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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01088438
Other study ID # NBME0708-12
Secondary ID
Status Completed
Phase N/A
First received March 12, 2010
Last updated April 11, 2011
Start date July 2008
Est. completion date June 2010

Study information

Verified date March 2011
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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 standardized patients (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; the investigators hypothesize better performance in the intervention arm. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 189
Est. completion date June 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Fourth-year medical students at University of Illinois at Chicago

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Behavioral:
Contextualization workshop
A four-hour course on contextualization.

Locations

Country Name City State
United States University of Illinois at Chicago Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Chicago The National Board of Medical Examiners

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schwartz A, Weiner SJ, Harris IB, Binns-Calvey A. An educational intervention for contextualizing patient care and medical students' abilities to probe for contextual issues in simulated patients. JAMA. 2010 Sep 15;304(11):1191-7. doi: 10.1001/jama.2010.1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Developing an Appropriate Treatment Plan (for Contextual Variant of Encounters) 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 No
Primary Probing for Contextual Issues 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 No
Primary Probing for Biomedical Issues 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 No
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