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

Not Applicable

Completed

• Conditions: Delirium
• Interventions: Other: Bundle; Other: Standard Paramedical and Medical practices

• Registration Number: NCT03125252
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2016-10-27
• Study First Submitted: 2017-03-05
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-24
• Primary Completion: 2020-04
• Status Verified: 2020-11
• Study Completion: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 379

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bundle	Bundle	Specific action plan : ABCDE, complemented with care related to the nursing and paramedical role concerning the patient's environmental factors
Control	Standard Paramedical and Medical practices	Standard paramedical and medical practices

Primary Outcome Measures

Name	Time	Method
Incidence rate of delirium	Day 60	CAM-ICU Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.

Secondary Outcome Measures

Name	Time	Method
Quality of life at one year	Year 1	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.
Duration of the delirium between the diagnosis and the resolution of the delirium	Day 60	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.	Day 60 and month 3	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).

Trial Locations

Locations (14)

Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Nord Hospital; 🇫🇷 Marseille, France

Hospital Castres-Mazamet; 🇫🇷 Castres, France

Saint-André Hospital; 🇫🇷 Bordeaux, France

Estaing Hospital; 🇫🇷 Clermont-Ferrand, France

Montauban Hospital; 🇫🇷 Montauban, France

Hospital; 🇫🇷 Montpellier, France

Saint-Joseph Hospital; 🇫🇷 Marseille, France

Caremeau Hospital; 🇫🇷 Nîmes, France

Perpignan Hospital; 🇫🇷 Perpignan, France

University Hospital Toulouse; 🇫🇷 Toulouse, France

Jacques Puel Hospital; 🇫🇷 Rodez, France

Oncologic Hospital; 🇫🇷 Toulouse, France

Rangueil Hospital; 🇫🇷 Toulouse, France