"PROTECT-ICU: Impact of an Educational Intervention

NCT07542613 | Recruiting

• 1 other identifier: MC- 2025-093
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Post Intensive Care Syndrome (PICS); Critical Illness

Keywords

Post-intensive care syndrome; critical illness; delirium prevention; early mobilization; Sedation management; Family engagement in intensive care; ABCDEF bundle; Quality of care in intensive care; Staff training in intensive care

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months after hospital discharge

Secondary Outcomes (9)

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

  From the date of study inclusion until ICU discharge, death, or up to 21 days, whichever occurs first; adherence to the ABCDEF bundle assessed daily during ICU stay.

• Variation in global adherence to the ABCDEF bundles across participating ICUs

  From the date of study inclusion until ICU discharge, death, or up to 21 days, whichever occurs first; adherence to the ABCDEF bundle assessed daily during ICU stay.

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

  1 month, 6 months, and 12 months after hospital discharge

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

  From study inclusion until the date of ICU discharge, death, or 21 days after study inclusion, whichever came first.

• Adherence to the expanded A-Z bundle and its individual components after the training intervention

  During ICU stay, up to 21days or until ICU discharge

Study Arms (2)

Training on Standard ABCDEF Bundle (A-F)

EXPERIMENTAL

Clusters (intensive care units) randomized to this arm will receive a standardized staff training program focused on the standard ABCDEF bundle (A-F). After completion of the training period, adherence to the ABCDEF bundle will be assessed in routine clinical practice using daily data collection tools (CRF) for consecutively admitted eligible ICU participants for up to 21days or until ICU discharge or death, whichever occurs first. Follow-up assessments are scheduled at 1, 3, 6, and 12 months after hospital discharge.

Behavioral: Standardized Training on the ABCDEF Care Bundle (A-F)

Training on Expanded ABCDEF Bundle (A-Z)

EXPERIMENTAL

Clusters (intensive care units) randomized to this arm will receive a standardized staff training program focused on an expanded ABCDEF bundle (A-Z), which includes additional care elements beyond A-F. After completion of the training period, adherence to the expanded bundle will be assessed in routine clinical practice using daily data collection tools (CRF) for consecutively admitted eligible ICU participants for up to 21 days or until ICU discharge or death, whichever occurs first. Follow-up assessments are scheduled at 1, 3, 6, and 12 months after hospital discharge.

Behavioral: Standardized training on the expanded ABCDEF care bundle (A-Z)

Interventions

Standardized Training on the ABCDEF Care Bundle (A-F) BEHAVIORAL

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

Training on Standard ABCDEF Bundle (A-F)

Standardized training on the expanded ABCDEF care bundle (A-Z) BEHAVIORAL

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

Training on Expanded ABCDEF Bundle (A-Z)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Carola Giménez-Esparza Vich: lead

Study Sites (2)

Vega Baja University Hospital

Orihuela, Alicante, 03314, Spain

RECRUITING

Vega Baja University Hospital

Murcia, Murcia, 30005, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

postintensive care syndrome; Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• CAROLA GIMENEZ-ESPARZA VICH, MD, MSc

  Vega Baja University Hospital, Orihuela, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CAROLA GIMENEZ-ESPARZA VICH, MD, MSc

CONTACT

+34639339791; carolagimenezesparzavich@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. No parties are masked in this study, as the trial is conducted as an open-label, cluster randomized design in which ICU teams and investigators are aware of group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: This is a multicenter, cluster-randomized, parallel-group trial in which the randomization unit is the intensive care unit (ICU). Participating ICUs are assigned in a 1:1 ratio to one of two intervention groups and maintain the assigned strategy throughout the study period. All eligible patients admitted to each ICU receive standard clinical care according to local practice, while the ICU implements either the standard ABCDEF (A-F) package or an expanded ABCDEF (A-Z) package. The intervention is implemented at the ICU level through a structured training program for staff, and outcomes are compared simultaneously between the two randomized ICU groups.

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: April 21, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Pseudonymized IPD and supporting documents will become available no earlier than 6 months after publication of the primary results and will remain available for at least 5 years thereafter, subject to applicable legal and ethical requirements.
• Access Criteria: Access to pseudonymized individual medical data will be granted to qualified researchers to conduct scientifically sound, ethically appropriate, and methodologically rigorous analyses related to the objectives of the PROTECT-ICU study. Applications must include a written research proposal describing the study objectives, planned analyses, and statistical methods, as well as confirmation of compliance with applicable data protection and ethics regulations. Prior to data disclosure, a formal data-sharing agreement specifying permitted uses, confidentiality obligations, and publication rights must be signed. Data will be shared via a secure repository or encrypted transfer managed by the coordination center. All requests will be reviewed by the PROTECT-ICU Steering Committee, which will evaluate scientific merit, feasibility, ethical considerations, and compliance with the original consent and regulatory requirements before granting access.

Locations

ES (2)