Keywords
Sars-Cov-2, Intensive Care, ICU-diary, Mental Health, Quality of Life, Memories, Post-Intensive Care Syndrome (PICS), PICS-Family.
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Rutjes-Weurding L, Pouwels S, van Oers J et al. The effect of ICU diaries on the occurrence of impaired mental health and quality of life of ICU SARS-CoV-2 patients and their families: a protocol for an observational cohort study [version 1; peer review: peer review discontinued]. F1000Research 2022, 11:707 (https://doi.org/10.12688/f1000research.121821.1)
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Study Protocol
The effect of ICU diaries on the occurrence of impaired mental health and quality of life of ICU SARS-CoV-2 patients and their families: a protocol for an observational cohort study
[version 1; peer review: peer review discontinued]
PUBLISHED 27 Jun 2022
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PEER REVIEW DISCONTINUED
This article is included in the Emerging Diseases and Outbreaks gateway.
Abstract
Corresponding author:
Laura Rutjes-Weurding
Competing interests:
No competing interests were disclosed.
Grant information:
The author(s) declared that no grants were involved in supporting this work.
Copyright:
© 2022 Rutjes-Weurding L et al.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Rutjes-Weurding L, Pouwels S, van Oers J et al. The effect of ICU diaries on the occurrence of impaired mental health and quality of life of ICU SARS-CoV-2 patients and their families: a protocol for an observational cohort study [version 1; peer review: peer review discontinued]. F1000Research 2022, 11:707 (https://doi.org/10.12688/f1000research.121821.1)
First published: 27 Jun 2022, 11:707 (https://doi.org/10.12688/f1000research.121821.1)
Latest published: 27 Jun 2022, 11:707 (https://doi.org/10.12688/f1000research.121821.1)
Introduction
During intensive care unit (ICU) admission patients experience significant physical and psychological stressors. In recent years there has been more attention on the long-term effects of ICU admission on patients and their family (Marra et al., 2018). The adverse effects, such as muscle weakness, cognitive dysfunction or mental health problems, are known as post-intensive care syndrome (PICS) and post-intensive care syndrome family (PICS-F) (Davidson et al., 2012; Mikkelsen et al., 2020). Patients and caregivers are at risk of developing anxiety, depression or post-traumatic stress disorder (PTSD) symptoms with prevalence ranging from 10 up to 57 percent (Lewis et al., 2018). A meta-analysis of (Parker et al., 2015) showed that one in five critical illness survivors has clinically important PTSD symptoms. Post-ICU patients are at risk of suffering from delusional memories and gaps in their memory (Egerod et al., 2011). These delusional memories can be one of the triggers to developing PTSD symptoms (Jones & Griffiths, 2007; Parker et al., 2015). The absence of memories of the ICU period can be devastating for patients and puts strain on the relationship with family who are asked to fill in the gaps, but who have difficulty talking about it (Jones & Griffiths, 2007).
SARS-CoV-2 has added even more stressors to the ICU admission. Patients were isolated from their loved ones and faced an uncertain course of the disease (Dutheil et al., 2021). Most patients with SARS-CoV-2 who required ICU care and mechanical ventilation, had a long ICU length of stay, needed prolonged sedation, analgesia and even muscular blocking agents (Nanwani-Nanwani et al., 2022). This increases the risk of impaired recall and therefore PTSD, as mentioned above. Relatives also experienced worrisome times, with extra limitations and concerns due to SARS-CoV-2 (Dutheil et al., 2021). Hospitals visitation policies became more strict (Weiner et al., 2021); for example at Elisabeth-Tweesteden Hospital relatives were allowed limited time to visit or were not able to visit as patients were transported to different hospitals across the country. Relatives could often not support the patients during admission or intubation other than via phone and they themselves were also limited in receiving support due to lock-down regulations. This may enhance the mental health problems associated with PICS-F (Dutheil et al., 2021).
