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

doi:10.1001/jama.2019.9058

. 2019 Jul 16;322(3):229–239. doi: 10.1001/jama.2019.9058

Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation

A Randomized Clinical Trial

Maité Garrouste-Orgeas ^1,^2,^3,^✉, Cécile Flahault ⁴, Isabelle Vinatier ⁵, Jean-Philippe Rigaud ⁶, Nathalie Thieulot-Rolin ⁷, Emmanuelle Mercier ⁸, Antoine Rouget ⁹, Hubert Grand ¹⁰, Olivier Lesieur ¹¹, Fabienne Tamion ^12,¹³, Rebecca Hamidfar ¹⁴, Anne Renault ¹⁵, Erika Parmentier-Decrucq ¹⁶, Yannick Monseau ¹⁷, Laurent Argaud ¹⁸, Cédric Bretonnière ^19,²⁰, Alexandre Lautrette ^21,²², Julio Badié ²³, Eric Boulet ²⁴, Bernard Floccard ²⁵, Xavier Forceville ²⁶, Eric Kipnis ²⁷, Lilia Soufir ²⁸, Sandrine Valade ²⁹, Naike Bige ³⁰, Alain Gaffinel ³¹, Olfa Hamzaoui ³², Georges Simon ³³, Marina Thirion ³⁴, Lila Bouadma ^1,³⁵, Audrey Large ³⁶, Jean-Paul Mira ³⁷, Nora Amdjar-Badidi ³⁸, Mercé Jourdain ^16,³⁹, Paul-Henri Jost ⁴⁰, Virginie Maxime ⁴¹, François Santoli ⁴², Stéphane Ruckly ², Christel Vioulac ⁴, Marie Annick Leborgne ⁴, Lucie Bellalou ⁴, Léonor Fasse ⁴, Benoit Misset ¹², Sébastien Bailly ^1,⁴³, Jean-François Timsit ^1,^2,³⁵

¹Infection, Antimicrobials, Modelling, Evolution (IAME), UMR 1137, INSERM, Paris Diderot University, Department of Biostatistics - HUPNVS. - AP-HP, UFR de Médecine - Bichat University Hospital, Paris, France

²Department of Biostatistics, Outcomerea, Paris, France

³Medical unit, French British Hospital, Levallois-Perret, France

⁴LPPS-EA4057, Laboratory of Psychopathology and Health Process, Paris Descartes University, Paris, France

⁵Medical ICU, Les Oudaries Hospital, La Roche-sur-Yon, Vendée, France

⁶Department of Intensive Care, Dieppe General Hospital, Dieppe, France

⁷Medical-Surgical ICU, General Hospital, Melun, France

⁸CRICS-TRIGGERSEP group, Medical-Surgical ICU, Tours University Hospital, Tours, France

⁹Medical-Surgical ICU, Rangueil University Hospital, Toulouse, France

¹⁰Medical-Surgical ICU, Hospital Robert Boulin, Libourne, France

¹¹Medical-Surgical ICU, General Hospital, La Rochelle, France

¹²Medical ICU, University Medical Center, Rouen, France

¹³INSERM U-1096, University of Rouen, Rouen, France

¹⁴Medical ICU, Albert Michallon University Hospital, Grenoble, France

¹⁵Medical ICU, La Cavale Blanche University Hospital, Brest, France

¹⁶Group of medical ICUs, Lille University Hospital, Lille, France

¹⁷Medical-Surgical ICU, General Hospital, Périgueux, France

¹⁸Medical ICU, Edouard Herriot University Hospital, Lyon, France

¹⁹Medical ICU, Nantes University Hospital, Nantes, France

²⁰EA3826, Laboratory of Clinical and Experimental Therapeutics of Infections, University of Nantes, Nantes, France

²¹Medical ICU, Gabriel-Montpied University Hospital, Clermont Ferrand, France

²²LMGE UMR CNRS 6023, University of Clermont-Ferrand, Clermont Ferrand, France

²³Medical-Surgical ICU, General Hospital Belfort-Montbéliard, Belfort, France

²⁴Medical ICU, Beaumont General Hospital, Beaumont, France

²⁵Medical ICU, Hospices Civils de Lyon, Edouard Herriot University Hospital, Lyon, France

²⁶Medical-Surgical ICU, Great Hospital of East Francilien, Meaux, France

²⁷Surgical ICU, Lille University Hospital, Lille, France

²⁸Medical-Surgical ICU, Saint Joseph Hospital Network, Paris, France

²⁹Medical ICU, Saint Louis University Hospital, Paris, France

³⁰Medical ICU, Saint Antoine University Hospital, Paris, France

³¹Medical-Surgical ICU, Gustave Roussy Cancer Campus, Villejuif, France

³²Medical Surgical ICU, University Hospital Paris -Sud, Beclère University Hospital, Clamart, France

³³Medical-Surgical ICU, General Hospital, Troyes, France

³⁴Medical-Surgical ICU, General Hospital Victor Dupouy, Argenteuil, France

³⁵Medical ICU, Bichat University Hospital, Paris, France

³⁶Medical ICU, François Mitterrand University Hospital, Dijon, France

³⁷Medical ICU, Cochin University Hospital, Paris Centre Hospital Group, AP-HP, Paris, France

³⁸Medical-Surgical ICU, General Hospital René Dubos, Pontoise, France

³⁹Lille University, Inserm U1190, Lille, France

⁴⁰Surgical ICU, Henri Mondor University Hospital, Créteil, France

⁴¹Medical ICU, Raymond Poincaré University Hospital, Garches, France

⁴²Medical ICU, General Hospital Robert Ballanger, Aulnay-Sous-Bois, France

⁴³Grenoble Alpes University, INSERM, University hospital Grenoble Alpes, HP2, Grenoble, France

^✉

Corresponding Author: Maité Garrouste-Orgeas, MD, Service de Médecine Interne, Hopital Franco-Britannique, 4 rue Kléber, 92 300 Levallois-Perret, France (maite.garrouste@ihfb.org).

Accepted for Publication: June 12, 2019.

Author Contributions: Drs Timsit and Bailly had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Vinatié and Rigaud contributed equally to the study.

Concept and design: Garrouste-Orgeas, Misset, Bailly, Timsit.

Acquisition, analysis, or interpretation of data: Garrouste-Orgeas, Flahault, Vinatier, Rigaud, Thieulot-Rolin, Rouget, Grand, Lesieur, Tamion, Hamidfar, Renault, Parmentier-Decrucq, Monseau, Argaud, Bretonnière, Lautrette, Badie, Floccard, Forceville, Kipnis, Valade, Bigé, Gaffinel, Hamzaoui, Simon, Thirion, Bouadma, Large, Mira, Amdjar-Badidi, Jourdain, Jost, Maxime, Santoli, Ruckly, Vioulac, Le Borgne, Belallou, Fasse, Bailly, Timsit.

Drafting of the manuscript: Garrouste-Orgeas, Ruckly, Timsit.

Critical revision of the manuscript for important intellectual content: Flahault, Vinatier, Rigaud, Thieulot-Rolin, Mercier, Rouget, Grand, Lesieur, Tamion, Hamidfar, Renault, Parmentier-Decrucq, Monseau, Argaud, Bretonnière, Lautrette, Badie, Boulet, Floccard, Forceville, Kipnis, Valade, Bigé, Gaffinel, Hamzaoui, Simon, Thirion, Bouadma, Large, Mira, Amdjar-Badidi, Jost, Maxime, Santoli, Vioulac, Le Borgne, Belallou, Fasse, Misset, Bailly, Timsit.

Statistical analysis: Flahault, Ruckly, Vioulac, Le Borgne, Fasse, Bailly, Timsit.

Obtained funding: Garrouste-Orgeas.

Administrative, technical, or material support: Garrouste-Orgeas, Vioulac, Timsit.

Supervision: Boulet, Vioulac, Fasse, Timsit.

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.

Funding/Support: This study was funded through a grant from the Fondation de France (ENG 5032) and was sponsored by the Saint Joseph Hospital Network.

Role of the Funder/Sponsor: The funder/sponsor has no role in the design or conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: This study was performed on behalf of the Outcomerea research group.

Data Sharing Statement: See Supplement 4.

Additional Contributions: We thank Céline Feger, MD (EMIBiotech Society), who received compensation for her editorial review, for her assistance in preparing the manuscript. We thank the clinicians of all centers in participating in the elaboration of the diaries. We thank Emmanuelle Sacco, PhD, and Kelly Tiercelet, MSc, (Saint Joseph Hospital Network) in the supervision of the study. They did not receive compensation for their role in the study.

