StudentsNCT05479110
The Effectiveness of Using Empathy Courses to Guide OT Students in Case-base Clinical Reasoning
A study testing Empathy experience courses and case-base clinical reasoning and case studies in people with Students, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
Clinical reasoning is an important cognitive process in medical decision making. In recent years, medical education advocates holistic medicine, but systematic learning is rare in school education.Therefore, this study used an empathy experience course to conduct a case-oriented clinical reasoning training course to… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Students
- What is being tested?
- Empathy experience courses and case-base clinical reasoning and case studies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2022to 30 Nov 2023
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Occupational therapy students from National Taiwan University, Kaohsiung Medical University, Sun Yat-sen Medical University, National Cheng Kung University, Chang Gung University, IShou University, Fu Jen Catholic University, and Asia University who have completed their major credits and will be interning in a clinical hospital.
- Must be at least 20 years old and under 65 years old.
Who cannot join
- Those who are unable to attend the whole course.
- Those who have not completed their school credits and are unable to go to the clinical hospital for internship.
- Those who do not speak Chinese or English as their native language.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Using Empathy Experience Courses to Guide Occupational Therapy Students in Case-base Clinical Reasoning- A Pilot Study
Clinical reasoning is an important cognitive process in medical decision making. In recent years, medical education advocates holistic medicine, but systematic learning is rare in school education.Therefore, this study used an empathy experience course to conduct a case-oriented clinical reasoning training course to improve the empathy and clinical reasoning skills of pre-clinical students in occupational therapy through four sessions.
Read the detailed description
Objective: To investigate effectiveness of using empathy experience courses to guide the students who prior to occupational therapy(OT) practice in case-base clinical reasoning.
Materials and Methods: 30 students were recruited from 8 universities in Taiwan and randomly divided into an experimental group and a control group. The experimental group was given four 3-hour training sessions over 2 weeks, which included group instruction on empathy experience, clinical reasoning, and functional therapy case-oriented learning, while the control group was given case studies. Tests were administered before and after the series of sessions, including case report writing, C-JES-HPS, SACRR, and a follow-up visit at the end of the first phase of clinical practice using the C-JES-HPS and SACRR; course satisfaction surveys were completed after each session and at the follow-up visit to observe course satisfaction, usefulness, and recommendations. Data were analyzed using SPSS (version 20.0) with a significance level of 0.05. Univariate analyses with repeated measures 2-way analysis of variance were used to compare changes in empathy and clinical reasoning ability between the two groups of subjects and course satisfaction was presented as descriptive statistics. It was hypothesized that a case-oriented clinical reasoning training program using an empathy experience program would improve empathy and clinical reasoning skills in pre-practicum students in occupational therapy.
- Conditions
- Students
- Being tested
- Empathy experience courses and case-base clinical reasoning, case studies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empathy experience courses and case-base clinical reasoningBehavioural
Four 3-hour training sessions over 2 weeks, which included group instruction on empathy experience, clinical reasoning, and functional therapy case-oriented learning.
case studiesOther
active control: case studies(text)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group was given four 3-hour training sessions over 2 weeks, which included group instruction on empathy experience, clinical reasoning, and functional therapy case-oriented learning. Receives: Behavioral: Empathy experience courses and case-base clinical reasoning |
| Control group | Active comparator | The control group was given case studies(text). Receives: Other: case studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese version of the Jefferson Scale of Empathy-Health Profession Students
A total of 20 questions were used to self-assess participants' empathy status and were scored using a 7-point Likert scale. The content covered three sections, including 10 questions on the perspective taking section, 8 questions on the compassionate care section, and 2 questions on standing in the patient's shoes.
Measured: Change from Baseline at 2 weeks
The Self-Assessment of Clinical Reflection and Reasoning
A 26-item, five-point Likert scale was used to self-assess clinical reasoning skills, including strongly disagree, disagree, unsure, agree, and strongly agree.
