None listed
Conditions
Brief summary
This study will be a mixed methods design. The first component is a prospective cohort study using validated tools (questionnaires) to assess and quantify the level of disability in the 12 months following critical illness. Functional disability will be assessed using WHODAS 2.0. Other important variables related to disability are Health-related quality of life, mental health, and cognition; and these will be assessed post-discharge, and after six months and 12 months. This will address Aims I and II of the study. The second component is a qualitative study that will explore the process of recovery for participants. The major impetus will be to identify the ongoing needs (met and unmet) in the year following critical illness, (aim III of the study). This design will use a nested convenience sample conducting semi-structured Interviews at around 6-8 months post discharge home. The aims of this study are: I. To estimate the proportion of intensive care survivors with moderate or severe disability at different time-points after discharge. II. To describe the data distributions of a variety of relevant clinical variables in intensive care survivors and estimate associations between baseline characteristics of intensive care survivors and disability and its change with time. III. To describe unmet health needs in ICU survivors. The primary outcome for the prospective cohort study is the prevalence of moderate or severe disability, as defined by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS-12) 6 months after discharge. The Hypothesis is “in adult ICU patients who have had a prolonged stay in the ICU, > 20% will experience moderate to severe disability in the year following critical illness”
Interventions
There is a growing emphasis on the survivorship journey, morbidity, and poor quality of life for patients post Critical Illness (Hodgson et al. 2017). New or worsening of impairments in any of the physical, mental health or cognitive function is collectively known as the Post Intensive Care Syndrome (PICS) a common occurrence post critical illness (Needham et al. 2012). Not only do impairments relating to cognition, mental health, and physical function create new and lasting disability, but qual
There is a growing emphasis on the survivorship journey, morbidity, and poor quality of life for patients post Critical Illness (Hodgson et al. 2017). New or worsening of impairments in any of the physical, mental health or cognitive function is collectively known as the Post Intensive Care Syndrome (PICS) a common occurrence post critical illness (Needham et al. 2012). Not only do impairments relating to cognition, mental health, and physical function create new and lasting disability, but quality of life, return to work and social aspects, are also affected. This observational study will be the first of its kind in New Zealand exploring level of disability, quality of life, impairments in Mental health, cognition, and physical function in patients discharged from Wellington Hospital ICU. This study overall will be a mixed methods design (observational and qualitative). The first component is a prospective cohort study using validated tools (questionnaires) to assess and quantify the level of disability in the 12 months following critical illness. Functional disability will be assessed using WHODAS 2.0. Other important variables related to disability are Health-related quality of life, mental health, and cognition; and these will be assessed post-discharge, and after six months and 12 months using the following: • Health-related Quality of Life: EQ-5D-5L derived health utilities • Mental health– Impact of events Scale Revised (IES-R), Hospital Anxiety and Depression scale (HADS), Cognitive function - The Montreal Cognitive Assessment – Blind (MOCA-Blind) All questionnaires will be delivered by the research coordinator over the phone. The questionnaires will likely take around 25 mins which the research team and ETHICS panel felt was manageable for participants and are also a minimum core set of tools to evaluate PICS suggested by Critical Care Experts (Needham et al. 2018; Mikkelsen et al. 2020). The second component is a qualitative study that will explore the process of recovery for participants. The major impetus will be to identify the ongoing needs (met and unmet) in the year following critical illness, (aim III of the study). This design will use a nested convenience sample conducting semi-structured Interviews, conducted by the primary coordinating investigator at around 6-8 months post discharge home. This part of the study will use grounded theory, so sample size cannot be pre-determined, however it is anticipated that around 10-20 participants may be used (the first 10-20 participants who are called at the 6 months follow up). The interviews will be wherever the participant chooses to be conducted, but preference will be for the participants home (with other options offered such as a meeting room in the hospital, or via ZOOM or over the phone).
Sponsors
University Of Otago, Wellington
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patient participants will be adult ICU patients admitted to Wellington ICU who are > 18 years old, been in an ICU for seven or more consecutive days, or patients who were mechanical ventilated for >48 hours. Patients who have been in another New Zealand ICU/Critical Care Unit prior to retrieval to Wellington ICU will be included once both admissions = >7 days. Mechanical Ventilation is defined as a positive pressure ventilation (PPV) mode via an Endotracheal, Nasotracheal or Tracheostomy tube. Patients who have been extubated from PPV for a period and then reintubated are also included if both periods of PPV exceed 72 hours.
Exclusion criteria
Patients who are < 18 years old • Non-English speakers • Patients not expected to survive their hospital stay (deemed by ICU Senior Medical Officer (SMO) once inclusion criteria met). • Patients in whom follow up would be challenging/impossible (e.g., prisoners, people who are homeless). • Patients with pre-existing neuromuscular disorder (e.g., Muscular Dystrophy, Multiple Sclerosis, Myasthenia Gravis, Guillain Barre). • Neurovascular/neurotrauma/status epilepticus. • Patients who have hypoxic/ischemic brain injury/encephalopathy. • Significant pre-existing psychiatric disease or intellectual disability such that the patient was mentally, cognitively, or functionally impaired prior to ICU admission. • Patients with diagnosed neurodegenerative disease • Patients with prior moderate to severe cognitive impairment (as recorded in the patient health records/medical notes). • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
Outcome results
None listed