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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Cristiane B Leitao, MD contact

55 51 33598127 ext. 8127

cleitao@hcpa.edu.br

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.

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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.

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 groups in NCT04261101
Study groupRoleWhat they receive
Block AExperimentalTest intervention with questions regarding diabetes and adrenal
Receives: Other: Test-enhanced learning
Block BActive comparatorTest 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.

  1. 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)
  1. Immediate retention test

    Scores in immediate retention test (12 questions, in the same day as the TEL session)

    Measured: immediately after test

  2. 24 multiple choice questions test at 6 months

    Scores in 24 multiple choice questions test at 6 months

    Measured: 6 months

  3. Metacognition questionnaires - professors

    Results of metacognition questionnaires (not a scale)

    Measured: 4 weeks

  4. 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.

  1. First posted7 Feb 2020
  2. Study startFeb 2020 (estimated)
  3. Primary completionDec 2020 (estimated)
  4. Study completionJul 2021 (estimated)

Resources

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)
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

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.

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