Hematologic DiseasesPBSNCT02435316
Comparison of Educational Methods for Teaching Peripheral Blood Smears
A study testing Case vignette-based teaching of cell recognition and Compare-contrast basic science teaching of cell recognition in people with Hematologic Diseases, run by The Reading Hospital and Medical Center at 1 site in United States.
Trial summary
This is a prospective, randomized controlled, crossover trial comparing the effectiveness one two curricular designs to teaching peripheral blood smears to residents. Read more about this study
- Who is it for?
- Ages 26 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hematologic Diseases
- What is being tested?
- Case vignette-based teaching of cell recognition and Compare-contrast basic science teaching of cell recognition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to 12 Feb 2013
- 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 26 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Internal medicine and Family Medicine residents and faculty at The Reading Hospital and Medical Center having completed medical school
Who cannot join
- Practicing/ board certified hematologists
Trial locations and contacts
1 site in 1 country.
United States1 site
Reading Health System
West Reading, Pennsylvania, 19612
About this study
Official title: A Randomized, Controlled Cross Over Trial of Two Educational Methods and Their Additive Effects in the Recognition of Abnormal Peripheral Blood Smears
This is a prospective, randomized controlled, crossover trial comparing the effectiveness one two curricular designs to teaching peripheral blood smears to residents.
Read the detailed description
General Approach:
This study will employ a randomized, controlled design and will use as its outcomes two separate post-tests, one after the first teaching session and one 4 weeks after the second intervention.
Design The investigators are attempting to find whether the combination of basic science education using an 1-hour additive microskills- building method along with compare/ contrast model versus a 1-hour traditional case-based format would improve performance on a visual recognition test of hematology questions. A final test at 4 weeks after the cross-over between the two groups will also help investigators analyze whether the order of exposure to the teaching method would have an impact on the final performance.
Sampling, including sample size and statistical power:
Sample size will be between 40-50 resident physicians meeting inclusion criteria for the study. There is not enough data in the literature to effectively determine power, so we will use a convenience sample of the largest feasible group (around 40).
Collection of data:
Data will be collected on an excel spreadsheet and will be permanently de-identified on that spreadsheet; it will be kept on a password-protected site.
Information management and analysis software:
Data will be entered into a password protected excel spreadsheet and each study participant will be assigned a unique identifier code which will be used to link the data. Statistical analysis will be performed using SPSS version 20.
Data entry, editing and management, including handling of data collection forms, different versions of data, and data storage and disposition:
Paper surveys and tests will be collected, recorded and locked; they will be destroyed 2 years after termination of the study. A paired t-test will be used to compare the two samples means for significance.
Quality Control / Assurance:
Pretest and post-tests will be checked against a gold standard, a hospital board-certified hematopathologist, to check the quality of the slides.
Bias in data collection, measurement and analysis:
Given the small numbers of participants expected, a Type 1 error (failure to detect a difference in groups when one exists) is possible, as the study will possibly be underpowered.
- Conditions
- Hematologic Diseases
- Being tested
- Case vignette-based teaching of cell recognition, Compare-contrast basic science teaching of cell recognition
- Keywords
- Education
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case vignette-based teaching of cell recognitionOther
Intervention group members will be taught peripheral blood smears by using power point slides and utilizing additive microskills using the compare/ contrast technique to recognize various cell types. Memory will be reinforced by using cases to help recognize the clinical importance of learning about individual cell types.
Compare-contrast basic science teaching of cell recognitionOther
The control group will be given a traditional 60-minute lecture using board review questions with accompanying pictures of peripheral blood smears, without explaining individual cell type.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Group 1 will receive 1 hour of compare-contrast basic science teaching of cell recognition to enhance recognition of those photographs, followed by 1 hour Case vignette-based teaching of cell recognition 2 weeks later Receives: Other: Case vignette-based teaching of cell recognition; Other: Compare-contrast basic science teaching of cell recognition |
| Group 2 | Active comparator | Group 2 will receive 1 hour of Case vignette-based teaching of cell recognition followed by compare-contrast basic science teaching of cell recognition 2 weeks later Receives: Other: Case vignette-based teaching of cell recognition; Other: Compare-contrast basic science teaching of cell recognition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in post test scores at 2 and 4 weeks after education
Primary outcome was an improvement in test score from pre-test to 2 and 4-week post-test. All participants took a 15-question pretest in addition to a posttest at 2 and 4 weeks. Each test consisted of pictures of various cell types from the peripheral blood.
