Integrating the Fundamentals of Care Framework Into Italian Nursing Education (FoC-FORM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nursing Students
• Intervention / Treatment: Other: Theoretical and classroom learning interventions; Other: Simulation interventions; Other: Internship interventions

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gianluca Catania, Dr; Phone Number: 00390103538485; Email: gianluca.catania@edu.unige.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fundamental of Care Framework implementation; Educational interventions related to introduction of FoC framework and taking charge of patients and their fundamental needs will be realized during theoretical, simulation and internship learning.	Other: Theoretical and classroom learning interventions; aim of intervention: introduce students to the conceptual framework of fundamental of care, focus on three dimensions necessary for the delivery of high-quality fundamental care (the nurse-patient relationship; addressing different fundamental needs; and a context that supports these goals) components and activities: educational interventions to understand how the communication and the relationship of trust between nurse and patient are the prerequisites for high quality nursing care;; drawing attention to five essential relational elements for establishing the nurse-patient relationship (Trust; Focus; Anticipate; Know; Evaluate) mode of delivery: classroom lessons on philosophies and theories on communication and trust; small-group learning on realistic cases focused on fundamental needs to develop reflexivity, analytical skills, investigation duration of the intervention: 12 hours of theoretical and classroom learning; Other: Simulation interventions; aim of intervention: To develop active listening and use of non-verbal and verbal communication skills to establish a therapeutic relationship based on compassion, trust and respect; to apply the FoC conceptual framework, reflexivity and analytical skills to meet patient fundamental needs. Students will express these goals during simulation activities with behaviours outlined by the FoC framework. components and activities: - Implementation of communication simulation activities to develop interaction skills with patients; Implementation of simulation activities to apply the FoC conceptual framework and reflection to meet patient fundamental needs in realistic scenarios. mode of delivery: - simulation activities on communication and trust Use ad hoc validated scenarios to apply the FoC conceptual framework to develop reflection and meet patient fundamental needs. duration of the intervention: 25 hours; Other: Internship interventions; Aim of intervention: to apply active listening and non-verbal communication skills; to use the FoC conceptual framework, reflexivity, and analytical skills to meet patient fundamental needs. Students will express these goals during simulation activities with behaviours outlined by the FoC framework. components and activities: - to establish effective and trusting communication with patients to demonstrate compassion and respect and to enable patients to remain calm, involved and dignified; to apply the FoC conceptual framework to meet patient fundamental needs. mode of delivery: attendance of clinical internship; analysis and reflections guided by the clinical preceptor on real cases using elements of FoC conceptual framework. duration of the intervention: 150 hours of internship.
No Intervention: No Fundamental of Care Framework implementation; the participants of no intervention group will receive the standard training as scheduled on the curriculum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
technical and relational FOC based performance of students after simulation.	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.	At the end of simulation learning. (approximately 7 months after the beginning of the study)
technical and relational FOC based performance of students after internship.	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.	At the end of internship learning. (approximately 10 months after the beginning of the study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of perception of fundamental of care by nurses, internship preceptors and students	All nurses working in the internship departments will be asked to answer the questionnaire that investigates how nurses perceive fundamental care concerning the importance, the frequency of implementation and the degree of responsibility perceived. The nursing perception questionnaire on fundamental nursing care consists of 4 sections (evaluation for every 13 fundamental needs in terms of importance recognized by organization and nurses, frequency of implementation, degree of responsibility perceived, need to have advanced competencies). The tool uses a five-point Likert scale and yes/no answers.	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	Skills acquired on fundamental of care will be assessed and how the learning process helps develop them by 'Fundamentals of Care' Learning Questionnaire - Basic Care Revised The questionnaire consists of 46 questions and uses a 4-point Likert scale to express the degree of agreement concerning learning fundamental of care and how it was learned (lesson or internship)	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 nursing students on the learning environment and supervision of FOC learning during the clinical internship	The Clinical Learning Environment, Supervision and Nurse Teacher Scale (CLES+T) scale consists of 34 statements divided into five sub-dimensions: "Pedagogical atmosphere on the ward" (nine items), "Leadership style of the ward manager" (four items), "Premises of nursing on the ward" (four items), "Supervisory relationship" (eight items) and "Role of the nurse teacher (NT)" (nine items). The CLES + T items are responded to on a 5-point Likert-type scale with higher values indicating more significant agreement with the statement.	Immediately after the end of students' internship (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	Patients will be asked to complete a questionnaire to evaluate: the perception of fundamental needs present during the hospitalization;; identification of fundamental needs, indicated as being present by the patients, by the students during their internship;; effectiveness of interventions implemented by the clinical-care team to respond of fundamental needs indicated by patients The patient FoC outcomes questionnaire consists of 12 questions divided into five sub-dimensions: "Communication and education", "relationship", "Nutrition and hydration" , "Elimination" and "Personal hygiene and clothing" . The patient FoC outcomes items are responded to on a 4-point Likert-type scale.	During the students internship, at the end of hospitalization, immediately before discharge from the hospital (approximately 10 months after the beginning of the study)

Collaborators and Investigators

• Sponsor: University of Genova
• Investigators: Principal Investigator: Annamaria Bagnasco, Prof, Department of Health Sciences, University of Genoa

Publications and helpful links

General Publications

• Kitson A, Conroy T, Wengstrom Y, Profetto-McGrath J, Robertson-Malt S. Defining the fundamentals of care. Int J Nurs Pract. 2010 Aug;16(4):423-34. doi: 10.1111/j.1440-172X.2010.01861.x.
• Feo R, Kitson A. Promoting patient-centred fundamental care in acute healthcare systems. Int J Nurs Stud. 2016 May;57:1-11. doi: 10.1016/j.ijnurstu.2016.01.006. Epub 2016 Feb 1. Review.
• Bagnasco A, Timmins F, de Vries JMA, Aleo G, Zanini M, Catania G, Sasso L. Understanding and addressing missed care in clinical placements - Implications for nursing students and nurse educators. Nurse Educ Today. 2017 Sep;56:1-5. doi: 10.1016/j.nedt.2017.05.015. Epub 2017 May 23.
• Feo R, Rasmussen P, Wiechula R, Conroy T, Kitson A. Developing effective and caring nurse-patient relationships. Nurs Stand. 2017 Mar 8;31(28):54-63. doi: 10.7748/ns.2017.e10735.
• Feo R, Conroy T, Alderman J, Kitson A. Implementing fundamental care in clinical practice. Nurs Stand. 2017 Apr 5;31(32):52-62. doi: 10.7748/ns.2017.e10765.
• Huisman-de Waal G, Feo R, Vermeulen H, Heinen M. Students' perspectives on basic nursing care education. J Clin Nurs. 2018 Jun;27(11-12):2450-2459. doi: 10.1111/jocn.14278.
• Voldbjerg SL, Laugesen B, Bahnsen IB, Jørgensen L, Sørensen IM, Grønkjaer M, Sørensen EE. Integrating the fundamentals of care framework in baccalaureate nursing education: An example from a nursing school in Denmark. J Clin Nurs. 2018 Jun;27(11-12):2506-2515. doi: 10.1111/jocn.14354.
• Saarikoski M, Warne T, Kaila P, Leino-Kilpi H. The role of the nurse teacher in clinical practice: an empirical study of Finnish student nurse experiences. Nurse Educ Today. 2009 Aug;29(6):595-600. doi: 10.1016/j.nedt.2009.01.005. Epub 2009 Feb 18.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: FoC-FORM 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No