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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

2026년 9월 15일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

140

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Mina AKTER, Doctoral Student
  • 전화번호: +8801749211811, +81-0709094627
  • 이메일: minajack417@gmail.com

연구 연락처 백업

  • 이름: Dr. Subrata Kumar Mondal, MBBS, MCPS, DA, FCPS
  • 전화번호: +88-01715437240
  • 이메일: subrata326@yahoo.com

연구 장소

  • 방글라데시
    • Dhaka Division
      • Dhaka, Dhaka Division, 방글라데시, 1000
        • Dhaka Medical College & Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위화되지 않음
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: 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.
실험적: 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.
행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence Rate of Ventilator-Associated Events
기간: 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
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Knowledge Score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hiroshima University

수사관

  • 연구 책임자: Michiko Moriyama, PhD, Professor, Division of Nursing Science, Graduate School of Biomedical and Health Sciences ,Hiroshima University,Japan

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2026년 12월 1일

연구 완료 (추정된)

2026년 12월 1일

연구 등록 날짜

최초 제출

2026년 8월 21일

QC 기준을 충족하는 최초 제출

2026년 8월 26일

처음 게시됨 (실제)

2026년 9월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 15일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BMRC/NREC/2025-2027/201

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다