^✉

Corresponding author.

PMCID: PMC6635906 PMID: 31310299

Key Points

Question

What is the effect of an intensive care unit (ICU) diary, filled out by family members and ICU clinicians, on posttraumatic stress disorder symptoms among patients receiving mechanical ventilation?

Findings

In this randomized clinical trial of 657 patients, significant posttraumatic stress disorder symptoms at 3 months, defined as an Impact Event Scale-Revised score greater than 22 (range, 0-88; a higher score indicates more severe symptoms), occurred in 29.9% of patients in the ICU diary group and 34.3% of patients in the control group, a difference that did not reach statistical significance.

Meaning

These findings do not support the use of ICU diaries for preventing posttraumatic stress disorder symptoms after ICU hospitalization.

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

This randomized clinical trial compared the effects of a diary filled out by clinicians and family members during an intensive care unit (ICU) stay to ground their memory of events after discharge vs usual care on symptoms of posttraumatic stress disorder, anxiety, and depression in patients and family members after discharge.

Introduction

Each year, millions of patients throughout the world survive a hospitalization that included a stay in an intensive care unit (ICU). ICU survivors can experience a variety of physical, cognitive, and emotional sequelae.^1,2 In particular, mental health disorders associated with an ICU stay include anxiety,³ depression symptoms,⁴ posttraumatic stress disorder (PTSD) symptoms,^5,6 and complicated grief for families.⁷

It is possible that impaired recall of the ICU stay, potentially accompanied by hallucinations or delusions, contributes to the posttraumatic stress.⁸ Thus, use of an ICU diary given to the patient at discharge to consult at will could offer benefit.⁹ By providing objective information to patients, which could help fill in memory gaps, ICU diaries have allowed them to abandon unrealistic experiences, reconstruct their experience,¹⁰ gain a sense of reality,¹¹ and resolve differences in experience with their families.¹² However, studies exploring the usefulness of ICU diaries in preventing psychological post–intensive care syndrome were often conducted with small numbers of patients¹³ or select samples¹⁴ or with various design characteristics,¹⁵ outcome measures, and length of follow-up that compromised comparision.^9,15

This multicenter study was designed to assess the effect of an ICU diary on the occurrence of mental health consequences in patients and their families in the ICU setting.

Methods

Study Design and Oversight

This assessor-blinded, multicenter, randomized clinical trial compared the use of an ICU diary filled out by clinicians and family members during the ICU stay with usual care. Written informed consent was obtained from 1 family member (the closest to the patient; the patient’s spouse, partner, children, parents, or other were considered in that order). In accordance with the French law, the ethics committee of Ile de France II approved the study on June 11, 2015, including delayed consent from patients unable to make decisions at the time of randomization. The trial protocol has been published¹⁶ and is available in Supplement 1. The statistical analysis plan is available in Supplement 2.

Randomization

The patients were randomized in a 1:1 ratio into 2 groups, stratified by center, using a secure web-based random number generator to select permuted blocks, with a block size of 4.

Study Setting

ICUs with physician leaders who were members of the French Society of Intensive Care or French Society of Anesthesiology were recruited via the Outcomerea research network, a French nonprofit organizational research network. To be included, ICUs had to have more than 8 beds, a physician and nurse on staff in the ICU who would take responsibility for study organization, and agreement by the ICU clinicians that they would contribute to the diary if a patient was assigned to the intervention group and avoid use of a diary if the patient was assigned to the control group.

Study Participants

Inclusion Criteria

Consecutive patients who were undergoing mechanical ventilation were approached by the clinicians. Eligible patients had to be aged at least 18 years, receiving mechanical ventilation for at least 48 hours that was initiated within 48 hours of ICU admission, and have a family member present during the inclusion period and able to visit the patient during the ICU stay. Both the patient and family member had to have sufficient French-language skills for follow-up telephone interviews.

Exclusion Criteria

Patients were ineligible if they had no family members visiting them, were under legal guardianship, or had a preadmission diagnosis of psychosis or dementia. Also, patients with acute neurologic diseases, with cardiac arrest at admission, who were mute or deaf, and whose status was considered by the investigator as highly likely to lead to death or withdrawal of life support within 48 hours were excluded. Patients included in another trial with a telephone interview after ICU discharge were also excluded.

Study Intervention

The intervention tested was an ICU diary completed by clinicians and family members of patients in the ICU. A description of the content and writing guidelines is available in the eMethods in Supplement 3. Prior to patient transfer out of the ICU, a concluding note was written by an ICU clinician. The ICU diary was detailed to the patient in the ICU room a few days before discharge and was given to the patient or, if the patient was confused, to the family member who consented to the study at or as close as possible to the day of discharge. In cases in which the patient died, the diary was concluded with a condolence letter and mailed to the family. To promote adherence to the intervention, the central study coordinating team held an educational meeting with clinicians in each center, the local physician and nurse coordinators monitored each diary, and the laboratory of psychopathology and health process coordinating center performed content analysis of a random sample of diaries. The control group received usual ICU care with no ICU diary.

Outcomes

Primary and secondary outcomes were measured by a psychologist (C.V.) hired for the study. The psychologist was blind to the randomization group when contacting patients and family members (the 1 family member per patient who consented to the study and provided a phone number). If a patient or family member spoke about the diary during the interview, the unblinded interview was registered.

Primary Outcomes

The primary outcome was PTSD symptoms in patients 3 months after ICU discharge, measured by the Impact of Event Scale-Revised (IES-R) questionnaire.¹⁷ Significant PTSD symptoms were defined as an IES-R score greater than 22 (range, 0-88; higher scores indicate more severe symptoms).^15,18 There is no established minimal clinically important difference for the IES-R scale. Ancillary outcomes related to the primary outcome included the median IES-R score and scores for the 3 domains (intrusion, avoidance, and hyperarousal) that make up the IES-R score.

Secondary Outcomes

PTSD symptoms were evaluated in family members 3 months after ICU discharge, with significant symptoms defined as an IES-R score greater than 22.^17,18 Anxiety and depression syndromes in both patients and family members were evaluated 3 months after ICU discharge using the Hospital Anxiety and Depression Scale (HADS) score (range, 0-42; higher scores indicate worse symptoms). Significant anxiety and depression symptoms were defined as a score greater than 8 for anxiety and depression subscales (range for each subscale, 0-21).¹⁹ The minimal clinically important difference was 2.5 for each subscale.²⁰

Recollection of patient memories of the ICU stay was evaluated 3 months after ICU discharge by the validated ICU memory tool questionnaire.²¹ The ICU memory tool questionnaire asked patients about specific factual (faces, family, alarms, voices, lights, darkness, clock, breathing tube, suctioning, tube in nose, and wards rounds), emotional (panic, pain, being uncomfortable, feeling confused, feeling anxious or frightened, and feeling down), and delusional (dreams, nightmares, hallucinations, and someone trying to harm) memories.

Content analysis of ICU diaries was described with a grid¹⁵ that was developed using Delphi techniques by a panel of 11 members (3 ICU physicians of different units, 1 ICU nurse, 2 psychologists, 2 hospital visiting volunteers, 1 person from the general population with a history of admission to an ICU, and 1 former ICU patient and his wife) that described 6 categories (eTable 1 in Supplement 3). The content analysis of the diaries was performed by 4 psychologists (M.A.L., L.B., C.F., and L.F.).

Adverse Events

Adverse events were assessed during the telephone interview 3 months after discharge by the psychologist and reported to the relevant ICU clinical team in instances in which family members or patients needed psychological support.

Post Hoc Secondary Outcomes

The number of times the patient reported reading the diary was explored during an interview with the patient 6 months after ICU discharge. PTSD symptoms and anxiety and depression symptoms were assessed in family members of deceased patients.

Sample Size

PTSD has been previously reported in 15% to 64%^9,15,18,22 of patients in the ICU and in 29.8% to 67%^5,15,18,23 of family members of patients in the ICU. We hypothesized that the rate of PTSD in patients (the percentage with an IES-R >22) would be 40% in the control group and 26% in the intervention group. To detect a difference of 14% between the 2 groups with a type I error of .05 and a power of 80%, 352 patients (176 in each group) were required at 3 months. Assuming an overall rate of 50% of mortality, re-hospitalization, or impossibility of interviewing the patient (eg, due to refusal, sequelae, or loss to follow-up), we included 700 patients and their family member in the 35 centers.

