Ventilator Associated Pneumonia (VAP)EBP in NursingNCT06624540
Effect of Implementing Evidence-based Practice and Nurse's Behavior Change on Quality of Care in Intensive Care Unit: Focus on Ventilator Associated Pneumonia in a Tertiary Hospital in Bangladesh
A study testing This is a pre- and post- quasi-experimental study. and Education with EBP in people with Ventilator Associated Pneumonia (VAP) and Evidence Based Practice, run by Hiroshima University at 2 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventilator Associated Pneumonia (VAP), Evidence Based Practice
- What is being tested?
- This is a pre- and post- quasi-experimental study. and Education with EBP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Oct 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Who will be a registered nurse in Bangladesh.
- Who will agree to participate in this study and the EBP training.
- Irrespective of age and sex, participant must be 18 years old.
- Legal guardian of a patient consents to participation in the study
- Intubated patients after admission.
Who cannot join
- Who will not directly involve patient care in ICU.
- Study 3:
- Who stays less than 2 days at the GICU.
- Who dies or is extubated within 2 days after admitted in the GICU.
- ICU readmission.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Bangladesh1 site, 1 recruiting
- Recruiting
Dhaka Medical College Hospital
Dhaka
Prof. (Dr.) Md Mozaffer Hossain, DA, FCPS, +88-01713015380, mozaffer1963@gmail.com
Karima Khatun, MPH, +88-01879127118, dmchns53@gmail.com
Japan1 site, 1 recruiting
- Not yet recruiting
Hiroshima University
Hiroshima, Kasumi 1-2-3 Minami-ku, 734-8553
Michiko Moriyama, Ph. D, +81-82-257-5367, morimich@hiroshima-u.ac.jp
Nahida Akhter, Ph. D Fellow
About this study
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:
Read more
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:
- To determine the incidence of adverse events (VAP rate, MDRPU rate, PU rate, CLABSI rate), length of stay and survival rate in ICU.
- To evaluate the effectiveness of EBP education by changing nurses' behavior and determine its impact on improving patient outcomes in the ICU.
- To evaluate the effectiveness of EBP including proper equipment use and changed nurses behavior acquired through the training for better patient outcome (VAP ratio) in the ICU.
- To examine the feasibility of evaluation process and outcomes and successful implementation of EBP in ICU.
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.
- Being tested
- This is a pre- and post- quasi-experimental study., Education with EBP
- Keywords
- evidence based practice, Ventilator Associated Pneumonia, Nurses Knowledge
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a pre- and post- quasi-experimental study.Behavioural
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.
Education with EBPBehavioural
Also called Phase 2: Nurses EBP training
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Phase 2: All Nurses in GICU; Phase 3: All patients admitted in the general GICU | Experimental | 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 Receives: Behavioral: This is a pre- and post- quasi-experimental study.; Behavioral: Education with EBP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Measured: 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
Measured: 2 months
Secondary outcomes (11)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 6 months
VAP episode
Number of new ventilator-associated pneumonia cases occurring in ICU patients during the study period.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start10 Oct 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated Pneumonia (VAP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1: Incidence of adverse events in ICU(VAP rate, MDRPU rate, PU rate, CLABSI rate) length of stay, survival rate. Phase 2: A pre- and post- quasi-experimental study to evaluate the knowledge and skill of nurses. Phase 3: A pre- and post- quasi-experimental study to evaluate the outcomes of the patients in the ICU, using study 1 historical data as a control.
- Masking
- None (open label)
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahida Akhter, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624540
- Sponsor's protocol ID
- BMRC/NREC/2022-2025/338
- Other IDs
- 584 19 05 2024, 24K02733
- Acronym
- EBP in Nursing
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Akhter N, Zhou X, Elhabashy S, Huq KATME, Okamoto M, Latif MA, Babaita AO, Moriyama M. Effect of evidence-based education program with mentoring system for prevention of ventilator-associated pneumonia on nurses' competency to improve quality care for patients in the intensive care unit: a quasi-experimental study in a tertiary hospital in Bangladesh. Front Public Health. 2026 Jan 9;13:1674223. doi: 10.3389/fpubh.2025.1674223. eCollection 2025.
