RecruitingNot Applicable

"PROTECT-ICU: Impact of an Educational Intervention

Spain900 participantsStarted 2026-02-16

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is focused on an educational intervention for ICU staff rather than a new drug or procedure, can you explain how it might actually change the care I receive in the ICU and whether that could affect my risk of developing Post-Intensive Care Syndrome?
2The study is measuring whether PICS is present at 3 months after I leave the hospital — what does PICS actually look like in someone who's been critically ill, and is that something I or my family should be watching for regardless of whether I join this trial?
3This trial involves something called the ABCDEF care bundle — can you walk me through what those elements are and whether that approach is already part of how your ICU team cares for patients like me?
4Since this study doesn't involve an experimental drug or device, what would be different about my experience as a participant compared to receiving standard critical care, and are there any additional commitments or follow-up appointments involved?
5Given that I'm facing critical illness, would you recommend I focus on standard treatment first, or is there a reason you think being part of this PICS-prevention research could be a good fit for my situation right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Presence of Post-Intensive Care Syndrome (PICS) at 3 months after hospital discharge following a standardized training program on the standard ABCDEF care bundle

Timeframe: 3 months after hospital discharge

Trial details

NCT IDNCT07542613

SponsorCarola Giménez-Esparza Vich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

CAROLA GIMENEZ-ESPARZA VICH, MD, MSc

+34639339791 carolagimenezesparzavich@gmail.com

View on ClinicalTrials.gov More Post Intensive Care Syndrome (PICS) trials