Trial Outcomes & Findings for Intervening to Prevent Contextual Errors in Medical Decision Making (NCT NCT00856557)
NCT ID: NCT00856557
Last Updated: 2015-04-24
Results Overview
A target health outcome improvement for each patient is prospectively defined at the first visit in which a contextual red flag is noted. The study outcome is what proportion of a physician's patients achieve their target health outcome improvement as documented in the medical record at 9 months post first visit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
138 participants
Primary outcome timeframe
After 9 months of the recorded visit
Results posted on
2015-04-24
Participant Flow
Resident physicians were consented and recruited from two clinical training facilities on a rolling basis over 30 months.
Participant milestones
| Measure |
Seminar and Practicum
Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.
Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care.
|
No Intervention
No educational intervention
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
76
|
|
Overall Study
Received Intervention/Control
|
62
|
76
|
|
Overall Study
Tested With Standardized Patients
|
62
|
76
|
|
Overall Study
With Patients With Contextual Flags
|
50
|
60
|
|
Overall Study
COMPLETED
|
50
|
60
|
|
Overall Study
NOT COMPLETED
|
12
|
16
|
Reasons for withdrawal
| Measure |
Seminar and Practicum
Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.
Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care.
|
No Intervention
No educational intervention
|
|---|---|---|
|
Overall Study
No patients with contextual flags
|
12
|
16
|
Baseline Characteristics
Intervening to Prevent Contextual Errors in Medical Decision Making
Baseline characteristics by cohort
| Measure |
Seminar and Practicum
n=62 Participants
Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.
Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care.
|
No Intervention
n=76 Participants
No educational intervention
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=5 Participants
|
76 participants
n=7 Participants
|
138 participants
n=5 Participants
|
|
Year in residency
Post Grad Yr (PGY) 1
|
7 participants
n=5 Participants
|
12 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Year in residency
PGY2
|
31 participants
n=5 Participants
|
45 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Year in residency
PGY3
|
24 participants
n=5 Participants
|
19 participants
n=7 Participants
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 9 months of the recorded visitA target health outcome improvement for each patient is prospectively defined at the first visit in which a contextual red flag is noted. The study outcome is what proportion of a physician's patients achieve their target health outcome improvement as documented in the medical record at 9 months post first visit.
Outcome measures
| Measure |
Seminar and Practicum
n=50 Participants
Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.
Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care.
|
No Intervention
n=60 Participants
No educational intervention
|
|---|---|---|
|
Health Outcome Improvement Rate
|
0.68 proportion of physician's patients
Standard Deviation 0.37
|
0.59 proportion of physician's patients
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: During initial patient recordingsProportion of encounters in which physician probed contextual red flags expressed by patients and identified via audio recordings.
Outcome measures
| Measure |
Seminar and Practicum
n=62 Participants
Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.
Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care.
|
No Intervention
n=76 Participants
No educational intervention
|
|---|---|---|
|
Rate of Contextual Probing
|
.26 proportion of physician's patients
Standard Deviation .25
|
.27 proportion of physician's patients
Standard Deviation .29
|
SECONDARY outcome
Timeframe: During initial patient recordingsProportion of patient encounters in which the physician's plan of care addressed contextual factors identified in the audio recordings
Outcome measures
| Measure |
Seminar and Practicum
n=62 Participants
Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.
Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care.
|
No Intervention
n=76 Participants
No educational intervention
|
|---|---|---|
|
Rate of Contextual Planning
|
.18 proportion of physician's patients
Standard Deviation .23
|
.21 proportion of physician's patients
Standard Deviation .24
|
Adverse Events
Seminar and Practium
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Intervention
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place