Prediction of the Post-intensive Care Syndrome

Critical Care Clinical Trial

— PREPICS  

Official title:

Prediction of the Post-intensive Care Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05690438
• Other study ID #: Dnr KS K2022-4466
• Status: Recruiting
• Start date: January 9, 2023
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Region Stockholm
• Contact: Anna Milton
• Phone: +46812370000
• Email: anna.milton[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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' 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.

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 posttraumatic 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 >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) included in study I-III daily wellbeing will be evaluated with a digital diary where patients will be asked to answer 10+8 short questions regarding their present mood two times per day for a total of 30 days. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Care
• Syndrome

Locations

Country	Name	City	State
Sweden	Capio S:t Göran's Hospital	Stockholm
Sweden	Danderyd's Hospital	Stockholm
Sweden	Karolinska University Hospital	Stockholm
Sweden	Södersjukhuset	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Region Stockholm	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive accuracy of a psychological screening method	Validation of a previously developed screening method for psychological problems three months post-ICU	Outcome measured three months after ICU discharge
Primary	Predictive accuracy of a physical screening method	Validation of a previously developed screening method for physical problems three months post-ICU	Outcome measured three months after ICU discharge
Primary	Frailty (assessed with the clinical frailty scale) and psychological outcome after ICU stay, assessed with the Hospital Anxiety and Depression Scale.	Assessment of associations between frailty (assessed with the clinical frailty scale) and the development of symptoms of depression and anxiety post-ICU.	Outcome measured three months after ICU discharge
Primary	Frailty (assessed with the clinical frailty scale) and psychological outcome after ICU stay, assessed with the Post-Traumatic Stress 14-Question Inventory.	Assessment of associations between frailty (assessed with the clinical frailty scale) and the development of the post-traumatic stress symptoms.	Outcome measured three months after ICU discharge
Primary	Frailty (assessed with the clinical frailty scale) and physical outcome after ICU stay, assessed with the Barthel Index.	Assessment of associations between frailty (assessed with the clinical frailty scale) and the development of the post-intensive care syndrome physical problems.	Outcome measured three months after ICU discharge
Primary	Pain (assessed with the numeric rating scale, NRS) and physical outcome after ICU stay, assessed with the Barthel Index.	Assessment of associations between pain and the development of the post-intensive care syndrome physical aspects.	Outcome measured three months after ICU discharge
Primary	Pain (assessed with the numeric rating scale, NRS) and psychological outcome after ICU stay, assessed with the Post-Traumatic Stress 14-Question Inventory.	Assessment of associations between pain and the development of symptoms of post-traumatic stress post-ICU.	Outcome measured three months after ICU discharge
Primary	Pain (assessed with the numeric rating scale, NRS) and psychological outcome after ICU stay, assessed with the Hospital Anxiety and Depression Scale.	Assessment of associations between pain and the development of symptoms of depression and anxiety post-ICU.	Outcome measured three months after ICU discharge
Primary	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).	Assessment of associations between resilience and the development of the post-intensive care syndrome physical problems.	Outcome measured three months after ICU discharge
Primary	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.	Assessment of associations between resilience and the development of symptoms of depression and anxiety post-ICU.	Outcome measured three months after ICU discharge
Primary	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	Assessment of associations between resilience and the development of symptoms of post-traumatic stress post-ICU.	Outcome measured three months after ICU discharge
Primary	Daily well-being in ICU survivors	Digital diary with questions related to well-being for individual ICU survivors for 30 days post-ICU discharge	During one month after ICU discharge
Secondary	Health-related quality of life in patients with psychological and/or physical problems post-ICU	Health-related quality of life assessed with the RAND-36	Inclusion during one year, follow-up three months post-ICU discharge
Secondary	Health-related quality of life in patients with pain post-ICU	HRQL assessed with the RAND-36	Inclusion during one year, follow-up three months post-ICU discharge
Secondary	Health-related quality of life and associations with pre-ICU frailty assessed with the Clinical Frailty Scale.	HRQL assessed with the RAND-36, frailty with the clinical frailty scale.	Inclusion during one year, follow-up three months post-ICU discharge
Secondary	Health-related quality of life and associations with resilience	HRQL assessed with the RAND-36	Inclusion during one year, follow-up three months post-ICU discharge
Secondary	Validation of questionnaires in a Swedish ICU population and psychometric testing	Used questionnaires will be validated in a Swedish ICU population and psychometric testing will be performed.	One year
Secondary	Clinical frailty, assessed with the Clinical Frailty Scale, and ICU length-of-stay	Clinical frailty and associations with ICU length-of-stay	Outcome measured at discharge from the ICU
Secondary	Clinical frailty, assessed with the Clinical Frailty Scale, and duration of mechanical ventilation in ICU	Clinical frailty and associations with duration of mechanical ventilation in ICU	Outcome measured at discharge from the ICU
Secondary	Clinical frailty, assessed with the Clinical Frailty Scale, and symptoms of psychological problems post-ICU assessed with the Hospital Anxiety and Depression Scale.	Clinical frailty and associations with symptoms of depression and anxiety three months post-ICU	Outcome measured three months after discharge from the ICU
Secondary	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.	Clinical frailty and associations with symptoms of post-traumatic stress three months post-ICU	Outcome measured three months after discharge from the ICU
Secondary	Clinical frailty, assessed with the Clinical Frailty Scale, and physical performance at ICU discharge assessed with the Chelsea Critical care physical assessment tool	Clinical frailty and associations with physical status at ICU discharge	Outcome measured at discharge from the ICU
Secondary	Clinical frailty, assessed with the Clinical Frailty Scale, and ICU mortality.	Clinical frailty and associations with ICU mortality	Outcome measured at discharge from the ICU
Secondary	Clinical frailty, assessed with the Clinical Frailty Scale, and three-month physical function assessed with the Barthel Index.	Clinical frailty and associations with post-ICU physical functioning.	Outcome measured three months after discharge from the ICU