"PROTECT-ICU: Impact of an Educational Intervention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarola Giménez-Esparza Vich

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Standardized Training on the ABCDEF Care Bundle (A-F)
  • Standardized training on the expanded ABCDEF care bundle (A-Z)

Treatment groups

900 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Carola Giménez-Esparza Vich

Lead sponsor

Spanish Society of Critical Care Medicine and Coronary Units

Sponsor institution