Clinical trial NCT05690438: Prediction of the Post-intensive Care Syndrome
Official title: Prediction of the Post-intensive Care Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Care
Keywords: Post-intensive care syndrome
Depression
Anxiety
Post-traumatic stress
Physical disability
Pain
Frailty
Resilience
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2023-01-19
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General adult ICU population, all admitted patients will be consecutively screened for inclusion.

Brief summary: The goal of this observational study is to assess whether a screening of patients at discharge from the intensive care unit (ICU) can predict psychological and physical problems three months later.

The main questions to answer are:

1. Can the screening method at ICU discharge predict psychological symptoms three months after ICU stay?
2. Can the screening method at ICU discharge predict new-onset physical disability three months after ICU stay?
3. Does pain, resilience (the individuals\&#39; ability to handle distress) and frailty affect the risk of developing psychological and physical problems three months after ICU stay? All adult patients with an ICU stay 12 hours or longer will be assessed for inclusion in the study. Three months after discharge from the ICU included patients will be asked to digitally answer a set of questionnaires, rating symptoms of depression, anxiety, post-traumatic stress and ability to perform activities of daily living. Patients will also be asked to state their health-related quality of life and on-going pain, how the pain affects their everyday life and the ability to endure difficult situations.

Detailed description: Firstly, the investigators hypothesize that two novel screening instruments, developed by the research group, for identification of intensive care unit (ICU) survivors with elevated risk for psychological and physical morbidity have high external validity. Secondly, the investigators hypothesize that frailty, pain and resilience will affect the probability of developing post-intensive care syndrome (PICS) three months post-ICU.

The specific objectives with the project are:

1. To assess the predictive value and hence the validity of a screening instrument assessing the risk for

   1. psychological problems (study I)
   2. new-onset physical disability (study II) three months post-ICU
2. To evaluate if pain, frailty and resilience, i.e the individual's ability to handle distress, affect the development of PICS three months post-ICU (study III)
3. To assess individual daily wellbeing with a digital diary (study IV)

Studies I-III are observational cohort studies including 800 adult patients admitted to the ICU for a minimum of 12 hours. Consecutively discharged ICU patients will be assessed with the PROGRESS-ICU screening instruments, generating an individual risk in percentage for a) psychological problems and b) new-onset physical disability three months post-ICU. The instruments consists of questions regarding depressive symptoms, traumatic memories from the ICU stay, social support and age and an evaluation of the patient´s physical status at ICU discharge, assessed with the first five items of the Chelsea Critical Care Physical Assessment Tool, CPAx. Patients will also be asked to state their level of pain at discharge with a numeric rating scale (NRS). Basic demographics will be collected from the patient data management system, such as sex, admission diagnosis, severity of illness, ICU length of stay and duration of mechanical ventilation. Patients or next of kin will also be asked to state the patients' level of independence in performing ten different ADLs two weeks prior to hospitalisation, assessed with the Barthel Index (BI). Frailty will be assessed with the Clinical Frailty Scale (CFS).

Three months after ICU discharge, patients will be asked to digitally, or on paper by regular mail, fill out validated questionnaires assessing level of symptoms of depression, anxiety (Hospital Anxiety and Depression Scale (HADS)) and post-traumatic stress (Post-Traumatic Stress Symptom 14-question inventory (PTSS-14)). New-onset physical disability will be assessed with the Barthel index (BI), a questionnaire assessing the level of independency in performing activities of daily living. In accordance with the cut-offs recommended in the literature, and level used for caseness in the studies developing the screening instruments, a HADS subscale score ≥11 and a PTSS-14 part B score \&gt;45 will define clinically substantial psychological symptoms 24,25. A BI score reduction of ≥10 compared to baseline will define substantial new-onset physical disability and is close to the minimum clinically important difference suggested for the BI. At the three months follow-up patients will also be assessed regarding pain with the NRS and resilience with the modified version of the validated questionnaire Psychological Inflexibility in Pain Scale (PIPS), addressing the tendency to avoid situations that could imply pain or other discomforts. Self-efficay will also be assessed, i.e. the belief in one's ability to handle distress as a measure of resilience with the General self-efficacy scale. Health-related quality of life will be assessed with the RAND-36. The investigators also plan to perform psychometric testing of the questionnaires used and validate them in Swedish for the relevant population.

In a subgroup of patients (n=15) daily wellbeing will be evaluated with a digital diary where patients will be asked to answer short questions regarding their present mood twice a day for a total of 30 days (14 days in a row, with a pause for 4 weeks and a new 14-day period of digital diary questions). The questions will be available to patients via an application in a smartphone/tablet, reminding them to answer the questions twice a day through a message/push notification. This will render multiple data points for each individual enabling analyses of the development over time as well as individual variations. Fifteen participants are deemed sufficient for a first analysis of aggregated individual data. This type of data is also an important step towards the next phase, to develop tailored interventions matching the specific needs of the individual ICU survivor.

Eligibility criteria: Inclusion Criteria:

* Adult patients, ≥18 years old, with an ICU stay ≥12 hours, surviving to ICU discharge.

