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

NCT07796724 | Not Yet Recruiting DMC

• 1 other identifier: BMRC/NREC/2025-2027/201
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventilator-Associated Events; Acute Kidney Injury; Clinical Reasoning

Keywords

VAE

Outcome Measures

Primary Outcomes (2)

• Change in Clinical Reasoning Competency Score

  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)

• Incidence Rate of Ventilator-Associated Events

  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

Secondary Outcomes (8)

• Change in Knowledge Score

  Baseline, immediately post-intervention (midline), and 2-month post-intervention follow-up (endline)

• Change in Nurses Practice Score

  Baseline, immediately post-intervention (midline), and 2-month post-intervention follow-up (endline)

• Change in Nurse-Physician Collaboration Score

  Baseline, immediately post-intervention (midline), and 2-month post-intervention follow-up (endline)

• Incidence Rate of Ventilator-Associated Pneumonia

  During the 2-month pre-intervention and the 2-month post-intervention observation period

• Incidence of Acute Kidney Injury

  During the 2-month pre-intervention and the 2-month post-intervention observation period

Study Arms (2)

Historical Control group-Eligible mechanically ventilated ICU patients with usual standard care

NO INTERVENTION

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.

Experimental-Eligible mechanically ventilated ICU patients with intervention

EXPERIMENTAL

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.

Behavioral: evidence-based respiratory and renal care training with case-based discussion

Interventions

evidence-based respiratory and renal care training with case-based discussion BEHAVIORAL

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.

Experimental-Eligible mechanically ventilated ICU patients with intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hiroshima University: lead

Study Sites (1)

Dhaka Medical College & Hospital

Dhaka, Dhaka Division, 1000, Bangladesh

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Michiko Moriyama, PhD

  Professor, Division of Nursing Science, Graduate School of Biomedical and Health Sciences ,Hiroshima University,Japan

  STUDY DIRECTOR

Central Study Contacts

Mina AKTER, Doctoral Student

CONTACT

+8801749211811, +81-0709094627; minajack417@gmail.com

Dr. Subrata Kumar Mondal, MBBS, MCPS, DA, FCPS

CONTACT

+88-01715437240; subrata326@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a sequential, two-arm, quasi-experimental study conducted in two phases. In the pre-intervention phase, baseline nurses' outcomes will be assessed, and historical data will be collected from eligible mechanically ventilated ICU patients who received usual care before implementation of the intervention. In the post-intervention phase, ICU nurses will receive the Training with Case-based Discussion Program, followed by assessment of nurses' outcomes. Patient outcomes will be assessed among eligible mechanically ventilated ICU patients receiving care after implementation of the intervention and compared with the historical pre-intervention patient group.

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-08

Locations

BA (1)