"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."
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Presence of Post-Intensive Care Syndrome (PICS) at 3 months after hospital discharge following a standardized training program on the standard ABCDEF care bundle
研究概览
简要总结
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.
详细描述
Background and Rationale PROTECT-ICU is a multicenter, implementation-focused study designed to evaluate the impact of a structured educational intervention targeting intensive care unit (ICU) healthcare professionals on adherence to evidence-based care practices and on patient-centered outcomes after critical illness.
Although survival after critical illness has improved, a substantial proportion of ICU survivors develop persistent physical, cognitive, and psychological impairments, commonly referred to as post-intensive care syndrome (PICS). These long-term sequelae are associated with reduced functional recovery, decreased quality of life, and increased healthcare utilization. Despite growing awareness of PICS, effective strategies to prevent or mitigate its development remain insufficiently established.
The ABCDEF bundle provides a structured framework to optimize ICU care processes, integrating key elements related to analgesia, sedation management, ventilatory support, delirium monitoring and prevention, early mobilization, and family engagement. However, adherence remains heterogeneous across ICUs, and its impact on long-term outcomes remains uncertain.
Additional domains of care, including nutritional optimization, sleep quality, infection prevention, minimization of iatrogenic complications, discharge planning, continuity of care, and psychological and social support, may also influence recovery after critical illness. These elements have been incorporated into an expanded A-Z framework developed through multidisciplinary collaboration and expert consensus.
Objectives The primary objective of the PROTECT-ICU study is to evaluate whether implementation of a structured training program for ICU professionals reduces the incidence of post-intensive care syndrome (PICS) at three months after hospital discharge in patients treated after completion of the educational intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Training on Standard ABCDEF Bundle (A-F)
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.
干预措施: Standardized Training on the ABCDEF Care Bundle (A-F) (Behavioral)
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.
干预措施: Standardized training on the expanded ABCDEF care bundle (A-Z) (Behavioral)
结局指标
主要结局
Presence of Post-Intensive Care Syndrome (PICS) at 3 months after hospital discharge following a standardized training program on the standard ABCDEF care bundle
时间窗: 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.
次要结局
- 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 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)
- 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)
- Incidence of post-intensive care syndrome (PICS) at 1 month, 6 months, and 12 months after hospital discharge following implementation of the training intervention on the standard and expanded ABCDEF care bundles(1 month, 6 months, and 12 months after hospital discharge)
- Health-related quality of life (SF-12 Physical and Mental Component Scores)(At 1, 3, 6, and 12 months after hospital discharge.)
- Health-related quality of life (EQ-5D-5L Visual Analogue Scale)(At 1, 3, 6, and 12 months after hospital discharge.)
- Health-related quality of life (EQ-5D-5L Utility Index)(At 1, 3, 6, and 12 months after hospital discharge.)
研究者
Carola Giménez-Esparza Vich
Sponsor-Investigator
Spanish Society of Critical Care Medicine and Coronary Units