Trial Outcomes & Findings for Measuring Quality of Medical Student Performance at Contextualizing Care (NCT NCT01088438)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

189 participants

Primary outcome timeframe

1 month

Results posted on

2011-05-06

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Contextualization Workshop A four-hour course on contextualization.	Control No intervention
Overall Study STARTED	94	95
Overall Study COMPLETED	65	59
Overall Study NOT COMPLETED	29	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Contextualization Workshop A four-hour course on contextualization.	Control No intervention
Overall Study Withdrawal by Subject	11	6
Overall Study Lost to Follow-up	18	30

Baseline Characteristics

Measuring Quality of Medical Student Performance at Contextualizing Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contextualization Workshop n=94 Participants A four-hour course on contextualization.	Control n=95 Participants No intervention	Total n=189 Participants Total of all reporting groups
Age Continuous	28.8 years STANDARD_DEVIATION 3.6 • n=5 Participants	28.8 years STANDARD_DEVIATION 3.6 • n=7 Participants	28.8 years STANDARD_DEVIATION 3.6 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	41 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	54 Participants n=7 Participants	99 Participants n=5 Participants
Race/Ethnicity, Customized White	30 participants n=5 Participants	34 participants n=7 Participants	64 participants n=5 Participants
Race/Ethnicity, Customized Non-White	64 participants n=5 Participants	61 participants n=7 Participants	125 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Contextualization Workshop n=64 encounters (contextual variant) A four-hour course on contextualization.	Control n=59 encounters (contextual variant) No intervention
Developing an Appropriate Treatment Plan (for Contextual Variant of Encounters)	0.67 proportion of contextual encounters Interval 0.55 to 0.79	0.24 proportion of contextual encounters Interval 0.13 to 0.35

PRIMARY outcome

Timeframe: 1 month

Population: ITT

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.

Outcome measures

Outcome measures
Measure	Contextualization Workshop n=258 encounters A four-hour course on contextualization.	Control n=236 encounters No intervention
Probing for Contextual Issues	0.86 proportion of encounters Interval 0.82 to 0.9	0.61 proportion of encounters Interval 0.55 to 0.67

PRIMARY outcome

Timeframe: 1 month

Population: ITT

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.

Outcome measures

Outcome measures
Measure	Contextualization Workshop n=258 encounters A four-hour course on contextualization.	Control n=236 encounters No intervention
Probing for Biomedical Issues	0.77 proportion of encounters Interval 0.72 to 0.82	0.77 proportion of encounters Interval 0.72 to 0.82

Adverse Events

Contextualization Workshop

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alan Schwartz

University of Illinois at Chicago

Phone: 312-996-2070

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place