NCT00856557

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 years until next milestone

Results Posted

Study results publicly available

November 25, 2014

Completed
Last Updated

April 24, 2015

Status Verified

October 1, 2014

Enrollment Period

3.1 years

First QC Date

March 3, 2009

Results QC Date

October 27, 2014

Last Update Submit

April 6, 2015

Conditions

Psychosocial Circumstances

Keywords

Patients with complex psychosocial needs

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Rate of Contextual Probing

    During initial patient recordings

  • Rate of Contextual Planning

    During initial patient recordings

Study Arms (2)

Seminar and Practicum

EXPERIMENTAL

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

No intervention

NO INTERVENTION

No educational intervention.

Interventions

Seminar and PracticumBEHAVIORAL

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.

Seminar and Practicum

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

  • 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.

    PMID: 23784847RESULT

  • 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.

    PMID: 23588745RESULT

  • 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.

    PMID: 20841532RESULT

Results Point of Contact

Title
Dr. Saul J. Weiner
Organization
Jesse Brown VA Medical Center
Saul.Weiner@va.gov
3125192697

Study Officials

  • Saul J. Weiner, MD

    Jesse Brown VA Medical Center, Chicago, IL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 5, 2009

Study Start

October 1, 2009

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

April 24, 2015

Results First Posted

November 25, 2014

Record last verified: 2014-10

Locations

US(1)