- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07754903
Basic Trauma Training Programme for Newly Graduated Nurses in Saudi Trauma Centres (BTTS)
Evaluating the Basic Trauma Training (BTT) Programme on Workforce Sustainability Among Newly Graduated Nurses in Saudi Level One Trauma Centres: Protocol for a Two-Site, Non-Equivalent Comparison-Group Quasi-Experimental Study
New nurses often find it difficult to adjust when they start working in fast-paced, high-pressure trauma units, and many leave their jobs within the first two years. This study looks at whether a two-day training programme, called Basic Trauma Training (BTT), helps newly graduated nurses in Saudi trauma hospitals feel more confident, satisfied and engaged in their work, and more likely to stay in the nursing profession.
The study takes place at two trauma hospitals in Saudi Arabia. Because it is not practical to randomly assign nurses to groups in this real-world hospital setting, the study compares an earlier group of new nurses, who receive standard hospital orientation only, with a later group, who receive standard orientation plus the two-day BTT training. Both groups complete questionnaires before and after their orientation or training period, answering questions about job satisfaction, engagement, stress and their plans to stay in the role. The study also looks at actual staff retention using hospital employment records at 6 and 12 months. Nurses in the comparison group are offered the BTT training later, once their part of the study is complete, so that everyone has the chance to take part in the training.
Обзор исследования
Статус
Условия
Подробное описание
This is a two-site, non-equivalent comparison-group quasi-experimental study using a pre-test/post-test design. Allocation is non-random and determined by intake cohort within each participating site: an earlier intake of eligible newly graduated nurses forms the comparator group, and a subsequent intake forms the intervention group, so that study arm is not confounded with site.
The intervention, Basic Trauma Training (BTT), is a structured two-day (14 contact-hour) educational programme developed in alignment with Saudi Commission for Health Specialties (SCFHS) Specialised Professional Programme accreditation standards. It comprises five modules: trauma systems and primary survey principles; advanced trauma assessment and clinical reasoning; critical trauma interventions and patient safety; interprofessional communication and team leadership; and psychological preparedness, peer support and self-care. Delivery combines didactic teaching, high-fidelity simulation using the PEARLS debriefing framework, and facilitated reflective discussion. The comparator condition is standard institutional orientation (approximately five days of general clinical induction without trauma-specific structured training). Comparator-arm participants are offered BTT, with the same continuing professional development credit, after their follow-up assessment (waitlist design).
Individual-level randomisation was not adopted due to contamination risk between nurses working on the same unit, and because staffing and rostering decisions are governed by institutional service demand rather than research allocation. Contamination is managed through scheduling separation, controlled distribution of training materials, and a two-item contamination check at follow-up.
The primary outcome is workforce sustainability, a formative composite index of four equally weighted, standardised components: job satisfaction (MOAQ-JSS), work engagement (UWES-9), personal burnout (CBI-PB, reverse scored), and retention intention. The primary analysis is a linear mixed-effects model with a time-by-arm interaction term, adjusting for site, prior trauma exposure, months since graduation, and delivery block. Secondary outcomes include the four composite components analysed individually, role transition stress (Rizzo Role Ambiguity and Role Conflict scales), trauma-care self-efficacy, general self-efficacy (GSE-10), and actual workforce retention from institutional HR records at 6 and 12 months. An exploratory mediation analysis examines whether role transition stress and self-efficacy mediate the effect of BTT on workforce sustainability.
The study is reported in accordance with the SPIRIT 2025 statement for trial protocols and the TREND statement for non-randomised intervention evaluations, with intervention reporting following the TIDieR checklist.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Abdulaziz Sultan L. Alanazi
- Номер телефона: +966 53 113 0431
- Электронная почта: sultan.phdscholar@lincoln.edu.my
Учебное резервное копирование контактов
- Имя: Faridah Mohd Said Dr.
