EndocrinopathyNCT04261101
Test-enhanced Learning to Prepare for Future Learning in Endocrinology
A study testing Test-enhanced learning in people with Endocrinopathy and Educational Problems, run by Hospital de Clinicas de Porto Alegre.
Trial summary
The use of test-enhanced learning with causal connection and in preparation for future learning has been used in health educational setting with positive results. However, most studies were performed in a controlled lab scenario and not in the "real world" of medicine classes, decreasing the external applicability of… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Endocrinopathy, Educational Problems
- What is being tested?
- Test-enhanced learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Feb 2020to Jul 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
- Students will be consecutively invited to participated in the study before starting their Endocrinology placement and will be included after agreeing to participate and signing an informed consent
Who cannot join
- Students absent on the day of study intervention or on the four-week assessment will be excluded from analysis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Test-enhanced Learning Using Causal Connections to Prepare for Future Learning in Endocrinology: a Randomized Clinical Trial
The use of test-enhanced learning with causal connection and in preparation for future learning has been used in health educational setting with positive results. However, most studies were performed in a controlled lab scenario and not in the "real world" of medicine classes, decreasing the external applicability of such experiments. Therefore, the aim of present study is to evaluate if a session of test-enhanced learning at the beginning of endocrinology course, using basic-clinical sciences connections of key concepts, would prepare for future learning of endocrinology on a theory-practical 4-week endocrinology course.
Methods Study design, participants and description of undergraduate endocrinology course This is a prospective, single center, non-blinded, RCT. Participants are students of medicine from Universidade Federal do Rio Grande do Sul (UFRGS), Brazil, in their third year of Medical School, recruited at the beginning of endocrinology undergraduate clinical placement. This clinical trial follows the Consolidated Standards of Reporting Trials (CONSORT) statement, which includes the completing the CONSORT checklist.
Read more
Sample size Based in a previous study, to find a difference in the percentage of correct answers in a cognitive test to evaluate retention of 12%, considering a SD of 26%, alpha error of 5%, beta error of 20%, and repeated assessments (baseline, 3 weeks and 6 months), 35 students will be necessary in each group. To account for possible losses of follow-up, 84 students will be included.
Study intervention All students will receive, in advance, a text with basic sciences information relevant to the learning of Endocrinology (supplementary material), with instructions to study the text before intervention day.
Students will be randomized to one of the interventions: TEL with questions about diabetes and adrenal (Block A, 6 questions) or thyroid and hypophysis (Block B, 6 questions). Important endocrinology concepts, such as fuel metabolism and circadian rhythm will be included in Block A, and feedback loops and hormone synthesis in Block B. Specific hormone functions will be part of both TEL Blocks.
Assessments At the same day of intervention, students will answer all questions 12 of the TEL session (questions from blocks A and B) with best answer multiple choice questions (immediate retention test). After 3 weeks and 6 months, the transfer of knowledge will be assessed with a 24 multiple choice questions test, based in clinical cases.
Read the detailed description
Introduction The ability to connect previous learned basic-sciences concepts to patient's clinical features can help improve clinical reasoning. While experts use several shortcuts to reach a correct diagnosis, such as clinical presentation patterns, "stored" due to years of exposure to real cases, the novice need other strategies to build diagnostic scripts to achieve expertise. Inexperienced medical students acquire clinical reasoning by exploring why specific symptoms occur, usually based on basic science mechanisms. Even experienced physicians apply these connections to solve difficult cases, though sometimes, not in a conscious way. Benefits of causal connections between basic and clinical sciences for clinical reasoning is supported by randomized clinical trials (RCTs). When teaching endocrinology, this strategy acquires additional relevance, as basic concepts regarding hormone action and regulation (ex: feedback loops) are commonly utilized in day-to-day patient care.
