Prediction of the Post-intensive Care Syndrome

NCT ID: NCT05690438

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 773 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2025-04-30

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' 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 >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.

Conditions

Critical Care

Keywords

Post-intensive care syndrome; Depression; Anxiety; Post-traumatic stress; Physical disability; Pain; Frailty; Resilience

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Region Stockholm

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anna Milton

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Milton

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet/Karolinska University Hospital

Locations

Karolinska University Hospital

Stockholm, , Sweden

Capio S:t Göran's Hospital

Stockholm, , Sweden

Danderyd's Hospital

Stockholm, , Sweden

Södersjukhuset

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

Dnr KS K2022-4466

Identifier Type: -

Identifier Source: org_study_id