AzTrials
AzTrials

Critical IllnessPTSD-REANCT03991611

Reducing Post-traumatic Stress Disorder After ICU Discharge With the IPREA3 Program

A study testing Administration of the IPREA3 questionnaire, Immediate feedback through electronic reminder messages and Targeted interventions in each ICU to reduce discomforts in people with Critical Illness, run by Centre Hospitalier of Chartres at 33 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critical Illness
What is being tested?
Administration of the IPREA3 questionnaire, Immediate feedback through electronic reminder messages and Targeted interventions in each ICU to reduce discomforts
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,312 participants
Where
33 sitesFrance
Study dates
1 Nov 2019to 1 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Deceased during the ICU stay
  • Minors
  • Under trusteeship
  • Without affiliation to a social security scheme
  • Transferred to another ICU
  • Already hospitalized in ICU during the current short stay
Show all 11Show fewer
  • 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

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

France33 sites

  • CHU Angers

    Angers, 49100

  • CHU d'Angers

    Angers, 49933

  • CH d'Auxerre

    Auxerre, 89000

  • CH de Blois

    Blois, 41016

  • Clinique Convert

    Bourg-en-Bresse, 01000

  • CH Bourges

    Bourges, 18033

  • Hôpital Louis Pasteur

    Chartres, 28000

  • CHU de Dijon

    Dijon, 21079

  • CH de Douai

    Douai, 59507

  • CH Emile Roux

    Le Puy-en-Velay, 43000

  • CH de Lens

    Lens, 62300

  • Hôpital Edouard Herriot

    Lyon, 69437

  • CH de Mâcon

    Mâcon, 71000

  • Hôpital Européen de Marseille

    Marseille, 13003

  • Hôpital Nord_APHM

    Marseille, 13015

  • Hôpital Nord_APHM

    Marseille, 13326

  • CH de l'Agglomération Montargoise

    Montargis, 45207

  • GHR Mulhouse Sud-Alsace

    Mulhouse, 68100

  • Clinique Ambroise Paré

    Neuilly-sur-Seine, 92200

  • Hôpital Pasteur 2_CHU de Nice

    Nice, 06006

  • Hôpital Saint-Louis_APHP

    Paris, 75010

  • Gaston Cordier_GH La Pitié-Salpêtrière-Charles Foix_APHP

    Paris, 75013

  • GH La Pitié-Salpêtrière-Charles Foix_APHP

    Paris, 75013

  • Husson Mourier_GH La Pitié-Salpêtrière-Charles Foix_APHP

    Paris, 75013

  • CHU de Poitiers

    Poitiers, 86021

  • Hôpital privé Claude Galien

    Quincy-sous-Sénart, 91480

  • CH Victor Provo

    Roubaix, 59100

  • NCT+ - St Gatien

    Saint-Cyr-sur-Loire, 37540

  • Nouvel Hôpital Civil_CHU de Strasbourg

    Strasbourg, 67091

  • Hôpital de Hautepierre_CHU de Strasbourg

    Strasbourg, 67098

  • Hôpital Sainte Musse

    Toulon, 83000

  • CHRU de Tours

    Tours, 37044

  • CH de Troyes

    Troyes, 1000

Other trials in France

About this study

Official title: Tailored Multicomponent Program for Discomfort Reduction in Critically il Patients May Decrease Post-traumatic Stress Disorder in General ICU Survivors at One Year

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.

Read the 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.

Being tested
Administration of the IPREA3 questionnaire, Immediate feedback through electronic reminder messages, Targeted interventions in each ICU to reduce discomforts, 6 months follow-up to assess the prevalence of PTSD symptoms, 1 year follow-up to assess psychiatric morbidity
Keywords
Critical care, Post-traumatic stress disorder, Discomfort, Tailored program, Patient-reported outcome, ICU, COVID-19
Medical subject headings
Critical Illness, Stress Disorders, Post-Traumatic, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Administration of the IPREA3 questionnaireOther

    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

  • Immediate feedback through electronic reminder messagesOther

    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

  • Targeted interventions in each ICU to reduce discomfortsOther

    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.

  • 6 months follow-up to assess the prevalence of PTSD symptomsOther

    Psychologist will collect the PCL-5, HAD-S, WHOQOL-BREF, LEC-5 items during the telephone follow-up, 6 months after ICU discharge .

  • 1 year follow-up to assess psychiatric morbidityOther

    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 .

