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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03991611 on ClinicalTrials.gov