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NCT Number: NCT07820826

Theory-Based Educational Program for VAP Prevention and Nursing Care in Intensive Care Units

Ventilator-associated pneumonia (VAP) is an important challenge in intensive care and requires nurses to apply evidence-based preventive practices consistently in mechanically ventilated patients. This multicenter cluster-randomized controlled trial evaluates the effectiveness of a theory-based structured educational program designed to improve VAP prevention knowledge, reflective nursing practice related to invasive mechanical ventilation, quality of nursing care, and family satisfaction with intensive care unit (ICU) care. The program integrates evidence-based VAP prevention education with clinical decision-making, case-based learning, simulation, reflective exercises, structured debriefing, and practice-improvement planning. Adult ICU nurses working in Ministry of Health hospitals in Jordan are assigned by ICU cluster to either the educational intervention or usual care. Outcomes are assessed at baseline, immediately after the intervention, and six months after completion to evaluate immediate effects and sustainability. VAP prevention knowledge is the primary outcome, while reflective nursing practice, quality of nursing care, and family satisfaction with ICU care are secondary outcomes.

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Key information

About this study

This study is a national, multicenter, two-arm, parallel-group cluster-randomized controlled trial evaluating a theory-based structured educational program for nurses working in adult intensive care units (ICUs) affiliated with the Ministry of Health in Jordan. Cluster randomization is conducted at the ICU level to reduce contamination among nurses working within the same clinical environment.

The educational program is theoretically grounded in Schön's Reflective Practice Theory and was developed to support the integration of evidence-based VAP prevention knowledge with clinical reasoning and reflective nursing practice. The program consists of four weekly educational sessions, each lasting approximately three hours, for a total of approximately 12 contact hours. Educational strategies include interactive lectures, case-based learning, group discussion, clinical scenarios, demonstration, simulation-based learning, reflective exercises, structured debriefing, and practice-improvement planning.

The first session focuses on VAP prevention knowledge and clinical decision-making, including VAP risk factors, mechanisms contributing to VAP development, evidence-based preventive practices, oral care, positioning, airway and secretion management, aspiration prevention, hand hygiene, and relevant ventilator-care bundle components. The second session addresses nursing care of mechanically ventilated patients and the integration of reflective practice into routine ICU care. The third session uses simulation-based clinical scenarios involving mechanically ventilated patients and is followed by structured reflective debriefing. The fourth session integrates the major concepts, addresses barriers to implementation, and supports the development of individualized practice-improvement plans.

Participants in the control group receive usual institutional care and education. Routine institutional education and patient-safety procedures are not withheld. The study-specific structured educational program is not provided to control ICUs during the active intervention period.

Study outcomes are assessed at three prespecified time points: baseline (T0), immediately after completion of the educational program (T1), and six months after intervention completion (T2). The primary outcome is VAP prevention knowledge. Secondary nurse-level outcomes include reflective nursing practice related to invasive mechanical ventilation and quality of nursing care. Family satisfaction with ICU care is evaluated as a family-level secondary outcome using the FS-ICU 24R. Family respondents are recruited independently of participating nurses and are linked to the relevant ICU and assessment period rather than to individual nurses.

The primary treatment effect is evaluated by examining the difference in change between intervention and control groups over time, with particular emphasis on the group-by-time interaction from baseline to the immediate post-intervention assessment. The six-month assessment evaluates retention and sustainability of intervention effects. Longitudinal analyses account for the clustered nature of the trial and repeated measurements.

The study was conducted among attending nurses working in intensive care units affiliated with the Ministry of Health (MOH), Jordan, during the period from August 2025 to February 2026.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Registered nurses employed by a participating Ministry of Health hospital in Jordan.
  • Nurses assigned to a participating adult intensive care unit (ICU).
  • Nurses providing direct patient care to mechanically ventilated or critically ill patients.
  • Nurses with sufficient clinical experience to participate in the study procedures.

Willingness to participate voluntarily and provide written informed consent.

Exclusion criteria

  • Administrative nurses without direct bedside responsibilities.
  • Nurses on extended leave during the intervention period.
  • Nurses expected to leave the participating ICU before completion of the immediate post-intervention assessment.

Treatment and study plan

Theory-Based Structured Educational Program

Behavioral

A standardized, theory-based structured educational program developed for ICU nurses and grounded in Schön's Reflective Practice Theory. The program consists of four weekly sessions, each lasting approximately three hours, for approximately 12 total contact hours. The sessions integrate evidence-based VAP prevention education, clinical decision-making, invasive mechanical ventilation nursing care, case-based learning, simulation-based learning, reflective exercises, structured debriefing, and practice-improvement planning. The intervention is designed to support the application of VAP prevention knowledge through clinical reasoning and reflective nursing practice.

Usual Care

Behavioral

Usual institutional care and education provided to ICU nurses according to routine hospital policies and clinical practices. Routine institutional education, patient-safety procedures, and standard clinical care are not withheld. The study-specific theory-based structured educational program is not provided to control ICUs during the active intervention period.

Primary outcomes

  1. VAP Prevention Knowledge

    Time frame: Baseline (T0) to immediately post-intervention (T1), with a six-month follow-up assessment (T2) to evaluate retention and sustainability.

    VAP prevention knowledge among ICU nurses, assessed using the validated VAP knowledge questionnaire developed by Labeau et al. Higher scores indicate greater knowledge regarding VAP prevention.

Secondary outcomes

  1. Reflective Nursing Practice Related to Invasive Mechanical Ventilation

    Time frame: Baseline (T0), immediately post-intervention (T1), and six months after intervention completion (T2).

    Reflective nursing practice related to invasive mechanical ventilation, assessed using the Questionnaire for Reflective Practice of Nursing Involving Invasive Mechanical Ventilation (Q-RPN-IMV). Higher scores indicate a greater level of reflective nursing practice.

  2. Quality of Nursing Care in the Intensive Care Unit

    Time frame: Baseline (T0), immediately post-intervention (T1), and six months after intervention completion (T2).

    Quality of nursing care in the ICU, assessed using the Quality of Nursing Care Scale-ICU. Higher scores indicate better quality of nursing care according to the instrument's established scoring framework.

  3. Family Satisfaction with ICU Care

    Time frame: Baseline (T0), immediately post-intervention (T1), and six months after intervention completion (T2).

    Family satisfaction with ICU care, assessed at the family level using the Family Satisfaction in the ICU (FS-ICU 24R). The outcome reflects family members' satisfaction with ICU care, including satisfaction with care and decision-making and communication.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

JAWAD AHMAD ABU-SHENNAR

Other

Registry information

Official study title

Effectiveness of a Theory-Based Structured Educational Program on VAP Prevention Knowledge, Reflective Nursing Practice, Quality of Nursing Care, and Family Satisfaction With ICU Care: A Multicenter Cluster-Randomized Controlled Trial

Acronym: TSEP-VAP-2026

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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