Study groups in NCT03991611
Study groupRoleWhat they receive
IPREA3 programExperimentalApplication of the IPREA 3 program (multicomponent intervention to reduce perceived discomforts in critically ill patients) for at least 5 months
Receives: Other: Administration of the IPREA3 questionnaire; Other: Immediate feedback through electronic reminder messages; Other: Targeted interventions in each ICU to reduce discomforts; Other: 1 year follow-up to assess psychiatric morbidity
Intermediate groupOtherApplication of the IPREA 3 program (multicomponent intervention to reduce perceived discomforts in critically ill patients) for less than 5 months
Receives: Other: Administration of the IPREA3 questionnaire; Other: Immediate feedback through electronic reminder messages; Other: Targeted interventions in each ICU to reduce discomforts
Standard careActive comparatorStandard care
Receives: Other: Administration of the IPREA3 questionnaire; Other: 1 year follow-up to assess psychiatric morbidity
PTSD-REA_COVID cohortOtherICU admission between March 1, 2020 and April 30, 2020.
Receives: Other: 6 months follow-up to assess the prevalence of PTSD symptoms; Other: 1 year follow-up to assess psychiatric morbidity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of posttraumatic stress disorder (PTSD) symptoms at one year after ICU discharge and 6 months ( PTSD-REA_COVID cohort)

    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).

    Measured: One year after ICU discharge

Secondary outcomes (16)

  1. ICU stay's duration

    Measured: The day of ICU discharge

  2. Number of days with mechanical ventilation

    Measured: The day of ICU discharge

  3. Overall score of discomfort assessed from the IPREA3 questionnaire

    Measured: The day of ICU discharge

  4. The duration of hospital stay after ICU discharge

    Measured: 6 months ( PTSD-REA_COVID cohort) or 1 year after ICU discharge and

  5. Intrusion Symptom Category B assessed from the PCL-5 (Posttraumatic Stress Disorder Checklist ) (Items 1-5)

    Recurrent or involuntary distressing dreams, memories, thoughts, or feelings related to the traumatic event(s)

    Measured: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge

  6. Persistent Avoidance Category C assessed from the PCL-5 (Items 6-7)

    Avoidance or efforts to avoid internal or external reminders of the traumatic event(s)

    Measured: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge

  7. Negative Alterations in Cognitions and Mood Category D assessed from PCL 5 (Items 8-14)

    Persistent and exaggerated negative beliefs about oneself, the world, others, negative mood states, inability to experience positive emotions

    Measured: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge

  8. Alterations in arousal and reactivity Category E assessed from the PCL-5 (Items 15-20)

    Marked increase in arousal or reactivity such as irritability, hypervigilance, exaggerated startle response, sleep or concentration problems exaggerated startle response

    Measured: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge

  9. Score of the sub-scale A of the questionnaire HAD-S (Hospital and Anxiety Depression Scale)

    Allowing to estimate the presence of anxious symptoms. The scale HAD contains 14 items rated from 0 to 3. The score of Anxiety ( total A) is obtained by summing items 1-3-5-7-9-11-13 and the depressive dimension (total D) is obtained by summing items 2-4-6-8-10-12-14. The maximal note for each of them is 21.

    8 points is a minimum threshold for determining whether the anxiety is clinically meaningful

    Measured: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge

  10. Score of the sub-scale D of the questionnaire HAD-S ( Hospital and Anxiety Depression Scale)

    Allowing to estimate the presence of anxious symptoms. The scale HAD contains 14 items rated from 0 to 3. The score of Anxiety ( total A) is obtained by summing items 1-3-5-7-9-11-13 and the depressive dimension (total D) is obtained by summing items 2-4-6-8-10-12-14. The maximal note for each of them is 21.

    8 points is a minimum threshold for determining whether Depression is clinically meaningful

    Measured: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge

  11. Score obtained from The World Health Organization Quality of Life (WHOQOL-BREF)

    The WHOQOL-BREF measure the following broad domains: physical health, psychological health, social relationships, and environment.

    Each item is rated from 0 to 5. The score of each domain is obtained by summing items then standardized on a scale of 0 (worst quality of life related to health in the dimension explored) to 100 (better quality of liferelated to health in the dimension explored).

    Measured: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge

  12. Number of emergency stays

    Since ICU discharge

    Measured: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge

  13. Number of hospitalization

    Since ICU discharge

    Measured: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge

  14. Number of psychiatric or psychological consultation

    Since ICU discharge

    Measured: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge

  15. The place of leaving after ICU stay

    Evaluated in population of patients living at home before the ICU stay.

    Measured: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge

  16. Presence of professional activity

    Evaluated in population of patients with a professional activity before ICU stay

    Measured: 6 months ( PTSD-REA_COVID cohort) and1 year after ICU discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2019
  2. Study start1 Nov 2019
  3. Primary completion31 Jul 2022 (estimated)
  4. Study completion1 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Sequential
Model description
Stepped wedge cluster randomized trial
Masking
Single blind
Who is masked
Participant
Enrolment
3,312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03991611
Sponsor's protocol ID
2019-A00151-56
Acronym
PTSD-REA
Status last verified
Jul 2021
First submitted
11 Jun 2019
Last updated
23 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Jones C. Surviving the intensive care: residual physical, cognitive, and emotional dysfunction. Thorac Surg Clin. 2012 Nov;22(4):509-16. doi: 10.1016/j.thorsurg.2012.07.003. Epub 2012 Aug 25.

    PubMed 23084614

  • Jones C, Skirrow P, Griffiths RD, Humphris GH, Ingleby S, Eddleston J, Waldmann C, Gager M. Rehabilitation after critical illness: a randomized, controlled trial. Crit Care Med. 2003 Oct;31(10):2456-61. doi: 10.1097/01.CCM.0000089938.56725.33.

