Intervening to Prevent Contextual Errors in Medical Decision Making

• ClinicalTrials.gov Identifier: NCT00856557
• Recruitment Status: Completed
• First Posted: March 5, 2009
• Results First Posted: November 25, 2014
• Last Update Posted: April 24, 2015
• Sponsor: US Department of Veterans Affairs
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description

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

Condition or disease	Intervention/treatment	Phase
Psychosocial Circumstances	Behavioral: Seminar and Practicum	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Intervening to Prevent Contextual Errors in Medical Decision Making
• Study Start Date: October 2009
• Actual Primary Completion Date: November 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

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.	Behavioral: Seminar 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.
No Intervention: No intervention; No educational intervention.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Illinois

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, United States, 60612

Sponsors and Collaborators

US Department of Veterans Affairs

Investigators

• Principal Investigator: Saul J. Weiner, MD; Jesse Brown VA Medical Center, Chicago, IL

More Information

Publications of Results:

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.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00856557
• Other Study ID Numbers: EDU 08-430
• First Posted: March 5, 2009
• Results First Posted: November 25, 2014
• Last Update Posted: April 24, 2015
• Last Verified: October 2014

Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):

Patients with complex psychosocial needs