Implementation of Clinical Nutrition Practice Guidelines in Surgical ICUs

NCT07337798 | Not Yet Recruiting

• 1 other identifier: iPARIHS-SICU-2025
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ICU Patients; Surgical; Nutrition Intervention; Enteral Nutrition; Enteral Nutrition Intolerance

Keywords

Clinical Nutrition; Surgical Intensive Care Units; i-PARIHS Framework; Implementation Science; Clinical practice guideline

Outcome Measures

Primary Outcomes (1)

• Adherence of ICU Healthcare Professionals to Clinical Nutrition Practice Guidelines

  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.

  At baseline (prior to implementation) and at 6 months after implementation.

Secondary Outcomes (1)

• Proportion of Surgical Critically Ill Patients Achieving Energy and Protein Intake Targets During ICU Stay

  From ICU admission (Day 1) to ICU discharge

Other Outcomes (11)

• Time to Initiation of Enteral Nutrition After ICU Admission

  From ICU admission (Day 1) to initiation of enteral nutrition (up to 7 days).

• Frequency of Enteral Nutrition Interruptions During ICU Stay

  From ICU admission (Day 1) to ICU discharge

• GLIM Classification

  At ICU admission (Day 1) and ICU discharge

Study Arms (1)

Guideline Implementation Group

EXPERIMENTAL

Participants in this single-arm study will receive an evidence-based, context-adapted clinical nutrition practice guideline implemented in surgical intensive care units (ICUs) using an i-PARIHS-guided translation strategy. The implementation includes guideline localization, expert consensus validation, education and training, on-site facilitation, audit and feedback, and continuous process optimization. Outcomes will be assessed before and after guideline implementation to evaluate changes in healthcare professional adherence to clinical nutrition recommendations and nutrition-related clinical outcomes among surgical critically ill patients.

Behavioral: Guideline Implementation

Interventions

Guideline Implementation BEHAVIORAL

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

Guideline Implementation Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• The Affiliated Hospital of Qingdao University: collaborator

Central Study Contacts

Ru Bin Han, Professor

CONTACT

+86 13701103033; hanbinru8723@163.com

Chen Xin, Mr.

CONTACT

+86 17863992191; 1014974593@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 13, 2026
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share