    PubMed 14530751

  • Pacella ML, Hruska B, Delahanty DL. The physical health consequences of PTSD and PTSD symptoms: a meta-analytic review. J Anxiety Disord. 2013 Jan;27(1):33-46. doi: 10.1016/j.janxdis.2012.08.004. Epub 2012 Sep 13.

    PubMed 23247200

  • Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.

    PubMed 24088092

  • Davydow DS, Hough CL, Zatzick D, Katon WJ. Psychiatric symptoms and acute care service utilization over the course of the year following medical-surgical ICU admission: a longitudinal investigation*. Crit Care Med. 2014 Dec;42(12):2473-81. doi: 10.1097/CCM.0000000000000527.

    PubMed 25083985

  • Dowdy DW, Eid MP, Dennison CR, Mendez-Tellez PA, Herridge MS, Guallar E, Pronovost PJ, Needham DM. Quality of life after acute respiratory distress syndrome: a meta-analysis. Intensive Care Med. 2006 Aug;32(8):1115-24. doi: 10.1007/s00134-006-0217-3. Epub 2006 Jun 17.

    PubMed 16783553

  • Granja C, Lopes A, Moreira S, Dias C, Costa-Pereira A, Carneiro A; JMIP Study Group. Patients' recollections of experiences in the intensive care unit may affect their quality of life. Crit Care. 2005 Apr;9(2):R96-109. doi: 10.1186/cc3026. Epub 2005 Jan 31.

    PubMed 15774056

  • McKinley S, Aitken LM, Alison JA, King M, Leslie G, Burmeister E, Elliott D. Sleep and other factors associated with mental health and psychological distress after intensive care for critical illness. Intensive Care Med. 2012 Apr;38(4):627-33. doi: 10.1007/s00134-012-2477-4. Epub 2012 Feb 9.

    PubMed 22318635

  • Schelling G, Richter M, Roozendaal B, Rothenhausler HB, Krauseneck T, Stoll C, Nollert G, Schmidt M, Kapfhammer HP. Exposure to high stress in the intensive care unit may have negative effects on health-related quality-of-life outcomes after cardiac surgery. Crit Care Med. 2003 Jul;31(7):1971-80. doi: 10.1097/01.CCM.0000069512.10544.40.

    PubMed 12847391

  • Bienvenu OJ, Gellar J, Althouse BM, Colantuoni E, Sricharoenchai T, Mendez-Tellez PA, Shanholtz C, Dennison CR, Pronovost PJ, Needham DM. Post-traumatic stress disorder symptoms after acute lung injury: a 2-year prospective longitudinal study. Psychol Med. 2013 Dec;43(12):2657-71. doi: 10.1017/S0033291713000214. Epub 2013 Feb 26.

    PubMed 23438256

  • Davydow DS, Gifford JM, Desai SV, Needham DM, Bienvenu OJ. Posttraumatic stress disorder in general intensive care unit survivors: a systematic review. Gen Hosp Psychiatry. 2008 Sep-Oct;30(5):421-34. doi: 10.1016/j.genhosppsych.2008.05.006. Epub 2008 Jul 30.

    PubMed 18774425

  • Jones C, Griffiths RD, Humphris G, Skirrow PM. Memory, delusions, and the development of acute posttraumatic stress disorder-related symptoms after intensive care. Crit Care Med. 2001 Mar;29(3):573-80. doi: 10.1097/00003246-200103000-00019.

    PubMed 11373423

  • Schelling G, Stoll C, Haller M, Briegel J, Manert W, Hummel T, Lenhart A, Heyduck M, Polasek J, Meier M, Preuss U, Bullinger M, Schuffel W, Peter K. Health-related quality of life and posttraumatic stress disorder in survivors of the acute respiratory distress syndrome. Crit Care Med. 1998 Apr;26(4):651-9. doi: 10.1097/00003246-199804000-00011.

    PubMed 9559601

  • Jackson JC, Hart RP, Gordon SM, Hopkins RO, Girard TD, Ely EW. Post-traumatic stress disorder and post-traumatic stress symptoms following critical illness in medical intensive care unit patients: assessing the magnitude of the problem. Crit Care. 2007;11(1):R27. doi: 10.1186/cc5707.

    PubMed 17316451

  • Parker AM, Sricharoenchai T, Raparla S, Schneck KW, Bienvenu OJ, Needham DM. Posttraumatic stress disorder in critical illness survivors: a metaanalysis. Crit Care Med. 2015 May;43(5):1121-9. doi: 10.1097/CCM.0000000000000882.

    PubMed 25654178

Questions about this trial

What is this clinical trial studying?

A study testing Administration of the IPREA3 questionnaire, Immediate feedback through electronic reminder messages and Targeted interventions in each ICU to reduce discomforts in people with Critical Illness, run by Centre Hospitalier of Chartres at 33 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03991611, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
PTSD-REA Clinical Trial NCT03991611 | AzTrials