Clinical trial NCT05177627: Integrating the Fundamentals of Care Framework Into Italian Nursing Education
Official title: Integrating the Fundamentals of Care Framework Into Italian Nursing Education
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nursing Students
Lead sponsor: University of Genova
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 240
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Students participating in the study will be randomly assigned to two groups:

1. experimental group with educational interventions of integration of the FoC framework (learning according to the FoC framework with the contents of the current curriculum);
2. control group without intervention (learning according to the current educational model and the contents of the current curriculum); A researcher not involved in the educational interventions and data collection of the study at the University of Genoa will randomly assign in a 1: 1 ratio the students to the two groups extracted from the lists of students provided by the universities based on a table of random numbers.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: technical and relational FOC based performance of students after simulation.
timeFrame: At the end of simulation learning. (approximately 7 months after the beginning of the study)
measure: technical and relational FOC based performance of students after internship.
timeFrame: At the end of internship learning. (approximately 10 months after the beginning of the study)
Secondary outcomes:
measure: Change of perception of fundamental of care by nurses, internship preceptors and students
timeFrame: 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.
measure: Change of perception of nursing students about how nursing student learn the fundamentals of care
timeFrame: Immediately after the end of students' theoretical, simulation and internship learning (complete FoC learning path). Approximately 10 months after the beginning of the study
measure: perception of nursing students on the learning environment and supervision of FOC learning during the clinical internship
timeFrame: Immediately after the end of students' internship (approximately 10 months after the beginning of the study)
measure: perception of patients concerning to identification of fundamental needs and the responses received to these needs
timeFrame: During the students internship, at the end of hospitalization, immediately before discharge from the hospital (approximately 10 months after the beginning of the study)
Other outcomes:
Locations:
Study officials:
affiliation: Department of Health Sciences, University of Genoa
name: Annamaria Bagnasco, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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