- Номер телефона: +60122200419
- Электронная почта: faridah.msaid@lincoln.edu.my
Места учебы
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Ulaishah / Shumaisi
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Riyadh, Ulaishah / Shumaisi, Саудовская Аравия, 12746
- King Saud Medical City
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Контакт:
- Official Contact
- Номер телефона: 0114670000
- Электронная почта: ksu@edu.sa
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Контакт:
- Back Up Contact
- Номер телефона: +966 58 218 1818
- Электронная почта: info@ksmc.med.sa
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Главный следователь:
- Abdulaziz L Alanazi
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Saudi Commission for Health Specialties (SCFHS) licensure
- Less than 12 months of post-licensure clinical experience at baseline
- Current direct patient-facing employment in a trauma-related intensive care unit at King Saud Medical City or Northern Medical Tower
- Willing and able to provide written informed consent
Exclusion Criteria:
- More than 12 months of post-licensure clinical experience
- Employment outside trauma-related ICU settings
- Agency or temporary staffing status
- Extended leave during the intervention or data-collection period
- Prior formal trauma-specific training (ATCN, TNCC) before enrolment
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Intervention (BTT)
Participants receive the Basic Trauma Training (BTT) programme, a two-day (14 contact-hour) simulation-based educational intervention, in addition to standard institutional orientation
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A structured two-day, 14-contact-hour educational programme comprising five modules: trauma systems and primary survey principles; advanced trauma assessment and clinical reasoning; critical trauma interventions and patient safety; interprofessional communication and team leadership; and psychological preparedness, peer support and self-care.
Delivered via didactic teaching, high-fidelity simulation using the PEARLS debriefing framework, and facilitated reflective discussion.
|
|
Экспериментальный: Comparator (Standard Orientation)
Participants receive standard institutional orientation only (approximately five days of general clinical induction, without trauma-specific structured training).
BTT is offered to this group after their follow-up (T1) assessment.
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Standard existing onboarding programme for newly employed nursing staff, comprising approximately five days of general clinical induction without trauma-specific structured training.
Content and duration are documented at baseline to characterise the comparator condition precisely.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Workforce Sustainability (Composite Index)
Временное ограничение: Baseline (T0) and 4-6 weeks post-intervention/orientation (T1)
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A formative composite index of four equally weighted, standardised (z-score) components: job satisfaction (Michigan Organizational Assessment Questionnaire Job Satisfaction Subscale, MOAQ-JSS, 3 items, 7-point Likert), work engagement (Utrecht Work Engagement Scale, UWES-9, 0-6 frequency scale), personal burnout (Copenhagen Burnout Inventory, CBI-PB, 6 items, 0-100 scale, reverse scored), and retention intention (validated instrument, to be finalised).
Each component is standardised using the pooled baseline mean and SD across both arms at T0, and the four standardised components are averaged.
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Baseline (T0) and 4-6 weeks post-intervention/orientation (T1)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Job Satisfaction
Временное ограничение: Baseline (T0) and 4-6 weeks post-intervention/orientation (T1)
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Measured using the Michigan Organizational Assessment Questionnaire Job Satisfaction Subscale (MOAQ-JSS, 3 items, 7-point Likert scale)
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Baseline (T0) and 4-6 weeks post-intervention/orientation (T1)
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Abdulaziz L Alanazi, Lincoln University College
- Директор по исследованиям: Faridah M Said, Lincoln University College
Публикации и полезные ссылки
Общие публикации
- Aggar C, Bloomfield J, Thomas TH, Gordon CJ. Australia's first transition to professional practice in primary care program for graduate registered nurses: a pilot study. BMC Nurs. 2017 Mar 23;16:14. doi: 10.1186/s12912-017-0207-5. eCollection 2017.
- Lyu XC, Huang SS, Ye XM, Zhang LY, Zhang P, Wang YJ. What influences newly graduated registered nurses' intention to leave the nursing profession? An integrative review. BMC Nurs. 2024 Jan 19;23(1):57. doi: 10.1186/s12912-023-01685-z.
- Rush KL, Janke R, Duchscher JE, Phillips R, Kaur S. Best practices of formal new graduate transition programs: An integrative review. Int J Nurs Stud. 2019 Jun;94:139-158. doi: 10.1016/j.ijnurstu.2019.02.010. Epub 2019 Feb 26.
- Duchscher JE. Transition shock: the initial stage of role adaptation for newly graduated registered nurses. J Adv Nurs. 2009 May;65(5):1103-13. doi: 10.1111/j.1365-2648.2008.04898.x. Epub 2009 Dec 9.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- BTT-KSMC-NMT-2026
- N1C-IRB-26-04-21 (Другой идентификатор: Institutional Review Board, Northern Border Health Cluster (Arar))
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .