed by the trusted person and the patient upon waking
  • Hospitalized in reanimation service (first hospitalization or transfer of another service)
  • 48 hours of sedation with intubation during hospitalization (all combinations of morphine, hypnotics, sedatives, anesthetics, narcoleptics)
  • Francophone (able to understand all evaluations)

Criteria for the inclusion of 50 delirium positive patients drawn from the Toulouse center (participating in the neuropsychological evaluation): In addition to those mentioned above:

  • Absence of pre-existing cognitive impairment (patients whose relative has completed the IQCode questionnaire and whose score is <3.4 points)
  • Visual, auditory (authorized equipment) skills and adequate oral or written expression for the proper conduct of neuropsychological tests.

Exclusion Criteria:

  • Pregnant women
  • Evolutive neurological disease leading to cognitive impairment (multiple sclerosis, Parkinson's disease, Alzheimer's disease), and / or focal neurological disease leading to cognitive impairment (head trauma, stroke, ...)
  • Evolving psychiatric illness (including severe depression)
  • Voluntary drug poisoning
  • Patients who have already participated in the study

Sites / Locations

  • Saint-André Hospital
  • Hospital Castres-Mazamet
  • Estaing Hospital
  • Gabriel Montpied
  • Nord Hospital
  • Saint-Joseph Hospital
  • Montauban Hospital
  • Hospital
  • Caremeau Hospital
  • Perpignan Hospital
  • Jacques Puel Hospital
  • University Hospital Toulouse
  • Oncologic Hospital
  • Rangueil Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Bundle

Control

Arm Description

Specific action plan : ABCDE, complemented with care related to the nursing and paramedical role concerning the patient's environmental factors

Standard paramedical and medical practices

Outcomes

Primary Outcome Measures

Incidence rate of delirium
CAM-ICU Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.

Secondary Outcome Measures

Duration of the delirium between the diagnosis and the resolution of the delirium
The duration of the delirium (in days) between the diagnosis and the resolution of the delirium will be done until 60 days of the stay of the patients in intensive care.
Evaluation of cognitive and psycho-behavioral functions.
Cognitive and psycho-behavioral functions are usually evaluated by a corpus of test : memory : Test of 5 words and Free Recall Test executive : Fast Evaluation Battery for Executive Functions, Trail Making Test, Digit Span, Stroop and Verbal Fluences and Animals praxis : Mahieux's Test language : D0 80 behavior : Montgomery's scale (depression), Starkstein's scale (apathy).
Quality of life at one year
The evaluation of 142 first patients delirium positive: the first 12 patients delirium positive in the 6 centers of the arm to which Toulouse will not belong, and the first 14 patients delirium positive in the 5 centers of the arm to which Toulouse will belong (Toulouse excluded), 1 year after the date of their inclusion in the study during their hospitalization in reanimation service. This evaluation of Quality of life of the first patients detected positive to delirium will be carried out using the validated French standardized questionnaire or Short Form 36 item (SF-36) which will be sent by post to the patient's home.