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 posted6 May 2015 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completion12 Feb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Reading Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony A. Donato, The Reading Hospital and Medical Center
- Investigators
- Anthony Donato, MD, Study director, The Reading Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435316
- Sponsor's protocol ID
- TRHMC 016-12
- Acronym
- PBS
- Status last verified
- Mar 2023
- First submitted
- 30 Apr 2015
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Cross Over Trial of Two Educational Methods and Their Additive Effects in the Recognition of Abnormal Peripheral Blood Smears
- ClinicalTrials.gov ID
- NCT02435316
- Acronym / sponsor ID
- PBS / TRHMC 016-12
- Conditions
- Hematologic Diseases
- Keywords
- Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Reading Hospital and Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- 12 Feb 2013 (actual)
- First posted
- 6 May 2015 (estimated)
- 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.
This is a prospective, randomized controlled, crossover trial comparing the effectiveness one two curricular designs to teaching peripheral blood smears to residents.
Detailed description
General Approach:
This study will employ a randomized, controlled design and will use as its outcomes two separate post-tests, one after the first teaching session and one 4 weeks after the second intervention.
Design The investigators are attempting to find whether the combination of basic science education using an 1-hour additive microskills- building method along with compare/ contrast model versus a 1-hour traditional case-based format would improve performance on a visual recognition test of hematology questions. A final test at 4 weeks after the cross-over between the two groups will also help investigators analyze whether the order of exposure to the teaching method would have an impact on the final performance.
Sampling, including sample size and statistical power:
Sample size will be between 40-50 resident physicians meeting inclusion criteria for the study. There is not enough data in the literature to effectively determine power, so we will use a convenience sample of the largest feasible group (around 40).
Collection of data:
Data will be collected on an excel spreadsheet and will be permanently de-identified on that spreadsheet; it will be kept on a password-protected site.
Information management and analysis software:
Data will be entered into a password protected excel spreadsheet and each study participant will be assigned a unique identifier code which will be used to link the data. Statistical analysis will be performed using SPSS version 20.
Data entry, editing and management, including handling of data collection forms, different versions of data, and data storage and disposition:
Paper surveys and tests will be collected, recorded and locked; they will be destroyed 2 years after termination of the study. A paired t-test will be used to compare the two samples means for significance.
Quality Control / Assurance:
Pretest and post-tests will be checked against a gold standard, a hospital board-certified hematopathologist, to check the quality of the slides.
Bias in data collection, measurement and analysis:
Given the small numbers of participants expected, a Type 1 error (failure to detect a difference in groups when one exists) is possible, as the study will possibly be underpowered.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Case vignette-based teaching of cell recognition, Other: Compare-contrast basic science teaching of cell recognitionGroup 1 will receive 1 hour of compare-contrast basic science teaching of cell recognition to enhance recognition of those photographs, followed by 1 hour Case vignette-based teaching of cell recognition 2 weeks later |
| Group 2 | Active comparator | Other: Case vignette-based teaching of cell recognition, Other: Compare-contrast basic science teaching of cell recognitionGroup 2 will receive 1 hour of Case vignette-based teaching of cell recognition followed by compare-contrast basic science teaching of cell recognition 2 weeks later |
Who may qualify
- Ages
- 26 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Internal medicine and Family Medicine residents and faculty at The Reading Hospital and Medical Center having completed medical school
Key exclusion criteria (1 listed)
- Practicing/ board certified hematologists
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 vignette-based teaching of cell recognitionIntervention group members will be taught peripheral blood smears by using power point slides and utilizing additive microskills using the compare/ contrast technique to recognize various cell types. Memory will be reinforced by using cases to help recognize the clinical importance of learning about individual cell types. | Other | Group 1, Group 2 |
| Compare-contrast basic science teaching of cell recognitionThe control group will be given a traditional 60-minute lecture using board review questions with accompanying pictures of peripheral blood smears, without explaining individual cell type. | Other | Group 1, Group 2 |
Primary outcome
Improvement in post test scores at 2 and 4 weeks after education
Time frame: 4 weeks
Primary outcome was an improvement in test score from pre-test to 2 and 4-week post-test. All participants took a 15-question pretest in addition to a posttest at 2 and 4 weeks. Each test consisted of pictures of various cell types from the peripheral blood.
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 29 Mar 2023.
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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.
Anthony Donato, MD study director
The Reading Hospital and Medical Center
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 vignette-based teaching of cell recognition and Compare-contrast basic science teaching of cell recognition in people with Hematologic Diseases, run by The Reading Hospital and Medical Center at 1 site in United States.
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: finished, as of the sponsor's last update on 29 Mar 2023. 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 United States. 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?
Improvement in post test scores at 2 and 4 weeks after education (time frame: 4 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 29 Mar 2023.