Reported Experience Measurement on Reducing Patient Discomfort in Intensive Care

NCT07525284 | Recruiting

• 1 other identifier: 2025-A01796-43
• Study Type: interventional
• Target: 1,242
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

PTSD - Post Traumatic Stress Disorder

Keywords

PTSD; IPREA questionnaire

Outcome Measures

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

  3 months

Study Arms (2)

Arm PREMREA +

EXPERIMENTAL

Patients in this arm will benefit from measures taken from PREMREA program

Other: PREMREA program

Arm PREMREA -

NO INTERVENTION

Patients in this arm do not benefit from measures taken from PREMREA program

Interventions

PREMREA program OTHER

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.

Arm PREMREA +

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Almaviva Sante: lead

Study Sites (1)

Hôpital Privé La Casamance

Aubagne, France, 13400, France

RECRUITING

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Pierre KALFON, MD

CONTACT

+ 33 6 38 39 24 18; pierrekalfon@sfr.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 13, 2026
• Study Start: December 19, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)