Test-enhanced learning is an effective strategy to optimize knowledge acquisition, through formative assessment with the sole objective to promote learning. Testing improves learning through two means: a) an indirect benefit, as it stimulates preparation for the test, and b) through a direct effect, in which the mental effort to answer a question mobilizes and brain connections and reinforces learning. This educational tool has been studied in health professions education, including medical school and clinical training. The utilization of test-enhanced learning with short answers is more efficacious than only restudy or self-explanation. Moreover, the effect lasted for at least 6 months.
More important than content retention and linkage between biomedical concepts and clinical features, is the idea that knowledge must be applied in a different context in the future, a capacity named adaptive expertise. An essential part of training for adaptive expertise is preparation for future learning. It means that a learning session should prepare the student for future acquisition of content, competences and abilities. Medicine is certainly an area where adaptive expertise is crucial, as biological sciences are in continuous progress, requiring constant and continued education.
The use of test-enhanced learning with causal connection and in preparation for future learning has been used in health educational setting with positive results. However, most studies were performed in a controlled lab scenario and not in the "real world" of medicine classes, decreasing the external applicability of such experiments. Therefore, the aim of this study is to evaluate if a session of test-enhanced learning at the beginning of endocrinology course, using basic-clinical sciences connections of key concepts, would prepare for future learning of endocrinology on a theory-practical 4-week endocrinology course.
Methods Study design, participants and description of undergraduate endocrinology course This is a prospective, single center, non-blinded, RCT. Participants are students of medicine from Universidade Federal do Rio Grande do Sul (UFRGS), Brazil, in their third year of Medical School, recruited at the beginning of endocrinology undergraduate clinical placement. This clinical trial follows the Consolidated Standards of Reporting Trials (CONSORT) statement, which includes the completing the CONSORT checklist.
Sample size Based in a previous study, to find a difference in the percentage of correct answers in a cognitive test to evaluate retention of 12%, considering a SD of 26%, alpha error of 5%, beta error of 20%, and repeated assessments (baseline, 3 weeks and 6 months), 35 students will be necessary in each group. To account for possible losses of follow-up, 84 students will be included.
Study intervention All students will receive, in advance, a text with basic sciences information relevant to the learning of Endocrinology (supplementary material), with instructions to study the text before intervention day.
Students will be randomized to one of the interventions: TEL with questions about diabetes and adrenal (Block A, 6 questions) or thyroid and hypophysis (Block B, 6 questions). Important endocrinology concepts, such as fuel metabolism and circadian rhythm will be included in Block A, and feedback loops and hormone synthesis in Block B. Specific hormone functions will be part of both TEL Blocks.
Assessments At the same day of intervention, students will answer all questions 12 of the TEL session (questions from blocks A and B) with best answer multiple choice questions (immediate retention test). After 3 weeks and 6 months, the transfer of knowledge will be assessed with a 24 multiple choice questions test, based in clinical cases.
- Conditions
- Endocrinopathy, Educational Problems
- Being tested
- Test-enhanced learning
- Medical subject headings
- Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test-enhanced learningOther
Test-enhanced learning with short answers of questions regarding diabetes and adrenal
| Study group | Role | What they receive |
|---|---|---|
| Block A | Experimental | Test intervention with questions regarding diabetes and adrenal Receives: Other: Test-enhanced learning |
| Block B | Active comparator | Test intervention with questions regarding thyroid and hypophysis Receives: Other: Test-enhanced learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 multiple choice questions test at 3 weeks
Scores in 24 multiple choice questions test to assess learning transfer from basic sciences to Endocrinology, in 3 weeks. This is an special designed test. It is not a scale. The score will be zero to 24. The highest score indicates the best performance.
Measured: 3 weeks
Secondary outcomes (4)
Immediate retention test
Scores in immediate retention test (12 questions, in the same day as the TEL session)
Measured: immediately after test
24 multiple choice questions test at 6 months
Scores in 24 multiple choice questions test at 6 months
Measured: 6 months
Metacognition questionnaires - professors
Results of metacognition questionnaires (not a scale)
Measured: 4 weeks
Metacognition questionnaires - students
Results of metacognition questionnaires (not a scale)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study startFeb 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndocrinopathyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristiane B Leitao, MD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261101
- Sponsor's protocol ID
- 26118919.6.0000.5327
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2020
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-enhanced Learning Using Causal Connections to Prepare for Future Learning in Endocrinology: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04261101
- Acronym / sponsor ID
- 26118919.6.0000.5327
- Conditions
- Endocrinopathy, Educational Problems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Feb 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 7 Feb 2020 (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.