ICU diaries have been investigated as a tool to prevent or reduce psychological problems after ICU admission, such as anxiety, depression or PTSD (McIlroy et al., 2019). It is important to make a difference between the prevention and the reduction of symptoms in, for example PTSD and anxiety. Studies showed no significant effect on prevention of PTSD (Wang et al., 2020), but did show a reduction of symptoms (Parker et al., 2015). It is also important to make a distinction of the effect on patients and the effect on relatives. The systematic review of (McIlroy et al., 2019) showed no reduction of PTSD symptoms in patients, but (McIlroy et al., 2019) and (Jones et al., 2012) did show a significant reduction of these symptoms in their relatives. Multiple studies have shown a significant reduction of anxiety and depression symptoms in patients due to ICU diaries (Knowles & Tarrier, 2009; Kredentser et al., 2018; McIlroy et al., 2019).
Besides the impact of the ICU diaries on the symptoms, patients have stated they value the diaries and that the diaries can help fill in the gaps and complete their fragmented illness narrative (Egerod & Bagger, 2010; Glimelius Petersson et al., 2018; O’Gara & Pattison, 2016; Pattison et al., 2019; Tavares et al., 2019). The ICU diaries may aid in the communication between patients and family members (Huynh et al., 2017; Jones et al., 2012; Pattison et al., 2019) or strengthen the bond by sharing the story (Nielsen, et al., 2019). Participating in writing the diary can help family members cope, maintain the relationship and support the patient (Nielsen & Angel, 2016; Roulin, Hurst, & Spirig, 2007).
The results of the studies are promising, but the overall quality is lacking (Lewis et al., 2018). More research is needed on the possibilities of ICU diaries to help patients and their relatives. This study will contribute to the research on PICS(-F) and ICU diaries. This study protocol describes the methods of research on this topic in SARS-CoV-2 patients. It pioneers on the psychological problems of PICS of SARS-CoV-2 patients and the use of ICU diaries in this group.
Methods
Objectives
The goal of this study is to evaluate the effect of ICU diaries on the prevalence of PTSD, anxiety and depression symptoms in patients, admitted with SARS-CoV-2 and their relatives. The secondary objectives are to evaluate:
1. The effect of ICU diaries on symptoms of PTSD, anxiety and depression over time; three months after initial testing.
2. The effect of ICU diaries on the recollection of memories.
3. The way the patients and relatives value and use the diary.
We hypothesize that the ICU diary will aid in processing the negative experiences of the ICU admission and thereby lower the prevalence of PTSD, anxiety and depression symptoms over time. We also expect the diary to contribute to the recollection of memories and help patients and relatives with the completion of their illness narrative.
Study design
This study is an observational single center cohort study that will be performed at the Elisabeth-Tweesteden Hospital in Tilburg, the Netherlands.
Patient inclusion
Patients are admitted to the ICU either directly from the emergency department or from a SARS-CoV-2 ward. Patients with Sars-Cov-2 admitted to the ICU are included following the inclusion and exclusion criteria.
Inclusion criteria are as follows:
• Age 18 year or older.
• Admission to the ICU because of respiratory insufficiency due to SARS-CoV-2 pneumonia.
• Proven SARS-Cov-2 by PCR or computer aided tomography- (CAT) scan before or during admission to the ICU.
• Mechanical ventilation for more than 48 hours.
Exclusion criteria are as follows:
A relative, chosen by the patient will be included. This relative needs to be 18 years or older. Informed consent for the study will be obtained after discharge. Patients who do not desire to visit the post-ICU after care clinic will be asked to participate in the research from home.
SARS-CoV-2 detection
From patients admitted to the hospital, suspected for SARS-CoV-2, a PCR test on SARS-CoV-2 is conducted in a pharyngeal swab. If the first PCR test is negative and there is a clinically high suspicion, PCR testing in sputum and faeces is continued. If a PCR test is positive or a chest CAT-scan showed abnormalities highly suspect for SARS-CoV-2, the patient is considered SARS-CoV-2 positive. Abnormalities on the chest CAT-scan are considered highly suspicious of a SARS-CoV-2 infection with a COVID-19 Reporting and Data System (CO-RADS) score of five. CO-RADS is a standardized assessment for pulmonary involvement of SARS-Cov-2 developed by the Dutch Radiological Society (Prokop et al., 2020). SARS-CoV-2 infection may become definite during any time of the hospital stay (Sethuraman et al., 2020).
