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Набор скоро начнётся NCT07360366

Interprofessional Collaboration in the Cardiac Intensive Care Unit (CICU): An Action-Research Training Project

Без фазы С лечением Interprofessional Relations Interprofessional Education Attitude of Health Personnel Intensive Care Units

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: The training phase of the project consists of an interactive course aimed at healthcare professionals (physicians, nurses and OSS) to improve their ability to recognise and enact effective collaborati.
Кому может быть актуально
Состояния в реестре: Interprofessional Relations, Interprofessional Education, Attitude of Health Personnel, Intensive Care Units. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Обзор

This study evaluates the impact of a structured interprofessional training program on daily collaboration within the Cardiac Intensive Care Unit (CICU/UTIC) at the University Hospital of Parma. In high-intensity clinical settings, rapid and accurate coordination between physicians, nurses, and healthcare assistants is vital. Ineffective teamwork often leads to communication breakdowns, potentially compromising patient safety and care quality. This project investigates whether an interactive, scenario-based educational program can strengthen role clarity, communication, and shared decision-making. The study seeks to determine if an active-learning program using interactive branching scenarios improves interprofessional collaboration more effectively than traditional methods. The researchers hypothesize that this simulation-based approach will significantly enhance professional outcomes, including self-efficacy, shared decision-making, and commitment to both the team and the profession. The study utilizes a convenience sample (approx. 5 physicians, 30 nurses, 8 healthcare assistants, and 10 students). Eligible participants include staff and students currently or recently active in the Parma CICU who provide informed consent. The intervention is delivered via a Moodle-based platform featuring case-based simulations. These scenarios replicate complex clinical pathways, such as: Cath-lab and Electrophysiology procedures. Heart failure management. TAVI (Transcatheter Aortic Valve Implantation) preparation. As participants navigate these scenarios, they must make critical decisions and receive immediate feedback designed to reinforce collaborative best practices. Data Collection and Timeline Data is gathered at three intervals: T0 (Baseline), T1 (Post-training), and T2 (6-month follow-up). Validated questionnaires measure: Attitudes toward physician-nurse collaboration. Perceived daily collaboration and decision-making satisfaction. Professional commitment and work-related self-efficacy. The training phase spans six months, with a subsequent six-month follow-up, totaling a 24-month project duration. Ethics and Privacy Risks are minimal, primarily involving the time required for participation. The primary benefit is the development of skills that foster safer, more coordinated patient care. Privacy is strictly maintained through pseudo-anonymization, with data access restricted to the research team.

Подробное описание

Background and Rationale Interprofessional collaboration is critical for patient safety and organizational efficiency in high-complexity environments like the Cardiac Intensive Care Unit (CICU). Despite its importance, there is a lack of structured, transferable training models for daily clinical practice. Poor cooperation is linked to preventable adverse events and caregiver burnout. This study, promoted by the Azienda Ospedaliero-Universitaria di Parma, addresses this gap using an "action-research" approach integrated with digital tools for situated learning.

Study Design and Intervention This is a longitudinal, prospective study. The intervention consists of a specialized training program using interactive branching scenarios created with H5P software and hosted on a Moodle-based platform. These simulations replicate complex clinical situations across four key CICU pathways:

Hemodynamics. Electrophysiology. Heart Failure. TAVI (Transcatheter Aortic Valve Implantation) preparation. The program requires learners to make clinical and collaborative decisions, receiving immediate feedback to improve teamwork, role clarity, and communication.

Data Collection and Analysis The study evaluates outcomes at three specific intervals:

T0: Baseline (pre-intervention). T1: Post-intervention (immediately following training). T2: Follow-up at six months to evaluate sustainability Assessment tools include the Jefferson Scale of Attitudes Toward Physician-Nurse Collaborative Relationship (JSAPNC) , the Nurse-Physician Collaboration Scale (NPCS) , and the Maslach Burnout Inventory (MBI) for self-efficacy. Statistical evaluation will utilize Linear Mixed Models (LMM) to analyze longitudinal changes and individual trajectories.Ethics and Data Management The study follows a pseudo-anonymized data protocol, with access restricted to the research team. Participants provide written informed consent prior to enrollment. The project duration is estimated at 24 months.

