Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial
Maité Garrouste-Orgeas, Cécile Flahault, Isabelle Vinatier, Jean-Philippe Rigaud, Nathalie Thieulot-Rolin, Emmanuelle Mercier, Antoine Rouget, Hubert Grand, Olivier Lesieur, Fabienne Tamion, Rebecca Hamidfar, Anne Renault, Erika Parmentier-Decrucq, Yannick Monseau, Laurent Argaud, Cédric Bretonnière, Alexandre Lautrette, Julio Badié, Eric Boulet, Bernard Floccard, Xavier Forceville, Eric Kipnis, Lilia Soufir, Sandrine Valade, Naike Bige, Alain Gaffinel, Olfa Hamzaoui, Georges Simon, Marina Thirion, Lila Bouadma, Audrey Large, Jean-Paul Mira, Nora Amdjar-Badidi, Mercé Jourdain, Paul-Henri Jost, Virginie Maxime, François Santoli, Stéphane Ruckly, Christel Vioulac, Marie Annick Leborgne, Lucie Bellalou, Léonor Fasse, Benoit Misset, Sébastien Bailly, Jean-François Timsit, Maité Garrouste-Orgeas, Cécile Flahault, Isabelle Vinatier, Jean-Philippe Rigaud, Nathalie Thieulot-Rolin, Emmanuelle Mercier, Antoine Rouget, Hubert Grand, Olivier Lesieur, Fabienne Tamion, Rebecca Hamidfar, Anne Renault, Erika Parmentier-Decrucq, Yannick Monseau, Laurent Argaud, Cédric Bretonnière, Alexandre Lautrette, Julio Badié, Eric Boulet, Bernard Floccard, Xavier Forceville, Eric Kipnis, Lilia Soufir, Sandrine Valade, Naike Bige, Alain Gaffinel, Olfa Hamzaoui, Georges Simon, Marina Thirion, Lila Bouadma, Audrey Large, Jean-Paul Mira, Nora Amdjar-Badidi, Mercé Jourdain, Paul-Henri Jost, Virginie Maxime, François Santoli, Stéphane Ruckly, Christel Vioulac, Marie Annick Leborgne, Lucie Bellalou, Léonor Fasse, Benoit Misset, Sébastien Bailly, Jean-François Timsit
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.
Conflict of interest statement
Conflict of Interest Disclosures: Dr Garrouste-Orgeas reports grants from Fondation de France during the conduct of the study. Dr Bouadma reported receiving grants from Fondation De France during the conduct of the study. Dr Kipnis reported receiving grants, personal fees, and nonfinancial support from MSD France, personal fees from Pfizer and Sanofi, and nonfinancial support from Astellas and LFB Biomédicament outside the submitted work. Dr Mira reported receiving personal fees from Roche and personal fees from AKSA outside the submitted work. Dr Simon reported receiving a grant from Centre Hospitalier de Troyes. Dr Soufir reported receiving grants from Groupe Hospitalier Paris Saint Joseph during the conduct of the study. Dr Bailly reported receiving consulting fees for methodology from ICUREsearch society. Dr Timsit reported receiving personal fees and grants from Medical Specialties Distributors, personal fees from Pfizer, Nabriva, and Biomerieux, and grants from Astelas outside the submitted work. No other disclosures were reported.
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Source: PubMed