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| Name | Class |
|---|---|
| The National Board of Medical Examiners | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contextualization workshop | Experimental | A four-hour course on contextualization. |
|
| Control | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contextualization workshop | Behavioral | A four-hour course on contextualization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Schwartz, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20841532 | Result | 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.2010.1297. |
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All fourth-year medical students at the University of Illinois at Chicago (UIC) College of Medicine who were enrolled in internal medicine subinternships at one of 2 sites (UIC or Jesse Brown Veterans Administration Medical Center) July 2008 - April 2009 or August 2009 - April 2010 were eligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | Contextualization Workshop | A four-hour course on contextualization. |
| FG001 | Control | No intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Contextualization Workshop | A four-hour course on contextualization. |
| BG001 | Control | No intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT. In one case, a participant did not receive a contextual variant encounter because the standardized patient was ill, and this encounter is excluded. | Posted | Number | 95% Confidence Interval | proportion of contextual encounters | 1 month | encounters (contextual variant) | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Contextualization Workshop | A four-hour course on contextualization. |
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Small number of cases and variants. Alternating assignment of site to intervention/control. Substantial drop-out (sensitivity analysis finds results robust to conservative imputation for drop-outs).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alan Schwartz | University of Illinois at Chicago | 312-996-2070 | alansz@uic.edu |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number of participants identifying as "White" race. | Number | participants |
|
A four-hour course on contextualization. |
| OG001 | Control | No intervention |
|
|
|
| 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. | ITT | Posted | Number | 95% Confidence Interval | proportion of encounters | 1 month | encounters | Participants |
|
|
|
|
| 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. | ITT | Posted | Number | 95% Confidence Interval | proportion of encounters | 1 month | encounters | Participants |
|
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|
| 0 |
| 94 |
| 0 |
| 94 |
| EG001 | Control | No intervention | 0 | 95 | 0 | 95 |
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