Diagnosis, Education, Medical, Undergraduate, Medical History Taking
Conditions
Keywords
medical education, decision making, diagnostic error, contextualization
Brief 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.
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.
Interventions
BEHAVIORALContextualization workshop
A four-hour course on contextualization.
Sponsors
The National Board of Medical Examiners
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fourth-year medical students at University of Illinois at Chicago
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Developing an Appropriate Treatment Plan (for Contextual Variant of Encounters) | 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. |
| Probing for Contextual Issues | 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. |
| Probing for Biomedical Issues | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Contextualization Workshop A four-hour course on contextualization. | 94 |
| Control No intervention | 95 |
| Total | 189 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 18 | 30 |
| Overall Study | Withdrawal by Subject | 11 | 6 |
Baseline characteristics
| Characteristic | Contextualization Workshop | Control | Total |
|---|---|---|---|
| Age Continuous | 28.8 years STANDARD_DEVIATION 3.6 | 28.8 years STANDARD_DEVIATION 3.6 | 28.8 years STANDARD_DEVIATION 3.6 |
| Race/Ethnicity, Customized Non-White | 64 participants | 61 participants | 125 participants |
| Race/Ethnicity, Customized White | 30 participants | 34 participants | 64 participants |
| Sex: Female, Male Female | 49 Participants | 41 Participants | 90 Participants |
| Sex: Female, Male Male | 45 Participants | 54 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 94 | 0 / 95 |
| serious Total, serious adverse events | 0 / 94 | 0 / 95 |
Outcome results
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.
Time frame: 1 month
Population: ITT. In one case, a participant did not receive a contextual variant encounter because the standardized patient was ill, and this encounter is excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contextualization Workshop | Developing an Appropriate Treatment Plan (for Contextual Variant of Encounters) | 0.67 proportion of contextual encounters |
| Control | Developing an Appropriate Treatment Plan (for Contextual Variant of Encounters) | 0.24 proportion of contextual encounters |
Comparison: Null hypothesis: proportion of encounters with contextual red flag in which appropriate treatment is planned is the same in the two groups.p-value: <0.001Chi-squared
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.
Time frame: 1 month
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contextualization Workshop | Probing for Biomedical Issues | 0.77 proportion of encounters |
| Control | Probing for Biomedical Issues | 0.77 proportion of encounters |
Comparison: Null hypothesis is equal proportion of encounters probed in control and intervention groups.p-value: 0.85Chi-squared
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.
Time frame: 1 month
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contextualization Workshop | Probing for Contextual Issues | 0.86 proportion of encounters |
| Control | Probing for Contextual Issues | 0.61 proportion of encounters |
Comparison: Null hypothesis is equal proportion of contextual red flags probed in control and intervention groups.p-value: <0.001Chi-squared