Post-ICU Syndrome and Social Determinants of Healths
ConditionPost-Intensive Care Syndrome (PICS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPontificia Universidad Catolica de Chile
About this trial
Medical intensive care has improved dramatically, and today, 70% to 80% of critically ill patients survive. However, several survivors face long-term psychological, cognitive, and/or physical sequelae after discharge and challenges in resuming their lives. These conditions are known as Post-Intensive Care Syndrome (PICS). PICS is a multifaceted disorder that affects many patients who survive critical illness and receive treatment in the ICU. 'It can persist for weeks, months, and years after discharge, negatively affecting the quality of life of survivors and their families, generating financial consequences, and increasing the utilization of healthcare services. It can persist for weeks, months, and years after discharge, negatively affecting survivors' and their families' quality of life, creating financial burdens, and increasing healthcare utilization. Researchers have identified several PICS risk factors linked to sociodemographic and psychosocial conditions, including social support, isolation, and survivors' social position. Taken together, these findings highlight the role of social determinants of health (SDH) in explaining PICS and the different outcomes among survivors. We propose that applying an SDH framework can enhance understanding of PICS, its determinants, trajectories, and outcomes. Consequently, this study aims to examine the trajectories of PICS among ICU survivors and the role of SDH, including sociodemographic factors, social support, loneliness, perceived social position, among other factors, as well as the role of biomarkers and ICU treatments.
We will conduct a longitudinal cohort study with 400 patients from 5 different ICUs in Chile who received critical care. Patients will be evaluated based on sociodemographic factors and their treatment in the ICU, SDH measures, psychosocial factors, biomarkers, and PICS symptoms at discharge and at 3, 6, and 12 months. Latent class analysis (LCA) will identify distinct latent profiles based on patterns of PICS symptoms. It will then examine social determinants of health (SDH) as covariates to determine whether they are associated with different profiles. These results will contribute to our understanding of PICS and inform interventions to prevent it and support the recovery process among survivors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 18 years of age or older
Patients with critical illness who have been on a ventilator for at least 48 hours
Disqualifiers
Presence of mental or intellectual disability before hospitalization
Early limitation of therapeutic effort
Primary neurological injury (e.g., anoxic injury, stroke, or traumatic brain injury)
Anticipated death within 3 months of discharge (e.g., recommended palliative care)
Trial population
Patients aged 18 years or older with critical illness who have been on a ventilator for at least 48 hours will be invited to participate in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Cognition status post-ICU
The MOCA instrument will be administered to patients. The total possible score is 22 points; a score of 18 or above is considered normal
Time frame
From enrolment to the third, sixth, and twelfth months post-discharge from ICU2
Anxiety post ICU
This mental health condition will be evaluated in patients with the HADS total scores for anxiety ranging from 0 to 21, categorized as: normal (0-7), mild (8-10), moderate (11-14), or severe (15-21).
Time frame
From enrollment to the third, sixth, and twelfth months post-discharge from ICU3
Depressive symptoms post-ICU
This mental health condition will be evaluated in patients with HADS total depression scores ranging from 0 to 21, categorized as: normal (0-7), mild (8-10), moderate (11-14), or severe (15-21).
Time frame
From enrollment to the third, sixth, and twelfth months post-discharge from ICU4
Functional independence post-ICU
Barthel will be used in patients; scores are ordered as follows: 0-20 total dependence, 21-60 severe dependence, 61-90 moderate dependence, 91-99 slight dependence, and 100 independence.
Time frame
From enrollment to the third, sixth, and twelfth months post-discharge from ICUSecondary outcomes
1
Health-related quality of life, measured with the EuroQol 5-Dimension 3-Level questionnaire (EQ-5D-3L) index value
EQ-5D is one of the most widely used health state descriptive systems and is used for valuation in Chile. EQ-5D questionnaires have 5 dimensions: "Mobility", "Human Autonomy", "Current Activities", "Pain / Discomfort", and "Anxiety / Depression," and all dimensions are described by 3 problem levels corresponding to patient response choices. A quality-of-life score is calculated based on the questionnaire responses.
Time frame
From the enrolment to 3, 6, and 12 months post-discharge from the ICU2
Visual Analog Scale
The EuroQol Visual Analog Scale, part of the EQ-5D instrument, records the participant's self-rated overall health on the day of assessment, as a measure of health-related quality of life. Participants mark their health on a vertical scale ranging from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"); higher scores indicate better self-rated health (better outcome).
Time frame
From the enrolment to 3, 6, and 12 months post-discharge from the ICU3
Clinical Frailty Scale (CFS)
The Clinical Frailty Scale is a clinical judgment-based frailty tool that evaluates specific domains, including comorbidity, function, and cognition. Scores range from 1 (very fit) to 9 (terminally ill); higher scores indicate greater frailty (worse outcomes). The CFS is recommended in Chile to assess frailty in older adults admitted to the ICU.
Time frame
3, 6, and 12 months after the ICU discharge.4
Pittsburgh Sleep Quality Index (PSQI).
The Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality over the past month. Its 19 items generate seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction), each ranging from 0 to 3. The sum of the seven components yields a global score ranging from 0 to 21; higher scores indicate worse sleep quality (worse outcome). A global score greater than 5 indicates poor sleep quality.
Time frame
3, 6, and 12 months after ICU discharge.Sponsors and contacts
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Source ClinicalTrials.gov