PROTECT-ICU: Training ICU staff to reduce post-ICU health problems

"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."

This trial will test whether training ICU staff to use a standard or expanded care bundle helps adults who spend at least 48 hours in the ICU have fewer physical, thinking, or emotional problems three months after hospital discharge.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 900 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Spanish Society of Critical Care Medicine and Coronary Units (Academic / other)
• Locations: 2 sites (Orihuela, Alicante and 1 other locations)
• Trial ID: NCT07542613 on ClinicalTrials.gov

What this trial studies

PROTECT-ICU is a multicenter, implementation-focused trial that provides structured training to ICU healthcare teams on either the standard ABCDEF bundle or an expanded A–Z bundle. The study compares patient outcomes before and after the training and also compares ICUs receiving the standard versus the expanded bundle. The primary outcome is the proportion of patients who develop post-intensive care syndrome (PICS) three months after discharge; secondary outcomes include adherence to recommended care practices in daily ICU care. Training is delivered at participating hospitals with local implementation support and follow-up assessments after discharge.

Who should consider this trial

Good fit: Adults aged 18 or older who remain in the ICU for at least 48 hours and can provide informed consent (or have a legal representative who can consent) are the intended participants.

Not a fit: Patients with decisions to limit life-sustaining treatment, expected ICU discharge within 24 hours, life expectancy under three months, severe preexisting cognitive impairment, or inability to attend follow-up are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, the training could reduce the number of ICU survivors who develop PICS and improve functional recovery and quality of life.

How similar studies have performed: Components of the ABCDEF bundle have been associated with reduced delirium and improved short-term ICU outcomes, but evidence that staff training prevents long-term PICS is limited, so this implementation approach is partly novel.

Eligibility criteria

Inclusion Criteria:

1. Adults aged 18 years or older
2. Patients who stay in the intensive care unit (ICU) for at least 48 hours
3. Written informed consent provided by the patient, or by a legal representative or family member if the patient is unable to decide

Exclusion Criteria:

1. 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)
2. Patients expected to be discharged from the ICU within the next 24 hours
3. 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)
4. Patients with a life expectancy of less than 3 months
5. Patients with severe cognitive impairment or severe mental illness before ICU admission that would make assessments difficult
6. Patients with severe brain injury or severe neurological diseases that prevent proper evaluation of physical or cognitive function

Where this trial is running

Orihuela, Alicante and 1 other locations

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

Study contacts

• Principal investigator: CAROLA GIMENEZ-ESPARZA VICH, MD, MSc — Vega Baja University Hospital, Orihuela, Spain
• Study coordinator: CAROLA GIMENEZ-ESPARZA VICH, MD, MSc

Conditions Post Intensive Care Syndrome; Critical Illness; Post-intensive care syndrome; critical illness; delirium prevention; early mobilization; Sedation management; Family engagement in intensive care