"PROTECT-ICU: Impact of an Educational Intervention

Recruiting now · Not applicable

Conditions studied: Post Intensive Care Syndrome (PICS), Critical Illness

In brief

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.

Key facts

Study ID

NCT07542613

Run by

Carola Giménez-Esparza Vich

People needed

900

Starts

2026-02-16

Expected to finish

2028-01-01

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• Vega Baja University Hospital — Orihuela, Alicante, Spain (enrolling)
• Vega Baja University Hospital — Murcia, Murcia, Spain

Full record on ClinicalTrials.gov

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