跳至主要内容
临床试验/NCT07828301
NCT07828301招募中不适用

Post-ICU Syndrome: Exploring the Role of Social Determinants on Trajectories and Outcomes

Pontificia Universidad Catolica de Chile5 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
5
主要终点
Cognition status post-ICU

研究概览

简要总结

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. We will assess patients using sociodemographic factors, ICU treatment, 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. We 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.

详细描述

In recent decades, advances in intensive care have substantially reduced mortality, with survival rates now ranging from 70 to 80% among critically ill patients. However, a considerable number of these survivors experience persistent sequelae after discharge from the intensive care unit (ICU), affecting their functionality, well-being, and ability to resume their everyday life. This set of sequelae has been conceptualized as Post-Intensive Care Syndrome (PICS), defined as the onset or worsening of physical, cognitive, and/or mental health impairments that develop after ICU hospitalization and persist beyond hospital discharge (Needham DM, et al., 2012). PICS is a complex, multifactorial condition that can last for months or even years, significantly impacting the quality of life of survivors and their families (Harvey MA., 2016). PICS encompasses a wide range of clinical manifestations. Physically, patients may experience muscle weakness, joint stiffness, decreased mobility, persistent fatigue, and difficulty performing activities of daily living. Cognitively, memory impairment, difficulty concentrating, deterioration of executive functions, and reduced attention span have been reported. Some patients also develop ICU-associated delirium, characterized by confusion, disorientation, and mental status changes. Symptoms of anxiety, depression, post-traumatic stress disorder (PTSD), and sleep disturbances are commonly reported psychological symptoms. These sequelae can reduce overall functional capacity, make it harder to return to work, and lead to loss of independence and impaired social participation, directly affecting the quality of life of patients and their caregivers. Prospective studies have shown that the consequences of PICS extend beyond the clinical setting, affecting occupational, social, and economic dimensions. In a UK cohort, one-third of survivors lost their jobs or retired within six months of discharge, and this proportion remained high at 12 months. In addition, a significant proportion required assistance with self-care, usually provided by family members, which negatively affected caregivers' employment and income. Persistent pain and fatigue were associated with a lower probability of returning to work.

Although PICS is highly prevalent, estimates vary considerably by population, definitions used, and timing of assessment after ICU discharge. Nevertheless, available evidence suggests that between 50% and 70% of intensive care survivors present one or more symptoms consistent with PICS; approximately six out of ten patients continue to experience at least one sequela a year after discharge. Physical impairments affect between 30% and 80% of patients, while cognitive impairment has been reported in ranges from 25% to 75%. In terms of mental health, the prevalence of anxiety and depression varies between 20% and 50%, and PTSD symptoms affect up to 20-30% of survivors. In addition, 30% to 60% have limitations in performing activities of daily living and reduced functional capacity, highlighting the magnitude of PICS's impact on long-term recovery.

Several risk factors for developing PICS have been identified, including advanced age, female gender, the presence of previous comorbidities, and lower educational or socioeconomic status (Brown SM., 2019). More broadly, these risk factors point to the relevance of social determinants of health (SDH), defined as the conditions in which people are born, grow, live, work, and age, as well as the social, economic, and political systems that shape these conditions (Braveman P., 2014), which are closely linked to health inequalities. Within this framework, perceived social position, an individual's subjective standing relative to others in society, distinct from objective indicators such as income or education, has emerged as a key determinant: survivors in lower social positions tend to present worse outcomes than those in higher positions (Jain S., 2022). This is explained because social position translates into psychosocial factors such as social support, loneliness, and chronic stress, which are associated with the worst health outcomes.

Consistent with this perspective, research findings suggest that psychological and social factors play a central role in the development and persistence of PICS. The ICU experience can be traumatic, and post-discharge stressors-such as loss of independence, financial difficulties, and caregiving overload-can perpetuate symptoms. The negative impact on the health outcomes of survivors may be intensified due to the psychosocial conditions associated with the SDH, already present before hospitalization in the ICU; anxiety, depression, or PTSD during hospitalization, as well as a history of mental illness, increases the risk of persistent psychological sequelae.

In summary, despite the growing body of research on post-intensive care syndrome (PICS), it remains defined as a set of symptoms, despite the heterogeneity of the disorders patients present with. This approach limits our understanding of the condition and the design of interventions, as PICS encompasses multiple combinations of symptoms and trajectories of evolution. Identifying patient groups with different symptom profiles, along with associated factors and their evolution over time, can provide researchers and clinicians with the input needed to advance our understanding. Recognizing the influence of psychosocial factors described in the SDH model on post-ICU outcomes represents a promising avenue to advance this knowledge, building on available evidence, although mostly descriptive, that psychosocial factors contribute to PICS outcomes. Understanding how social determinants relate to different symptom patterns and trajectories would help identify intervention points to reduce the impact of social conditions on recovery. Consequently, this study seeks to deepen understanding of PICS, provide evidence for intervention design, and contribute to improving long-term outcomes and quality of life for ICU survivors, while also reinforcing efforts to optimize post-ICU care and attention to the sequelae of critical illness.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 years of age or older
  • Patients with critical illness who have been on a ventilator for at least 48 hours

排除标准

  • 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)
  • Uncontrolled psychiatric illness at hospital admission
  • Communication limitations (e.g., does not speak Spanish)
  • Unlikely to adhere to follow-up (e.g., no fixed address, difficult to locate at follow-up)

结局指标

主要结局

Cognition status post-ICU

时间窗: From enrolment to the third, sixth, and twelfth months post-discharge from 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

Anxiety post ICU

时间窗: From enrollment to the third, sixth, and twelfth months post-discharge from 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).

Depressive symptoms post-ICU

时间窗: From enrollment to the third, sixth, and twelfth months post-discharge from 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).

Functional independence post-ICU

时间窗: From enrollment to the third, sixth, and twelfth months post-discharge from 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.

次要结局

  • Health-related quality of life(From the enrolment to 3, 6, and 12 months post-discharge from the ICU)
  • Analog Visual Scale(From the enrolment to 3, 6, and 12 months post-discharge from the ICU)
  • Clinical Frailty Scale (CFS)(3, 6, and 12 months after the ICU discharge.)
  • Pittsburgh Sleep Quality Index (PSQI).(3, 6, and 12 months after ICU discharge.)
  • The fatigue assessment scale(3, 6, and 12 months after ICU discharge.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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