Actively Recruiting
"PROTECT-ICU: Impact of an Educational Intervention
Led by Carola Giménez-Esparza Vich · Updated on 2026-04-21
900
Participants Needed
2
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 such as mechanical ventilation, vasoactive drugs, dialysis, or resuscitation
- Patients expected to be discharged from the ICU within the next 24 hours
- Patients unable to attend follow-up visits after hospital discharge due to relocation, language barriers, transfer, 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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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
CONTACT
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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