Clinical ReasoningNCT05504824
The Effect of Case-Based Education on the Development of Nursing Students' Clinical Reasoning Skills
A study testing Case-based education in people with Clinical Reasoning and Critical Illness, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study was conducted to determine the effect of case-based education on the development of clinical reasoning skills of nursing students in critical illnesses. Methods: The study was conducted between January 20 and June 30, 2021 using a pilot randomized controlled trial design. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Clinical Reasoning, Critical Illness
- What is being tested?
- Case-based education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Having completed the "Medical Nursing" and Surgical Nursing" courses,
- Volunteering to participate in the study,
- Participate in "Case-Based Education"
Who cannot join
- Not being willing to participate in the study,
- Abandoning the "Case-Based Education" practice
- Not taking one or two of the "Medical Nursing" and "Surgical Nursing" courses at all, or to have taken them but unsuccessfully
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Nursing
Ankara, 06230
About this study
Official title: The Effect of Case-Based Education on the Development of Nursing Students' Clinical Reasoning Skills in Critical Illness: A Pilot Randomized Controlled Trial
Aim: This study was conducted to determine the effect of case-based education on the development of clinical reasoning skills of nursing students in critical illnesses.
Methods: The study was conducted between January 20 and June 30, 2021 using a pilot randomized controlled trial design. In the study, 22 volunteer students were assigned to the experimental and control groups by simple randomization. The experimental group was given case-based education to improve their clinical reasoning skills, and the control group continued the standard education process. Data were collected using a Student Information Form, the Clinical Reasoning Case Form (CRCF), the Student Satisfaction with Education Questionnaire, and a Form for Views on the Education. In the evaluation of data, frequency values, Fisher exact test, Mann-Whitney U, and Wilcoxon tests, Cohen's d coefficient for effect size, ITT analysis, and covariance analysis were used.
Read the detailed description
Aim of the study This study was conducted to determine the effect of case-based education on the development of nursing students' clinical reasoning skills in critical illnesses.
Research hypotheses H01: There is no difference between the experimental group and the control group in terms of their CRCF scores.
H02: Case-based education on clinical reasoning has no positive effect on student satisfaction.
- Conditions
- Clinical Reasoning, Critical Illness
- Being tested
- Case-based education
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case-based educationOther
The education phase This stage included the explanation of the CR process, the analysis of CR cases, the drafting of new cases suitable for the CR process by students, and the analysis process.
The education program was carried out on a web platform (Zoom) consistent with the changes in the COVID-19 pandemic process. The CR cases to be used in case-based education were sent to the students via e-mail before the group interview to make sure students came prepared for the group discussion. In case-based education, after the students read the case, they were asked some questions to determine their decisions and reasoning.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Students in both experimental groups were applied the student information form and the pretest of the CRCF between May 18 and 20, 2021 before the education. The schedule of the education intervention was determined according to the convenience of the students in the experimental group. Accordingly, the experimental group was given education between June 8 and 11, 2021. After the education sessions were completed, experimental groups were applied the CRCF as a posttest on June 28, 2021. The students in the experimental group were asked to fill out the "Student Satisfaction with Education Questionnaire" and the "Form for Views on the Education" online. Receives: Other: Case-based education |
| Control group | No intervention | Students in control groups were applied the student information form and the pretest of the CRCF between May 18 and 20, 2021 before the education. The students in the control group continued their current standard education process. After the education sessions were completed, control groups were applied the CRCF as a posttest on June 28, 2021. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Student Information Form
This form consists of 9 questions, including students' nicknames, age, gender, duration of clinical experience, level of school success, and views on the nursing process
Measured: The measurement was collected one week before education.
Clinical Reasoning Case Form (CRCF)
There were 10 clinical cases on the CRCF prepared for the objectives of these three steps in students' clinical reasoning process. The cases involved critical illness, and early warning findings that show worsening in critical illness and are used to determine priority nursing diagnosis.
Five people, who were experts in the field of medical nursing and had clinical experience, were consulted between February 15 and 28, 2021 to confirm the clinical accuracy and reality of CR cases and their content and comprehensibility. The content validity index of expert opinions evaluated with the Davis technique was determined as 1.
Measured: The first measurement was collected one week before education. The second measurement was collected 3 weeks after education.
Secondary outcomes (2)
Student Satisfaction with Education Questionnaire
A questionnaire adapted from the study of Lee et al. (2010) was used to evaluate students' satisfaction with the education given. A 6-point Likert-type scale (1= strongly disagree, 6= strongly agree) was used to evaluate the ten items of the questionnaire. The 10th item on the questionnaire is reverse coded. High scores on the questionnaire indicate a high level of satisfaction.
Measured: The measurement was collected 3 weeks after education.
Form for Views on the Education
The effectiveness of the education model was evaluated by the researchers with a SWOT analysis (strengths, weaknesses, opportunities, and threats) based on data collected from students in the experimental group without obtaining nicknames or personal information after the completion of the education via an online questionnaire that consisted of 4 questions about the strengths, weaknesses, perceived threats, and opportunities of the education model.
Measured: The measurement was collected 3 weeks after education.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start18 May 2021
- Primary completion28 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical ReasoningStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Öztürk Birge, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504824
- Sponsor's protocol ID
- AU-OBIRGE-001
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Case-Based Education on the Development of Nursing Students' Clinical Reasoning Skills in Critical Illness: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05504824
- Acronym / sponsor ID
- AU-OBIRGE-001
- Conditions
- Clinical Reasoning, Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: This study was conducted to determine the effect of case-based education on the development of clinical reasoning skills of nursing students in critical illnesses.