Collection of diary input
From the first day the patient is admitted to the ICU unit it is standard care to keep a diary daily onwards. During every shift the nurse writes a few sentences on the events of the day, a feeling or conclusion, in a paper diary. At the ICU, the patient’s family is encouraged to contribute to the diary and take pictures of the patient. At discharge the patient receives the diary. If the patient passed away during their stay, the diary is given to the family. The family member will then be excluded from the study.
Data collection
At three months after discharge all ICU patients are invited to the post-ICU aftercare clinic for follow-up. During this visit patients will be screened for mental or cognitive health problems using the psychosocial screening instrument for adult trauma patients (PSIT) and the cognitive failure questionnaire (CFQ). In addition to this standard care, patients will receive, during this study, the short-form health survey 36 (SF-36), the ICU memory tool and a questionnaire on how they used and valued the diary. The questionnaires will also be handed to a relative chosen by the patient. The questionnaires will be completed either digitally or written.
The PSIT, a validated tool for adult trauma patients., consists of 15 items measuring three subscales on a 4-point Likert scale: mood disturbances, anxiety and/or PTSD and social or sexual problems/decreased self-confidence (Karabatzakis et al., 2019). The PSIT is internally consistent, with an alpha coefficient of 0.92 (Karabatzakis et al., 2019). Cognitive dysfunction will be screened using the Cognitive Failure Questionnaire (CFQ) (Broadbent et al., 1982). The CFQ tests the frequency of mistakes using 25 items with a 5-point scale. A higher score corresponds with a higher frequency in cognitive mistakes. CFQ is internally consistent (alpha coefficient 0.92-0.93) (Bridger et al., 2013). Quality of life will be assessed by the short-form health survey 36 (SF-36) (Ware & Sherbourne, 1992). The SF-36 consists of 36 questions addressing physical performance, social functioning, mental health and perceived health. A higher score corresponds with a better health condition. The internal consistency is measured at a Cronbach’s alpha score 0.71 to 0.93 (Vander Zee et al., 1996). The recollection of patients’ of their ICU stay will be evaluated by the ICU memory tool; consisting of fourteen questions about factual and delusional memories, amnesic periods and quality of the memories. The ICU memory tool is internally consistent with Cronbach’s alpha measured at 0.86 (Jones et al., 2000). To assess the appreciation of the diary a questionnaire is developed on how participants used the diary and how they valued it. The questionnaire consists of one question on how many times the diary is used, three questions, using a 5-point Likert scale, addressing if the diary aided in processing the admission and if it helped to clarify memories and one open-ended question for comments on the diary.
The five questionnaires (PSIT, CFQ, SF-36, ICU memory tool and the value questionnaire) will also be sent, digitally or on paper, to patients who do not wish to visit the ICU aftercare clinic but do want to participate in this research.
Three months after the initial testing the patient and their relative will receive the questionnaires, by mail or e-mail, a second time. See Figure 1 for the study timeline.
Figure 1. Study timeline.
PSIT: psychosocial screening instrument adult trauma patients, CFQ: Cognitive Failure Questionnaire, SF36: short-form health survey-36, ICU: intensive care unit.
The following patient characteristics are recorded: gender, age, medical history, duration of SARS-CoV-2 symptoms, number of days between first day of illness and ICU admission, total duration of hospital stay, duration of ICU stay, use of muscular blocking agents and complications, deceased relatives.
The following characteristics are recorded for each selected relative: gender, age, relationship with patient, history of SARS-CoV-2 infection, number of times family member visited the patient, whether or not the family member wrote in the diary.
Statistical analysis
Data processing, statistical analyses and power calculation
Due to the nature of the study, no official power calculation was done. The study of Nanwani-Nanwani et al. (2022) showed a higher prevalence of PICS in mechanically ventilated SARS-CoV-2 patients compared to the regular ICU population (Mikkelsen et al., 2020); respectively 75% versus 64%. When considering the possible effect of ICU diaries on PICS in SARS-CoV-2 patients no data are published to date. In an earlier single center study of (Kredentser et al., 2018), who included 58 regular ICU patients, patients with ICU diaries had significantly lower psychological PICS symptoms. Based on previous studies, the prevalence of PICS, which is higher in the SARS-CoV-2 population, and considering the follow-up time of six months we aim to include 50 patients (and their relatives). Considering 10% loss to follow-up 55 patients will be recruited for this study.