Measured: Change from Baseline at 2 weeks
Secondary outcomes (1)
Satisfaction Questionnaire
The researchers designed the form to understand the subjects' satisfaction with the content of the training course, the usefulness of the training course for clinical practice, and their suggestions for the training course. Satisfaction with the content of the training course and the usefulness of the training course for clinical practice were rated on a five-point Likert scale of very dissatisfied, dissatisfied, fair, satisfied, and very satisfied.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for StudentsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanyun Hsiao, Principal investigator, Taipei Medical University, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479110
- Sponsor's protocol ID
- TMU-JIRB N202112011
- Status last verified
- Jun 2022
- First submitted
- 21 Jun 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Addy TM, Hafler J, Galerneau F. Faculty Development for Fostering Clinical Reasoning Skills in Early Medical Students Using a Modified Bayesian Approach. Teach Learn Med. 2016 Oct-Dec;28(4):415-423. doi: 10.1080/10401334.2016.1186551. Epub 2016 Jun 9.
PubMed 27283028Cooper N, Bartlett M, Gay S, Hammond A, Lillicrap M, Matthan J, Singh M; UK Clinical Reasoning in Medical Education (CReME) consensus statement group. Consensus statement on the content of clinical reasoning curricula in undergraduate medical education. Med Teach. 2021 Feb;43(2):152-159. doi: 10.1080/0142159X.2020.1842343. Epub 2020 Nov 18.
PubMed 33205693Daniel M, Rencic J, Durning SJ, Holmboe E, Santen SA, Lang V, Ratcliffe T, Gordon D, Heist B, Lubarsky S, Estrada CA, Ballard T, Artino AR Jr, Sergio Da Silva A, Cleary T, Stojan J, Gruppen LD. Clinical Reasoning Assessment Methods: A Scoping Review and Practical Guidance. Acad Med. 2019 Jun;94(6):902-912. doi: 10.1097/ACM.0000000000002618.
PubMed 30720527Duca NS, Glod S. Bridging the Gap Between the Classroom and the Clerkship: A Clinical Reasoning Curriculum for Third-Year Medical Students. MedEdPORTAL. 2019 Jan 25;15:10800. doi: 10.15766/mep_2374-8265.10800.
PubMed 31139730Huhn K, Gilliland SJ, Black LL, Wainwright SF, Christensen N. Clinical Reasoning in Physical Therapy: A Concept Analysis. Phys Ther. 2019 Apr 1;99(4):440-456. doi: 10.1093/ptj/pzy148.
PubMed 30496522Jamieson M, Krupa T, O'Riordan A, O'Connor D, Paterson M, Ball C, Wilcox S. Developing empathy as a foundation of client-centred practice: evaluation of a university curriculum initiative. Can J Occup Ther. 2006 Apr;73(2):76-85. doi: 10.2182/cjot.05.0008.
PubMed 16680911Min Simpkins AA, Koch B, Spear-Ellinwood K, St John P. A developmental assessment of clinical reasoning in preclinical medical education. Med Educ Online. 2019 Dec;24(1):1591257. doi: 10.1080/10872981.2019.1591257.
PubMed 30935299Posel N, Mcgee JB, Fleiszer DM. Twelve tips to support the development of clinical reasoning skills using virtual patient cases. Med Teach. 2015;37(9):813-8. doi: 10.3109/0142159X.2014.993951. Epub 2014 Dec 19.
PubMed 25523009Svalastog AL, Donev D, Jahren Kristoffersen N, Gajovic S. Concepts and definitions of health and health-related values in the knowledge landscapes of the digital society. Croat Med J. 2017 Dec 31;58(6):431-435. doi: 10.3325/cmj.2017.58.431. No abstract available.
PubMed 29308835Ten Cate O. Competency-Based Postgraduate Medical Education: Past, Present and Future. GMS J Med Educ. 2017 Nov 15;34(5):Doc69. doi: 10.3205/zma001146. eCollection 2017.
PubMed 29226237Wenham J, Best M, Kissane DW. Systematic review of medical education on spirituality. Intern Med J. 2021 Nov;51(11):1781-1790. doi: 10.1111/imj.15421.
