NCT07397364

Brief Summary

Study title: Impact of nurses' behavior change and implementing evidence-based practice to improve quality indicators in intensive care units in low-and middle-income countries Background and Rationale: Quality care is crucial for preventing adverse events and improving patient survival rates in healthcare settings, especially in the intensive care units (ICU). To improve patient outcomes, complying with evidence-based practice (EBP) and continuous monitoring of quality indicators by Plan-Do-Check- Act (PDCA) cycle is effective; in which "P: decide and plan target actions", "D: implement the plans", "C: measure and evaluate the indicators", and "A: discuss the next step for improvement". Regarding quality indicators at ICU, Japan has achieved the highest global survival rate with the fewest adverse events. In a scoping review, when EBPs were implemented, 90% of the studies showed improved patient outcomes, and 94% found a positive return on investment. In ICU, EBP is essential for providing high-quality care, reducing errors, educating healthcare professionals, ensuring the efficacy of treatments, and fostering trust and good patient care relationships. In Egypt, as a one of the low-and middle-income countries (LMICs), 59.9% of ICU patients had poor outcomes, with a 14.9% mortality rate. The incidence rate of total device- associated infections was 35.3/1000 device-days. The incidence of VAP is 38.4%, and it has reached 75% in some Egyptian hospitals; contrarily, in Japan, where Bundle care (evidence-based guideline) is strictly followed by nurses, the incidence of VAP is only 5.7%. EBP is hindered in LMICs by a lack of research infrastructure, a knowledge gap, poor nursing management, and limitation of resources. However, promoting this change will require increased advocacy of nurses, technical advancements, and integration into curricula and continuing education programs. Moreover, global collaboration is imperative for comprehensive development. Objectives: Primary Objective: Improve the quality of care in the ICU through implementation of EBP (indicated by selected quality indicators which assessed as routine work monthly in the selected ICU). Secondary Objective: To enhance ICU nurses' professional competency in applying EBP. The level of compatibility between the research proposal and the department's research goals. There is a high level of compatibility between the research proposal and the department's research goals, particularly in terms of enhancing the competency of ICU staff through targeted training, improving the quality of care, and ultimately contributing to better patient outcomes. The level of compatibility between the research proposal and the NCI 's research Plan. The research proposal demonstrates a high level of compatibility with the NCI's research plan through the implementation of the latest evidence-based practices (EBP), standardized care protocols, and up-to-date clinical guidelines. It also aims to reduce contributing factors associated with increased morbidity and complication rates, thereby aligning with the institute's goals to advance patient safety and care quality. \- Study Design: An open- label, prospective, parallel-group (1:1), non-randomized controlled trial, with a pre- and post-design.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

January 21, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

February 9, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 21, 2026

Last Update Submit

February 4, 2026

Conditions

Keywords

Evidence-Based PracticeNurses' Behavior ChangeIntensive Care UnitQuality IndicatorsVentilator-Associated Pneumonia

Outcome Measures

Primary Outcomes (2)

  • Incidence of Ventilator-Associated Pneumonia (VAP)

    Incidence of ventilator-associated pneumonia measured as the number of new VAP cases per 1,000 ventilator-days in the ICU. using Ventilator-Associated Pneumonia (VAP) Assessment Sheet based on (CDC/NHSN) criteria

    Up to 5 months

  • Incidence of Central Line-Associated Bloodstream Infection (CLABSI)

    Incidence of central line-associated bloodstream infection measured as the number of new CLABSI cases per 1,000 central line-days in the ICU. using Adult CLABSI Assessment \& Audit Checklist. based on (CDC/NHSN) criteria

    Up to 5 months

Secondary Outcomes (4)

  • Nurse Competency Score

    Up to 5 months

  • Incidence of Pressure Ulcers

    Up to 5 months

  • Length of ICU Stay

    Up to 5 months

  • ICU Survival Rate

    Up to 5 months

Study Arms (2)

Intervention Group (Evidence-Based Practice Implementation)

EXPERIMENTAL

Participants in this arm will receive a structured evidence-based practice (EBP) education and behavior change program. The intervention includes theoretical training on EBP principles, simulation-based skills training, and supervised implementation of evidence-based ICU care bundles guided by the Plan-Do-Check-Act (PDCA) cycle. The program aims to improve nurses' competency, motivation, and adherence to evidence-based practices to reduce ICU-acquired complications.

Procedure: Evidence based practices bundles of care

Control Group (Usual ICU Care)

NO INTERVENTION

Participants in this arm will continue providing routine ICU nursing care according to existing hospital policies and standard clinical guidelines. No additional EBP education or behavior change intervention will be provided during the study period. After completion of the study, participants in this arm will be offered the EBP education program.

Interventions

Participants in this arm will receive a structured evidence-based practice (EBP) education and behavior change program. The intervention includes theoretical training on EBP principles, simulation-based skills training, and supervised implementation of evidence-based ICU care bundles guided by the Plan-Do-Check-Act (PDCA) cycle. The program aims to improve nurses' competency, motivation, and adherence to evidence-based practices to reduce ICU-acquired complications.

Intervention Group (Evidence-Based Practice Implementation)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • For nurses:
  • Willing to participate in this research.
  • hold the existing position for at least three months.
  • participants were required to have at least two years of critical care experience.
  • For patients:

You may not qualify if:

  • for nurse:
  • Nurses intending to leave their jobs within the study period (five months) were excluded.
  • For patients:
  • admitted with Pressure ulcers.
  • intubated outside the NCI
  • Patients develop VAP in less than 48 hrs. after initiation of mechanical ventilation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute

Cairo, Old Cairo, Egypt

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-AssociatedPressure Ulcer

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michiko Moriyama, professor

    Hiroshima University

    STUDY DIRECTOR

Central Study Contacts

Sameh Elhabashy, Assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Development of the EBP educational program and materials: * The EBP education program (prototype, Table 1) is developed by this research team based on pedagogical method based on our research studies. Since nurses have not studied EBP and low motivation to change, this program introduces global comparison of quality indicators and online showing and exchange ICU-HUH situation by visual stimulation (awareness development). * After learning theories of EBP, each skill will be practiced in simulation training using manikins (Kyoto Kagaku, Japan \& ICU-HUH originally developed materials). Using demonstration and redomnistration. * Skills training content will be provided from ICU- HUH (CN, Okamoto). Development of the in-ward training system will be also supported by nursing department of HUH under the framework of collaboration.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 9, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations