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Intervening to Prevent Contextual Errors in Medical Decision Making

Intervening to Prevent Contextual Errors in Medical Decision Making

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00856557
Enrollment
138
Registered
2009-03-05
Start date
2009-10-31
Completion date
2012-12-31
Last updated
2015-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosocial Circumstances

Keywords

Patients with complex psychosocial needs

Brief summary

This study assessed whether a medical education intervention improves the quality of medical decision making in the care of patients with complex psychosocial -- or contextual -- needs that are essential to address when planning their care. A group of internal medicine residents were randomly assigned to participate in the seminar and practicum and then they, along with a control group that had not participated, were assessed for the quality of their clinical decision making and its impact on patient care. The study also assessed whether contextualization of care is associated with better patient health care outcomes

Detailed description

We enrolled 139 internal medicine residents at 2 VA hospitals, Jesse Brown and Hines, in a randomized controlled design. Half participated in a 4 hour seminar series integrated into their ambulatory curriculum. Each month a total of 8 residents participated. Following the intervention there were 3 levels of assessment: (1) All participants, intervention and control, participated in a brief exercise interviewing 4 standardized patients (SPs). Note that we separately enlisted the assistance of 8 attending physicians to assist with case development for these SPs. (2) The research team subsequently enrolled 3 real patients from each physician's practice with red flags such as poor adherence, or missed visits, suggestive of contextual issues that need to be addressed. Physicians were scored on their performance at identifying the underlying contextual factors that account for these red flags and on formulating an appropriate plan of care. (3) The coders prospectively defined successful vs. unsuccessful outcomes for each case. At the follow up visit data was collected on whether the desired outcome was achieved. The analysis compared the skills, performance and outcomes of the intervention compared with the control group to determine the efficacy of training residents to individualize care.

Interventions

BEHAVIORALSeminar and Practicum

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.

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Internal Medicine Residency with continuity of care clinics at either Jesse Brown or Hines VA Medical Centers

Exclusion criteria

* All resident physicians who do not meet inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Health Outcome Improvement RateAfter 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.

Secondary

MeasureTime frameDescription
Rate of Contextual ProbingDuring initial patient recordingsProportion of encounters in which physician probed contextual red flags expressed by patients and identified via audio recordings.
Rate of Contextual PlanningDuring initial patient recordingsProportion of patient encounters in which the physician's plan of care addressed contextual factors identified in the audio recordings

Countries

United States

Participant flow

Recruitment details

Resident physicians were consented and recruited from two clinical training facilities on a rolling basis over 30 months.

Participants by arm

ArmCount
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.
62
No Intervention
No educational intervention
76
Total138

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyNo patients with contextual flags1216

Baseline characteristics

CharacteristicNo InterventionTotalSeminar and Practicum
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
76 Participants138 Participants62 Participants
Region of Enrollment
United States
76 participants138 participants62 participants
Sex: Female, Male
Female
43 Participants74 Participants31 Participants
Sex: Female, Male
Male
33 Participants64 Participants31 Participants
Year in residency
PGY2
45 participants76 participants31 participants
Year in residency
PGY3
19 participants43 participants24 participants
Year in residency
Post Grad Yr (PGY) 1
12 participants19 participants7 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 620 / 76
serious
Total, serious adverse events
0 / 620 / 76

Outcome results

Primary

Health Outcome Improvement Rate

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.

Time frame: After 9 months of the recorded visit

ArmMeasureValue (MEAN)Dispersion
Seminar and PracticumHealth Outcome Improvement Rate0.68 proportion of physician's patientsStandard Deviation 0.37
No InterventionHealth Outcome Improvement Rate0.59 proportion of physician's patientsStandard Deviation 0.43
Comparison: Null hypothesis is equal distribution of proportion of successful encounters among groupsp-value: 0.33Wilcoxon (Mann-Whitney)
Comparison: Considering all encounters (n=179) of all physicians for who outcomes were measured (n=111) together, are encounters in which physicians contextualized the plan of care more likely to be associated with target health outcome achievement than encounters in which physicians did not, controlling for clustering of encounters within physicians. (Generalized logistic mixed model, with random intercept for physician)p-value: 0.036Mixed Models Analysis
Secondary

Rate of Contextual Planning

Proportion of patient encounters in which the physician's plan of care addressed contextual factors identified in the audio recordings

Time frame: During initial patient recordings

ArmMeasureValue (MEAN)Dispersion
Seminar and PracticumRate of Contextual Planning.18 proportion of physician's patientsStandard Deviation 0.23
No InterventionRate of Contextual Planning.21 proportion of physician's patientsStandard Deviation 0.24
p-value: 0.39Wilcoxon (Mann-Whitney)
Secondary

Rate of Contextual Probing

Proportion of encounters in which physician probed contextual red flags expressed by patients and identified via audio recordings.

Time frame: During initial patient recordings

ArmMeasureValue (MEAN)Dispersion
Seminar and PracticumRate of Contextual Probing.26 proportion of physician's patientsStandard Deviation 0.25
No InterventionRate of Contextual Probing.27 proportion of physician's patientsStandard Deviation 0.29
p-value: 0.99Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026