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In recent years, the survival rate among intensive care patients has improved due to advancements in diagnosing severe infections and the use of broad-spectrum antibiotics. However, many survivors face long-term complications, known as Post-Intensive Care Syndrome (PICS), including physical, cognitive, and psychological impairments such as post-traumatic stress disorder (PTSD), anxiety, and depression. Approximately 9-27% of ICU survivors develop these symptoms, particularly those hospitalized due to sepsis. Common risk factors include traumatic hospital experiences, delirium, and extended mechanical ventilation. Despite the prevalence of these issues, most medical centers lack structured models for screening and early intervention, highlighting the need for evaluations of early intervention strategies to support at-risk patients post-discharge and improve their quality of life.
In recent years, there has been a significant increase in the survival rate of patients hospitalized in intensive care, due in part to improved capabilities in diagnosing and treating severe infections and sepsis, the use of broad-spectrum antibiotics, and the development of advanced life-support technologies. However, alongside this rise in survival, it has become evident that many patients continue to suffer from long-term complications following their discharge from intensive care. This phenomenon is described in the literature as Post-Intensive Care Syndrome (PICS) and encompasses physical, cognitive, and psychological impairments that develop or persist after an intensive care stay.
Among the prominent psychological consequences following an intensive care unit (ICU) stay is post-traumatic stress disorder (PTSD), alongside symptoms of anxiety and depression. Various studies indicate that a significant proportion (9-27%) of ICU survivors develop post-traumatic symptoms; while these may appear during the hospital stay itself, they sometimes develop or worsen after discharge. Potential risk factors for the development of these symptoms include traumatic experiences during the hospital stay, delirium, prolonged mechanical ventilation, exposure to certain medications, and the severity of the underlying illness.
Patients hospitalized in the ICU due to sepsis constitute a particularly high-risk population for developing these symptoms, given the severity of the illness, the duration of the hospital stay, and exposure to numerous invasive procedures. Beyond the psychological impact, post-traumatic symptoms can significantly affect patients' quality of life, daily functioning, and recovery process following hospital discharge.
Despite the prevalence of this phenomenon, most medical centers currently lack a structured model for screening and early intervention among patients discharged from the ICU. Most research in this field focuses on identifying the phenomenon or describing its risk factors, whereas data regarding the efficacy of early interventions to prevent PTSD following ICU hospitalization remain limited.
In light of this, there is a need to evaluate the feasibility of an early intervention model for patients discharged from the intensive care unit following hospitalization for sepsis. Such an intervention could help identify at-risk patients early, reduce the severity of psychological symptoms, and improve their quality of life after hospital discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early psychiatric intervention | Experimental | Interventional arm. Early intervention after discharge from ICU. |
|
| No intervention | No Intervention | Observational arm. No intervention after discharge from ICU. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychiatric interview | Other | Psychiatric interview for 45 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| PTSD risk according to PCL-5 | Post Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5). The PCL-5 is widely used in clinical and research settings to screen for PTSD, assess symptom severity, and monitor treatment progress over time. Total scores can range from 0 to 80, with higher scores indicating greater PTSD symptom severity. In addition to a raw score being presented, a mean score is also computed, which is the subscale score divided by the number of items within that subscale. The average score can help determine elevated symptom clusters when comparing each of the four subscales. These scores range between 0 to 4, where higher scores represent higher severity. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Depression risk | Patient Health Questionnaire-9 is a validated, 9-question tool to assess for the degree of depression present in an individual. The total score ranges from 0 to 27. The higher the score is the more severe the depression is. | 30 days |
| General well being |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Leshin Carmel, MD | Contact | +972525253037 | danielles@bmc.gov.il | |
| Pnina Nir | Contact | pninan@bmc.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| daniel Leshin Carmel, MD | Barzilai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barzilai Medical Center | Recruiting | Ashkelon | Israel |
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This is a prospective, single-center study comparing the incidence of post-traumatic stress disorder (PTSD) in patients discharged from the intensive care unit following hospitalization for sepsis, contrasting early intervention with no intervention. As this is a pilot study assessing the feasibility of early intervention, a maximum of 60 participants will be recruited and randomly assigned to one of two groups: intervention or control.
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This questionnaire is designed to measure general well-being, including negative well-being, energy and positive well-being. The Well-Being Questionnaire (W-BQ) was first developed in the early 1980s as a 22-item measure. The range is from 0 to 110, the higher the score the better is the general well being. |
| 30 days |
| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| D018805 | Sepsis |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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