Measuring and reducing patient discomfort during intensive care
Reported Experience Measurement on Reducing Patient Discomfort in Intensive Care
NA · Almaviva Sante · NCT07525284
This program tests whether a tailored, multi-component feedback program using the IPREA questionnaire can reduce traumatic experiences and later PTSD symptoms for adults discharged after at least three days in intensive care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1242 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Almaviva Sante (other) |
| Locations | 1 site (Aubagne, France) |
| Trial ID | NCT07525284 on ClinicalTrials.gov |
What this trial studies
The program implements the IPREA 16-item discomfort questionnaire at ICU discharge and provides immediate, simple feedback to caregivers plus monthly comparative unit-level reports to drive practice change. A doctor/non-medical caregiver team leads the intervention and promotes specific reminders and adjustments in routine care based on reported patient discomforts. The approach builds on the IPREA3 model of systematic measurement and feedback to reduce overall discomfort scores during ICU stays. The current implementation seeks to broaden that model and examine downstream effects on anxiety, depression, and post-intensive care syndrome symptoms.
Who should consider this trial
Good fit: Adults aged 18 or older who were hospitalized in intensive care for at least three calendar days, discharged alive, speak French, can complete the IPREA questionnaire, and are covered by a social security scheme are ideal candidates.
Not a fit: Patients who cannot complete the IPREA questionnaire, those under legal protection or detained by judicial/administrative order, individuals hospitalized without consent, and pregnant or breastfeeding women are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could reduce traumatic ICU experiences, lower subsequent PTSD/anxiety/depression rates, and improve recovery and quality of life after intensive care.
How similar studies have performed: A prior IPREA3 study (Kalfon et al., 2017) showed that a similar tailor-made, multi-component program significantly reduced overall ICU discomfort scores, though long-term effects on PTSD/PICS remain less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aubagne, France
- Hôpital Privé La Casamance — Aubagne, France, France (RECRUITING)
Study contacts
- Study coordinator: Pierre KALFON, MD
- Email: pierrekalfon@sfr.fr
- Phone: + 33 6 38 39 24 18
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PTSD - Post Traumatic Stress Disorder, PTSD, IPREA questionnaire