PubMed 41584199
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Implementing Evidence-based Practice and Nurse's Behavior Change on Quality of Care in Intensive Care Unit: Focus on Ventilator Associated Pneumonia in a Tertiary Hospital in Bangladesh
- ClinicalTrials.gov ID
- NCT06624540
- Acronym / sponsor ID
- EBP in Nursing / BMRC/NREC/2022-2025/338
- Keywords
- evidence based practice, Ventilator Associated Pneumonia, Nurses Knowledge
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the incidence of adverse events (VAP rate, MDRPU rate, PU rate, CLABSI rate), length of stay and survival rate in ICU.
- To evaluate the effectiveness of EBP education by changing nurses' behavior and determine its impact on improving patient outcomes in the ICU.
- To evaluate the effectiveness of EBP including proper equipment use and changed nurses behavior acquired through the training for better patient outcome (VAP ratio) in the ICU.
- To examine the feasibility of evaluation process and outcomes and successful implementation of EBP in ICU.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1: Incidence of adverse events in ICU(VAP rate, MDRPU rate, PU rate, CLABSI rate) length of stay, survival rate. Phase 2: A pre- and post- quasi-experimental study to evaluate the knowledge and skill of nurses. Phase 3: A pre- and post- quasi-experimental study to evaluate the outcomes of the patients in the ICU, using study 1 historical data as a control.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Phase 2: All Nurses in GICU; Phase 3: All patients admitted in the general GICU | Experimental | Behavioral: This is a pre- and post- quasi-experimental study., Behavioral: Education with EBPNurses: All nurses who work at GICU of DMCH Patients: all patients who will admit at the assigned GICU during the study period of DMCH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Who will be a registered nurse in Bangladesh.
- Who will agree to participate in this study and the EBP training.
- Irrespective of age and sex, participant must be 18 years old.
- Legal guardian of a patient consents to participation in the study
- Intubated patients after admission.
Key exclusion criteria (5 listed)
- Who will not directly involve patient care in ICU.
- Who stays less than 2 days at the GICU.
- Who dies or is extubated within 2 days after admitted in the GICU.
- ICU readmission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a pre- and post- quasi-experimental study.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. | Behavioural | Experimental: Phase 2: All Nurses in GICU; Phase 3: All patients admitted in the general GICU |
| Education with EBPAlso: Phase 2: Nurses EBP trainingPhase 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. | Behavioural | Experimental: Phase 2: All Nurses in GICU; Phase 3: All patients admitted in the general GICU |
Primary outcome
The nurse's skill performance is related to VAP checklist
Time frame: Study 2: 6 months
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%)
Incidence rate of ventilator-associated pneumonia (VAP)
Time frame: 2 months
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
11 secondary outcomes
A nurse's motivation level will be measured
Time frame: 6 month
Nurses' sustained implementation measured
Time frame: 6 months
Organizational readiness measured
Time frame: 6 months
Nurses knowledge and practice related to VAP prevention measured.
Time frame: 6 months
VAP episode
Time frame: 2 months
Interval of VAP occurrence
Time frame: 2 months
Micro-organism link to VAP
Time frame: 2 months
Mortality and morbidity rate
Time frame: 2 months
Onset of VAP
Time frame: 2 months
Length of stay ICU patients
Time frame: 2 months
Survival rate in ICU
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Derived from this study: PubMed 41584199Akhter N, Zhou X, Elhabashy S, Huq KATME, Okamoto M, Latif MA, Babaita AO, Moriyama M. Effect of evidence-based education program with mentoring system for prevention of ventilator-associated pneumonia on nurses' competency to improve quality care for patients in the intensive care unit: a quasi-experimental study in a tertiary hospital in Bangladesh. Front Public Health. 2026 Jan 9;13:1674223. doi: 10.3389/fpubh.2025.1674223. eCollection 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing This is a pre- and post- quasi-experimental study. and Education with EBP in people with Ventilator Associated Pneumonia (VAP) and Evidence Based Practice, run by Hiroshima University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nahida Akhter, Ph. D Fellow (+88-0192-547-8065, nahida1789@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The nurse's skill performance is related to VAP checklist (time frame: Study 2: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06624540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.