Enteral Nutrition, Enteral Nutrition Intolerance, ICU Patients, Nutrition Intervention, Surgical
Conditions
Keywords
Clinical Nutrition, Surgical Intensive Care Units, i-PARIHS Framework, Implementation Science, Clinical practice guideline
Brief summary
The goal of this interventional clinical trial is to evaluate whether the implementation of an evidence-based, context-adapted clinical nutrition practice guideline can improve clinical nutrition management in surgical intensive care units (ICUs) in China. The guideline is selected based on the best available evidence from existing surgical and critical care nutrition guidelines, adapted to the Chinese healthcare context, and implemented using an i-PARIHS-guided translation strategy. The trial involves ICU healthcare professionals working in surgical ICUs of tertiary general hospitals, while assessing nutrition-related clinical outcomes among surgical critically ill patients. The main questions it aims to answer are: Does guideline implementation improve ICU healthcare professionals' adherence to recommended clinical nutrition practice guidelines? Does the implementation of the clinical nutrition practice guideline improve the proportion of surgical critically ill patients who achieve recommended energy and protein intake targets during ICU stay? Researchers will compare outcomes before and after guideline implementation to determine whether the i-PARIHS-guided guideline translation improves nutrition management processes, healthcare professional performance, and patient-related clinical outcomes. Participants will: Complete baseline and post-implementation assessments related to clinical nutrition knowledge, attitudes, and practices. Participate in guideline-based education, training, and implementation activities guided by the i-PARIHS framework. Apply the adapted clinical nutrition practice guideline during routine clinical care in surgical ICUs. Be evaluated through on-site audits, questionnaires, and clinical data collection during the implementation process.
Detailed description
This study is an interventional, multicenter implementation clinical trial designed to translate and apply an evidence-based clinical nutrition practice guideline in surgical intensive care units (ICUs) in China, guided by the i-PARIHS framework. The guideline is developed through a structured process that includes identification of best available evidence from existing surgical and critical care nutrition guidelines, contextual adaptation to the Chinese healthcare setting, guideline item localization, and expert consensus validation. The implementation strategy is informed by the i-PARIHS framework, with particular emphasis on facilitation, local context assessment, and engagement of key stakeholders. A series of structured implementation activities, including education, training, on-site facilitation, audit and feedback, and continuous process optimization, are conducted to support guideline uptake in routine clinical practice. The implementation process follows a pre- and post-implementation design, allowing for comparison of outcomes before and after guideline translation. The primary outcomes focus on (1) adherence of ICU healthcare professionals to recommended clinical nutrition practice guidelines and (2) the proportion of surgical critically ill patients achieving recommended energy and protein intake targets during ICU stay. Secondary outcomes are assessed to comprehensively evaluate the impact of guideline implementation on nutrition delivery processes and patient-related clinical outcomes. These include: Timing of enteral nutrition initiation after ICU admission Frequency of enteral nutrition interruptions during ICU stay Global Leadership Initiative on Malnutrition (GLIM) classification at ICU discharge Cumulative daily energy and protein balance, including total caloric and protein surplus or deficit per day during ICU stay Laboratory indicators at ICU discharge, including urea-to-creatinine ratio, serum albumin, globulin, interleukin-6 (IL-6), and C-reactive protein (CRP) Length of ICU stay Clinical outcomes during ICU hospitalization All-cause 28-day mortality Data are collected through a combination of on-site clinical audits, standardized questionnaires, electronic medical record extraction, and laboratory testing. Outcomes related to healthcare professionals are measured using structured adherence assessment tools and knowledge-attitude-practice evaluations, while patient-related outcomes are derived from routinely collected clinical and laboratory data. The feasibility, appropriateness, and effectiveness of the guideline implementation are evaluated based on changes in outcome measures, process indicators, and participant satisfaction. The findings of this study are intended to inform scalable and context-sensitive strategies for optimizing clinical nutrition management in surgical ICUs within the Chinese healthcare system.
