"PROTECT-ICU: Impact of an Educational Intervention

Brief Summary The goal of this study is to learn if a structured training program for intensive care unit (ICU) staff can reduce health problems after a stay in the ICU in adults. These health problems are called post-intensive care syndrome (PICS). PICS includes new or worse physical, thinking, or emotional problems after a serious illness. These problems can affect daily activities, independence, memory, mood, and overall quality of life. The main questions this study aims to answer are: Does a training program for ICU staff reduce the number of people who develop PICS three months after leaving the hospital? Does the training improve how often ICU teams apply recommended care practices in daily care? Researchers will compare patients treated before and after the training program to see if the training reduces PICS. Researchers will also compare ICUs that receive training on the standard ABCDEF care bundle with those that receive training on an expanded care bundle (A-Z), which includes additional practices such as nutrition, sleep, infection prevention, safety measures, and psychological and social support, to see if the expanded approach provides additional benefits. Before the training program, participating ICUs will collect information about their usual care. ICU staff will then complete the assigned training program. After the training, ICUs will continue to provide usual care, and researchers will record how often the trained care practices are used in daily clinical practice. Participants are adults who stay in the ICU for at least 48 hours and leave the hospital alive. Participants will: Receive usual ICU care Be followed up after hospital discharge at 1, 3, 6, and 12 months Complete tests and questionnaires about physical health, memory, mood, and quality of life The main result researchers will measure is the number of participants who develop PICS three months after leaving the hospital, focusing on those treated after the training program.

Background and Rationale PROTECT-ICU is a multicenter, implementation-focused study designed to evaluate the impact of a structured educational intervention targeting intensive care unit (ICU) healthcare professionals on adherence to evidence-based care practices and on patient-centered outcomes after critical illness. Although survival after critical illness has improved, a substantial proportion of ICU survivors develop persistent physical, cognitive, and psychological impairments, commonly referred to as post-intensive care syndrome (PICS). These long-term sequelae are associated with reduced functional recovery, decreased quality of life, and increased healthcare utilization. Despite growing awareness of PICS, effective strategies to prevent or mitigate its development remain insufficiently established. The ABCDEF bundle provides a structured framework to optimize ICU care processes, integrating key elements related to analgesia, sedation management, ventilatory support, delirium monitoring and prevention, early mobilization, and family engagement. However, adherence remains heterogeneous across ICUs, and its impact on long-term outcomes remains uncertain. Additional domains of care, including nutritional optimization, sleep quality, infection prevention, minimization of iatrogenic complications, discharge planning, continuity of care, and psychological and social support, may also influence recovery after critical illness. These elements have been incorporated into an expanded A-Z framework developed through multidisciplinary collaboration and expert consensus. Objectives The primary objective of the PROTECT-ICU study is to evaluate whether implementation of a structured training program for ICU professionals reduces the incidence of post-intensive care syndrome (PICS) at three months after hospital discharge in patients treated after completion of the educational intervention. Secondary objectives include: To assess changes in adherence to bundle-based care practices following the training program To evaluate temporal trends in PICS over time To explore whether training on an expanded A-Z framework provides additional benefit compared with training on the standard ABCDEF bundle Study Design PROTECT-ICU is a multicenter, cluster-randomized, interventional study with a pre-post (before-after) component. Participating ICUs constitute the unit of randomization and implementation. Following an initial baseline phase, participating ICUs are randomly assigned at the cluster level to receive training on one of two care frameworks: Training on the standard ABCDEF bundle Training on the expanded A-Z bundle This cluster-randomized approach is chosen to minimize contamination within centers and to ensure feasibility of implementation in routine clinical practice. The study includes three sequential phases: Baseline phase: collection of data on routine clinical practice and baseline adherence to care bundle components Training phase: deliver Покажи пълното описание...

Inclusion Criteria: 1. Adults aged 18 years or older 2. Patients who stay in the intensive care unit (ICU) for at least 48 hours 3. Written informed consent provided by the patient, or by a legal representative or family member if the patient is unable to decide Exclusion Criteria: 1. Patients with a decision to limit life-sustaining treatments (for example, not starting or stopping treatments such as mechanical ventilation, vasoactive drugs, dialysis, or resuscitation) 2. Patients expected to be discharged from the ICU within the next 24 hours 3. Patients who are unable to attend follow-up visits after hospital discharge (for example, due to relocation, language barriers, transfer to or from another hospital, or inability to attend clinic visits) 4. Patients with a life expectancy of less than 3 months 5. Patients with severe cognitive impairment or severe mental illness before ICU admission that would make assessments difficult 6. Patients with severe brain injury or severe neurological diseases that prevent proper evaluation of physical or cognitive function