Dataset Information

Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial.

ABSTRACT:

Importance

Keeping a diary for patients while they are in the intensive care unit (ICU) might reduce their posttraumatic stress disorder (PTSD) symptoms.

Objectives

To assess the effect of an ICU diary on the psychological consequences of an ICU hospitalization.

Design, setting, and participants

Assessor-blinded, multicenter, randomized clinical trial in 35 French ICUs from October 2015 to January 2017, with follow-up until July 2017. Among 2631 approached patients, 709 adult patients (with 1 family member each) who received mechanical ventilation within 48 hours after ICU admission for at least 2 days were eligible, 657 were randomized, and 339 were assessed 3 months after ICU discharge.

Interventions

Patients in the intervention group (n = 355) had an ICU diary filled in by clinicians and family members. Patients in the control group (n = 354) had usual ICU care without an ICU diary.

Main outcomes and measures

The primary outcome was significant PTSD symptoms, defined as an Impact Event Scale-Revised (IES-R) score greater than 22 (range, 0-88; a higher score indicates more severe symptoms), measured in patients 3 months after ICU discharge. Secondary outcomes, also measured at 3 months and compared between groups, included significant PTSD symptoms in family members; significant anxiety and depression symptoms in patients and family members, based on a Hospital Anxiety and Depression Scale score greater than 8 for each subscale (range, 0-42; higher scores indicate more severe symptoms; minimal clinically important difference, 2.5); and patient memories of the ICU stay, reported with the ICU memory tool.

Results

Among 657 patients who were randomized (median [interquartile range] age, 62 [51-70] years; 126 women [37.2%]), 339 (51.6%) completed the trial. At 3 months, significant PTSD symptoms were reported by 49 of 164 patients (29.9%) in the intervention group vs 60 of 175 (34.3%) in the control group (risk difference, -4% [95% CI, -15% to 6%]; P = .39). The median (interquartile range) IES-R score was 12 (5-25) in the intervention group vs 13 (6-27) in the control group (difference, -1.47 [95% CI, -1.93 to 4.87]; P = .38). There were no significant differences in any of the 6 prespecified comparative secondary outcomes.

Conclusions and relevance

Among patients who received mechanical ventilation in the ICU, the use of an ICU diary filled in by clinicians and family members did not significantly reduce the number of patients who reported significant PTSD symptoms at 3 months. These findings do not support the use of ICU diaries for preventing PTSD symptoms.

Trial registration

ClinicalTrials.gov Identifier: NCT02519725.

SUBMITTER: Garrouste-Orgeas M

PROVIDER: S-EPMC6635906 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial.

Garrouste-Orgeas Maité M Flahault Cécile C Vinatier Isabelle I Rigaud Jean-Philippe JP Thieulot-Rolin Nathalie N Mercier Emmanuelle E Rouget Antoine A Grand Hubert H Lesieur Olivier O Tamion Fabienne F Hamidfar Rebecca R Renault Anne A Parmentier-Decrucq Erika E Monseau Yannick Y Argaud Laurent L Bretonnière Cédric C Lautrette Alexandre A Badié Julio J Boulet Eric E Floccard Bernard B Forceville Xavier X Kipnis Eric E Soufir Lilia L Valade Sandrine S Bige Naike N Gaffinel Alain A Hamzaoui Olfa O Simon Georges G Thirion Marina M Bouadma Lila L Large Audrey A Mira Jean-Paul JP Amdjar-Badidi Nora N Jourdain Mercé M Jost Paul-Henri PH Maxime Virginie V Santoli François F Ruckly Stéphane S Vioulac Christel C Leborgne Marie Annick MA Bellalou Lucie L Fasse Léonor L Misset Benoit B Bailly Sébastien S Timsit Jean-François JF

JAMA 20190701 3

<h4>Importance</h4>Keeping a diary for patients while they are in the intensive care unit (ICU) might reduce their posttraumatic stress disorder (PTSD) symptoms.<h4>Objectives</h4>To assess the effect of an ICU diary on the psychological consequences of an ICU hospitalization.<h4>Design, setting, and participants</h4>Assessor-blinded, multicenter, randomized clinical trial in 35 French ICUs from October 2015 to January 2017, with follow-up until July 2017. Among 2631 approached patients, 709 adu ...[more]

PMID: 31310299

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Dataset Information

Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial.

Importance

Objectives

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial.

Similar Datasets

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