Implementation of Clinical Nutrition Practice Guidelines in Surgical ICUs

NCT ID: NCT07337798

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-20
• Study Completion Date: 2026-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Guideline Implementation Group

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.

Group Type: EXPERIMENTAL

Guideline Implementation

Intervention Type: 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

Interventions

Guideline 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ru Bin Han, Professor

Role: CONTACT

hanbinru8723@163.com

+86 13701103033

Chen Xin, Mr.

Role: CONTACT

1014974593@qq.com

+86 17863992191

Other Identifiers

iPARIHS-SICU-2025

Identifier Type: -

Identifier Source: org_study_id