Statistical Analysis

Patients were analyzed according to their randomization group. For the primary outcome, the analysis sets constituted patients with a complete IES-R score at 3 months. For secondary outcomes, because additional missing values were rare, the analyses were performed with the same data set used for the primary outcome. Data are described as number and percent for qualitative variables and median and interquartile range (IQR) for quantitative variables. Comparisons between groups were performed using χ² tests for qualitative variables and the nonparametric Mann-Whitney test. The absolute differences in percentages for primary and secondary outcomes were computed with exact binomial CIs. To assess the effect of possible confounding on the IES-R score, 2 multivariable regressions were performed. The first considered the IES-R score as a continuous variable and was a generalized linear multivariable mixed model based on a negative binomial distribution with a random effect to account for clustering within centers. The goodness of fit of the model was assessed by the generalized χ². The second regression modeled the probability of an IES-R score of greater than 22 by using a stratified logistic regression. For both models, the variable selection was performed in 2 steps: a univariable regression was performed and variables with a P value less than .20 were considered for the multivariable analysis. The model with the minimum log-likelihood value was retained as the final model for the generalized linear multivariable mixed model. The final logistic model was determined by stepwise selection.

The generalized linear multivariable mixed model included the following variables: presence of a diary (forced), age, the Simplified Acute Physiology Score II, sex, duration of benzodiazepine exposure, duration of fentanyl exposure, weaning failure and reintubation, episode of delirium,²⁴ emotional memories, and delusional memories. The final logistic regression model included the following variables: presence of a diary (forced), age, sex, the Simplified Acute Physiology Score II, duration of propofol exposure, acute respiratory failure/chronic obstructive respiratory disease, emotional memories, and delusional memories.

All analyses were performed by using SAS version 9.4 (SAS Institute). All statistical comparisons were performed using 2-sided tests, with a P value less than .05 considered significant. However, because of the potential for type I error due to multiple comparisons, findings for analyses of the secondary outcomes should be interpreted as exploratory.

Results

Study Population and Follow-up

All 35 ICUs recruited patients for 16 months, from October 2015 to January 2017 (Figure; eTable 2 and eTable 3 in Supplement 3). Follow-up was completed in July 2017. Three of the 35 ICUs were routinely using an ICU diary before the beginning of the trial. Overall, 709 patients were eligible. A total of 52 patients declined participation and 657 patients were randomized (325 in the control group and 332 in the intervention group). Follow-up at 3 months with full completion of the IES-R was obtained in 339 patients (51.6%; 175 in the control group and 164 in the intervention group) and 563 family members (85.6%; 282 in the control group and 281 in the intervention group). Baseline characteristics were similar between the eligible patients and patients who withdrew consent (eTable 4 in Supplement 3). Baseline characteristics were similar between patients and family members in the intervention and control groups (eTable 5 in Supplement 3) and between patients and family members in the outcome analysis in the intervention and control groups (Table 1).

Table 1. Baseline Characteristics of Patients and Family Members Included in a Study of the Effect of an Intensive Care Unit (ICU) Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation.

Characteristic	No. (%)
Characteristic	Intervention Group	Control Group
Patients^a	(n = 164)	(n = 175)
Age, median (IQR), y	62.5 (49.5-70)	61 (51-70)
Sex
Male	110 (67.1)	103 (58.9)
Female	54 (32.9)	72 (41.1)
SAPS II, median (IQR)^b	51.5 (38.5-66.5)	53 (39-66)
Patient status
Medical patient	122 (74.4)	138 (78.9)
Unscheduled surgery	35 (21.3)	31 (17.7)
Scheduled surgery	7 (4.3)	6 (3.4)
Main symptom at admission
Acute respiratory failure/COPD	75 (45.7)	84 (48)
Shock and multi-organ failure	66 (40.2)	68 (38.8)
Coma	12 (7.3)	9 (5.1)
Trauma	7 (4.3)	5 (2.9)
Metabolic	2 (1.2)	2
Acute renal failure	1 (0.6)	0
Monitoring/scheduled surgery	1 (0.6)	7 (4)
ICU events
Physical constraint	121 (73.8)	126 (72)
Episode of delirium^c	56 (34.1)	58 (33.1)
Weaning failure and re-intubation	18 (11)	19 (10.9)
Self-extubation	11 (6.7)	13 (7.4)
Unexpected cardiac arrest	9 (5.5)	7 (4)
Fall	4 (2.4)	0
Prognosis^d
No fatal illness	125 (76.2)	132 (75.4)
Fatal illness within 5 y	35 (21.3)	38 (21.7)
Fatal illness within 1 y	4 (2.4)	5 (2.9)
Limitation of daily activity^e
None	79 (48.2)	89 (50.9)
Moderate	66 (40.2)	62 (35.4)
Severe	14 (8.5)	21 (12)
Total dependency	5 (3)	3 (1.7)
Treatment duration, median (IQR), d
Mechanical ventilation	9 (6-15)	9 (5-15)
Noninvasive ventilation	0 (0-3)	0 (0-2)
Fentanyl	6 (3-11)	6 (3-10)
Benzodiazepines	3.5 (2-8.5)	4 (2-9)
Propofol	1 (0-3)	0 (0-3)
Duration of stay, median (IQR), d
ICU	14 (9-22)	14 (9-24)
Hospital	29 (16-49)	27 (17-45)
DFLST	4 (2.4)	5 (2.9)
Discharge	164 (100)	175 (100)
Family Members	(n = 281)	(n = 282)
Age, median (IQR), y	56.5 (45-66)	55 (44.5-66)
Sex
Male	73 (26)	86 (30.5)
Female	208 (74)	196 (69.5)
Relationship with the patient
Spouse/partner	156 (55.5)	155 (55)
Children	84 (29.9)	86 (30.5)
Other	25 (8.9)	33 (11.7)
Parents	16 (5.7)	8 (2.8)
Occupation^f	(n = 274)	(n = 277)
Primary	3 (1.1)	3 (1.1)
Secondary	9 (3.3)	23 (8.3)
Tertiary	181 (66.1)	172 (62.1)
None	22 (8.0)	21 (7.6)
Retired	59 (21.5)	58 (20.9)
Health occupation	35 (12.6)	30 (10.8)
Educational level	(n = 273)	(n = 272)
None	2 (0.73)	3 (1.1)
Upper secondary education	44 (16.1)	40 (14.7)
High school	56 (20.5)	56 (20.6)
Technical college	76 (27.8)	79 (29)
Associate degree	29 (10.6)	19 (7)
Bachelor degree	30 (11)	46 (16.9)
Master degree	36 (13.2)	29 (10.7)
Previous ICU hospitalization, No./total No. (%)	14/277 (5.1)	18/275 (6.5)

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Abbreviations: COPD, chronic obstructive pulmonary disease; DFLST, decision to forgo life-sustaining treatments; IQR, interquartile range; SAPS, Simplified Acute Physiologic Score.

^{^a}

Patients had no missing data.

^{^b}

SAPS II is used to predict hospital mortality (range, 0-162; higher scores indicate higher likelihood of mortality).

^{^c}

Episodes of delirium were diagnosed using the Confusion Assessment Method for the Intensive Care Unit.²⁴

^{^d}

Based on the McCabe score, which explores subjective prognosis of comorbid conditions at ICU admission.

^{^e}

Based on the Acute Physiology and Chronic Health Evaluation score.

^{^f}

Occupations were grouped into agricultural (primary), industrial (secondary), or commercial or related to administration or human health or public action (tertiary).

Primary Outcome

The number of patients with an IES-R score greater than 22 was 49 of 164 (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). For the ancillary outcomes related to the primary outcome measure, the median (IQR) 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; Table 2). Symptoms of intrusion, avoidance, and hyperarousal were not significantly different between the intervention and control groups in patients or family members (Table 2 and Table 3). During the interview, 2 patients spoke spontaneously of their diary to the psychologist.

Table 2. Patient Outcomes at 3-Month Follow-up in a Study of the Effect of an Intensive Care Unit (ICU) Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation.

