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Effectiveness of an Evidence-Based Respiratory and Renal Care Training With Case-Based Discussion on Nurses' Clinical Reasoning, Knowledge & Practice, Nurse-Physician Collaboration and Mechanically Ventilated Patient Outcomes in a Tertiary-Level ICU in Bangladesh

2026年9月15日 更新者：MINA AKTER、Hiroshima University

This study will evaluate the effectiveness of an evidence-based respiratory and renal care training program combined with case-based discussion on nurses' clinical reasoning, knowledge & practice, nurse-physician collaboration, as well as selected clinical outcomes among mechanically ventilated patients in a tertiary-level ICU in Bangladesh.

The intervention will provide structured education and practical training to ICU nurses on evidence-based respiratory and renal care for mechanically ventilated patients. Case-based discussions will be conducted to promote clinical reasoning, evidence-based decision-making, and nurse-physician collaboration during daily ICU rounds.

Nurses' outcomes will be assessed before and after the intervention, focusing on clinical reasoning, knowledge, practice, and nurse-physician collaboration.

Patient outcomes will be assessed using historical pre-intervention data and post-intervention data among eligible mechanically ventilated ICU patients, focusing on ventilator-associated events (VAE), ventilator-associated pneumonia (VAP), Acute Kidney Injury (AKI), duration of mechanical ventilation, ICU length of stay, and ICU mortality.

The study is intended to determine whether evidence-based respiratory and renal care training with case-based discussion can improve ICU nurses' clinical reasoning, knowledge, practice, nurse-physician collaboration and contribute to improved outcomes among mechanically ventilated patients.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Background and Rationale:

Critically ill patients requiring mechanical ventilation are at high risk of complications related to respiratory and renal dysfunction, including ventilator-associated events (VAE), ventilator-associated pneumonia (VAP), acute kidney injury (AKI), prolonged mechanical ventilation, prolonged intensive care unit (ICU) stay, and death. Prevention, early recognition, and appropriate management of these complications require ICU nurses to possess adequate knowledge, clinical reasoning ability, practical skills, and effective communication and collaboration with physicians and other members of the ICU team.

In resource-limited settings, including Bangladesh, gaps in ICU staffing, continuing professional education, standardized clinical practices, and multidisciplinary communication may affect the quality and safety of care provided to mechanically ventilated patients. Evidence-based training that combines theoretical education with practical application and case-based clinical discussion may improve nurses' ability to recognize patient deterioration, interpret clinical findings, apply evidence-based interventions, and communicate effectively with physicians and other ICU professionals.

This study will evaluate an evidence-based respiratory and renal care training program combined with structured case-based discussion for ICU nurses in a tertiary-level ICU in Bangladesh. The intervention is designed to strengthen nurses' clinical reasoning, knowledge, clinical practice, and nurse-physician collaboration in the care of mechanically ventilated patients.

The study will also examine whether improvements in nursing competency and collaborative clinical decision-making are associated with improved patient outcomes.

研究类型

介入性

注册 (估计的)

140

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Mina AKTER, Doctoral Student
  • 电话号码：+8801749211811, +81-0709094627
  • 邮箱：minajack417@gmail.com

研究联系人备份

  • 姓名：Dr. Subrata Kumar Mondal, MBBS, MCPS, DA, FCPS
  • 电话号码：+88-01715437240
  • 邮箱：subrata326@yahoo.com

学习地点

  • 孟加拉国
    • Dhaka Division
      • Dhaka、Dhaka Division、孟加拉国、1000
        • Dhaka Medical College & Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

For nurses:

  • Registered nurses employed in the ICU at the time of enrollment
  • Involved in direct patient care
  • Willing to participate and provide informed written consent

For Patients:

  • Age ≥18 years
  • Patients receive mechanical ventilation for at least ≥ 48 hours
  • Legal guardian of the patients who will provide informed written consent

Exclusion Criteria:

