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Clinical Trials/NCT05177627
NCT05177627
Unknown
Not Applicable

Integrating the Fundamentals of Care Framework Into Italian Nursing Education

University of Genova0 sites240 target enrollmentJanuary 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nursing Students
Sponsor
University of Genova
Enrollment
240
Primary Endpoint
technical and relational FOC based performance of students after internship.
Last Updated
4 years ago

Overview

Brief Summary

Research has shown a gap in what is important to patients and what is important to nurses when providing care. When the patient's fundamental needs are not recognized, such as hygiene, nutrition, mobilization, communication, he feels humiliated, ignored. The study aims to improve patient outcomes by educational interventions to integrate the Fundamental of Care (FoC) framework into nursing education.

A multi-centre randomized controlled trial will be conducted to evaluate the effectiveness of integrating the FoC framework into nursing education. Outcomes perceived by patients and their families relate to meeting the fundamental care needs.

Detailed Description

Background and Significance: Since 2010, to fill the gap in what is essential when providing care in a complex and challenging environment, both for patients and nurses, a line of research has developed to study the fundamental of nursing care. The "Fundamentals of Care (FoC) Frameworks" defines FoC as fundamental activities for the patient, through which the patient feels at the centre of care and feels attention and respect around him. The framework outlines three dimensions necessary for delivering high-quality fundamental care: the nurse-patient relationship; addressing different fundamental needs; and a context that supports these goals. A positive and trusting nurse-patient relationship is the basis for delivering fundamental care and forms the core of the framework. FOCs are often implicit or invisible in nursing education, taught as an introductory part in the first year of the course and rarely addressed in subsequent years. The study aims to improve patient outcomes by educational interventions to integrate the FUNDAMENTAL OF CARE FRAMEWORK into nursing education. Objectives: The substantive objectives of the study are: 1) To describe how nurses, internship preceptors, students and patients and their families perceive fundamental care; 2) Assessing learning process in developing FOC skills of nursing students; 3) Assessing nursing students perception of the learning environment and the supervision related to learning of FOC skills during the clinical internship; 4) Assessing the perceived outcomes of patients and their families related to meet the fundamental care needs. Design: multi-centre randomized controlled trial Sample: Students of nursing degree enrolled in the first year of the course, internship preceptors nurses who work in the internship departments of students enrolled in the first year of nursing degree, and patients over the age of 18, cognitively intact, assisted in the internship departments, who have the following three needs: (1) nutrition; (2) elimination; (3) personal hygiene will be included. Measures: All outcomes will be measured with established criteria and with instruments used in previous studies or developed by the investigators and found validated and reliable. Analysis: In addition to descriptive statistics, statistical tests to analyze differences in the scores between groups will be used to address the objectives.

Registry
clinicaltrials.gov
Start Date
January 2022
End Date
March 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Milko Zanini

Assistant Professor

University of Genova

Eligibility Criteria

Inclusion Criteria

  • All students of nursing degree enrolled in the first year of the course who will choose to participate in the study
  • All internship preceptors nurses who work in the internship departments of students enrolled in the first year of nursing degree will choose to participate in the study.
  • All patients over the age of 18 assisted in the internship departments who choose to participate in the study who have the following three needs: (1) nutrition; (2) elimination; (3) personal hygiene.

Exclusion Criteria

  • Patients who are unable to answer the questionnaire independently, with altered mental status, with hospitalization of fewer than 24 hours

Outcomes

Primary Outcomes

technical and relational FOC based performance of students after internship.

Time Frame: At the end of internship learning. (approximately 10 months after the beginning of the study)

Technical and relational performance acquired on fundamental of care will be assessed by Objective Clinical Structured Examination (OSCE). Scenarios built ad hoc for applying the FoC conceptual framework will be used as an evaluation test. Checklists will be used for the assessment of technical skills and observation grids to assess communication skills. The student communication performance will be evaluated using a validated assessment grid (Guilbert, 1990), which consist of four variables (i.e., terminology, listening, attention, and clarity), broken down into five levels of expected, observable communicative behaviours. Values between -2 and +2 will be used to evaluate every variable. Checklists consist of a list of tasks. Each task will be evaluated with a score of 0 if not performed or performed incorrectly, with a score of 1 if performed correctly. The passing score is 80% of the tasks performed correctly.

technical and relational FOC based performance of students after simulation.

Time Frame: At the end of simulation learning. (approximately 7 months after the beginning of the study)

Technical and relational performance acquired on fundamental of care will be assessed by Objective Clinical Structured Examination (OSCE). Scenarios built ad hoc for applying the FoC conceptual framework will be used as an evaluation test. Checklists will be used for the assessment of technical skills and observation grids to assess communication skills. The student communication performance will be evaluated using a validated assessment grid (Guilbert, 1990), which consist of four variables (i.e., terminology, listening, attention, and clarity), broken down into five levels of expected, observable communicative behaviours. Values between -2 and +2 will be used to evaluate every variable. Checklists consist of a list of tasks. Each task will be evaluated with a score of 0 if not performed or performed incorrectly, with a score of 1 if performed correctly. The passing score is 80% of the tasks performed correctly.

Secondary Outcomes

  • perception of nursing students on the learning environment and supervision of FOC learning during the clinical internship(Immediately after the end of students' internship (approximately 10 months after the beginning of the study))
  • Change of perception of fundamental of care by nurses, internship preceptors and students(perception of FoCs data will be collected at 3 time points: "baseline, before FoC framework training of trainers"; immediately after FoC framework training of trainers, immediately after the end of students' internship.)
  • Change of perception of nursing students about how nursing student learn the fundamentals of care(Immediately after the end of students' theoretical, simulation and internship learning (complete FoC learning path). Approximately 10 months after the beginning of the study)
  • perception of patients concerning to identification of fundamental needs and the responses received to these needs(During the students internship, at the end of hospitalization, immediately before discharge from the hospital (approximately 10 months after the beginning of the study))

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