Reported Experience Measurement on Reducing Patient Discomfort in Intensive Care (PREMREA)

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

Study Overview

• Status: Recruiting
• Conditions: PTSD - Post Traumatic Stress Disorder
• Intervention / Treatment: Other: PREMREA program

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

• Study Type: Interventional
• Enrollment (Estimated): 1242
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre KALFON, MD; Phone Number: + 33 6 38 39 24 18; Email: pierrekalfon@sfr.fr

Study Locations

• France
  • France
    • Aubagne, France, France, 13400
      • Recruiting
      • Hôpital Privé La Casamance
      • Contact: Pierre KALFON, MD; Phone Number: + 33 6 38 39 24 18; Email: pierrekalfon@sfr.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• Patient who speaks French and has signed an informed consent form

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm PREMREA +; Patients in this arm will benefit from measures taken from PREMREA program	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.
No Intervention: Arm PREMREA -; Patients in this arm do not benefit from measures taken from PREMREA program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Collaborators and Investigators

• Sponsor: Almaviva Sante

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; IPREA questionnaire
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Combat Disorders
• Other Study ID Numbers: 2025-A01796-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No