An interventional study of This is a pre- and post- quasi-experimental study. and Education with EBP in Ventilator Associated Pneumonia (VAP) and Evidence Based Practice, sponsored by Hiroshima University. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Hiroshima University · Not applicable, Interventional, and Health services research
Quality of care is crucial for preventing adverse events such as infection in the intensive care units (ICUs). The most common ICU-acquired infections include pneumonia such as ventilator-associated pneumonia (VAP), Central Line Bloodstream Infection (CLABSI), catheter-associated urinary tract in, Medical Device Related Pressure Ulcer (MDRPU) and Pressure Ulcer (PU). This study explores the patient outcome in ICU by examining the causes and prevalence of ICU-acquired infection. The implementation of evidence-based practice (EBP) to reduce infection and change the nurses practice (behavioral changes) to adhere with EBP based on simulation-based training.
General objective:
To evaluate the effect of EBP by using recent technologies-based equipment to prevent VAP and promote behavior change among nurses for better outcome of the patient in ICU.
Specific Objectives:
Hypothesis:
It is hypothesize that implementing EBP in ICU, including new equipment use and nurses training, will improve patient outcome.
These research consist of three studies:
Phase 1: Incidence of adverse events (VAP rate, MDRPU rate, PU rate, CLABSI rate), length of stay and survival rate in ICU. The patients of General ICU will be followed up after admission up to discharge or death at ICU. The investigators use the study findings for our subsequent intervention study 3 as historical data.
Phase 2: A pre- and post- quasi-experimental study will be conducted for 6 months to evaluate the nurse's competency on EBP after getting 1-month EBP training. This study has 3 steps: (1) Pre-observation period to measure nurse's competency level for 2-month, (2) nurse's EBP training period with preparation for 1 month, and (3) post-implementation period to measure nurse's competency and implementation of EBP practice for 2 months. Study nurses will receive EBP training, EBP and proper equipment for patient management. The nurses will receive EBP education and training with necessary equipment, such as a close suction catheter, an endotracheal tube, a suction device, and a mouth care brush. In this study, use global standard equipment for the patients safety.
Phase 3: A pre- and post- quasi-experimental study will be implemented to evaluate the efficacy of EBP implementation. The investigators use new equipment and implement EBP for patients and assess the patient outcomes. The investigators compare the findings from study 1 (as historical data) with the data from this study 3.
The investigators will compare the VAP infection prevalence and patients' outcomes related to ICU-acquired infection between pre- and post- test phase.
420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 85 are open to participants now.
This study's planned enrollment of 272 is above the median of 115 across 276 interventional studies indexed under Pneumonia, Ventilator-Associated.
Browse Pneumonia, Ventilator-Associated studies →Hiroshima University is the lead sponsor of 45 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study 2:
Inclusion criteria:
Exclusion criteria:
Study 3:
Inclusion Criteria:
Exclusion Criteria:
Nurses: All nurses who work at GICU of DMCH Patients: all patients who will admit at the assigned GICU during the study period of DMCH
Behavioral: This is a pre- and post- quasi-experimental study. · Behavioral: Education with EBP
We will use new equipment and implement EBP (VAP management) for patients by trained nurses (Phase 2) and check the outcome of the patients. We will compare our phase 1 findings for this study as historical data.
Phase 2: Nurse's EBP training ( VAP management), 2 hours lecture and 3 hours skill training for total 4 times in 1 month. Phase 3: Introduce new equipment necessary for EBP implementation for VAP management, and EBP-trained nurses implementation for VAP management.
Also known as: Phase 2: Nurses EBP training
The nurse's skill performance is related to VAP checklist
Nurses' skill performance related to VAP prevention measured using a researcher-developed 64-item observational checklist based on evidence-based practice guidelines. Unit of Measure: Total skill performance score (range 0-140), categorized as: * High: ≥112 (≥80%) * Moderate: 70-111 (50-79%) * Low: \<70 (\<50%)
Time frame: Study 2: 6 months
Incidence rate of ventilator-associated pneumonia (VAP)
Number of new ventilator-associated pneumonia cases occurring in ICU patients during the study period. Unit of Measure: VAP cases per 1,000 ventilator days. Data will be collected: Patients' demographic data (age, sex, occupation etc.) Medical past and current history (diagnosis, treatment, medication, hospitalization). Reasons and date to be admitted to ICU. Treatment in ICU. Daily laboratory data taken in ICU. Daily biological data including vital signs. Results of patients' stay during ICU. Duration of ventilation Diagnosis of VAP
Time frame: 2 months
A nurse's motivation level will be measured
A nurse's motivation level will be measured by the Motivation scale. . Total 12 items, and score ranges 1 lower motivation and 10 higher motivations.
Time frame: 6 month
Nurses' sustained implementation measured
Nurses' sustained implementation measured by Nurses sustained implementation scale. The total item is 28, and 4-point liker scale. Scores ranges from 28 (no sustainability) to 112 (good sustainability).
Time frame: 6 months
Organizational readiness measured
Organizational readiness measured by Organizational readiness scale. Total 03 items convergent validity (r = 0.42 - 0.72) for the correlations between the shortened and longer scales.
Time frame: 6 months
Nurses knowledge and practice related to VAP prevention measured.
Measured by researcher modified nurses knowledge related to VAP prevention scale total 12 \& 6 items.
Time frame: 6 months
VAP episode
Number of new ventilator-associated pneumonia cases occurring in ICU patients during the study period.
Time frame: 2 months
Interval of VAP occurrence
Number of days from date/time of ICU admission to date/time of first diagnosis of ventilator-associated pneumonia (VAP). If no VAP occurs, observation is censored at ICU discharge or death. Unit of Measure: Days (time-to-event) - report as median (IQR) and mean ± SD; consider Kaplan-Meier estimates for time-to-event.
Time frame: 2 months
Micro-organism link to VAP
After diagnosis of CLABSI then identify what kind organism relate to CLABSI. Type and frequency of microorganisms identified in laboratory-confirmed CLABSI cases. Unit of Measure: Number of cases per microorganism
Time frame: 2 months
Mortality and morbidity rate
Mortality and morbidity rate of ICU patients All-cause mortality among ICU patients during the study period. Unit of Measure: Percentage (%)。Occurrence of ICU-related adverse events (VAP). Unit of Measure: Number of patients with adverse events
Time frame: 2 months
Onset of VAP
Classification of first VAP episode as early-onset or late-onset based on time from initiation of mechanical ventilation. Unit of Measure: Number and percentage (%) of patients with early-onset and late-onset VAP.
Time frame: 2 months
Length of stay ICU patients
Average length of stay ICU patients. Mean length of stay in the intensive care unit for enrolled patients. Unit of Measure: Days (mean ± SD)
Time frame: 2 months
Survival rate in ICU
Average survival rate of ICU. Data will be collected: Length of stay and survival rate. Proportion of enrolled patients alive at ICU discharge. Unit of Measure: Percentage (%) of patients surviving to ICU discharge.
Time frame: 2 months
Plan to share: No — IPD will not be share due to personal confidentiality of the participants. When the data will be available and we will share the data according to the recommendations of the clinical trial registration and the requests of the journals.
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