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临床试验/NCT07820826
NCT07820826已完成不适用

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

JAWAD AHMAD ABU-SHENNAR1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
600
试验地点
1
主要终点
VAP Prevention Knowledge

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Theory-Based Structured Educational Program

Experimental

Participants in ICUs assigned to the intervention group receive a theory-based structured educational program designed to improve VAP prevention knowledge, reflective nursing practice related to invasive mechanical ventilation, and quality of nursing care. The program consists of four weekly sessions of approximately three hours each and incorporates interactive education, case-based learning, clinical scenarios, simulation, reflective exercises, structured debriefing, and practice-improvement planning.

干预措施: Theory-Based Structured Educational Program (Behavioral)

Usual Care

Active Comparator

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

干预措施: Usual Care (Behavioral)

结局指标

主要结局

VAP Prevention Knowledge

时间窗: 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.

次要结局

  • Reflective Nursing Practice Related to Invasive Mechanical Ventilation(Baseline (T0), immediately post-intervention (T1), and six months after intervention completion (T2).)
  • Quality of Nursing Care in the Intensive Care Unit(Baseline (T0), immediately post-intervention (T1), and six months after intervention completion (T2).)
  • Family Satisfaction with ICU Care(Baseline (T0), immediately post-intervention (T1), and six months after intervention completion (T2).)

研究者

发起方
JAWAD AHMAD ABU-SHENNAR
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

JAWAD AHMAD ABU-SHENNAR

ASST.PROF.DR

Jerash Private University

研究点 (1)

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