The use of test-enhanced learning with causal connection and in preparation for future learning has been used in health educational setting with positive results. However, most studies were performed in a controlled lab scenario and not in the "real world" of medicine classes, decreasing the external applicability of such experiments. Therefore, the aim of present study is to evaluate if a session of test-enhanced learning at the beginning of endocrinology course, using basic-clinical sciences connections of key concepts, would prepare for future learning of endocrinology on a theory-practical 4-week endocrinology course.
Methods Study design, participants and description of undergraduate endocrinology course This is a prospective, single center, non-blinded, RCT. Participants are students of medicine from Universidade Federal do Rio Grande do Sul (UFRGS), Brazil, in their third year of Medical School, recruited at the beginning of endocrinology undergraduate clinical placement. This clinical trial follows the Consolidated Standards of Reporting Trials (CONSORT) statement, which includes the completing the CONSORT checklist.
Sample size Based in a previous study, to find a difference in the percentage of correct answers in a cognitive test to evaluate retention of 12%, considering a SD of 26%, alpha error of 5%, beta error of 20%, and repeated assessments (baseline, 3 weeks and 6 months), 35 students will be necessary in each group. To account for possible losses of follow-up, 84 students will be included.
Study intervention All students will receive, in advance, a text with basic sciences information relevant to the learning of Endocrinology (supplementary material), with instructions to study the text before intervention day.
Students will be randomized to one of the interventions: TEL with questions about diabetes and adrenal (Block A, 6 questions) or thyroid and hypophysis (Block B, 6 questions). Important endocrinology concepts, such as fuel metabolism and circadian rhythm will be included in Block A, and feedback loops and hormone synthesis in Block B. Specific hormone functions will be part of both TEL Blocks.
Assessments At the same day of intervention, students will answer all questions 12 of the TEL session (questions from blocks A and B) with best answer multiple choice questions (immediate retention test). After 3 weeks and 6 months, the transfer of knowledge will be assessed with a 24 multiple choice questions test, based in clinical cases.
Detailed description
Introduction The ability to connect previous learned basic-sciences concepts to patient's clinical features can help improve clinical reasoning. While experts use several shortcuts to reach a correct diagnosis, such as clinical presentation patterns, "stored" due to years of exposure to real cases, the novice need other strategies to build diagnostic scripts to achieve expertise. Inexperienced medical students acquire clinical reasoning by exploring why specific symptoms occur, usually based on basic science mechanisms. Even experienced physicians apply these connections to solve difficult cases, though sometimes, not in a conscious way. Benefits of causal connections between basic and clinical sciences for clinical reasoning is supported by randomized clinical trials (RCTs). When teaching endocrinology, this strategy acquires additional relevance, as basic concepts regarding hormone action and regulation (ex: feedback loops) are commonly utilized in day-to-day patient care.
Test-enhanced learning is an effective strategy to optimize knowledge acquisition, through formative assessment with the sole objective to promote learning. Testing improves learning through two means: a) an indirect benefit, as it stimulates preparation for the test, and b) through a direct effect, in which the mental effort to answer a question mobilizes and brain connections and reinforces learning. This educational tool has been studied in health professions education, including medical school and clinical training. The utilization of test-enhanced learning with short answers is more efficacious than only restudy or self-explanation. Moreover, the effect lasted for at least 6 months.
More important than content retention and linkage between biomedical concepts and clinical features, is the idea that knowledge must be applied in a different context in the future, a capacity named adaptive expertise. An essential part of training for adaptive expertise is preparation for future learning. It means that a learning session should prepare the student for future acquisition of content, competences and abilities. Medicine is certainly an area where adaptive expertise is crucial, as biological sciences are in continuous progress, requiring constant and continued education.