Outcomes	No. (%)		Risk Difference, % (95% CI)^a	Difference (95% CI)^a	P Value
Outcomes	Intervention Group	Control Group	Risk Difference, % (95% CI)^a	Difference (95% CI)^a	P Value
Primary outcome	(n = 164)	(n = 175)
Presence of PTSD symptoms (IES-R score>22)^b	49 (29.9)	60 (34.3)	−4 (−15 to 6)		.39
IES-R score, median (IQR)^b	12 (5 to 25)	13 (6 to 27)		−1.47 (−1.93 to 4.87)	.38
IES-R domain scores, median (IQR)
Intrusion	5 (2-9)	5 (2-11)		−0.25 (−1.64 to 1.12)	.74
Avoidance	4 (1-10)	5 (2-10)		−1.01 (−2.35 to 0.33)	.08
Hyperarousal	2 (0-6)	2 (0-5)		−0.08 (−1.11 to 0.94)	.64
Secondary outcomes
Depression and anxiety symptoms^c	(n = 163)	(n = 173)
HADS score, median (IQR)	9 (5-14)	9 (5-13)		−0.75 (−2.27 to 0.78)	.30
HADS-Anxiety score	5 (2-8)	6 (2-8)		−0.36 (−1.22 to 0.50)	.72
HADS-Depression score	4 (1-7)	3 (2-7)		−0.39 (−1.29 to 0.52)	.66
Symptoms of anxiety			0.7 (−9 to 11)		.91
Yes	51 (31.3)	53 (30.6)
No	112 (68.7)	120 (69.4)
Symptoms of depression			5 (−5 to 13)		.35
Yes	31 (19)	41 (23.7)
No	132 (81)	132 (76.3)
Memories of the ICU stay^d	(n = 158)	(n = 161)
Factual memories	141 (89.2)	143 (88.8)	0.4 (−7 to 8)		.90
Median (IQR)	5 (2 to 8)	6 (3 to 8)		−0.32 (−1.03 to 0.39)	.44
Emotional memories	119 (75.3)	127 (78.9)	4 (−6 to 13)		.45
Median (IQR)	2 (1-4)	2 (1 to 4)		−0.15 (−0.58 to 0.27)	.51
Delusional memories	106 (67.1)	108 (67.1)	0 (−11 to 11)		>.99
Median (IQR)	1 (0-2)	2 (0-2)		−0.07 (−0.35 to 0.22)	.57
Memories of the hospital stay before ICU admission	(n = 158)	(n = 161)	3 (−6 to 13)		.50
Not at all	82 (51.9)	74 (46)
Clearly	51 (32.3)	55 (34.2)
Vaguely	25 (15.8)	32 (19.9)
Memory of being in the ICU	(n = 158)	(n = 161)	6 (−4 to 17)		.23
Yes	102 (64.6)	114 (70.8)
No	56 (35.4)	47 (29.2)
Memories of transfer from ICU to ward	(n = 158)	(n = 161)	−3 (−11 to 5)		.56
Not at all	31(19.6)	27 (16.8)
Clearly	104 (65.8)	104 (64.6)
Vaguely	23 (14.6)	30 (18.6)
Unexplained feelings of panic and apprehension	(n = 158)	(n = 161)	2.7 (− 7 to 12)		.67
Yes	37 (23.4)	41 (25.5)
No	121 (76.6)	120 (25.5)
Intrusive memories just before hospital admission	(n = 158)	(n = 161)	−2 (−12 to 8)		.67
Yes	38 (24.1)	42 (26.1)
No	120 (75.9)	119 (73.9)
Discussion of ICU with family member	(n = 158)	(n = 161)	−2 (−10 to 7)		.71
Yes	131 (82.9)	136 (84.5)
No	27 (17.1)	25 (15.5)
Discussion of ICU with friend	(n = 158)	(n = 161)	−5 (−16 to 7)		.41
Yes	87 (55.1)	96 (59.9)
No	71 (44.9)	65 (40.4)
Discussion of ICU with nurse on the ward	(n = 158)	(n = 161)	−3 (−13 to 8)		.50
Yes	58 (36.7)	65 (40.4)
No	100 (60.3)	96 (59.6)
Discussion of ICU with physician of the ward	(n = 158)	(n = 161)	−4 (−14 to 7)		.47
Yes	48 (30.4)	55 (34.2)
No	110 (69.6)	106 (65.8)
Discussion of ICU with family physician	(n = 158)	(n = 161)	−2 (−13 to 9)		.86
Yes	75 (47.5)	78 (48.4)
No	83 (52.5)	83 (51.6)

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Abbreviations: HADS, Hospital Anxiety Depression Scale; IES-R, Impact of Event Scale-Revised; IQR, interquartile range; PTSD, posttraumatic stress disorder.

^{^a}

Risk difference and difference were not adjusted and correspond to intervention minus control.

^{^b}

Measured using the IES-R score (overall range, 0-88; intrusion range: 0-32; avoidance range: 0-28; hyperarousal range: 0-24; a higher score indicates more severe symptoms).¹⁷

^{^c}

Measured using the HADS score (overall range, 0-42; range for anxiety and depression subscales, 0-21; a higher score indicate more severe symptoms).

^{^d}

Recollection of memories of the ICU stay was evaluated with the ICU memory tool questionnaire²¹ 3 months after ICU discharge. The memory tool questionnaire asked patients about specific factual (faces, family, alarms, voices, lights, darkness, clock, breathing tube, suctioning, tube in nose, and wards rounds), emotional (panic, pain, being uncomfortable, feeling confused, feeling anxious or frightened, and feeling down) or delusional (dreams, nightmares, hallucinations, and someone trying to harm) memories.

Table 3. Secondary Outcomes in Families at 3-Month Follow-up in a Study of the Effect of an Intensive Care Unit (ICU) Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation.

Symptoms	Median (IQR)		Risk Difference (95% CI), %^a	Difference (95% CI)^a	P Value
Symptoms	Intervention Group	Control Group	Risk Difference (95% CI), %^a	Difference (95% CI)^a	P Value
PTSD^b	(n = 281)	(n = 282)
Presence of PTSD symptoms (IES-R score >22), No (%)	134 (47.7)	127 (45)	3 (−6 to 11)		.53
IES-R score	20 (11-35)	20 (10-37)		0.48 (−2.51 to 3.47)	.87
Intrusion score	10 (5-16)	10 (5-16)		0.15 (−1.08 to 1.37)	.87
Avoidance score	6 (2-11)	5 (2-11)		0.14 (−0.91 to 1.20)	.72
Hyperarousal score	3 (1-8)	3 (1-8)		0.17 (−0.76 to 1.12)	.99
Anxiety and Depression^c	(n = 286)	(n = 286)
HADS score	14 (9-20)	14 (9-22)		0.33 (−0.96 to 1.63)	.45
HADS-Anxiety score	7 (5-11)	7 (5-11)		0.28 (−0.47 to 1.04)	.65
HADS-Depression score	4 (1-7)	4 (1-7)		0.05 (−0.67 to 0.78)	.96
Presence of anxiety (HADS-Anxiety score >8), No. (%)	141 (49.3)	134 (46.9)	2 (−6 to 11)		.56
Presence of depression (HADS-Depression score >8), No. (%)	70 (24.5)	67 (23.4)	1 (−6 to 8)		.77

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Abbreviations: HADS, Hospital Anxiety and Depression Scale; IES-R, Impact of Event Scale-Revised; IQR, interquartile range; PTSD, posttraumatic stress disorder.

^{^a}

Not adjusted and correspond to the difference between the intervention minus the control.

^{^b}

Measured using the IES-R score (overall range, 0-88; intrusion range: 0-32; avoidance range: 0-28; hyperarousal range: 0-24; a higher score indicates more severe symptoms).¹⁷

^{^c}

Measured using the HADS score (overall range, 0-42; range for anxiety and depression subscales, 0-21; a higher score indicates more severe symptoms).

Prespecified Secondary Outcomes

Symptoms of anxiety were reported by 51 of 163 patients (31.3%) in the intervention group vs 53 of 173 (30.6%) in the control group (risk difference, 0.7% [95% CI, −9% to 11%]; P = .91). Symptoms of depression were reported in 31 patients (19%) in the intervention group vs 41 (23.7%) in the control group (risk difference, 5% [95% CI, −5% to 13%]; P = .35). The median (IQR) HADS anxiety scores were 5 (2-8) in the intervention group vs 6 (2-8) in the control group (difference, −0.36 [95% CI, −1.22 to 0.50]; P = .72). The median (IQR) HADS depression scores were 4 (1-7) in the intervention group vs 3 (2-7) in the control groups (difference, −0.39 [95% CI, −1.29 to 0.52]; P = .66; Table 2).

