- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00856557
Intervening to Prevent Contextual Errors in Medical Decision Making
April 6, 2015 updated by: US Department of Veterans Affairs
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
138
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60612
- Jesse Brown VA Medical Center, Chicago, IL
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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 intervention
No educational intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Outcome Improvement Rate
Time Frame: After 9 months of the recorded visit
|
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.
|
After 9 months of the recorded visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Contextual Probing
Time Frame: During initial patient recordings
|
Proportion of encounters in which physician probed contextual red flags expressed by patients and identified via audio recordings.
|
During initial patient recordings
|
Rate of Contextual Planning
Time Frame: During initial patient recordings
|
Proportion of patient encounters in which the physician's plan of care addressed contextual factors identified in the audio recordings
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During initial patient recordings
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Saul J. Weiner, MD, Jesse Brown VA Medical Center, Chicago, IL
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Weiner SJ, Kelly B, Ashley N, Binns-Calvey A, Sharma G, Schwartz A, Weaver FM. Content coding for contextualization of care: evaluating physician performance at patient-centered decision making. Med Decis Making. 2014 Jan;34(1):97-106. doi: 10.1177/0272989X13493146. Epub 2013 Jun 19.
- Weiner SJ, Schwartz A, Sharma G, Binns-Calvey A, Ashley N, Kelly B, Dayal A, Patel S, Weaver FM, Harris I. Patient-centered decision making and health care outcomes: an observational study. Ann Intern Med. 2013 Apr 16;158(8):573-9. doi: 10.7326/0003-4819-158-8-201304160-00001.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (ACTUAL)
November 1, 2012
Study Completion (ACTUAL)
December 1, 2012
Study Registration Dates
First Submitted
March 3, 2009
First Submitted That Met QC Criteria
March 4, 2009
First Posted (ESTIMATE)
March 5, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
April 24, 2015
Last Update Submitted That Met QC Criteria
April 6, 2015
Last Verified
October 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- EDU 08-430
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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