"PROTECT-ICU: Impact of an Educational Intervention

Condition(s) studied

Investigational drug(s) / intervention(s)

Standardized Training on the ABCDEF Care Bundle (A-F): Description of the intervention - Group 1 (ABCDEF A-F) This intervention consists of a standardized, structured training program for intensive care unit (ICU) staff focused on implementing the classic ABCDEF (A-F) care package. The program includes a month-long online educational course with standardized training materials, written checklists, pocket guides, and visual reminders displayed in the ICU. The training combines theoretical content with practical guidance on the daily clinical application of each component of the package. In addition, face-to-face training sessions are provided to reinforce key concepts and facilitate discussion among ICU staff. At least 75% of the staff in each participating ICU must complete the training, and understanding of the content is assessed through a short post-training questionnaire. Once the training is complete, ICU teams are expected to apply the ABCDEF A-F package in routine daily care and document compliance using standardized daily checklist

Standardized training on the expanded ABCDEF care bundle (A-Z): Description of the intervention - Group 2 (ABCDEF A-Z) This intervention consists of a standardized, structured training program for intensive care unit (ICU) staff focused on implementing the expanded ABCDEF (A-Z) care package. The program includes a month-long online educational course with standardized training materials, written checklists, pocket guides, and visual reminders displayed in the ICU. The training combines theoretical content with practical guidance on the daily clinical application of each component of the package, including additional elements beyond the classic package related to nutrition, sleep, infection prevention, safety, discharge planning, rehabilitation, psychological support, and other quality of care measures. In addition, face-to-face training sessions are provided to reinforce key concepts and facilitate discussion among ICU staff. At least 75% of staff members in each participating ICU are required to complete the training, and understanding of the cont

Study 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.

Eligibility

Primary outcome measure(s)

• Presence of Post-Intensive Care Syndrome (PICS) at 3 months after hospital discharge following a standardized training program on the standard ABCDEF care bundle — 3 months after hospital discharge
  PICS: new or worsened impairment compared with pre-ICU baseline in at least one of the following domains: 1. \- Physical: decline in functional status (Barthel Index \<100 with ≥10-15 point decrease or change in category) or reduced muscle strength (MRC \<48), or impaired mobility (TUG \>12 s) or reduced exercise capacity (6-minute walk test \<80% predicted, \<400 m or decrease ≥30 m) or reduced handgrip strength, (values below age- and sex-adjusted) or nutritional impairment (positive Malnutrition Universal Screening Tool MUST or weight loss \>10%) or dyspnea (modified Medical Research Council mMRC ≥2 or worsening ≥1), or impaired pulmonary function (FEV1, FVC or DLCO \<80% predicted). 2. \- Cognitive: Informant Questionnaire Cognitive Decline in the Elderly (IQCODE) \<3.4 with MoCA \<26, or IQCODE 3.4-3.6 with decrease of ≥3 points in Montreal Cognitive Assessment MoCA or change category 3. \- Psychological: Hospital Anxiety and Depression Scale HADS \>7 and/or Impact of Event Scale IES-R \>22.

Trial sites (2)

Other trials for the same condition