Interventions
BEHAVIORALGuideline Implementation
This behavioral intervention consists of the implementation of an evidence-based, context-adapted clinical nutrition practice guideline in surgical intensive care units (ICUs), guided by the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework. The intervention includes systematic guideline selection based on existing surgical and critical care nutrition guidelines, contextual adaptation to the Chinese healthcare setting, guideline localization and expert consensus validation, and structured implementation strategies. Key components of the intervention include education and training of ICU healthcare professionals, on-site facilitation, audit and feedback, and continuous process optimization to support adherence to guideline recommendations. The intervention is delivered at the unit level and integrated into routine clinical practice in surgical ICUs. Outcomes are evaluated using a pre- and post-implementation design to assess changes in healt
Sponsors
The Affiliated Hospital of Qingdao University
Xuanwu Hospital, Beijing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For ICU healthcare professionals: Employed at one of the participating study sites (tertiary general hospitals) Holds a valid Registered Nurse license issued in the People's Republic of China Currently working in frontline clinical nursing care in a surgical intensive care unit (ICU) during the study period At least 1 year of clinical working experience Able to understand the study objectives and procedures Willing to participate and able to provide written informed consent For surgical critically ill patients (outcome assessment population): Aged 18 years or older Admitted to a surgical ICU due to surgical-related conditions, including trauma, infection, malignancy, or postoperative complications Expected length of stay in the surgical ICU of at least 48 hours No restriction on sex Patient or legally authorized representative able to provide written informed consent
Exclusion criteria
For ICU healthcare professionals: Currently pregnant, breastfeeding, or planning pregnancy during the study period Temporarily assigned, rotating, externally dispatched, on long-term training, or on leave during the study period, making continuous participation impossible Participation in other interventional studies that may interfere with the implementation of this study Determined by the research team to have cognitive, communication, or other conditions that would make participation inappropriate For surgical critically ill patients: Diagnosed with brain death or awaiting organ donation Pregnant or breastfeeding women Concurrent participation in other nutrition-related clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence of ICU Healthcare Professionals to Clinical Nutrition Practice Guidelines | At baseline (prior to implementation) and at 6 months after implementation. | Adherence of ICU healthcare professionals to clinical nutrition practice guidelines, assessed using structured audit tools based on key guideline recommendations, including nutrition assessment, initiation and delivery of nutrition support, monitoring, and documentation practices. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Surgical Critically Ill Patients Achieving Energy and Protein Intake Targets During ICU Stay | From ICU admission (Day 1) to ICU discharge | The proportion of surgical critically ill patients whose actual daily energy and protein intake meets guideline-recommended targets during ICU stay. Energy and protein intake will be calculated based on prescribed targets and recorded enteral and/or parenteral nutrition delivery. Patients achieving both energy and protein targets will be considered as meeting the outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Enteral Nutrition Interruptions During ICU Stay | From ICU admission (Day 1) to ICU discharge | Number of enteral nutrition interruption events per patient during ICU stay, including interruptions due to procedures, intolerance, or clinical decisions, as documented in medical and nursing records. |
| GLIM Classification | At ICU admission (Day 1) and ICU discharge | Nutritional status at ICU admission and ICU discharge assessed using the Global Leadership Initiative on Malnutrition (GLIM) criteria, categorized according to standard GLIM diagnostic classifications. |
| Cumulative energy balance during ICU stay | From ICU admission (Day 1) to ICU discharge | Cumulative energy balance was calculated as the sum of the daily differences between delivered energy intake and prescribed energy targets during the ICU stay. |
| Cumulative protein balance during ICU stay | From ICU admission (Day 1) to ICU discharge | Cumulative protein balance was calculated as the sum of the daily differences between delivered protein intake and prescribed protein targets during the ICU stay. |
| Clinical Outcomes During ICU Stay | From ICU admission(Day 1) to ICU discharge | Clinical outcomes during ICU stay, including occurrence of major complications and need for advanced organ support, extracted from electronic medical records. |
| Serum Albumin Levels | At ICU admission (Day 1) and ICU discharge | Serum albumin concentrations measured at ICU admission (Day 1) and ICU discharge based on routine laboratory tests. |
| Serum C-Reactive Protein (CRP) Level | At ICU admission (Day 1) and ICU discharge | The serum CRP level will be measured from blood samples collected at ICU admission (Day 1) and ICU discharge. CRP is an acute-phase protein that reflects systemic inflammation. The measurement will be performed using standard laboratory methods available at the hospital laboratory. Data will be reported in mg/L. |
| Length of ICU Stay | From ICU admission (Day 1) to ICU discharge | Duration of ICU hospitalization, measured in days from ICU admission to ICU discharge. |
| All-Cause 28-Day Mortality | Up to 28 days after ICU admission | All-cause mortality within 28 days after ICU admission, determined from hospital records and follow-up data. |
| Urea-to-Creatinine Ratio | At ICU admission (Day 1) and ICU discharge | Serum urea-to-creatinine ratio measured at ICU admission (Day 1) and ICU discharge, derived from routine laboratory testing. |
| Time to Initiation of Enteral Nutrition After ICU Admission | From ICU admission (Day 1) to initiation of enteral nutrition (up to 7 days). | Time from ICU admission to the initiation of enteral nutrition, measured in hours, based on medical records and nutrition orders. |
Contacts
Primary ContactRu Bin Han, Professor
Backup ContactChen Xin, Mr.
Outcome results
None listed