Full Information

First Posted
March 5, 2017
Last Updated
November 10, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03125252
Brief Title
Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units
Acronym
DELIREA
Official Title
Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 27, 2016 (Actual)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
November 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective is to evaluate the impact of the "bundle of actions" on the delirium's incidence in resuscitation patients during their stay in the service, compared to a conventional treatment. The investigators therefore hypothesize that a set of coordinated paramedical actions in the prevention of delirium would reduce its incidence by 15% compared to conventional care.
Detailed Description
The "Bundle of Actions" is a coordinated and specific action plan, which has already been validated, focusing on the coordination of wake-up and respiration, the management of delirium, as well as the early mobility of the patient. Innovation consists of simple, reproducible nursing care that reduces triggers of delirium; as well as the use of two new approaches in reanimation: conversational hypnosis and early and comprehensive re-empowerment of the patient in the management of his pain and well-being.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Delirium, Reanimation, Conversational hypnosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
379 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bundle
Arm Type
Experimental
Arm Description
Specific action plan : ABCDE, complemented with care related to the nursing and paramedical role concerning the patient's environmental factors
Arm Title
Control
Arm Type
Other
Arm Description
Standard paramedical and medical practices
Intervention Type
Other
Intervention Name(s)
Bundle
Other Intervention Name(s)
ABCDE
Intervention Description
Awakening and Breathing Coordination Delirium monitoring and management (detection and management of delirium) Early mobility Factors of environment: thirst noise pain and well-being sleep isolation
Intervention Type
Other
Intervention Name(s)
Standard Paramedical and Medical practices
Intervention Description
The current recommendations recommend the following scheme: Identification and correction of an organic cause / factors (sepsis, metabolic disorders, withdrawal syndrome, pain) Use of non-pharmacological means (early mobilization, correction of sensory deficits, temporo-spatial reorientation strategies) Use of reference antipsychotic pharmacological means
Primary Outcome Measure Information:
Title
Incidence rate of delirium
Description
CAM-ICU Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.
Time Frame
Day 60
Secondary Outcome Measure Information:
Title
Duration of the delirium between the diagnosis and the resolution of the delirium
Description
The duration of the delirium (in days) between the diagnosis and the resolution of the delirium will be done until 60 days of the stay of the patients in intensive care.
Time Frame
Day 60
Title
Evaluation of cognitive and psycho-behavioral functions.
Description
Cognitive and psycho-behavioral functions are usually evaluated by a corpus of test : memory : Test of 5 words and Free Recall Test executive : Fast Evaluation Battery for Executive Functions, Trail Making Test, Digit Span, Stroop and Verbal Fluences and Animals praxis : Mahieux's Test language : D0 80 behavior : Montgomery's scale (depression), Starkstein's scale (apathy).
Time Frame
Day 60 and month 3
Title
Quality of life at one year
Description
The evaluation of 142 first patients delirium positive: the first 12 patients delirium positive in the 6 centers of the arm to which Toulouse will not belong, and the first 14 patients delirium positive in the 5 centers of the arm to which Toulouse will belong (Toulouse excluded), 1 year after the date of their inclusion in the study during their hospitalization in reanimation service. This evaluation of Quality of life of the first patients detected positive to delirium will be carried out using the validated French standardized questionnaire or Short Form 36 item (SF-36) which will be sent by post to the patient's home.
Time Frame
Year 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent signed by the trusted person and the patient upon waking Hospitalized in reanimation service (first hospitalization or transfer of another service) 48 hours of sedation with intubation during hospitalization (all combinations of morphine, hypnotics, sedatives, anesthetics, narcoleptics) Francophone (able to understand all evaluations) Criteria for the inclusion of 50 delirium positive patients drawn from the Toulouse center (participating in the neuropsychological evaluation): In addition to those mentioned above: Absence of pre-existing cognitive impairment (patients whose relative has completed the IQCode questionnaire and whose score is <3.4 points) Visual, auditory (authorized equipment) skills and adequate oral or written expression for the proper conduct of neuropsychological tests. Exclusion Criteria: Pregnant women Evolutive neurological disease leading to cognitive impairment (multiple sclerosis, Parkinson's disease, Alzheimer's disease), and / or focal neurological disease leading to cognitive impairment (head trauma, stroke, ...) Evolving psychiatric illness (including severe depression) Voluntary drug poisoning Patients who have already participated in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanny CROZES, nurse
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Study Director
Facility Information:
Facility Name
Saint-André Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hospital Castres-Mazamet
City
Castres
ZIP/Postal Code
81
Country
France
Facility Name
Estaing Hospital
City
Clermont-Ferrand
ZIP/Postal Code
63100
Country
France
Facility Name
Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63100
Country
France
Facility Name
Nord Hospital
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Saint-Joseph Hospital
City
Marseille
ZIP/Postal Code
13285
Country
France
Facility Name
Montauban Hospital
City
Montauban
ZIP/Postal Code
82000
Country
France
Facility Name
Hospital
City
Montpellier
ZIP/Postal Code
34090
Country
France
Facility Name
Caremeau Hospital
City
Nîmes
ZIP/Postal Code
30929
Country
France
Facility Name
Perpignan Hospital
City
Perpignan
ZIP/Postal Code
66046
Country
France
Facility Name
Jacques Puel Hospital
City
Rodez
ZIP/Postal Code
12027
Country
France
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Oncologic Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Rangueil Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16244013
Citation
Aissaoui Y, Zeggwagh AA, Zekraoui A, Abidi K, Abouqal R. Validation of a behavioral pain scale in critically ill, sedated, and mechanically ventilated patients. Anesth Analg. 2005 Nov;101(5):1470-1476. doi: 10.1213/01.ANE.0000182331.68722.FF.
Results Reference
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PubMed Identifier
19366412
Citation
Arend E, Christensen M. Delirium in the intensive care unit: a review. Nurs Crit Care. 2009 May-Jun;14(3):145-54. doi: 10.1111/j.1478-5153.2008.00324.x.
Results Reference
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PubMed Identifier
22467611
Citation
Balas MC, Vasilevskis EE, Burke WJ, Boehm L, Pun BT, Olsen KM, Peitz GJ, Ely EW. Critical care nurses' role in implementing the "ABCDE bundle" into practice. Crit Care Nurse. 2012 Apr;32(2):35-8, 40-7; quiz 48. doi: 10.4037/ccn2012229.
Results Reference
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PubMed Identifier
19697008
Citation
Chanques G, Payen JF, Mercier G, de Lattre S, Viel E, Jung B, Cisse M, Lefrant JY, Jaber S. Assessing pain in non-intubated critically ill patients unable to self report: an adaptation of the Behavioral Pain Scale. Intensive Care Med. 2009 Dec;35(12):2060-7. doi: 10.1007/s00134-009-1590-5.
Results Reference
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PubMed Identifier
23040288
Citation
Devlin JW, Brummel NE, Al-Qadheeb NS. Optimising the recognition of delirium in the intensive care unit. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):385-93. doi: 10.1016/j.bpa.2012.08.002.
Results Reference
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PubMed Identifier
15082703
Citation
Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
Results Reference
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PubMed Identifier
1246970
Citation
Erickson MH, Rossi EL. Two level communication and the microdynamics of trance and suggestion. Am J Clin Hypn. 1976 Jan;18(3):153-71. doi: 10.1080/00029157.1976.10403794. No abstract available.
Results Reference
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PubMed Identifier
18495054
Citation
Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3(Suppl 3):S3. doi: 10.1186/cc6149. Epub 2008 May 14.
Results Reference
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PubMed Identifier
19828283
Citation
Guenther U, Popp J, Koecher L, Muders T, Wrigge H, Ely EW, Putensen C. Validity and reliability of the CAM-ICU Flowsheet to diagnose delirium in surgical ICU patients. J Crit Care. 2010 Mar;25(1):144-51. doi: 10.1016/j.jcrc.2009.08.005. Epub 2009 Oct 13.
Results Reference
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PubMed Identifier
25482152
Citation
McCusker J, Cole MG, Voyer P, Monette J, Champoux N, Ciampi A, Vu M, Belzile E. Six-month outcomes of co-occurring delirium, depression, and dementia in long-term care. J Am Geriatr Soc. 2014 Dec;62(12):2296-302. doi: 10.1111/jgs.13159. Epub 2014 Dec 8.
Results Reference
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Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units

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