[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634663":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":77,"collaborators":25,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":25,"enrollmentInfo":91,"targetDuration":25,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Spanish Society of Critical Care Medicine and Coronary Units","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Standardized Training on the ABCDEF Care Bundle (A-F)",{"label":15,"type":10,"description":16,"interventionNames":17},"Training on Expanded ABCDEF Bundle (A-Z)","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.",[18],"Behavioral: Standardized training on the expanded ABCDEF care bundle (A-Z)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","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",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"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",[15],[31],{"name":32,"affiliation":33,"role":34},"CAROLA GIMENEZ-ESPARZA VICH, MD, MSc","Vega Baja University Hospital, Orihuela, Spain","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+34639339791","carolagimenezesparzavich@gmail.com",[41,64],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Vega Baja University Hospital","RECRUITING","Orihuela","Alicante","03314","Spain","ES",{"type":50,"coordinates":51},"Point",[52,53],-0.94401,38.08483,{"lat":53,"lon":52},[56,59,63],{"name":57,"role":37,"phone":58,"phoneExt":25,"email":39},"CAROLA GIMENEZ-ESPARZA VICH, MD,MSc","+34 639339791",{"name":60,"role":37,"phone":61,"phoneExt":25,"email":62},"Executive Director","+34 678670833","ricardo@semicyuc.org",{"name":32,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":42,"status":65,"city":66,"state":66,"zip":67,"country":47,"countryCode":48,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"NOT_YET_RECRUITING","Murcia","30005",{"type":50,"coordinates":69},[70,71],-1.13004,37.98704,{"lat":71,"lon":70},[74],{"name":75,"role":37,"phone":76,"phoneExt":25,"email":39},"CAROLA GIMENEZ-ESPARZA VICH","639339791",{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Carola Giménez-Esparza Vich","Sponsor-Investigator","100634663","protect-icu-impact-of-an-educational-intervention-100634663",false,"NCT07542613","\"PROTECT-ICU: Impact of an Educational Intervention","\"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.\"","PROTECT-ICU","Inclusion Criteria:\n\n1. Adults aged 18 years or older\n2. Patients who stay in the intensive care unit (ICU) for at least 48 hours\n3. Written informed consent provided by the patient, or by a legal representative or family member if the patient is unable to decide\n\nExclusion Criteria:\n\n1. 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)\n2. Patients expected to be discharged from the ICU within the next 24 hours\n3. 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)\n4. Patients with a life expectancy of less than 3 months\n5. Patients with severe cognitive impairment or severe mental illness before ICU admission that would make assessments difficult\n6. Patients with severe brain injury or severe neurological diseases that prevent proper evaluation of physical or cognitive function","ALL","18 Years",{"count":92,"type":93},900,"ESTIMATED","INTERVENTIONAL",[96],"NA","Brief Summary\n\nThe 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.\n\nThese 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.\n\nThe main questions this study aims to answer are:\n\nDoes 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?\n\nResearchers will compare patients treated before and after the training program to see if the training reduces PICS.\n\nResearchers 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.\n\nBefore 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.\n\nParticipants are adults who stay in the ICU for at least 48 hours and leave the hospital alive.\n\nParticipants will:\n\nReceive 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\n\nThe 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.",[99,100],"Post Intensive Care Syndrome (PICS)","Critical Illness",[102,103,104,105,106,107,108,109,110],"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","2026-04-17",{"date":113,"type":114},"2026-04-21","ACTUAL",{"date":116,"type":114},"2026-02-16",{"date":118,"type":93},"2028-01",{"name":79,"class":6},2]