Reducing Post-traumatic Stress Disorder After ICU Discharge With the IPREA3 Program
NCT03991611 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3312
Last updated 2022-03-23
Summary
Reducing discomfort in the intensive care unit (ICU) should be beneficial to longterm outcomes. This study assesses whether a tailored multicomponent program for discomfort reduction may be effective in reducing post-traumatic stress disorder (PTSD) symptoms at 1-year in general ICU survivors.
The psychiatric morbidity may be increased by the COVID-19 epidemic and its consequences on the healthcare system (patient care, reorganization of French ICUs). The main objective of PTSD-REA\_COVID cohort is to assess this psychiatric morbidity 6 months after an ICU stay during the epidemic period.
Conditions
- Critical Illness
Interventions
- OTHER
-
Administration of the IPREA3 questionnaire
On the day of the ICU discharge, the bedside nurse administers to the patient the 18-item IPREA questionnaire i.e the nurse asks the patient to rate from 0 to 10 the severity of each discomfort source contained in the IPREA3 questionnaire experienced during the entire stay in the ICU
- OTHER
-
Immediate feedback through electronic reminder messages
After the nurse had administered the questionnaire, warning messages are displayed on the screen corresponding to the key points to prevent the three discomforts reported with the highest scores
- OTHER
-
Targeted interventions in each ICU to reduce discomforts
These targeted interventions are implemented through the coordination of two local champions. The central coordination IPREA3 team sends each month to the local champions monthly and cumulative discomfort scores of their unit (overall score of discomfort and scores for each item) and their ranking relative to other units assigned to the interventional arm i.e applying the IPREA3 program. The local champions organize monthly meetings with the unit staff to present the results in terms of perceived discomforts measured by the IPREA questionnaire, identify main discomfort sources and actions to be conducted to reduce the discomforts reported with the highest scores in the unit and those that are most easily preventable, and assess the efficacy of already applied measures.
- OTHER
-
6 months follow-up to assess the prevalence of PTSD symptoms
Psychologist will collect the PCL-5, HAD-S, WHOQOL-BREF, LEC-5 items during the telephone follow-up, 6 months after ICU discharge .
- OTHER
-
1 year follow-up to assess psychiatric morbidity
Psychologist will collect the PCL-5, HAD-S, WHOQOL-BREF, LEC-5 and CTQ items during the telephone follow-up, 1 year after ICU discharge .
Sponsors & Collaborators
-
Centre Hospitalier of Chartres
lead OTHER
Principal Investigators
-
Pierre KALFON, MD PhD · CH Chartres
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-11-01
- Primary Completion
- 2022-07-31
- Completion
- 2023-01-01
Countries
- France
Study Locations
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