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Clinical Trials/NCT02435316
NCT02435316
Completed
Not Applicable

A Randomized, Controlled Cross Over Trial of Two Educational Methods and Their Additive Effects in the Recognition of Abnormal Peripheral Blood Smears

The Reading Hospital and Medical Center1 site in 1 country30 target enrollmentApril 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hematologic Diseases
Sponsor
The Reading Hospital and Medical Center
Enrollment
30
Locations
1
Primary Endpoint
Improvement in post test scores at 2 and 4 weeks after education
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
February 12, 2013
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anthony A. Donato

Associate Program Director, Inpatient Medicine

The Reading Hospital and Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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