"PROTECT-ICU: Impact of an Educational Intervention

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

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.

Adherence to the standard ABCDEF bundle and its individual components after the training intervention

Will be assessed as the proportion of eligible bundle components (A-F) correctly performed and documented per patient-day during ICU stay, using a standardized daily checklist specifically designed for the study, comparing the pre-intervention and post-intervention periods. Each component of the bundle (A: pain assessment and management; B: spontaneous awakening and breathing trials; C: choice and titration of sedation; D: delirium assessment and prevention; E: early mobilization; F: family engagement) will be evaluated individually on a daily basis. For each patient-day, components will be considered eligible based on clinical conditions, and adherence will be calculated as the percentage of correctly implemented components over the total number of eligible components. Overall adherence will be expressed as a continuous percentage at both the patient level and the ICU level. Adherence to each individual component will also be analyzed separately.

Variation in global adherence to the ABCDEF bundles across participating ICUs

Global adherence to the ABCDEF bundle will be assessed at the ICU level as the mean percentage of eligible bundle components (A-F) correctly performed and documented per patient-day during ICU stay, using a standardized daily checklist. For each ICU, overall adherence will be calculated as the proportion of completed components over the total number of eligible components across all included patients and study days. Adherence will be expressed as a continuous percentage. This outcome will evaluate variability in adherence between participating ICUs in both the pre-intervention and post-intervention periods. Differences across centers will be described and compared to identify heterogeneity in implementation of the bundle. In addition, the distribution of adherence values across ICUs will be analyzed, including measures of central tendency and dispersion, and variation over time will be explored to assess consistency of implementation.

Presence of Post-Intensive Care Syndrome (PICS) at 3 months after hospital discharge following training on the expanded ABCDEF bundle

ICS will be defined as new or worsened impairment compared with pre-ICU baseline in at least one of the following domains: 1. Physical domain: impairment defined by at least one of the following: decline in functional status (Barthel Index \<100 with ≥10-15 point decrease or change in category), reduced muscle strength (MRC \<48), impaired mobility (Timed Up and Go \>12 s), reduced exercise capacity (6-minute walk test \<80% predicted, \<400 m or decrease ≥30 m), reduced handgrip strength, nutritional impairment (positive MUST or weight loss \>10%), dyspnea (mMRC ≥2 or worsening ≥1), or impaired pulmonary function (FEV1, FVC or DLCO \<80% predicted). 2. \- Cognitive domain: IQCODE \<3.4 with MoCA \<26, or IQCODE 3.4-3.6 with a decrease of ≥3 points in MoCA or change in category 3. \- Psychological domain: impairment defined by clinically relevant symptoms (HADS \>7 and/or IES-R \>22). PICS is considered present if at least one domain is impaired.

Incidence of delirium during ICU stay after implementation of the training intervention

Delirium will be assessed prospectively during ICU stay using validated and standardized instruments, including the Confusion Assessment Method for the ICU (CAM-ICU) or equivalent tools routinely used at participating centers. Assessments will be performed at least once per shift and only during periods when patients are arousable (e.g., Richmond Agitation-Sedation Scale \[RASS\] ≥ -3). Delirium will be considered present if at least one positive assessment is recorded during ICU stay. The incidence of delirium will be expressed as the proportion of patients who develop delirium at any time during ICU admission. This outcome will evaluate whether implementation of the structured training intervention on the standard and expanded care bundles is associated with a reduction in the incidence of delirium compared with the pre-intervention period.