Design, Implementation and Evaluation of the Guided Observer Role in Clinical Simulation

Anaphylactic Reaction Clinical Trial

Official title:

Design, Implementation and Evaluation of the Guided Observer Role in Clinical Simulation. A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06405399
• Other study ID #: Simulación
• Status: Completed
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: November 25, 2023

Study information

• Verified date: April 2024
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the effectiveness of the guided observed role in a simulation learning programme for nursing students in acquiring the competence (knowledge, skills and attitudes) to care for patients affected by anaphylactic situations. This will be achieved by comparing the participants' simulation roles with the guided observed role.

The design was that of an exploratory randomised controlled trial. The variables employed to assess the efficacy of the intervention were competence and its associated attributes. These were measured using a ten-question multiple-choice test to assess knowledge; the simulation performance assessment using the Creighton Simulation Evaluation Instrument to assess skill; the learner's perception of the simulation's effectiveness in meeting their learning needs, through the Simulation Effectiveness Tool Modified (SET-M). Furthermore, the extent to which reflective thinking was achieved during the simulation was evaluated using the Self-Debriefing Reflection Rubric. Additionally, the students' perceptions of their role were assessed through seven open-ended questions.

Description:

The study was a prospective, randomised, double-blind controlled trial conducted from October to November 2023 at a Nursing Faculty. The participants were fourth-year Bachelor of Science in Nursing students from a University in the North of Spain. A convenience sample of students from the nursing programme participated in the study. The recommended sample size was 40 participants per group, accounting for a 10% allowance for withdrawals, missing data, and lost follow-up.

Following their registration to participate in the study, 123 students were screened by the researchers to determine their eligibility. Prior to the commencement of the research, the students were informed about the objectives and the project and they signed the informed consent form. Upon arrival at the simulation centre to develop the simulated experience, participants completed the pre-test assessment and were randomly assigned to either the intervention group (57 students) or the control group (56 students) at a 1:1 ratio using a computer-generated assignment. Following the simulation experience, participants completed the post-test assessment and the various tools of the research.

During the study, two participants in the intervention group and one in the control group were excluded due to missing follow-up (refusal to continue in the research), and one student in the control group was removed by statistical analysis. In total, 99 participants were included in the data analysis. The students completed the sociodemographic information (age, gender, and previous experience in simulation experiences with anaphylactic situations) and the data on different variables via the online platform Google Form.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: November 25, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

• Students enrolled in the 4rd year of nursing at the Faculty of Nursing of the University of Navarra and who voluntarily agree to participate in the study.

Exclusion Criteria:

• Students who had previously undergone a simulated clinical experience of managing an anaphylactic shock.

Related Conditions & MeSH terms

• Anaphylactic Reaction
• Anaphylaxis

Intervention

Other:
• Educational intervention. observation guide
An observation checklist based on the Lasater Clinical Judgment Rubric (LCJR) was created and adapted to the simulated clinical experience in order to address the learning outcomes to be achieved by nursing students. This resulted in a list of forty items divided into four main groups: patient safety (8 items), communication and relationship with the patient (7 items), teamwork (7 items) and technical skills (18 items).

Locations

Country	Name	City	State
Spain	University of Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge	In order to gauge the comprehension of information pertaining to a case of anaphylactic shock, a questionnaire comprising 10 multiple-choice inquiries, each presenting four possible responses, was devised. This questionnaire encapsulates the primary algorithms delineating the contemporary approach to managing anaphylactic shock, as outlined by the European Resuscitation Council in 2021, alongside delineations of requisite nursing interventions.	two months
Primary	Evaluation of the simulated experience: Creighton Simulation Evaluation Instrument (C-SEI)	In order to assess the proficiency development of students allocated to the intervention group (guided observers) and the control group (participants), the Creighton Simulation Evaluation Instrument (CSEI) was employed. The CSEI, translated and validated into Spanish in 2019, comprises 22 dichotomous items divided into four different components: assessment, communication, critical creative, and technical skills. The Cronbach's alpha internal consistency coefficient for the entire scale was 0.839. The exclusion of any one of the questions was not found to significantly enhance the internal consistency of the scale.	Two month
Secondary	Self-Debriefing Reflection Rubric	The tool comprised a set of six guiding questions, designed to assist with reflection on the experience based on Gibbs' (1988) Reflective Cycle. The questions are as follows: Q1-Description, Q2-Emotion, Q3-Evaluation, Q4-Analysis, Q5-Conclusion and Q6-Future Plan. The definitions of reflection levels proposed by Mezirow and the model of structured reflection were employed in the design of the Self-Debriefing Reflection Rubric for this study. The rubric comprised six items for the six questions, each with four possible rating levels. The responses were categorised as L-1 (Habitual Action), L-2 (Understanding), L-3 (Reflection), or L-4 (Critical Reflection). A mean rating of 3.0 or above for a student's submission indicated a consistent level of RT.	Two months
Secondary	Simulation Effectiveness Tool - Modified (SET-M)	In its updated form, the SET-M (Leighton, 2015) incorporates the simulation standards of best practices and terminology that have been established by the INACSL Standards Committee (INACSL Standards of Best Practice Simulation (INACSL Standards Committee, 2016)), The Quality and Safety Education for Nurses (QSEN) competencies (2007) and the Essentials of Baccalaureate Education for Professional Nursing Practice of the American Association of Colleges of Nursing (AACN) (2008). The SET-M is a useful instrument for evaluating the learner's perception of the effectiveness of the simulation in meeting their learning needs. The SET-M comprises 19 items, scored on a 3-point Likert scale: prebriefing (2 items), learning (6 items), confidence (6 items) and debriefing (5 items). The Spanish version of the SET-M was translated and validated, resulting in an internal consistency of 0.936 (Cronbach's alpha).	Two months
Secondary	Open ended questions	Seven open-ended questions were developed to ascertain the students' perceptions of their role (participant or guided observer) in the simulated clinical experience. A thematic review was conducted to identify the main categories, which were then used to inform the subsequent elaboration of the questions. For example, the question "Do you believe that the role of observer makes you more relaxed in the ECS?" was developed to assess the students' perceptions of the observer role. Similarly, the question "Has the observer role made you more passive in the ECS?" was designed to assess the students' views on the impact of the observer role on their behaviour.	Two months