Actively Recruiting
PROTECT-ICU: Impact of an Educational Intervention on the Implementation of an Expanded ABCDEF Bundle and Its Effect on Post-Intensive Care Syndrome - A Multicenter Cluster Randomized Clinical Trial
Led by Carola Giménez-Esparza Vich · Updated on 2026-04-21
900
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a structured training program for intensive care unit (ICU) staff can reduce health problems known as post-intensive care syndrome (PICS) in adults after they leave the hospital. PICS includes new or worsened physical, thinking, or emotional difficulties following serious illness, which can affect daily life, independence, memory, mood, and overall quality of life. This multicenter study compares patients treated before and after ICU staff training, focusing on whether the training reduces PICS three months after hospital discharge. The study also compares standard training on the ABCDEF care bundle with an expanded A-Z bundle that includes additional care elements like nutrition, sleep, infection prevention, safety, and psychological support. The study involves a cluster-randomized design where entire ICUs are assigned to receive training on either the standard ABCDEF bundle or the expanded A-Z bundle. The training program for ICU staff includes a month-long online course with educational materials, checklists, pocket guides, and visual reminders, plus face-to-face sessions to reinforce learning. After training, ICUs continue usual care while researchers track how often the trained care practices are followed during patients' ICU stays, up to 21 days or until discharge or death. Follow-up visits for patients occur at 1, 3, 6, and 12 months after hospital discharge. Participants are adults who stay in the ICU for at least 48 hours and leave the hospital alive. They will undergo tests and questionnaires on physical health, memory, mood, and quality of life during follow-up visits. Data collection includes ICU care details and patient outcomes, monitored using electronic forms with quality checks. The main outcome measured is the number of participants who develop PICS three months after discharge. Secondary outcomes include adherence to care bundles, incidence of delirium, and quality of life assessments at various timepoints. The study runs until 2028 and maintains ethical and data protection standards throughout.
CONDITIONS
Brief Title
"PROTECT-ICU: Impact of an Educational Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Patients who stay in the intensive care unit (ICU) for at least 48 hours
- Written informed consent provided by the patient, or by a legal representative or family member if the patient is unable to decide
You will not qualify if you...
- 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)
- Patients expected to be discharged from the ICU within the next 24 hours
- 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)
- Patients with a life expectancy of less than 3 months
- Patients with severe cognitive impairment or severe mental illness before ICU admission that would make assessments difficult
- Patients with severe brain injury or severe neurological diseases that prevent proper evaluation of physical or cognitive function
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 month for staff training before participant inclusion
Participants are treated in ICUs where staff have completed a structured educational program focused on implementing either the standard ABCDEF care bundle or the expanded ABCDEF care bundle. This training aims to improve adherence to evidence-based ICU care practices.
Participants receive care as part of routine ICU admission with daily adherence assessments for up to 21 days or until ICU discharge or death.
Duration - Up to 12 months after hospital discharge
Participants are followed after hospital discharge to assess physical function, cognitive performance, psychological status, and health-related quality of life to evaluate the incidence of post-intensive care syndrome (PICS) and other outcomes.
Follow-up visits at 1, 3, 6, and 12 months after hospital discharge
Trial Site Locations
Total: 2 locations
1
Vega Baja University Hospital
Orihuela, Alicante, Spain, 03314
Actively Recruiting
2
Vega Baja University Hospital
Murcia, Murcia, Spain, 30005
Not Yet Recruiting
Research Team
C
CAROLA GIMENEZ-ESPARZA VICH, MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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