The memories of the ICU stay that were reported by patients were not different between the groups (Table 2). Unexplained episodes of panic occurred in 37 patients (23.4%) in the intervention group vs 41 (25.5%) in the control group (risk difference, 2.7% [95% CI, −7% to 12%]; P = .67). In the intervention group, 106 of 158 patients (67.1%) experienced delusional memories vs 108 of 161 (67.1%) in the control group. Emotional memories were reported by 119 patients (75.3%) in the intervention group vs 127 (78.9%) in the control group (risk difference, 4% [95% CI, −6% to 13%]; P = .45).

The number of family members with an IES-R score greater than 22 was 134 of 281 (47.7%) in the intervention group vs 127 of 282 (45%) in the control group (risk difference, 3% [95% CI −6% to 11%]; P = .53). The median IES-R score of family members was 20 in both groups. There was not a significant between-group difference in anxiety and depression symptoms in family members (Table 3).

Of the 325 ICU diaries, a random sample of 66 diaries (20%) were photocopied at patient discharge. Of the 66 diaries, 20 were unreadable and 46 were eligible for the content analysis, which included 979 pages (median per diary, 13.5 [95% CI, 7-21]), 518 days (median per diary, 9.5 [95% CI, 5.2-12]), and 8888 meaningful segments (median per diary, 156 [95% CI, 86.2-282.5]). Of the 8888 meaningful segments of text, 4563 (51.3%) were written by family members, 3022 (34%) were written by nurses and nursing assistants, and 1303 (14.7%) were written by physicians. Of the 4322 meaningful segments written by clinicians, 2048 (47.4%) were category 2 (building a timeline of medical events), 798 (18.5%) were category 6 (explicitly demonstrating the presence, commitment, and support of clinicians and family), 602 (13.9%) were category 4 (demonstrating continuity of the patient’s life), and 389 (9%) were category 1 (defining places, spaces, and people) (eTable 6, eTable 7, eFigure 1, and eFigure 2 in Supplement 3).

Univariable and multivariable analysis assessing the risk factors of the increase of the IES-R score to greater than 22 in patients were reported in eTable 8 in Supplement 3 and Table 4. The occurrence of an unexpected cardiac arrest, emotional memories, and delusional memories of the ICU stay were significantly associated with an IES-R score greater than 22.

Table 4. Multivariable Analysis of the Occurrence of Posttraumatic Stress Disorder (PTSD) Symptoms Among Patients Receiving Mechanical Ventilation in the Intensive Care Unit (ICU) In a Study of the Effect of an ICU Diary^a.

Variables	IES-R Score		Presence of PTSD Symptoms (IES-R Score >22)
Variables	Rate Ratio (95% CI)	P Value	Odds Ratio (95%CI)	P Value
Intervention group	0.94 (0.78-1.13)	.52^b	0.92 (0.54-1.54)	.75
Age, y		.02
<52	1.19 (0.9-1.57)
52-62	0.97 (0.73-1.27)
63-70	0.78 (0.59-1.03)
>70	1
Female sex	1.21 (1-1.47)	.06	2.29 (1.33-3.91)	.002
Unexpected cardiac arrest	1.65 (1.06-2.57)	.03
Memories^c
Emotional	1.39 (1.09-1.79)	.009
Delusional	1.4 (1.12-1.74)	.003	3.54 (1.92-6.50)	<.001

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Abbreviations: IES-R, Impact of Event Scale-Revised.

^{^a}

Posttraumatic stress disorder symptoms were defined by an IES-R score >22 (range, 0-88; higher score indicates more severe symptoms).¹⁷

^{^b}

Variables in the patient multivariable analysis included presence of a diary (forced variable), age, Simplified Acute Physiology Score II, sex, duration of benzodiazepine and fentanyl exposure, weaning failure and re-intubation, delirium, and emotional and delusional memories, on the basis of a P value threshold of <.20. Variables were further excluded to select the multivariable model, which minimized the log likelihood. For IES-R score, the association measure is the result of the negative binomial regression as the estimated rate ratio with its 95% CI and corresponds to the effect of each factor on the IES-R score For example, the intervention group compared with the control group, while holding the other variables constant in the model, is expected to have an IES-R score 0.94 times lower. This comparison is nonsignificant. For binary value of the IES-R score, the association measure is the odds ratio with its 95% CI.

^{^c}

Recollection of the memories of the ICU stay was evaluated with the ICU memory tool questionnaire²¹ 3 months after ICU discharge. The memory tool questionnaire asked patients about specific factual (faces, family, alarms, voices, lights, darkness, clock, breathing tube, suctioning, tube in nose, and wards rounds), emotional (panic, pain, being uncomfortable, feeling confused, feeling anxious or frightened, and feeling down), or delusional (dreams, nightmares, hallucinations, and someone trying to harm) memories.

Adverse Events

No study-related adverse events were reported in either group.

Post Hoc Analysis

The number of readings of the diary by the patient could be assessed in 106 of 164 patients (64.6%). The median (range) number of readings per patient was 3 (2-4) (eResults in Supplement 3). The evaluation of primary and secondary outcomes in families of deceased patients did not exhibit any significant differences between groups (eTable 9 in Supplement 3).

Discussion

This randomized clinical trial of patients undergoing mechanical ventilation did not identify any significant difference between use of an ICU diary vs usual ICU care on the percentage of patients who reported PTSD symptoms. In addition, no significant between-group differences were found in any of the prespecified secondary outcomes. These results suggest that an ICU diary did not modify the psychological consequences of an ICU stay.

Improving post-ICU mortality is relevant for the most severely ill patients in the ICU. A systematic qualitative review suggested that it could be beneficial to address risk factors for PTSD symptoms early during the ICU stay.²⁵ The results of the current trial differ from results of previous randomized studies.^9,26 In a study with an unblinded outcome assessment, a diary and a psychoeducation program reduced depression and posttraumatic symptoms 3 months after ICU discharge.²⁶ Patients with more severe PTSD symptoms 1 month after ICU discharge (post hoc analysis) had a reduction of PTSD symptoms at 3 months.⁹

There are 4 possible explanations for the failure of the intervention used in this trial to prevent or reduce PTSD symptoms in patients. First, patients read their diary a median of 3 times, which was less than previously reported.²⁷ Second, the delivery of the ICU diary may have been suboptimal if not performed during a formal meeting. Third, reading the ICU diary can be stressful, yielding a negative emotional experience for some patients. Fourth, although the PTSD rate was in the middle range of the prevalence of PTSD in survivors of critical illness,⁶ the current study was not focused on high-risk patients, who may have different needs. Numerous preventive strategies have been evaluated to improve post-ICU morbidity.^22,28,29,30 Delivery of emotional support and coping strategies from a psychologist²⁸; a rehabilitation manual containing advice on psychological, psychosocial, and physical problems²²; and in-home telerehabilitation programs²⁹ were all inconclusive regarding their effect on patients after ICU discharge. A study of the effect of telephone and web-based coping skill training programs showed improved symptoms of distress among survivors of critical illness with high anxiety and depression symptoms at baseline.³⁰ The current trial adds insight to design studies to evaluate the diary in specific groups of patients, such as patients with trauma or severe PTSD symptoms at baseline.

The current trial also found that participation of families in the elaboration of ICU diaries did not modify their psychological outcomes. Qualitative evaluations have identified that ICUs diaries were useful during the ICU stay by helping families to assimilate and understand medical information, communicate with clinicians, and humanize the relationship with the patient or ICU team.³¹ These positive intra-ICU effects did not affect long-term outcomes. The findings of the current trial are consistent with reports of programs found to be ineffective for preventing psychological symptoms, such as family communication facilitators during the ICU stay³² or family support delivered by the ICU team.³³

Grieving families experienced a considerable burden of harm.⁷ In the current trial, grieving families received the ICU diary and there were no differences in their psychological outcomes, in contrast with other interventions previously examined (condolence letter), which may have worsened depression and PTSD symptoms in grieving family members.³⁴

The strengths of this trial were the recruitment of patients from a large set of centers with patient characteristics that were consistent with characteristics of patients usually admitted to ICUs in France.³⁵ The analysis of content of the diaries, which indicated a high rate of participation of each contributor in writing a day-to-day event, showed that the intervention was delivered in all centers with a high reliability.