For nurses:

  • Nurses on long-term leave and study leave during the intervention period
  • Nurses working exclusively in administrative or managerial roles
  • Nurses who did not complete the pre-test assessment

For Patients:

  • Patients mechanically ventilated for less than 48 hours.
  • Patients who have already developed VAE or VAP at ICU admission
  • Patients with end-stage renal disease on chronic dialysis prior to ICU admission
  • Readmissions to ICU during the same hospital stay

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：非随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：Historical Control group-Eligible mechanically ventilated ICU patients with usual standard care
Eligible mechanically ventilated ICU patients received usual standard ICU care before implementation of the intervention. Historical patient data will be collected from medical records. ICU nurses will be assessed at baseline before receiving the intervention. No study intervention was administered during this phase.
实验性的：Experimental-Eligible mechanically ventilated ICU patients with intervention
ICU nurses will receive evidence-based respiratory and renal care training with case-based discussion to strengthen clinical reasoning, nurse-physician collaboration, and application of evidence-based ICU care. Eligible mechanically ventilated ICU patients will receive evidence based care after implementation of the intervention, and their outcomes will be measured.
行为的：evidence-based respiratory and renal care training with case-based discussion

The intervention will be provided over 2 months period. The evidence-based respiratory and renal care training will address respiratory assessment and monitoring, oxygen therapy and airway care, mechanical ventilation basics and ventilator care bundle practices, sedation, weaning and early mobilization, renal assessment and early detection of AKI based on kidney disease: Improving Global Outcomes (KDIGO) criteria, AKI prevention & Renal Care Bundle, fluid balance and hemodynamic monitoring, Electrolyte & Acid-Base Management.

During daily ICU rounds, 10-15-minute bedside case discussions will be conducted for each mechanically ventilated ICU patients. An ICU consultant will facilitate the discussion using the ISBAR framework, involving the bedside nurse and other ICU team members. Each discussion will focus on the patient's current clinical condition, respiratory and renal assessment, interpretation of clinical findings, evidence-based care decisions, and appropriate management.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence Rate of Ventilator-Associated Events
大体时间：During the 2-month pre-intervention and the 2-month post-intervention observation period
The incidence rate of ventilator-associated events (VAE) among eligible mechanically ventilated ICU patients will be calculated as the number of VAE cases divided by the total number of ventilator days, multiplied by 1,000. VAE incidence will be compared between the pre-intervention and post-intervention periods.
During the 2-month pre-intervention and the 2-month post-intervention observation period
Change in Clinical Reasoning Competency Score
大体时间：Baseline, midline, and 2-month post-intervention follow-up (endline)
Clinical reasoning will be measured among participating ICU nurses using the 22-item Clinical Reasoning Competency Scale developed by Bae et al. (2023). Each item is rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), with a total score ranging from 22 to 110. Higher scores indicate greater clinical reasoning competency. The total CRCS score will be assessed at baseline, midline, and endline. Baseline assessment will be conducted before the intervention, midline assessment will be conducted during the intervention period, and endline assessment will be conducted 2 months after completion of the intervention as a post-intervention follow-up. Changes in clinical reasoning competency across the three assessment time points will be evaluated.
Baseline, midline, and 2-month post-intervention follow-up (endline)

