Intervening to Prevent Contextual Errors in Medical Decision Making

Psychosocial Circumstances Clinical Trial

Official title:

Intervening to Prevent Contextual Errors in Medical Decision Making

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856557
• Other study ID #: EDU 08-430
• Status: Completed
• Phase: N/A
• First received: March 3, 2009
• Last updated: April 6, 2015
• Start date: October 2009
• Est. completion date: December 2012

Study information

• Verified date: October 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Psychosocial Circumstances

Intervention

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.

Locations

Country	Name	City	State
United States	Jesse Brown VA Medical Center, Chicago, IL	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.2010.1 — View Citation

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: 10.1177/027298 — View Citation

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	After 9 months of the recorded visit	No
Secondary	Rate of Contextual Probing	Proportion of encounters in which physician probed contextual red flags expressed by patients and identified via audio recordings.	During initial patient recordings	No
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	During initial patient recordings	No