Limitations

This study had several limitations. First, symptoms of PTSD, anxiety, and depression were not evaluated at baseline in patients or family members. Second, completing an ICU diary is time-consuming³⁶ and some patients were not provided with a sufficiently detailed narrative of their stay in the diary, even if a recommendation for different clinical situations for ICU clinicians who completed the diaries tried to limit this phenomenon. Third, how patients and families shared the diary after ICU discharge was not assessed. Fourth, all the centers were in France so these results cannot be generalized to other countries. Fifth, the diary content analysis did not include all ICU diaries.

Conclusions

Among patients receiving mechanical ventilation in the ICU, the use of an ICU diary did not significantly reduce the percentage of patients who reported significant PTSD symptoms at 3 months. These findings do not support the use of ICU diaries for preventing PTSD symptoms.

Supplement 1.

Trial protocol

Click here for additional data file.^{(916KB, pdf)}

Supplement 2.

Statistical analysis plan

Click here for additional data file.^{(838.7KB, pdf)}

Supplement 3.

eMethods and eResults

Click here for additional data file.^{(2.3MB, pdf)}

Supplement 4.

Data sharing statement

Click here for additional data file.^{(20.9KB, pdf)}

Section Editor: Derek C. Angus, MD, MPH, Associate Editor, JAMA (angusdc@upmc.edu).

References

1.Pandharipande PP, Girard TD, Jackson JC, et al. ; BRAIN-ICU Study Investigators . Long-term cognitive impairment after critical illness. N Engl J Med. 2013;369(14):1306-1316. doi: 10.1056/NEJMoa1301372 [DOI] [PMC free article] [PubMed] [Google Scholar]
2.Needham DM, Davidson J, Cohen H, et al. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders’ conference. Crit Care Med. 2012;40(2):502-509. doi: 10.1097/CCM.0b013e318232da75 [DOI] [PubMed] [Google Scholar]
3.Azoulay E, Chevret S, Leleu G, et al. Half the families of intensive care unit patients experience inadequate communication with physicians. Crit Care Med. 2000;28(8):3044-3049. doi: 10.1097/00003246-200008000-00061 [DOI] [PubMed] [Google Scholar]
4.Adhikari NKJ, McAndrews MP, Tansey CM, et al. Self-reported symptoms of depression and memory dysfunction in survivors of ARDS. Chest. 2009;135(3):678-687. doi: 10.1378/chest.08-0974 [DOI] [PMC free article] [PubMed] [Google Scholar]
5.Jones C, Skirrow P, Griffiths RD, et al. Post-traumatic stress disorder-related symptoms in relatives of patients following intensive care. Intensive Care Med. 2004;30(3):456-460. doi: 10.1007/s00134-003-2149-5 [DOI] [PubMed] [Google Scholar]
6.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;43(5):1121-1129. doi: 10.1097/CCM.0000000000000882 [DOI] [PubMed] [Google Scholar]
7.Kentish-Barnes N, Chaize M, Seegers V, et al. Complicated grief after death of a relative in the intensive care unit. Eur Respir J. 2015;45(5):1341-1352. doi: 10.1183/09031936.00160014 [DOI] [PubMed] [Google Scholar]
8.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;29(3):573-580. doi: 10.1097/00003246-200103000-00019 [DOI] [PubMed] [Google Scholar]
9.Jones C, Bäckman C, Capuzzo M, et al. ; RACHEL group . Intensive care diaries reduce new onset post traumatic stress disorder following critical illness: a randomised, controlled trial. Crit Care. 2010;14(5):R168. doi: 10.1186/cc9260 [DOI] [PMC free article] [PubMed] [Google Scholar]
10.Egerod I, Bagger C. Patients’ experiences of intensive care diaries—a focus group study. Intensive Crit Care Nurs. 2010;26(5):278-287. doi: 10.1016/j.iccn.2010.07.002 [DOI] [PubMed] [Google Scholar]
11.Engström A, Grip K, Hamrén M. Experiences of intensive care unit diaries: “touching a tender wound”. Nurs Crit Care. 2009;14(2):61-67. doi: 10.1111/j.1478-5153.2008.00312.x [DOI] [PubMed] [Google Scholar]
12.Combe D. The use of patient diaries in an intensive care unit. Nurs Crit Care. 2005;10(1):31-34. doi: 10.1111/j.1362-1017.2005.00093.x [DOI] [PubMed] [Google Scholar]
13.Knowles RE, Tarrier N. Evaluation of the effect of prospective patient diaries on emotional well-being in intensive care unit survivors: a randomized controlled trial. Crit Care Med. 2009;37(1):184-191. doi: 10.1097/CCM.0b013e31819287f7 [DOI] [PubMed] [Google Scholar]
14.Aitken LM, Rattray J, Hull A, Kenardy JA, Le Brocque R, Ullman AJ. The use of diaries in psychological recovery from intensive care. Crit Care. 2013;17(6):253. doi: 10.1186/cc13164 [DOI] [PMC free article] [PubMed] [Google Scholar]
15.Garrouste-Orgeas M, Coquet I, Périer A, et al. Impact of an intensive care unit diary on psychological distress in patients and relatives. Crit Care Med. 2012;40(7):2033-2040. doi: 10.1097/CCM.0b013e31824e1b43 [DOI] [PubMed] [Google Scholar]
16.Garrouste-Orgeas M, Flahault C, Fasse L, et al. The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs. Trials. 2017;18(1):542. doi: 10.1186/s13063-017-2283-y [DOI] [PMC free article] [PubMed] [Google Scholar]
17.Rash CJ, Coffey SF, Baschnagel JS, Drobes DJ, Saladin ME. Psychometric properties of the IES-R in traumatized substance dependent individuals with and without PTSD. Addict Behav. 2008;33(8):1039-1047. doi: 10.1016/j.addbeh.2008.04.006 [DOI] [PMC free article] [PubMed] [Google Scholar]
18.de Miranda S, Pochard F, Chaize M, et al. Postintensive care unit psychological burden in patients with chronic obstructive pulmonary disease and informal caregivers: a multicenter study. Crit Care Med. 2011;39(1):112-118. doi: 10.1097/CCM.0b013e3181feb824 [DOI] [PubMed] [Google Scholar]
19.Zigmond AS, Snaith RP. The Hospital Anxiety And Depression Scale. Acta Psychiatr Scand. 1983;67(6):361-370. doi: 10.1111/j.1600-0447.1983.tb09716.x [DOI] [PubMed] [Google Scholar]
20.Chan KS, Aronson Friedman L, Bienvenu OJ, et al. Distribution-based estimates of minimal important difference for Hospital Anxiety And Depression Scale and impact of event scale-revised in survivors of acute respiratory failure. Gen Hosp Psychiatry. 2016;42:32-35. doi: 10.1016/j.genhosppsych.2016.07.004 [DOI] [PMC free article] [PubMed] [Google Scholar]
21.Jones C, Humphris G, Griffiths R. Preliminary validation of the ICUM tool: a tool for assessing memory of the intensive care experience. Clin Intensive Care. 2000;11:251-255. doi: 10.3109/tcic.11.5.251.255 [DOI] [Google Scholar]
22.Jones C, Skirrow P, Griffiths RD, et al. Rehabilitation after critical illness: a randomized, controlled trial. Crit Care Med. 2003;31(10):2456-2461. doi: 10.1097/01.CCM.0000089938.56725.33 [DOI] [PubMed] [Google Scholar]
23.McAdam JL, Fontaine DK, White DB, Dracup KA, Puntillo KA. Psychological symptoms of family members of high-risk intensive care unit patients. Am J Crit Care. 2012;21(6):386-393. doi: 10.4037/ajcc2012582 [DOI] [PubMed] [Google Scholar]
24.Ely EW, Margolin R, Francis J, et al. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001;29(7):1370-1379. doi: 10.1097/00003246-200107000-00012 [DOI] [PubMed] [Google Scholar]
25.Roberts MB, Glaspey LJ, Mazzarelli A, et al. Early interventions for the prevention of posttraumatic stress symptoms in survivors of critical illness: a qualitative systematic review. Crit Care Med. 2018;46(8):1328-1333. doi: 10.1097/CCM.0000000000003222 [DOI] [PubMed] [Google Scholar]
26.Kredentser MS, Blouw M, Marten N, et al. Preventing posttraumatic stress in ICU survivors: a single-center pilot randomized controlled trial of ICU diaries and psychoeducation. Crit Care Med. 2018;46(12):1914-1922. doi: 10.1097/CCM.0000000000003367 [DOI] [PubMed] [Google Scholar]
27.Ewens B, Chapman R, Tulloch A, Hendricks JM. ICU survivors’ utilisation of diaries post discharge: a qualitative descriptive study. Aust Crit Care. 2014;27(1):28-35. doi: 10.1016/j.aucc.2013.07.001 [DOI] [PubMed] [Google Scholar]
28.Peris A, Bonizzoli M, Iozzelli D, et al. Early intra-intensive care unit psychological intervention promotes recovery from post traumatic stress disorders, anxiety and depression symptoms in critically ill patients. Crit Care. 2011;15(1):R41. doi: 10.1186/cc10003 [DOI] [PMC free article] [PubMed] [Google Scholar]
29.Jackson JC, Ely EW, Morey MC, et al. Cognitive and physical rehabilitation of intensive care unit survivors: results of the RETURN randomized controlled pilot investigation. Crit Care Med. 2012;40(4):1088-1097. doi: 10.1097/CCM.0b013e3182373115 [DOI] [PMC free article] [PubMed] [Google Scholar]
30.Cox CE, Hough CL, Carson SS, et al. Effects of a telephone- and web-based coping skills training program compared with an education program for survivors of critical illness and their family members: a randomized clinical trial. Am J Respir Crit Care Med. 2018;197(1):66-78. doi: 10.1164/rccm.201704-0720OC [DOI] [PubMed] [Google Scholar]
31.Garrouste-Orgeas M, Périer A, Mouricou P, et al. Writing in and reading ICU diaries: qualitative study of families’ experience in the ICU. PLoS One. 2014;9(10):e110146. doi: 10.1371/journal.pone.0110146 [DOI] [PMC free article] [PubMed] [Google Scholar]
32.Curtis JR, Treece PD, Nielsen EL, et al. Randomized trial of communication facilitators to reduce family distress and intensity of end-of-life care. Am J Respir Crit Care Med. 2016;193(2):154-162. doi: 10.1164/rccm.201505-0900OC [DOI] [PMC free article] [PubMed] [Google Scholar]
33.White DB, Angus DC, Shields AM, et al. ; PARTNER Investigators . A randomized trial of a family-support intervention in intensive care units. N Engl J Med. 2018;378(25):2365-2375. doi: 10.1056/NEJMoa1802637 [DOI] [PubMed] [Google Scholar]
34.Kentish-Barnes N, Chevret S, Champigneulle B, et al. ; Famirea Study Group . Effect of a condolence letter on grief symptoms among relatives of patients who died in the ICU: a randomized clinical trial. Intensive Care Med. 2017;43(4):473-484. doi: 10.1007/s00134-016-4669-9 [DOI] [PubMed] [Google Scholar]
35.Timsit JF, Schwebel C, Bouadma L, et al. ; Dressing Study Group . Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: a randomized controlled trial. JAMA. 2009;301(12):1231-1241. doi: 10.1001/jama.2009.376 [DOI] [PubMed] [Google Scholar]
36.Nydahl P, Fischill M, Deffner T, Neudeck V, Heindl P. Diaries for intensive care unit patients reduce the risk for psychological sequelae: systematic literature review and meta-analysis [article in German]. Med Klin Intensivmed Notfmed. 2019;114(1):68-76. doi: 10.1007/s00063-018-0456-4 [DOI] [PubMed] [Google Scholar]