Normally distributed variables will be presented as mean and standard deviation (SD). Categorical variables will be presented as frequency with percentages. The quantitative data of the PSIT, CFQ, SF-36 will be compared over time in patients and in their relatives. Participants’ characteristics including if they received a diary, how they valued it and the memory recollection of ICU treatment will be reported. Multiple logistic regression analysis will be performed for analyzing the relation between mental health outcome and the use of ICU diaries in patients as well as their relatives. Change in PICS symptoms over time will be analyzed using longitudinal data analysis. Missing value analysis will be performed on missing data. Missing items in questionnaires will be addressed using multiple item imputation when necessary.
Demographic data will be extracted from the electronic patient file. Questionnaire data will be processed anonymously: outcomes of the questionnaire are coded, transcribed and analysed in data management software.
Partial result of participants who are lost during follow-up, will only be used in analysis of the first period. The number of missing data and participants lost to follow-up will be reported.
P-values of p<0.05 are considered statistically significant. Statistical Package for Social Sciences (SPSS, Chicago, IL, USA Version 27.0) (RRID:SCR_002865) will be used for data management and statistical analysis.
Ethics and dissemination
The medical ethics committee (MEC) of the Elisabeth-Tweesteden Hospital, part of the MEC of Brabant, the Netherlands approved the study (NW2021-68). The insights from this study will be used for the awareness of psychological PICS(-F) complaints and the development of prevention tools and aftercare for post-ICU Sars-CoV-2 patients. The results of the study will be published in a peer-reviewed journal.
Discussion
Post-intensive care syndrome has gained more attention in the recent years. Intensivists are aware of the importance of reducing the physical, psychological and cognitive consequences of an ICU admission. However, more research is needed on how to prevent these consequences. One promising tool, the ICU diary, has shown different results in the reduction or prevention of mental health problems in recent studies (Garrouste-Orgeas et al., 2019; McIlroy et al., 2019). With the SARS-CoV-2 virus the world faces a new challenge, with known and unknown consequences. Due to the need of long sedation and mechanical ventilation the risk of developing PICS is expected to be higher in this group (Bhatraju et al., 2020). Due to impaired memory, possibly accompanied by hallucinations or delusions, in post-ICU patients and limited visits for family, both patients and their families could benefit from an ICU diary to help complete the fragmented illness narrative (Egerod & Christensen, 2010; Egerod & Bagger, 2010; Egerod et al., 2011; O’Gara & Pattison, 2016; Pattison et al., 2019). This protocol outlines a study which will provide insight on the psychological problems of post-ICU SARS-CoV-2 patients and the possible effect of an ICU diary on PICS.
However, some limitations are worth mentioning. This study screens for anxiety, depression, PTSD, cognitive dysfunction, quality of life and memories by using different validated tools. Anxiety, depression and PTSD is screened using the psychosocial screening instrument for adult trauma patient (PSIT). The PSIT is a validated tool for adult trauma patients. Because of the similarities with ICU-patients, it is expected this tool is also applicable to ICU-patients, however this has not yet been validated in these patients. The psychological problems of patients and their family are investigated; however, it is important to realise different variables affect the mental health. For example, if a relative or friend has passed away due to SARS-CoV-2 this has an additional impact on the patient, it is not possible to adjust for these circumstances in the analysis of the data. If a patient has passed away, the family member will be excluded from the study. Not every diary is the same, as it is written by different members of the ICU staff and some have additional comments from family members. A content analysis is needed to elucidate the most helpful or important parts of a diary. As patients can choose whether or not to participate in the research, this may cause a selection bias. An attempt to minimize this bias has been to include patients who do not wish to visit the ICU-aftercare clinic but do want to participate.
Conclusions
In conclusion, this study protocol contributes to the limited research on ICU diaries and this study pioneers on the psychological problems of post-ICU SARS-CoV-2 patients. The results of this study are expected to show the importance of ICU diaries for the prevention of psychological problems in this group.
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how to cite this article
Rutjes-Weurding L, Pouwels S, van Oers J et al. The effect of ICU diaries on the occurrence of impaired mental health and quality of life of ICU SARS-CoV-2 patients and their families: a protocol for an observational cohort study [version 1; peer review: peer review discontinued] F1000Research 2022, 11:707 (https://doi.org/10.12688/f1000research.121821.1)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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