NCT07525284

Reported Experience Measurement on Reducing Patient Discomfort in Intensive Care

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,242 (estimated)
• Sponsor: Almaviva Sante · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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 duo and based on: 1. a systematic assessment by the caregiver in charge of the patient on the day of discharge from intensive care of any discomfort experienced during the entire stay, based on a specific questionnaire (Inconforts des Patients de REAnimation - IPREA - comprising 16 items of discomfort (Kalfon et al, 2010), 2. immediate feedback to caregivers with reminders of simple predetermined measures, 3. monthly comparative feedback to promote a positive spirit of emulation among participating intensive care units, 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, which includes 18 discomfort items * the questionnaire was completed by the patient themselves without the intervention of a caregiver (self-administration) to avoid potential bias associated with the administration of the questionnaire by a caregiver from the unit in which the patient was hospitalised * 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 and then applied without assessing the impact on patient perception as measured using the IPREA questionnaire * a longer programme learning period of 9 months (compared to 5 months during the IPREA3 study) to allow healthcare teams to better assimilate the changes to care practices decided upon during monthly feedback sessions * the launch of the PREMREA programme with a conference led by a patient expert to raise awareness among intensive care teams

Conditions

• PTSD - Post Traumatic Stress Disorder

Interventions

Type	Name	Description
OTHER	PREMREA program	PREMREA 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.

Timeline

• Start date: 2025-12-19
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: France