ABSTRACT
INTRODUCTION: A substantial proportion of intensive care unit (ICU) survivors develop psychological impairments after ICU treatment, part of the postintensive care syndrome, resulting in a decreased quality of life. Recent data suggest that an ICU-specific virtual reality intervention (ICU-VR) for post-ICU patients is feasible and safe, improves satisfaction with ICU aftercare, and might improve psychological sequelae. In the present trial, we firstly aim to determine whether ICU-VR is effective in mitigating post-traumatic stress disorder (PTSD)-related symptoms and secondly to determine the optimal timing for initiation with ICU-VR. METHODS AND ANALYSIS: This international, multicentre, randomised controlled trial will be conducted in 10 hospitals. Between December 2021 and April 2023, we aim to include 300 patients who have been admitted to the ICU ≥72 hours and were mechanically ventilated ≥24 hours. Patients will be followed for 12 consecutive months. Patients will be randomised in a 1:1:1 ratio to the early ICU-VR group, the late ICU-VR group, or the usual care group. All patients will receive usual care, including a mandatory ICU follow-up clinic visit 3 months after ICU discharge. Patients in the early ICU-VR group will receive ICU-VR within 2 weeks after ICU discharge. Patients in the late VR group will receive ICU-VR during the post-ICU follow-up visit. The primary objective is to assess the effect of ICU-VR on PTSD-related symptoms. Secondary objectives are to determine optimal timing for ICU-VR, to assess the effects on anxiety-related and depression-related symptoms and health-related quality of life, and to assess patient satisfaction with ICU aftercare and perspectives on ICU-VR. ETHICS AND DISSEMINATION: The Medical Ethics Committee United, Nieuwegein, the Netherlands, approved this study and local approval was obtained from each participating centre (NL78555.100.21). Our findings will be disseminated by presentation of the results at (inter)national conferences and publication in scientific, peer-reviewed journals. TRIAL REGISTRATION NUMBER: NL9812.
Subject(s)
Quality of Life , Virtual Reality , Critical Illness/psychology , Humans , Intensive Care Units , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Survivors/psychologyABSTRACT
INTRODUCTION: Illnesses requiring hospitalization are known to negatively impact psychological well-being and health-related quality of life (HRQoL) after discharge. The impact of hospitalization during the Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) pandemic on psychological well-being and health-related quality of life is expected to be higher due to the exceptional circumstances within and outside the hospital during the pandemic surge. The objective of this study was to quantify psychological distress up to three months after discharge in patients hospitalized during the first coronavirus disease 2019 (COVID-19) pandemic wave. We also aimed to determine HRQoL, to explore predictors for psychological distress and HRQoL, and to examine whether psychological distress was higher in COVID-19 confirmed patients, and in those treated in Intensive Care Units (ICUs). METHODS: In this single-center, observational cohort study, adult patients hospitalized with symptoms suggestive of COVID-19 between March 16 and April 28, 2020, were enrolled. Patients were stratified in analyses based on SARS-CoV-2 PCR results and the necessity for ICU treatment. The primary outcome was psychological distress, expressed as symptoms of post-traumatic stress disorder (PTSD), anxiety, and depression, up to three months post-discharge. Health-related quality of life (HRQoL) was the secondary outcome. Exploratory outcomes comprised predictors for psychological distress and HRQoL. RESULTS: 294 of 622 eligible patients participated in this study (median age 64 years, 36% female). 16% and 13% of these patients reported probable PTSD, 29% and 20% probable anxiety, and 32% and 24% probabledepression at one and three months after hospital discharge, respectively. ICU patients reported less frequently probable depression, but no differences were found in PTSD, anxiety, or overall HRQoL. COVID-19 patients had a worse physical quality of life one month after discharge, and ICU patients reported a better mental quality of life three months after discharge. PTSD severity was predicted by time after discharge and being Caucasian. Severity of anxiety was predicted by time after discharge and being Caucasian. Depression severity was predicted by time after discharge and educational level. CONCLUSION: COVID-19 suspected patients hospitalized during the pandemic frequently suffer from psychological distress and poor health-related quality of life after hospital discharge. Non-COVID-19 and non-ICU patients appear to be at least as affected as COVID-19 and ICU patients, underscoring that (post-)hospital pandemic care should not predominantly focus on COVID-19 infected patients.