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supplement 1.

Trial protocol

Click here for additional data file.^{(916KB, pdf)}

Supplement 2.

Statistical analysis plan

Click here for additional data file.^{(838.7KB, pdf)}

Supplement 3.

eMethods and eResults

Click here for additional data file.^{(2.3MB, pdf)}

Supplement 4.

Data sharing statement

Click here for additional data file.^{(20.9KB, pdf)}

[joi190070r1] 1.Pandharipande PP, Girard TD, Jackson JC, et al. ; BRAIN-ICU Study Investigators . Long-term cognitive impairment after critical illness. N Engl J Med. 2013;369(14):1306-1316. doi: 10.1056/NEJMoa1301372 [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi190070r2] 2.Needham DM, Davidson J, Cohen H, et al. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders’ conference. Crit Care Med. 2012;40(2):502-509. doi: 10.1097/CCM.0b013e318232da75 [DOI] [PubMed] [Google Scholar]

[joi190070r3] 3.Azoulay E, Chevret S, Leleu G, et al. Half the families of intensive care unit patients experience inadequate communication with physicians. Crit Care Med. 2000;28(8):3044-3049. doi: 10.1097/00003246-200008000-00061 [DOI] [PubMed] [Google Scholar]

[joi190070r4] 4.Adhikari NKJ, McAndrews MP, Tansey CM, et al. Self-reported symptoms of depression and memory dysfunction in survivors of ARDS. Chest. 2009;135(3):678-687. doi: 10.1378/chest.08-0974 [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi190070r5] 5.Jones C, Skirrow P, Griffiths RD, et al. Post-traumatic stress disorder-related symptoms in relatives of patients following intensive care. Intensive Care Med. 2004;30(3):456-460. doi: 10.1007/s00134-003-2149-5 [DOI] [PubMed] [Google Scholar]

[joi190070r6] 6.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;43(5):1121-1129. doi: 10.1097/CCM.0000000000000882 [DOI] [PubMed] [Google Scholar]

[joi190070r7] 7.Kentish-Barnes N, Chaize M, Seegers V, et al. Complicated grief after death of a relative in the intensive care unit. Eur Respir J. 2015;45(5):1341-1352. doi: 10.1183/09031936.00160014 [DOI] [PubMed] [Google Scholar]

[joi190070r8] 8.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;29(3):573-580. doi: 10.1097/00003246-200103000-00019 [DOI] [PubMed] [Google Scholar]

[joi190070r9] 9.Jones C, Bäckman C, Capuzzo M, et al. ; RACHEL group . Intensive care diaries reduce new onset post traumatic stress disorder following critical illness: a randomised, controlled trial. Crit Care. 2010;14(5):R168. doi: 10.1186/cc9260 [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi190070r10] 10.Egerod I, Bagger C. Patients’ experiences of intensive care diaries—a focus group study. Intensive Crit Care Nurs. 2010;26(5):278-287. doi: 10.1016/j.iccn.2010.07.002 [DOI] [PubMed] [Google Scholar]

[joi190070r11] 11.Engström A, Grip K, Hamrén M. Experiences of intensive care unit diaries: “touching a tender wound”. Nurs Crit Care. 2009;14(2):61-67. doi: 10.1111/j.1478-5153.2008.00312.x [DOI] [PubMed] [Google Scholar]

[joi190070r12] 12.Combe D. The use of patient diaries in an intensive care unit. Nurs Crit Care. 2005;10(1):31-34. doi: 10.1111/j.1362-1017.2005.00093.x [DOI] [PubMed] [Google Scholar]

[joi190070r13] 13.Knowles RE, Tarrier N. Evaluation of the effect of prospective patient diaries on emotional well-being in intensive care unit survivors: a randomized controlled trial. Crit Care Med. 2009;37(1):184-191. doi: 10.1097/CCM.0b013e31819287f7 [DOI] [PubMed] [Google Scholar]

[joi190070r14] 14.Aitken LM, Rattray J, Hull A, Kenardy JA, Le Brocque R, Ullman AJ. The use of diaries in psychological recovery from intensive care. Crit Care. 2013;17(6):253. doi: 10.1186/cc13164 [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi190070r15] 15.Garrouste-Orgeas M, Coquet I, Périer A, et al. Impact of an intensive care unit diary on psychological distress in patients and relatives. Crit Care Med. 2012;40(7):2033-2040. doi: 10.1097/CCM.0b013e31824e1b43 [DOI] [PubMed] [Google Scholar]

[joi190070r16] 16.Garrouste-Orgeas M, Flahault C, Fasse L, et al. The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs. Trials. 2017;18(1):542. doi: 10.1186/s13063-017-2283-y [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi190070r17] 17.Rash CJ, Coffey SF, Baschnagel JS, Drobes DJ, Saladin ME. Psychometric properties of the IES-R in traumatized substance dependent individuals with and without PTSD. Addict Behav. 2008;33(8):1039-1047. doi: 10.1016/j.addbeh.2008.04.006 [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi190070r18] 18.de Miranda S, Pochard F, Chaize M, et al. Postintensive care unit psychological burden in patients with chronic obstructive pulmonary disease and informal caregivers: a multicenter study. Crit Care Med. 2011;39(1):112-118. doi: 10.1097/CCM.0b013e3181feb824 [DOI] [PubMed] [Google Scholar]