Methods: The study was conducted between January 20 and June 30, 2021 using a pilot randomized controlled trial design. In the study, 22 volunteer students were assigned to the experimental and control groups by simple randomization. The experimental group was given case-based education to improve their clinical reasoning skills, and the control group continued the standard education process. Data were collected using a Student Information Form, the Clinical Reasoning Case Form (CRCF), the Student Satisfaction with Education Questionnaire, and a Form for Views on the Education. In the evaluation of data, frequency values, Fisher exact test, Mann-Whitney U, and Wilcoxon tests, Cohen's d coefficient for effect size, ITT analysis, and covariance analysis were used.
Detailed description
Aim of the study This study was conducted to determine the effect of case-based education on the development of nursing students' clinical reasoning skills in critical illnesses.
Research hypotheses H01: There is no difference between the experimental group and the control group in terms of their CRCF scores.
H02: Case-based education on clinical reasoning has no positive effect on student satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Case-based educationStudents in both experimental groups were applied the student information form and the pretest of the CRCF between May 18 and 20, 2021 before the education. The schedule of the education intervention was determined according to the convenience of the students in the experimental group. Accordingly, the experimental group was given education between June 8 and 11, 2021. After the education sessions were completed, experimental groups were applied the CRCF as a posttest on June 28, 2021. The students in the experimental group were asked to fill out the "Student Satisfaction with Education Questionnaire" and the "Form for Views on the Education" online. |
| Control group | No intervention | –Students in control groups were applied the student information form and the pretest of the CRCF between May 18 and 20, 2021 before the education. The students in the control group continued their current standard education process. After the education sessions were completed, control groups were applied the CRCF as a posttest on June 28, 2021. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Having completed the "Medical Nursing" and Surgical Nursing" courses,
- Volunteering to participate in the study,
- Participate in "Case-Based Education"
Key exclusion criteria (3 listed)
- Not being willing to participate in the study,
- Abandoning the "Case-Based Education" practice
- Not taking one or two of the "Medical Nursing" and "Surgical Nursing" courses at all, or to have taken them but unsuccessfully
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case-based educationThe education phase This stage included the explanation of the CR process, the analysis of CR cases, the drafting of new cases suitable for the CR process by students, and the analysis process. The education program was carried out on a web platform (Zoom) consistent with the changes in the COVID-19 pandemic process. The CR cases to be used in case-based education were sent to the students via e-mail before the group interview to make sure students came prepared for the group discussion. In case-based education, after the students read the case, they were asked some questions to determine their decisions and reasoning. | Other | Experimental group |
Primary outcome
Student Information Form
Time frame: The measurement was collected one week before education.
This form consists of 9 questions, including students' nicknames, age, gender, duration of clinical experience, level of school success, and views on the nursing process
Clinical Reasoning Case Form (CRCF)
Time frame: The first measurement was collected one week before education. The second measurement was collected 3 weeks after education.
There were 10 clinical cases on the CRCF prepared for the objectives of these three steps in students' clinical reasoning process. The cases involved critical illness, and early warning findings that show worsening in critical illness and are used to determine priority nursing diagnosis. Five people, who were experts in the field of medical nursing and had clinical experience, were consulted between February 15 and 28, 2021 to confirm the clinical accuracy and reality of CR cases and their content and comprehensibility. The content validity index of expert opinions evaluated with the Davis technique was determined as 1.
2 secondary outcomes
Student Satisfaction with Education Questionnaire
Time frame: The measurement was collected 3 weeks after education.
Form for Views on the Education
Time frame: The measurement was collected 3 weeks after education.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Altman, M. R., Kantrowitz-Gordon, I., Moise, E., Malcolm, K., Vidakovic, M., Barrington, W., ... \& de Castro, A. B. (2021). Addressing Positionality Within Case-Based Learning to Mitigate Systemic Racism in Health Care. Nurse Educator, 46(5), 284-289.Link provided by the sponsor.
- Banning, M. (2008). Clinical reasoning and its application to nursing: Concepts and research studies. Nurse education in practice, 8(3), 177-183.Link provided by the sponsor.
- Dekhtyar, M., Park, Y. S., Kalinyak, J., Chudgar, S. M., Fedoriw, K. B., Johnson, K. J., ... \& Stern, S. (2022). Use of a structured approach and virtual simulation practice to improve diagnostic reasoning. Diagnosis, 9(1), 69-76.Link provided by the sponsor.
- de Sá Tinôco, J. D., Cossi, M. S., \& de Carvalho Lira, A. L. B. (2021). Effect of educational intervention on clinical reasoning skills in nursing: A quasi-experimental study. Nurse EducatLink provided by the sponsor.
- Groves, M., Scott, I., \& Alexander, H. (2002). Assessing clinical reasoning: a method to monitor its development in a PBL curriculum. Medical teacher, 24(5), 507-515.Link provided by the sponsor.
- Hoffman, K. A., Aitken, L. M., \& Duffield, C. (2009). A comparison of novice and expert nurses' cue collection during clinical decision-making: Verbal protocol analysis. International journal of nursing studies, 46(10), 1335-1344.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case-based education in people with Clinical Reasoning and Critical Illness, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Student Information Form (time frame: The measurement was collected one week before education.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.