Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2026-03-11 @ 9:26 PM
Study NCT ID:
NCT00856557
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2009-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intervening to Prevent Contextual Errors in Medical Decision Making
Sponsor:
US Department of Veterans Affairs
Organization:
Study Overview
Official Title:
Intervening to Prevent Contextual Errors in Medical Decision Making
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: