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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

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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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Project description:Importance:This is the first multisite, randomized clinical trial of stellate ganglion block (SGB) outcomes on posttraumatic stress disorder (PTSD) symptoms. Objective:To determine whether paired SGB treatments at 0 and 2 weeks would result in improvement in mean Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity scores from baseline to 8 weeks. Design, Setting, and Participants:This multisite, blinded, sham-procedure, randomized clinical trial used a 2:1 SGB:sham ratio and was conducted from May 2016 through March 2018 in 3 US Army Interdisciplinary Pain Management Centers. Only physicians performing the procedures and the procedure nurses were aware of the intervention (but not the participants or assessors); their interactions with the participants were scripted and limited to the 2 interventions. Active-duty service members on stable psychotropic medication dosages who had a PTSD Checklist-Civilian Version (PCL-C) score of 32 or more at screening were included. Key exclusion criteria included a prior SGB treatment, selected psychiatric disorders or substance use disorders, moderate or severe traumatic brain injury, or suicidal ideation in the prior 2 months. Interventions:Paired right-sided SGB or sham procedures at weeks 0 and 2. Main Outcomes and Measures:Improvement of 10 or more points on mean CAPS-5 total symptom severity scores from baseline to 8 weeks, adjusted for site and baseline total symptom severity scores (planned a priori). Results:Of 190 screened individuals, 113 (59.5%; 100 male and 13 female participants; mean [SD] age, 37.3 [6.7] years) were eligible and randomized (74 to SGB and 39 to sham treatment), and 108 (95.6% of 113) completed the study. Baseline characteristics were similar in the SGB and sham treatment groups, with mean (SD) CAPS-5 scores of 37.6 (11.2) and 39.8 (14.4), respectively (on a scale of 0-80); 91 (80.0%) met CAPS-5 PTSD criteria. In an intent-to-treat analysis, adjusted mean total symptom severity score change was -12.6 points (95% CI, -15.5 to -9.7 points) for the group receiving SGB treatments, compared with -6.1 points (95% CI, -9.8 to -2.3 points) for those receiving sham treatment (P?=?.01). Conclusions and Relevance:In this trial of active-duty service members with PTSD symptoms (at a clinical threshold and subthreshold), 2 SGB treatments 2 weeks apart were effective in reducing CAPS-5 total symptom severity scores over 8 weeks. The mild-moderate baseline level of PTSD symptom severity and short follow-up time limit the generalizability of these findings, but the study suggests that SGB merits further trials as a PTSD treatment adjunct. Trial Registration:ClinicalTrials.gov identifier: NCT03077919.

Project description:The cancer experience may be marked by repeat stressors and/or traumas. The aim of our study was to assess traumatic events in a group of patients diagnosed with lymphoma and to determine which of these contribute to the development of Post-Traumatic Stress Disorder/PTSD. Two weeks after receiving a diagnosis of lymphoma, patients were referred for an assessment of peritraumatic distress (using the Peritraumatic Distress Inventory/PDI) and peritraumatic dissociation (using the Peritraumatic Dissociative Experiences Questionnaire/PDEQ). Three months after the diagnosis, we recorded the following parameters: the patients' worst experiences, the presence of PTSD symptoms, using the PTSD CheckList/PCL, as it related to the diagnosis, and symptoms of anxiety using the Hospital Anxiety and Depression/HAD scale and of depression using the Beck Depression Inventory/BDI-II. The study recruited 129 patients, with a mean age of 46 years (SD = 17.3); 70 (54%) men, 87 (67.5%) with Non-Hodgkin's lymphoma, and 42 with Hodgkin's lymphoma. Two weeks after the diagnosis, 49% of patients reported peritraumatic distress, and 20% peritraumatic dissociation, during or immediately after being informed of the lymphoma diagnosis. Three months after the diagnosis, the severity of PTSD symptoms was evaluated. At this stage none of the patients suffered PTSD, but 29 (23%) individuals exhibited partial PTSD: 13.4% correlated it to receiving the lymphoma diagnosis, 8% to telling family members, and 1.6% to adverse effects. Peritraumatic distress and dissociation as a result of receiving a lymphoma diagnosis, as well as anxiety and a mucositis within the first 3 months post-diagnosis, were factors that were significantly associated with PTSD symptoms, accounting for 35.8% in PTSD symptom load. Our study reveals that clinicians should assess the impact of a number of stressors, which are risk factors for PTSD symptoms, starting from the time point of the initial lymphoma diagnosis.

Project description:ImportanceProton pump inhibitors (PPIs) or histamine-2 receptor blockers (H2RBs) are often prescribed for patients as stress ulcer prophylaxis drugs in the intensive care unit (ICU). The comparative effect of these drugs on mortality is unknown.ObjectiveTo compare in-hospital mortality rates using PPIs vs H2RBs for stress ulcer prophylaxis.Design, setting, and participantsCluster crossover randomized clinical trial conducted at 50 ICUs in 5 countries between August 2016 and January 2019. Patients requiring invasive mechanical ventilation within 24 hours of ICU admission were followed up for 90 days at the hospital.InterventionsTwo stress ulcer prophylaxis strategies were compared (preferential use with PPIs vs preferential use with H2RBs). Each ICU used each strategy sequentially for 6 months in random order; 25 ICUs were randomized to the sequence with use of PPIs and then use of H2RBs and 25 ICUs were randomized to the sequence with use of H2RBs and then use of PPIs (13 436 patients randomized by site to PPIs and 13 392 randomized by site to H2RBs).Main outcomes and measuresThe primary outcome was all-cause mortality within 90 days during index hospitalization. Secondary outcomes were clinically important upper gastrointestinal bleeding, Clostridioides difficile infection, and ICU and hospital lengths of stay.ResultsAmong 26 982 patients who were randomized, 154 opted out, and 26 828 were analyzed (mean [SD] age, 58 [17.0] years; 9691 [36.1%] were women). There were 26 771 patients (99.2%) included in the mortality analysis; 2459 of 13 415 patients (18.3%) in the PPI group died at the hospital by day 90 and 2333 of 13 356 patients (17.5%) in the H2RB group died at the hospital by day 90 (risk ratio, 1.05 [95% CI, 1.00 to 1.10]; absolute risk difference, 0.93 percentage points [95% CI, -0.01 to 1.88] percentage points; P = .054). An estimated 4.1% of patients randomized by ICU site to PPIs actually received H2RBs and an estimated 20.1% of patients randomized by ICU site to H2RBs actually received PPIs. Clinically important upper gastrointestinal bleeding occurred in 1.3% of the PPI group and 1.8% of the H2RB group (risk ratio, 0.73 [95% CI, 0.57 to 0.92]; absolute risk difference, -0.51 percentage points [95% CI, -0.90 to -0.12 percentage points]; P = .009). Rates of Clostridioides difficile infection and ICU and hospital lengths of stay were not significantly different by treatment group. One adverse event (an allergic reaction) was reported in 1 patient in the PPI group.Conclusions and relevanceAmong ICU patients requiring mechanical ventilation, a strategy of stress ulcer prophylaxis with use of proton pump inhibitors vs histamine-2 receptor blockers resulted in hospital mortality rates of 18.3% vs 17.5%, respectively, a difference that did not reach the significance threshold. However, study interpretation may be limited by crossover in the use of the assigned medication.Trial registrationanzctr.org.au Identifier: ACTRN12616000481471.

Dataset Information

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

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

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