Tailored Multicomponent Program for Discomfort Reduction in Critically il Patients May Decrease Post-traumatic Stress Disorder in General ICU Survivors at One Year
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Critical Illness
- Sponsor
- Centre Hospitalier of Chartres
- Enrollment
- 3312
- Locations
- 32
- Primary Endpoint
- Presence of posttraumatic stress disorder (PTSD) symptoms at one year after ICU discharge and 6 months ( PTSD-REA_COVID cohort)
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed Description
After carrying out the cluster-randomized controlled IPREA3 study demonstrating that a tailored multicomponent program based on assessment of self-perceived discomfort, feedback to the healthcare teams, and tailored site-targeted measures was effective to decrease self-perceived overall discomfort, we performed the 1-year follow-up of ICUs survivors included in the IPREA3 study to assess psychiatric morbidity at 1 year. Our tailored multicomponent program was also associated with less PTSD at 1 year after ICU discharge. Based on this positive long-term result, this study confirms the need to implement a new strategy for reducing discomfort in the ICU based on such programs. PTSD-REA is a stepped wedge cluster randomized trial involving 18 ICUs. The exposure will be the implementation of a tailored multicomponent program consisting of assessment of ICU-related self-perceived discomforts, immediate and monthly feedback to the healthcare team, and site-specific tailored interventions. The eligible patients will be exposed vs. unexposed general adult ICU survivors. The prevalence of substantial posttraumatic stress disorder (PTSD) symptoms at 1 year will be assessed by using diagnostic criteria adapted to the new definition of PTSD according to DSM-5. The current context of the COVID-19 pandemic has considerably disrupted the ICUs organizations as well as the patients care which may lead to increased psychiatric morbidity. In this context, it seems necessary to assess this phenomenon in order to anticipate the consequences on patients but also on the healthcare system. The objectives of the PTSD-REA_COVID cohort are to assess the prevalence of PTSD symptoms, 6 months after ICU stay during COVID-19 epidemic and to compare the psychiatric morbidity at 1 year after an ICU stay during epidemic period and non epidmic period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who survived an ICU stay of at least 3 calendar days
- •Affiliation to a social security scheme
- •First stay in ICU during current short-term hospitalization
- •Patient's oral consent to participate in the PTSD-REA_COVID cohort
Exclusion Criteria
- •Deceased during the ICU stay
- •Under trusteeship
- •Without affiliation to a social security scheme
- •Transferred to another ICU
- •Already hospitalized in ICU during the current short stay
- •Already included in the study
- •Limitation and cessation of active treatment
- •Advance healthcare directive indicating the refusal of ICU stay
- •Irreversible state like diminished cognitive capacity based on the investigator's opinion or not understanding French sufficiently to be questioned (language barrier)
- •Subject not consenting to participate in the study
Outcomes
Primary Outcomes
Presence of posttraumatic stress disorder (PTSD) symptoms at one year after ICU discharge and 6 months ( PTSD-REA_COVID cohort)
Time Frame: One year after ICU discharge
PTSD symptoms at one year will be assessed from the PCL-5 which is a 20-item self-report measure that assesses the 20 DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) symptoms of PTSD. Each item is rated from 0 "Not at all" to 4 "Extremely". A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20).
Secondary Outcomes
- Overall score of discomfort assessed from the IPREA3 questionnaire(The day of ICU discharge)
- Persistent Avoidance Category C assessed from the PCL-5 (Items 6-7)(6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge)
- Intrusion Symptom Category B assessed from the PCL-5 (Posttraumatic Stress Disorder Checklist ) (Items 1-5)(6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge)
- ICU stay's duration(The day of ICU discharge)
- Number of days with mechanical ventilation(The day of ICU discharge)
- The duration of hospital stay after ICU discharge(6 months ( PTSD-REA_COVID cohort) or 1 year after ICU discharge and)
- Score of the sub-scale D of the questionnaire HAD-S ( Hospital and Anxiety Depression Scale)(6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge)
- Negative Alterations in Cognitions and Mood Category D assessed from PCL 5 (Items 8-14)(6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge)
- Alterations in arousal and reactivity Category E assessed from the PCL-5 (Items 15-20)(6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge)
- Score of the sub-scale A of the questionnaire HAD-S (Hospital and Anxiety Depression Scale)(6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge)
- Number of hospitalization(6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge)
- Number of psychiatric or psychological consultation(6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge)
- Number of emergency stays(6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge)
- The place of leaving after ICU stay(6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge)
- Score obtained from The World Health Organization Quality of Life (WHOQOL-BREF)(6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge)
- Presence of professional activity(6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge)