- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06997614
- Original Trial
Enhancing Critical Thinking Competency and Nursing Quality in Critically Ill Patient Care
March 18, 2026 updated by: Yuexiang Zhao, Taizhou Hospital
Enhancing Critical Thinking Competency and Nursing Quality in Critically Ill Patient Care: A Quasi-Experimental Study of an Evidence-Based Nutritional Management Protocol
The EBN-based nutritional management protocol effectively enhances junior nurses' specialized critical thinking competency and improves patient nutritional outcomes and satisfaction, demonstrating its potential to optimize critical care quality.
However, further validation through multicenter studies with larger cohorts, extended follow-up periods, and additional outcome measures is warranted.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study aims to develop an evidence-based nursing (EBN)-based nutritional management protocol for critically ill patients and assess its effects on junior nurses' specialized critical thinking competency and nursing quality.
A quasi-experimental design was employed, involving 7 junior nurses and 84 critically ill patients in each of the study and control groups.
The study group implemented the EBN-based protocol alongside structured training, while the control group adhered to conventional practices.
Nursing quality outcomes included assessments of nurses' specialized critical thinking skills, patient nutritional biomarkers (serum albumin, prealbumin), complication rates (aspiration, diarrhea, abdominal distension), and patient satisfaction.
Multivariate binary logistic regression analysis identified influencing factors.
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Taizhou, Jiangsu, China, 225300
- Taizhou Hospital of Traditional Chinese Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- diagnosis of critical illness by attending physicians or higher-qualified specialists according to established critical care diagnostic standards
- requirement for ICU admission with full access to standardized critical care and medical resources
- preserved partial gastrointestinal function without severe intestinal obstruction or perforation confirmed by certified nutritionists or senior nurses, enabling potential enteral nutrition (EN) or combined EN-parenteral nutrition (PN) support.
Exclusion Criteria:
- patients with severe cognitive impairment or psychiatric instability (e.g., advanced dementia, schizophrenia, status epilepticus) impairing capacity to engage in nutritional assessments or adhere to clinical protocols, which would jeopardize data collection reliability
- terminal-stage conditions (malignancies, renal/hepatic failure) with life expectancy < 7 days or exclusively receiving palliative care, leading to misalignment between their palliative nutritional goals and the study's therapeutic intervention objectives
- congenital metabolic disorders (e.g., phenylketonuria) or short bowel syndrome requiring specialized nutritional protocols, which were incompatible with conventional critical care nutritional protocols and could compromise the generalizability of study findings
- pregnancy/lactation due to unique nutritional demands and potential risks to fetal/infant development inherent in the study design, contravening established ethical standards
- cases involving transfer, voluntary discharge, or withdrawal of consent that compromised data completeness.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Conventional group
The conventional group adhered to conventional nutritional management methods and training
|
The conventional group adhered to conventional nutritional management methods and training
|
|
Other: Evidence-based nursing group
The study group implemented the EBN-based protocol alongside structured training
|
The study group implemented the EBN-based protocol alongside structured training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in Junior Nurses' Specialized Critical Thinking Competency
Time Frame: Baseline: Before training (Day 0). Post-intervention: 3 months after protocol implementation.
|
Change in critical thinking scores measured by the Chinese Critical Thinking Disposition Inventory (CTDI-CV), a 70-item scale evaluating 7 dimensions (truth-seeking, open-mindedness, analyticity, systematicity, self-confidence, inquisitiveness, cognitive maturity) on a 6-point Likert scale.
Higher scores indicate superior competency.
|
Baseline: Before training (Day 0). Post-intervention: 3 months after protocol implementation.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum Albumin Levels
Time Frame: ICU admission (Day 0) and Day 14.
|
Objective nutritional biomarker (g/L) measured via venous blood sampling.
|
ICU admission (Day 0) and Day 14.
|
|
Serum Prealbumin Levels
Time Frame: Day 0 and Day 14.
|
Short-term nutritional status marker (mg/L) assessed alongside albumin.
|
Day 0 and Day 14.
|
|
Patient Satisfaction
Time Frame: Day 15.
|
Self-reported satisfaction rated on a 5-point Likert scale (1: extremely dissatisfied, 5: extremely satisfied).
|
Day 15.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Aspiration
Time Frame: Daily monitoring until Day 14
|
Binary outcome (yes/no) recorded during EN/PN administration.
|
Daily monitoring until Day 14
|
|
Incidence of Diarrhea
Time Frame: Daily monitoring until Day 14.
|
Defined as ≥3 loose stools/day, documented by nurses.
|
Daily monitoring until Day 14.
|
|
Incidence of Abdominal Distension
Time Frame: Daily monitoring until Day 14.
|
Assessed via physical examination and patient reporting.
|
Daily monitoring until Day 14.
|
|
Body Weight Changes
Time Frame: Day 0 and Day 14.
|
Measured in kg (bedside scales for ambulatory patients; estimated for others).
|
Day 0 and Day 14.
|
|
Blood Glucose Fluctuations Description: Time Frame:
Time Frame: Daily until Day 14
|
Capillary/venous glucose levels (mmol/L) monitored per ICU protocol.
|
Daily until Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2025
Primary Completion (Actual)
October 5, 2025
Study Completion (Actual)
November 30, 2025
Study Registration Dates
First Submitted
May 21, 2025
First Submitted That Met QC Criteria
May 21, 2025
First Posted (Actual)
May 30, 2025
Study Record Updates
Last Update Posted (Actual)
March 19, 2026
Last Update Submitted That Met QC Criteria
March 18, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- No. 20240625
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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