Exclusion Criteria:

* No home address
* Dementia or other major cognitive dysfunction
* Unsufficient knowledge of the Swedish language for answering follow-up questionnaires
* Two or more limitations of treatment or moribund patient

Primary outcomes:
measure: Predictive accuracy of a psychological screening method
timeFrame: Outcome measured three months after ICU discharge
measure: Predictive accuracy of a physical screening method
timeFrame: Outcome measured three months after ICU discharge
measure: Frailty (assessed with the clinical frailty scale) and psychological outcome after ICU stay, assessed with the Hospital Anxiety and Depression Scale.
timeFrame: Outcome measured three months after ICU discharge
measure: Frailty (assessed with the clinical frailty scale) and psychological outcome after ICU stay, assessed with the Post-Traumatic Stress 14-Question Inventory.
timeFrame: Outcome measured three months after ICU discharge
measure: Frailty (assessed with the clinical frailty scale) and physical outcome after ICU stay, assessed with the Barthel Index.
timeFrame: Outcome measured three months after ICU discharge
measure: Pain (assessed with the numeric rating scale, NRS) and physical outcome after ICU stay, assessed with the Barthel Index.
timeFrame: Outcome measured three months after ICU discharge
measure: Pain (assessed with the numeric rating scale, NRS) and psychological outcome after ICU stay, assessed with the Post-Traumatic Stress 14-Question Inventory.
timeFrame: Outcome measured three months after ICU discharge
measure: Pain (assessed with the numeric rating scale, NRS) and psychological outcome after ICU stay, assessed with the Hospital Anxiety and Depression Scale.
timeFrame: Outcome measured three months after ICU discharge
measure: Resilience (assessed with the general self-efficacy scale, the pain catastrophizing scale and the psychological inflexibility in pain scale) and physical outcome after ICU stay (assessed with the Barthel Index).
timeFrame: Outcome measured three months after ICU discharge
measure: Resilience (assessed with the general self-efficacy scale, the pain catastrophizing scale and the psychological inflexibility in pain scale) and psychological outcome after ICU stay, assessed with the Hospital Anxiety and Depression Scale.
timeFrame: Outcome measured three months after ICU discharge
measure: Resilience (assessed with the general self-efficacy scale, the pain catastrophizing scale and the psychological inflexibility in pain scale) and psychological outcome after ICU stay
timeFrame: Outcome measured three months after ICU discharge
measure: Feasibility of a daily digital diary in ICU survivors
timeFrame: Diary questions during 14 + 14 days after ICU discharge, questionnaire at termination of the diary.
measure: Daily variations of well-being in ICU survivors
timeFrame: Digital diary questions during 14 + 14 days after ICU discharge, with follow-up questionnaires three months post-ICU
measure: With-in person associations between cognitive-affective state and daily well-being in ICU survivors
timeFrame: Digital diary questions during 14 + 14 days after ICU discharge, with follow-up questionnaires three months post-ICU
measure: Associations between high daily patterns of cognitive-affective state between individuals and psychological recovery
timeFrame: Digital diary questions during 14 + 14 days after ICU discharge, with follow-up questionnaires three months post-ICU
Secondary outcomes:
measure: Health-related quality of life in patients with psychological and/or physical problems post-ICU
timeFrame: Inclusion during one year, follow-up three months post-ICU discharge
measure: Health-related quality of life in patients with pain post-ICU
timeFrame: Inclusion during one year, follow-up three months post-ICU discharge
measure: Health-related quality of life and associations with pre-ICU frailty assessed with the Clinical Frailty Scale.
timeFrame: Inclusion during one year, follow-up three months post-ICU discharge
measure: Health-related quality of life and associations with resilience
timeFrame: Inclusion during one year, follow-up three months post-ICU discharge
measure: Validation of questionnaires in a Swedish ICU population and psychometric testing
timeFrame: One year
measure: Clinical frailty, assessed with the Clinical Frailty Scale, and ICU length-of-stay
timeFrame: Outcome measured at discharge from the ICU
measure: Clinical frailty, assessed with the Clinical Frailty Scale, and duration of mechanical ventilation in ICU
timeFrame: Outcome measured at discharge from the ICU
measure: Clinical frailty, assessed with the Clinical Frailty Scale, and symptoms of psychological problems post-ICU assessed with the Hospital Anxiety and Depression Scale.
timeFrame: Outcome measured three months after discharge from the ICU
measure: Clinical frailty, assessed with the Clinical Frailty Scale, and symptoms of post-traumatic stress post-ICU assessed with the Post-Traumatic Stress Symptom 14-Question Inventory.
timeFrame: Outcome measured three months after discharge from the ICU
measure: Clinical frailty, assessed with the Clinical Frailty Scale, and physical performance at ICU discharge assessed with the Chelsea Critical care physical assessment tool
timeFrame: Outcome measured at discharge from the ICU
measure: Clinical frailty, assessed with the Clinical Frailty Scale, and ICU mortality.
timeFrame: Outcome measured at discharge from the ICU
measure: Clinical frailty, assessed with the Clinical Frailty Scale, and three-month physical function assessed with the Barthel Index.
timeFrame: Outcome measured three months after discharge from the ICU
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Capio S:t Göran's Hospital
city: Stockholm
country: Sweden
facility: Danderyd's Hospital
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
affiliation: Karolinska Institutet/Karolinska University Hospital
name: Anna Milton
role: PRINCIPAL_INVESTIGATOR
References: