- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01088438
Measuring Quality of Medical Student Performance at Contextualizing Care
Study Overview
Status
Intervention / Treatment
Detailed Description
Clinical decision making requires two distinct skills: the ability to classify patients' conditions into diagnostic and management categories that permit the application of "best evidence" guidelines, and the ability to individualize or - more precisely - to contextualize care for patients whose circumstances and needs require variation from the standard approach to care. Most assessment in medical education places heavy emphasis on biomedical decision-making with little emphasis on how to incorporate contextual factors that may be essential to planning patients' care.
The goal of this project is to demonstrate and provide validity evidence for an innovative standardized patient (SP) method of assessing medical students in the clinical years on their ability to detect and respond to individual contextual factors in a patient encounter that overcomes the aforementioned challenges.
During the project, fourth-year medical students participating in a Medicine sub-internship will be randomized to an intervention group or a control group; the intervention group will receive additional training in the application of qualitative methodology to elicit and incorporate contextual factors in the clinical encounter. All students will participate in an SP assessment consisting of four SPs, blinded to trial arm, presenting cases with and without important biomedical and contextual factors in a counterbalanced factorial design. Performance will be compared between trial arms. In addition, performance will be compared with United States Medical Licensing Exam (USMLE) Step 2 clinical knowledge scores to determine whether contextualizing ability is independent of clinical knowledge, and consistency of performance across individual SP cases will be studied to determine the number of cases necessary to achieve sufficient reliability for the assessment to be used.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- University of Illinois at Chicago
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Fourth-year medical students at University of Illinois at Chicago
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No intervention
|
|
Experimental: Contextualization workshop
A four-hour course on contextualization.
|
A four-hour course on contextualization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Developing an Appropriate Treatment Plan (for Contextual Variant of Encounters)
Time Frame: 1 month
|
Probability that the learner writes a correct treatment plan for the standardized patient encounters undertaken at assessment at end of subinternship that include contextual red flags.
All learners are scheduled to see 4 encounters, based on combinations of four cases and four potential variants (baseline, biomedical, contextual, biocontextual) with counterbalancing by study month; each has a single contextual variant encounter.
Treatment plans are assessed by an investigator blinded to the learner's assignment to intervention or control group.
|
1 month
|
Probing for Contextual Issues
Time Frame: 1 month
|
Probability that the learner probes contextual red flags raised in standardized patient encounters undertaken at assessment at end of subinternship.
Each learner undertakes four encounters, each of which presents a contextual red flag that may or may not be probed; in a small number of cases, the standardized patient was ill and the learner undertook fewer than four encounters as a result.
Assessment of probing is made by an investigator blinded to learner's assignment to group.
|
1 month
|
Probing for Biomedical Issues
Time Frame: 1 month
|
Probability that the learner probes biomedical red flags raised in standardized patient encounters undertaken at assessment at end of subinternship.
Each learner undertakes four encounters, each of which presents a biomedical red flag that may or may not be probed; in a small number of cases, the standardized patient was ill and the learner undertook fewer than four encounters as a result.
Assessment of probing is made by an investigator blinded to learner's assignment to group.
|
1 month
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alan Schwartz, PhD, University of Illinois at Chicago
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NBME0708-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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