Parma University Hospital
Parma, Emilia-Romagna, 43126, Italy
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Alfonso Sollami Co-investigator
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Santina Gavagni Principal Investigator
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NCT Number: NCT07360366
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.
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Interventional
Not applicable
Parma, Emilia-Romagna, 43126, Italy
Alfonso Sollami Co-investigator
CONTACT
Santina Gavagni Principal Investigator
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 storyline and professional roles, and are divided into key phases with information, possible actions, and related consequences. Interactive elements allow learners to make decisions and engage with characters or objects, while meaningful feedback supports learning. Multiple pathways ensure a dynamic experience, supported by assessment criteria.
Time frame: Baseline (T0), immediately post-training (T1: approximately 1 month after baseline), and at 6-month follow-up (T2: 6 months after the intervention).
Measurement tool: Jefferson Scale of Attitudes Toward Physician-Nurse Collaborative Relationship (JSAPNC); Unit of measure: Mean total score on the Jefferson Scale of Attitudes toward Physician-Nurse Collaboration;Attitudes toward physician-nurse interprofessional collaboration will be assessed using JSAPNC, a structured, self-administered questionnaire designed to evaluate attitudes toward collaborative relationships between physicians and nurses. JSAPNC assesses key aspects of physician-nurse collaboration, including mutual respect, shared responsibility, teamwork, and professional roles. Participants respond to a series of items using a standardized response scale, and item responses are combined to generate a total score representing overall attitudes toward physician-nurse interprofessional collaboration. Higher total scores indicate more positive attitudes toward collaboration. The outcome measure is defined as the change in mean JSAPNC total score from baseline to 6 months.
Time frame: 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
Measurement tool: Nurse-Physician Collaboration Scale (NPCS).Unit of measure: Mean total score on the Nurse-Physician Collaboration Scale (NPCS). Perceived interprofessional collaboration will be assessed using the Nurse-Physician Collaboration Scale (NPCS), a structured, self-administered questionnaire designed to evaluate nurses' and physicians' perceptions of interprofessional collaboration. The NPCS assesses key dimensions of nurse-physician collaboration, including communication, shared decision-making, coordination of care, and professional relationships. Participants respond to a series of items using a standardized response scale, and item responses are combined to generate a total score representing the overall level of perceived interprofessional collaboration. Higher total scores indicate greater perceived collaboration. The outcome measure is defined as the change in mean NPCS total score from baseline to 6 months.
Time frame: 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).
Unit of measure: Mean total score on the Collaboration and Satisfaction with Care Decisions (CSACD) scale.
Perceived collaboration and satisfaction with care decisions will be assessed using the Collaboration and Satisfaction with Care Decisions (CSACD) Scale, a validated, structured, self-administered questionnaire. The CSACD includes 9 items, with a Collaboration subscale (7 items) and a Satisfaction subscale (2 items), rated on a 7-point Likert scale. Item responses are combined to generate a total score representing overall perceived collaboration and satisfaction with care decisions. The outcome measure is defined as the change in mean CSACD total score from baseline to 6 months.
Time frame: 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).
Unit of measure: Mean subscale scores on the Professional Commitment scale (12 items; range 12-60) and the Team Commitment scale (5 items; range 5-25). Professional and team commitment will be assessed using the Professional and Team Commitment Questionnaire, a structured, self-administered questionnaire designed to evaluate levels of commitment to one's profession and to the interprofessional team. The questionnaire assesses key dimensions of professional and team commitment, including identification with professional roles, engagement in team activities, and commitment to collaborative work. Participants respond to a series of items using a standardized response scale, and item responses are combined to generate a total score representing overall professional and team commitment. Higher total scores indicate greater levels of professional and team commitment. The outcome measure is defined as the change in mean Professional and Team Commitment total score from baseline to 6 months.
Time frame: Baseline (T0), immediately post-training (T1: ~1 month), and 6-month follow-up (T2).
Unit of measure: Mean score on the Personal Accomplishment subscale of the Maslach Burnout Inventory (MBI).
Work-related self-efficacy will be assessed using the Personal Accomplishment Subscale of the Maslach Burnout Inventory (MBI), a structured, self-administered questionnaire designed to evaluate individuals' feelings of competence and achievement in their professional work. The Personal Accomplishment Subscale measures key aspects of work-related self-efficacy, including perceived effectiveness, accomplishment, and competence in performing job-related tasks. Participants respond to a series of items using a standardized response scale, and item responses are combined to generate a total subscale score representing overall work-related self-efficacy. Higher scores indicate greater work-related self-efficacy. The outcome measure is defined as the change in mean Personal Accomplishment subscale score from baseline to 6 months.
Contact information is provided by the study sponsor or research team.
Alfonso Sollami Co - Investigator
CONTACT
Santina Gavagni Principal Investigator
CONTACT
Azienda Ospedaliero-Universitaria di Parma
Other
Acronym: COLLUTIC_25
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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