What is this study trying to find out about post-intensive care syndrome (PICS)?

This study is evaluating whether a structured training program for ICU staff can reduce the number of adults who develop post-intensive care syndrome (PICS) after leaving the hospital. Researchers want to see if training improves how often ICU teams use recommended care practices and whether an expanded care approach offers additional benefits. The study is led by Carola Giménez-Esparza Vich and involves multiple centers.

Who may be eligible for this post-intensive care syndrome clinical trial?

Adults aged 18 or older who have stayed in an ICU for at least 48 hours and can provide informed consent may be eligible. The study includes all genders and excludes those with decisions to limit life-support, expected ICU discharge within 24 hours, inability to attend follow-up visits, or severe cognitive or neurological impairments. Please review eligibility criteria for more details.

Is there any cost to participate in this post-intensive care syndrome clinical trial?

Study-related care, including training and follow-up assessments, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect support throughout the study without charges for study procedures.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07542613

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

Research Sites

39 weeks

Total Duration

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

Age: 18Years +

All Genders

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

Research Team

CAROLA GIMENEZ-ESPARZA VICH, MD, MSc

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