[joi190070r19] 19.Zigmond AS, Snaith RP. The Hospital Anxiety And Depression Scale. Acta Psychiatr Scand. 1983;67(6):361-370. doi: 10.1111/j.1600-0447.1983.tb09716.x [DOI] [PubMed] [Google Scholar]

[joi190070r20] 20.Chan KS, Aronson Friedman L, Bienvenu OJ, et al. Distribution-based estimates of minimal important difference for Hospital Anxiety And Depression Scale and impact of event scale-revised in survivors of acute respiratory failure. Gen Hosp Psychiatry. 2016;42:32-35. doi: 10.1016/j.genhosppsych.2016.07.004 [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi190070r21] 21.Jones C, Humphris G, Griffiths R. Preliminary validation of the ICUM tool: a tool for assessing memory of the intensive care experience. Clin Intensive Care. 2000;11:251-255. doi: 10.3109/tcic.11.5.251.255 [DOI] [Google Scholar]

[joi190070r22] 22.Jones C, Skirrow P, Griffiths RD, et al. Rehabilitation after critical illness: a randomized, controlled trial. Crit Care Med. 2003;31(10):2456-2461. doi: 10.1097/01.CCM.0000089938.56725.33 [DOI] [PubMed] [Google Scholar]

[joi190070r23] 23.McAdam JL, Fontaine DK, White DB, Dracup KA, Puntillo KA. Psychological symptoms of family members of high-risk intensive care unit patients. Am J Crit Care. 2012;21(6):386-393. doi: 10.4037/ajcc2012582 [DOI] [PubMed] [Google Scholar]

[joi190070r24] 24.Ely EW, Margolin R, Francis J, et al. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001;29(7):1370-1379. doi: 10.1097/00003246-200107000-00012 [DOI] [PubMed] [Google Scholar]

[joi190070r25] 25.Roberts MB, Glaspey LJ, Mazzarelli A, et al. Early interventions for the prevention of posttraumatic stress symptoms in survivors of critical illness: a qualitative systematic review. Crit Care Med. 2018;46(8):1328-1333. doi: 10.1097/CCM.0000000000003222 [DOI] [PubMed] [Google Scholar]

[joi190070r26] 26.Kredentser MS, Blouw M, Marten N, et al. Preventing posttraumatic stress in ICU survivors: a single-center pilot randomized controlled trial of ICU diaries and psychoeducation. Crit Care Med. 2018;46(12):1914-1922. doi: 10.1097/CCM.0000000000003367 [DOI] [PubMed] [Google Scholar]

[joi190070r27] 27.Ewens B, Chapman R, Tulloch A, Hendricks JM. ICU survivors’ utilisation of diaries post discharge: a qualitative descriptive study. Aust Crit Care. 2014;27(1):28-35. doi: 10.1016/j.aucc.2013.07.001 [DOI] [PubMed] [Google Scholar]

[joi190070r28] 28.Peris A, Bonizzoli M, Iozzelli D, et al. Early intra-intensive care unit psychological intervention promotes recovery from post traumatic stress disorders, anxiety and depression symptoms in critically ill patients. Crit Care. 2011;15(1):R41. doi: 10.1186/cc10003 [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi190070r29] 29.Jackson JC, Ely EW, Morey MC, et al. Cognitive and physical rehabilitation of intensive care unit survivors: results of the RETURN randomized controlled pilot investigation. Crit Care Med. 2012;40(4):1088-1097. doi: 10.1097/CCM.0b013e3182373115 [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi190070r30] 30.Cox CE, Hough CL, Carson SS, et al. Effects of a telephone- and web-based coping skills training program compared with an education program for survivors of critical illness and their family members: a randomized clinical trial. Am J Respir Crit Care Med. 2018;197(1):66-78. doi: 10.1164/rccm.201704-0720OC [DOI] [PubMed] [Google Scholar]

[joi190070r31] 31.Garrouste-Orgeas M, Périer A, Mouricou P, et al. Writing in and reading ICU diaries: qualitative study of families’ experience in the ICU. PLoS One. 2014;9(10):e110146. doi: 10.1371/journal.pone.0110146 [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi190070r32] 32.Curtis JR, Treece PD, Nielsen EL, et al. Randomized trial of communication facilitators to reduce family distress and intensity of end-of-life care. Am J Respir Crit Care Med. 2016;193(2):154-162. doi: 10.1164/rccm.201505-0900OC [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi190070r33] 33.White DB, Angus DC, Shields AM, et al. ; PARTNER Investigators . A randomized trial of a family-support intervention in intensive care units. N Engl J Med. 2018;378(25):2365-2375. doi: 10.1056/NEJMoa1802637 [DOI] [PubMed] [Google Scholar]

[joi190070r34] 34.Kentish-Barnes N, Chevret S, Champigneulle B, et al. ; Famirea Study Group . Effect of a condolence letter on grief symptoms among relatives of patients who died in the ICU: a randomized clinical trial. Intensive Care Med. 2017;43(4):473-484. doi: 10.1007/s00134-016-4669-9 [DOI] [PubMed] [Google Scholar]

[joi190070r35] 35.Timsit JF, Schwebel C, Bouadma L, et al. ; Dressing Study Group . Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: a randomized controlled trial. JAMA. 2009;301(12):1231-1241. doi: 10.1001/jama.2009.376 [DOI] [PubMed] [Google Scholar]

[joi190070r36] 36.Nydahl P, Fischill M, Deffner T, Neudeck V, Heindl P. Diaries for intensive care unit patients reduce the risk for psychological sequelae: systematic literature review and meta-analysis [article in German]. Med Klin Intensivmed Notfmed. 2019;114(1):68-76. doi: 10.1007/s00063-018-0456-4 [DOI] [PubMed] [Google Scholar]

PERMALINK

Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation

Maité Garrouste-Orgeas, MD

Cécile Flahault, PhD

Isabelle Vinatier, MD

Jean-Philippe Rigaud, MD, PhD

Nathalie Thieulot-Rolin, MD

Emmanuelle Mercier, MD

Antoine Rouget, MD

Hubert Grand, MD

Olivier Lesieur, MD, PhD

Fabienne Tamion, MD, PhD

Rebecca Hamidfar, MD

Anne Renault, MD

Erika Parmentier-Decrucq, MD

Yannick Monseau, MD

Laurent Argaud, MD, PhD

Cédric Bretonnière, MD

Alexandre Lautrette, MD, PhD

Julio Badié, MD

Eric Boulet, MD

Bernard Floccard, MD

Xavier Forceville, MD, PhD

Eric Kipnis, MD, PhD

Lilia Soufir, MD

Sandrine Valade, MD

Naike Bige, MD

Alain Gaffinel, MD

Olfa Hamzaoui, MD

Georges Simon, MD

Marina Thirion, MD

Lila Bouadma, MD, PhD

Audrey Large, MD

Jean-Paul Mira, MD, PhD

Nora Amdjar-Badidi, MD

Mercé Jourdain, MD, PhD

Paul-Henri Jost, MD

Virginie Maxime, MD

François Santoli, MD

Stéphane Ruckly, MSc

Christel Vioulac, PhD

Marie Annick Leborgne, MSc

Lucie Bellalou, MSc

Léonor Fasse, PhD

Benoit Misset, MD

Sébastien Bailly, PharmD, PhD

Jean-François Timsit, MD, PhD

Key Points

Question

Findings

Meaning

Abstract

Importance

Objectives

Design, Setting, and Participants

Interventions

Main Outcomes and Measures

Results

Conclusions and Relevance

Trial Registration

Introduction

Methods

Study Design and Oversight

Randomization

Study Setting

Study Participants

Inclusion Criteria

Exclusion Criteria

Study Intervention

Outcomes

Primary Outcomes

Secondary Outcomes

Adverse Events

Post Hoc Secondary Outcomes

Sample Size

Statistical Analysis

Results

Study Population and Follow-up

Figure. Flow of Patients Included in a Study of the Effect of an Intensive Care Unit (ICU) Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation.

Table 1. Baseline Characteristics of Patients and Family Members Included in a Study of the Effect of an Intensive Care Unit (ICU) Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation.

Table 4. Multivariable Analysis of the Occurrence of Posttraumatic Stress Disorder (PTSD) Symptoms Among Patients Receiving Mechanical Ventilation in the Intensive Care Unit (ICU) In a Study of the Effect of an ICU Diary^a.