The study is projected to commence on February 15, 2026.

Вмешательства

  • Другое The training phase of the project consists of an interactive course aimed at healthcare professionals (physicians, nurses and OSS) to improve their ability to recognise and enact effective collaborati
    The branching scenarios replicate complex and common clinical situations that require effective interprofessional collaboration. Each scenario is carefully designed with detailed clinical and organisational elements, including the simulated patient's medical history and care pathway in the cath-lab and electrophysiology unit prior to a TAVI procedure, vital signs, diagnostic tests, available resources, clinical objectives, and potential critical issues. Scenarios are structured around a defined

Первичные конечные точки

  • Name of the measurement: Change from Baseline in Mean Attitudes Toward Physician-Nurse Interprofessional Collaboration Score at 6 Months [Срок оценки: Baseline (T0), immediately post-training (T1: approximately 1 month after baseline), and at 6-month follow-up (T2: 6 months after the intervention).]
  • Name of the measurement: Change from Baseline in Mean Perceived Interprofessional Collaboration Score at 6 Months as Assessed by the Nurse-Physician Collaboration Scale (NPCS) [Срок оценки: T0 (Baseline): Before the start of the training intervention. T1 (Post-intervention): Immediately following the completion of the 6-month training program. T2 (Follow-up): Six months after the conclusion of the training to evaluate the sustainability]
  • Name of the measurement:Change from Baseline in Mean Collaboration and Satisfaction with Care Decisions (CSACD) Score at 6 Months. Measurement tool: Collaboration and Satisfaction with Care Decisions (CSACD) Scale [Срок оценки: T0: Baseline (before the training intervention). T1: Post-intervention (immediately following the 6-month training period). T2: Long-term follow-up (6 months after completing the training).]
  • Name of the measurement: Change from Baseline in Mean Professional and Team Commitment Scores at 6 Months as Assessed by the Professional and Team Commitment Questionnaire. Tool measurement: Professional and Team Commitment Questionnaire [Срок оценки: T0: Baseline (prior to the training intervention). T1: Post-intervention (immediately following the 6-month training period). T2: Follow-up (6 months after the completion of the training).]
  • Name of the measurement: Change from Baseline in Mean Work-related Self-Efficacy Score at 6 Months as Assessed by the Personal Accomplishment Subscale of the MBI Measurement tool: Maslach Burnout Inventory (MBI) - Personal Accomplishment Subscale [Срок оценки: Baseline (T0), immediately post-training (T1: ~1 month), and 6-month follow-up (T2).]

Критерии участия

Критерии включения

  • Healthcare professionals (physicians, nurses and healthcare assistants/OSS) employed in the Cardiac Intensive Care Unit (UTIC) of the University Hospital of Parma.
  • Healthcare professionals who have completed the training pathway and are still working in the unit at the time of the six-month follow-up.
  • Medical and nursing students who have carried out or are carrying out a clinical placement within the UTIC.
  • Ability to use a computer or mobile device, essential for participating in the online training activities (e.g. Moodle, H5P).
  • Provision of written informed consent before initiation of any study procedure.

Критерии исключения

  • Healthcare professionals who do not work in the cardiology setting or who are not employed in the UTIC of the AOU Parma.
  • Inability to participate in the training activities or assessment sessions for logistical, organisational or clinical reasons (e.g. planned prolonged absences during the study period).
  • Refusal or inability to provide informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Италия · 1 центр
  • Parma University Hospital — Parma

Идентификаторы

NCT: NCT07360366 · 502/2025/OSS /AOUPR

Первоисточники (государственные реестры)

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