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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units

Conditions
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Delirium

Intervention / Treatment
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* Other: Bundle
* Other: Standard Paramedical and Medical practices


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bundle<br>Specific action plan : ABCDE, complemented with care related to the nursing and paramedical role concerning the patient's environmental factors | Other: Bundle<br>* 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<br>* Other names: ABCDE;|
| Other: Control<br>Standard paramedical and medical practices | Other: Standard Paramedical and Medical practices<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of delirium | CAM-ICU Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale. | Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 60 | 
| 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). | Day 60 and month 3 | 
| 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. | Year 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Reanimation, Conversational hypnosis