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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02435316
Other study ID # TRHMC 016-12
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2012
Est. completion date February 12, 2013

Study information

Verified date March 2023
Source The Reading Hospital and Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, randomized controlled, crossover trial comparing the effectiveness one two curricular designs to teaching peripheral blood smears to residents.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 12, 2013
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 26 Years to 40 Years
Eligibility Inclusion Criteria: - Internal medicine and Family Medicine residents and faculty at The Reading Hospital and Medical Center having completed medical school Exclusion Criteria: - Practicing/ board certified hematologists

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Case vignette-based teaching of cell recognition
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 recognition
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.

Locations

Country Name City State
United States Reading Health System West Reading Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
The Reading Hospital and Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
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