NCT01088438

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 6, 2011

Completed
Last Updated

May 6, 2011

Status Verified

March 1, 2011

Enrollment Period

1.7 years

First QC Date

March 12, 2010

Results QC Date

March 14, 2011

Last Update Submit

April 11, 2011

Conditions

Keywords

medical educationdecision makingdiagnostic errorcontextualization

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Contextualization workshop

EXPERIMENTAL

A four-hour course on contextualization.

Behavioral: Contextualization workshop

Control

NO INTERVENTION

No intervention

Interventions

A four-hour course on contextualization.

Contextualization workshop

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related 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.2010.1297.

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

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).

Results Point of Contact

Title
Dr. Alan Schwartz
Organization
University of Illinois at Chicago

Study Officials

  • Alan Schwartz, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2010

First Posted

March 17, 2010

Study Start

July 1, 2008

Primary Completion

March 1, 2010

Study Completion

June 1, 2010

Last Updated

May 6, 2011

Results First Posted

May 6, 2011

Record last verified: 2011-03

Locations