NCT06624540

Brief 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 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:

  1. 1.To determine the incidence of adverse events (VAP rate, MDRPU rate, PU rate, CLABSI rate), length of stay and survival rate in ICU.
  2. 2.To evaluate the effectiveness of EBP education by changing nurses' behavior and determine its impact on improving patient outcomes in the ICU.
  3. 3.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.
  4. 4.To examine the feasibility of evaluation process and outcomes and successful implementation of EBP in ICU.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
272

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

December 15, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

September 12, 2024

Last Update Submit

December 9, 2025

Conditions

Keywords

evidence based practiceVentilator Associated PneumoniaNurses Knowledge

Outcome Measures

Primary Outcomes (2)

  • 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%)

    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

    2 months

Secondary Outcomes (11)

  • A nurse's motivation level will be measured

    6 month

  • Nurses' sustained implementation measured

    6 months

  • Organizational readiness measured

    6 months

  • Nurses knowledge and practice related to VAP prevention measured.

    6 months

  • VAP episode

    2 months

  • +6 more secondary outcomes

Study Arms (1)

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

Behavioral: This is a pre- and post- quasi-experimental study.Behavioral: Education with EBP

Interventions

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.

Experimental: Phase 2: All Nurses in GICU; Phase 3: All patients admitted in the general GICU

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
Experimental: Phase 2: All Nurses in GICU; Phase 3: All patients admitted in the general GICU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Who will be a registered nurse in Bangladesh.
  • Who will agree to participate in this study and the EBP training.

You may not qualify if:

  • Who will not directly involve patient care in ICU.
  • Study 3:
  • 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 stays less than 2 days at the GICU.
  • Who dies or is extubated within 2 days after admitted in the GICU.
  • ICU readmission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dhaka Medical College Hospital

Dhaka, Bangladesh

RECRUITING

Hiroshima University

Hiroshima, Kasumi 1-2-3 Minami-ku, 734-8553, Japan

NOT YET RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Nahida Akhter, Ph. D Fellow

CONTACT

Michiko Moriyama, Ph. D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Ph.D Fellow, Graduate School of Biomedical and Health Sciences, Hiroshima University, Japan.

Study Record Dates

First Submitted

September 12, 2024

First Posted

October 3, 2024

Study Start

October 10, 2024

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

December 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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.

Locations