PubMed 34142417
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Using Empathy Experience Courses to Guide Occupational Therapy Students in Case-base Clinical Reasoning- A Pilot Study
- ClinicalTrials.gov ID
- NCT05479110
- Acronym / sponsor ID
- TMU-JIRB N202112011
- Conditions
- Students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 29 Jul 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.
Clinical reasoning is an important cognitive process in medical decision making. In recent years, medical education advocates holistic medicine, but systematic learning is rare in school education.Therefore, this study used an empathy experience course to conduct a case-oriented clinical reasoning training course to improve the empathy and clinical reasoning skills of pre-clinical students in occupational therapy through four sessions.
Detailed description
Objective: To investigate effectiveness of using empathy experience courses to guide the students who prior to occupational therapy(OT) practice in case-base clinical reasoning.
Materials and Methods: 30 students were recruited from 8 universities in Taiwan and randomly divided into an experimental group and a control group. The experimental group was given four 3-hour training sessions over 2 weeks, which included group instruction on empathy experience, clinical reasoning, and functional therapy case-oriented learning, while the control group was given case studies. Tests were administered before and after the series of sessions, including case report writing, C-JES-HPS, SACRR, and a follow-up visit at the end of the first phase of clinical practice using the C-JES-HPS and SACRR; course satisfaction surveys were completed after each session and at the follow-up visit to observe course satisfaction, usefulness, and recommendations. Data were analyzed using SPSS (version 20.0) with a significance level of 0.05. Univariate analyses with repeated measures 2-way analysis of variance were used to compare changes in empathy and clinical reasoning ability between the two groups of subjects and course satisfaction was presented as descriptive statistics. It was hypothesized that a case-oriented clinical reasoning training program using an empathy experience program would improve empathy and clinical reasoning skills in pre-practicum students in occupational therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Empathy experience courses and case-base clinical reasoningThe experimental group was given four 3-hour training sessions over 2 weeks, which included group instruction on empathy experience, clinical reasoning, and functional therapy case-oriented learning. |
| Control group | Active comparator | Other: case studiesThe control group was given case studies(text). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Occupational therapy students from National Taiwan University, Kaohsiung Medical University, Sun Yat-sen Medical University, National Cheng Kung University, Chang Gung University, IShou University, Fu Jen Catholic University, and Asia University who have completed their major credits and will be interning in a clinical hospital.
- Must be at least 20 years old and under 65 years old.
Key exclusion criteria (3 listed)
- Those who are unable to attend the whole course.
- Those who have not completed their school credits and are unable to go to the clinical hospital for internship.
- Those who do not speak Chinese or English as their native language.
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 |
|---|---|---|
| Empathy experience courses and case-base clinical reasoningFour 3-hour training sessions over 2 weeks, which included group instruction on empathy experience, clinical reasoning, and functional therapy case-oriented learning. | Behavioural | Experimental group |
| case studiesactive control: case studies(text) | Other | Control group |
Primary outcome
Chinese version of the Jefferson Scale of Empathy-Health Profession Students
Time frame: Change from Baseline at 2 weeks
A total of 20 questions were used to self-assess participants' empathy status and were scored using a 7-point Likert scale. The content covered three sections, including 10 questions on the perspective taking section, 8 questions on the compassionate care section, and 2 questions on standing in the patient's shoes.
The Self-Assessment of Clinical Reflection and Reasoning
Time frame: Change from Baseline at 2 weeks
A 26-item, five-point Likert scale was used to self-assess clinical reasoning skills, including strongly disagree, disagree, unsure, agree, and strongly agree.
1 secondary outcome
Satisfaction Questionnaire
Time frame: up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Background: PubMed 27283028Addy TM, Hafler J, Galerneau F. Faculty Development for Fostering Clinical Reasoning Skills in Early Medical Students Using a Modified Bayesian Approach. Teach Learn Med. 2016 Oct-Dec;28(4):415-423. doi: 10.1080/10401334.2016.1186551. Epub 2016 Jun 9.
- Background: PubMed 33205693Cooper N, Bartlett M, Gay S, Hammond A, Lillicrap M, Matthan J, Singh M; UK Clinical Reasoning in Medical Education (CReME) consensus statement group. Consensus statement on the content of clinical reasoning curricula in undergraduate medical education. Med Teach. 2021 Feb;43(2):152-159. doi: 10.1080/0142159X.2020.1842343. Epub 2020 Nov 18.
- Background: PubMed 30720527Daniel M, Rencic J, Durning SJ, Holmboe E, Santen SA, Lang V, Ratcliffe T, Gordon D, Heist B, Lubarsky S, Estrada CA, Ballard T, Artino AR Jr, Sergio Da Silva A, Cleary T, Stojan J, Gruppen LD. Clinical Reasoning Assessment Methods: A Scoping Review and Practical Guidance. Acad Med. 2019 Jun;94(6):902-912. doi: 10.1097/ACM.0000000000002618.
- Background: PubMed 31139730Duca NS, Glod S. Bridging the Gap Between the Classroom and the Clerkship: A Clinical Reasoning Curriculum for Third-Year Medical Students. MedEdPORTAL. 2019 Jan 25;15:10800. doi: 10.15766/mep_2374-8265.10800.
- Background: PubMed 30496522Huhn K, Gilliland SJ, Black LL, Wainwright SF, Christensen N. Clinical Reasoning in Physical Therapy: A Concept Analysis. Phys Ther. 2019 Apr 1;99(4):440-456. doi: 10.1093/ptj/pzy148.
- Background: PubMed 16680911Jamieson M, Krupa T, O'Riordan A, O'Connor D, Paterson M, Ball C, Wilcox S. Developing empathy as a foundation of client-centred practice: evaluation of a university curriculum initiative. Can J Occup Ther. 2006 Apr;73(2):76-85. doi: 10.2182/cjot.05.0008.
- Background: PubMed 30935299Min Simpkins AA, Koch B, Spear-Ellinwood K, St John P. A developmental assessment of clinical reasoning in preclinical medical education. Med Educ Online. 2019 Dec;24(1):1591257. doi: 10.1080/10872981.2019.1591257.
- Background: PubMed 25523009Posel N, Mcgee JB, Fleiszer DM. Twelve tips to support the development of clinical reasoning skills using virtual patient cases. Med Teach. 2015;37(9):813-8. doi: 10.3109/0142159X.2014.993951. Epub 2014 Dec 19.
- Background: PubMed 29308835Svalastog AL, Donev D, Jahren Kristoffersen N, Gajovic S. Concepts and definitions of health and health-related values in the knowledge landscapes of the digital society. Croat Med J. 2017 Dec 31;58(6):431-435. doi: 10.3325/cmj.2017.58.431. No abstract available.
- Background: PubMed 29226237Ten Cate O. Competency-Based Postgraduate Medical Education: Past, Present and Future. GMS J Med Educ. 2017 Nov 15;34(5):Doc69. doi: 10.3205/zma001146. eCollection 2017.
- Background: PubMed 34142417Wenham J, Best M, Kissane DW. Systematic review of medical education on spirituality. Intern Med J. 2021 Nov;51(11):1781-1790. doi: 10.1111/imj.15421.
- Individual participant dataSharing planned: No
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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.
Hanyun Hsiao principal investigator
Taipei Medical University, Taiwan, R.O.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empathy experience courses and case-base clinical reasoning and case studies in people with Students, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 2 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: status not confirmed, as of the sponsor's last update on 29 Jul 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanyun Hsiao, master (+88622490088 ext. 1624, 10252@s.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese version of the Jefferson Scale of Empathy-Health Profession Students (time frame: Change from Baseline at 2 weeks). 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?
On the ClinicalTrials.gov record for NCT05479110, which also lists 11 linked publications.
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 29 Jul 2022.