次要结果测量

结果测量
措施说明
大体时间
Change in Knowledge Score
大体时间：Baseline, immediately post-intervention (midline), and 2-month post-intervention follow-up (endline)
knowledge will be assessed among participating ICU nurses using a 50-item researcher-developed multiple-choice questionnaire. Each correct response will receive one point, resulting in a total score ranging from 0 to 50. Higher scores indicate greater knowledge. The total knowledge score will be assessed at baseline, midline, and endline. Changes in knowledge across the three assessment time points will be evaluated.
Baseline, immediately post-intervention (midline), and 2-month post-intervention follow-up (endline)
Change in Nurses Practice Score
大体时间：Baseline, immediately post-intervention (midline), and 2-month post-intervention follow-up (endline)
ICU nurses practice will be assessed among participating ICU nurses using a 40-item practice checklist covering evidence-based respiratory and renal care practices. The total practice score will be calculated according to the predefined scoring procedure, with higher scores indicating better adherence to recommended clinical practices. The practice score will be assessed at baseline, midline, and endline. Changes in nursing practice across the three assessment time points will be evaluated.
Baseline, immediately post-intervention (midline), and 2-month post-intervention follow-up (endline)
Incidence Rate of Ventilator-Associated Pneumonia
大体时间：During the 2-month pre-intervention and the 2-month post-intervention observation period
The incidence rate of ventilator-associated pneumonia (VAP) will be assessed among eligible mechanically ventilated ICU patients. VAP will be identified according to the predefined diagnostic criteria specified in the study protocol. The VAP incidence rate will be calculated as the number of VAP cases divided by the total number of ventilator days, multiplied by 1,000. The incidence rate will be compared between the pre-intervention and post-intervention periods.
During the 2-month pre-intervention and the 2-month post-intervention observation period
Incidence of Acute Kidney Injury
大体时间：During the 2-month pre-intervention and the 2-month post-intervention observation period
The incidence of acute kidney injury (AKI) will be assessed among eligible ICU patients according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. AKI will be identified based on the predefined clinical and laboratory criteria specified in the study protocol. The proportion of patients who develop AKI during their ICU stay will be compared between the pre-intervention and post-intervention periods.
During the 2-month pre-intervention and the 2-month post-intervention observation period
ICU Mortality
大体时间：During the 2-month pre-intervention and the 2-month post-intervention observation period
ICU mortality will be defined as death occurring during the ICU admission among eligible patients. The proportion of patients who die during their ICU stay will be compared between the pre-intervention and post-intervention periods.
During the 2-month pre-intervention and the 2-month post-intervention observation period
Duration of Mechanical Ventilation
大体时间：During the 2-month pre-intervention and the 2-month post-intervention observation period
Duration of mechanical ventilation will be measured as the number of days from initiation of invasive mechanical ventilation until successful discontinuation of mechanical ventilation. The duration of mechanical ventilation will be compared between eligible patients in the pre-intervention and post-intervention periods.
During the 2-month pre-intervention and the 2-month post-intervention observation period
ICU Length of Stay
大体时间：During the 2-month pre-intervention and the 2-month post-intervention observation period
ICU length of stay will be measured as the number of days from ICU admission until ICU discharge or death. ICU length of stay will be compared between eligible patients in the pre-intervention and post-intervention periods.
During the 2-month pre-intervention and the 2-month post-intervention observation period
Change in Nurse-Physician Collaboration Score
大体时间：Baseline, immediately post-intervention (midline), and 2-month post-intervention follow-up (endline)
Nurse-physician collaboration will be assessed among participating ICU nurses using the Nurse-Physician Collaboration Scale developed by Ushiro (2009).Each item is rated on a 5-point Likert scale (1 = always to 5 = never), with a total score ranging from 27 to 135. Higher scores indicate poorer nurse-physician collaboration. Baseline assessment will be conducted before the intervention, midline assessment immediately after completion of the training intervention, and endline assessment 2 months after completion of the intervention as a post-intervention follow-up. Changes in nurse-physician collaboration across the three assessment time points will be evaluated.
Baseline, immediately post-intervention (midline), and 2-month post-intervention follow-up (endline)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hiroshima University

调查人员

  • 研究主任：Michiko Moriyama, PhD、Professor, Division of Nursing Science, Graduate School of Biomedical and Health Sciences ,Hiroshima University,Japan

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2026年8月21日

首先提交符合 QC 标准的

2026年8月26日

首次发布 (实际的)

2026年9月1日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BMRC/NREC/2025-2027/201

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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