The use of test-enhanced learning with causal connection and in preparation for future learning has been used in health educational setting with positive results. However, most studies were performed in a controlled lab scenario and not in the "real world" of medicine classes, decreasing the external applicability of such experiments. Therefore, the aim of this study is to evaluate if a session of test-enhanced learning at the beginning of endocrinology course, using basic-clinical sciences connections of key concepts, would prepare for future learning of endocrinology on a theory-practical 4-week endocrinology course.
Methods Study design, participants and description of undergraduate endocrinology course This is a prospective, single center, non-blinded, RCT. Participants are students of medicine from Universidade Federal do Rio Grande do Sul (UFRGS), Brazil, in their third year of Medical School, recruited at the beginning of endocrinology undergraduate clinical placement. This clinical trial follows the Consolidated Standards of Reporting Trials (CONSORT) statement, which includes the completing the CONSORT checklist.
Sample size Based in a previous study, to find a difference in the percentage of correct answers in a cognitive test to evaluate retention of 12%, considering a SD of 26%, alpha error of 5%, beta error of 20%, and repeated assessments (baseline, 3 weeks and 6 months), 35 students will be necessary in each group. To account for possible losses of follow-up, 84 students will be included.
Study intervention All students will receive, in advance, a text with basic sciences information relevant to the learning of Endocrinology (supplementary material), with instructions to study the text before intervention day.
Students will be randomized to one of the interventions: TEL with questions about diabetes and adrenal (Block A, 6 questions) or thyroid and hypophysis (Block B, 6 questions). Important endocrinology concepts, such as fuel metabolism and circadian rhythm will be included in Block A, and feedback loops and hormone synthesis in Block B. Specific hormone functions will be part of both TEL Blocks.
Assessments At the same day of intervention, students will answer all questions 12 of the TEL session (questions from blocks A and B) with best answer multiple choice questions (immediate retention test). After 3 weeks and 6 months, the transfer of knowledge will be assessed with a 24 multiple choice questions test, based in clinical cases.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block A | Experimental | Other: Test-enhanced learningTest intervention with questions regarding diabetes and adrenal |
| Block B | Active comparator | Other: Test-enhanced learningTest intervention with questions regarding thyroid and hypophysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Students will be consecutively invited to participated in the study before starting their Endocrinology placement and will be included after agreeing to participate and signing an informed consent
Key exclusion criteria (1 listed)
- Students absent on the day of study intervention or on the four-week assessment will be excluded from analysis.
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 |
|---|---|---|
| Test-enhanced learningTest-enhanced learning with short answers of questions regarding diabetes and adrenal | Other | Block A, Block B |
Primary outcome
24 multiple choice questions test at 3 weeks
Time frame: 3 weeks
Scores in 24 multiple choice questions test to assess learning transfer from basic sciences to Endocrinology, in 3 weeks. This is an special designed test. It is not a scale. The score will be zero to 24. The highest score indicates the best performance.
4 secondary outcomes
Immediate retention test
Time frame: immediately after test
24 multiple choice questions test at 6 months
Time frame: 6 months
Metacognition questionnaires - professors
Time frame: 4 weeks
Metacognition questionnaires - students
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Endocrinopathy
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 3
A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04)
Ovarian Cancer, Ovarian Neoplasms
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
RecruitingObservational study
Long-Term Follow-Up of Survivors of Pediatric Cushing Disease
Cushing Disease
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.
Cristiane B Leitao, MD principal investigator
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Test-enhanced learning in people with Endocrinopathy and Educational Problems, run by Hospital de Clinicas de Porto Alegre.
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 1 inclusion and 1 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 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Cristiane B Leitao, MD (55 51 33598127 ext. 8127, cleitao@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 multiple choice questions test at 3 weeks (time frame: 3 weeks). 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 7 Feb 2020.