Reported Experience Measurement on Reducing Patient Discomfort in Intensive Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlmaviva Sante
About this trial
Hospitalisation in intensive care is always traumatic and can lead to a long rehabilitation process, slowed down by symptoms of anxiety and/or depression, and/or post-traumatic stress disorder (PTSD). These psychiatric disorders, or post-intensive care syndrome (PICS), can persist for several years after hospitalisation in intensive care and cause functional disability. They are associated with the use of psychotropic drugs and mental health services, and impair health-related quality of life.
This research is based on the hypothesis that the traumatic nature of intensive care hospitalisation can be reduced by implementing programmes to improve intensive care hospitalisation conditions, promoting changes in the practices of all healthcare professionals involved in intensive care.
IPREA3 study (Kalfon et al, 2017) demonstrated that implementation of a tailor-made, multi-component programme, led by a doctor/non-medical caregiver significantly reduced the overall discomfort score (derived from the IPREA questionnaire) perceived by patients hospitalised in an intensive care unit with sufficient experience in applying this programme, having used it for at least 5 months (Kalfon et al, 2017) .
The originality and interest of this research, in comparison with the IPREA3 study, lie in the following aspects:
* the use of the most recent version of the IPREA questionnaire, * the questionnaire was completed by the patient themselves without the intervention of a caregiver (self-administration) * the fact that new care practices, aimed at humanising a stay in intensive care and making the experience of a stay in intensive care less traumatic, were described after the publication of the IPREA3 study a * a longer programme learning period of 9 months (compared to 5 months during the IPREA3 study) * the launch of the PREMREA programme with a conference led by a patient expert
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient, male or female, aged ≥ 18 years
Patient discharged alive from intensive care
Patient hospitalised in intensive care for at least three calendar days
Patient affiliated with or beneficiary of a social security scheme
Disqualifiers
Patients whose situation is incompatible with completing the IPREA questionnaire
Protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision
Patients hospitalised without consent
Pregnant and/or breastfeeding women
Trial design
Design model
Sequential
Treatments tested in this trial
PREMREA program
Other interventionPREMREA is a tailor-made, multi-component program led by a doctor/non-medical caregiver duo, consisting of the following elements: * Systematic completion of the 18-item IPREA questionnaire by the patient on the day of discharge. * Monthly feedback to all intensive care staff presenting the monthly results of the department and other participating departments, led by the doctor/non-medical caregiver duo. * Implementation of specific measures in the department, decided collectively and coordinated by the doctor/non-medical caregiver duo, and monitoring of these measures.
Treatment groups
1,242 Participants
are divided into 2 treatment groupsGroup A: Arm PREMREA +Experimental treatment 1 intervention
Group B: Arm PREMREA -No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Overall discomfort score
Overall discomfort score is obtained from the 18-item IPREA questionnaire. It consists of 18 pre-established items describing the most common sources of discomfort in intensive care : noise, excessive light, discomfort related to unfamiliar bedding, lack of sleep, thirst, hunger, cold, heat, pain, restriction of autonomy due to cables and infusion lines, lack of privacy, anxiety, isolation, limited visits from loved ones, lack of a telephone, insufficient information about current health status, difficulty breathing, depression (Baumstarck et al, 2019). For each of the 18 discomfort items, the patient gives a score between 0 (no discomfort at all) and 10 (maximum discomfort imaginable). The overall discomfort score is calculated as the average of the 18 discomfort scores multiplied by 10, resulting in a score between 0 and 100
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov