NCT01059942

Brief Summary

The aim of this project is to develop and validate a simple, flexible, reliable, real-time observation tool to evaluate hand-off practices. The Hand-off CEX is a paper-based instrument that can be used to evaluate either the sender or the receiver of hand-off communication. This tool is based on a previously-validated, widely-used, real-time educational evaluation tool (the Mini-CEX); published expert opinion; and our prior research . The investigators' tool incorporates unique role-based anchors for both senders and receivers that refer to verbal communication, professionalism and environment, hand-off domains informed by preliminary work and expert opinion. The Hand-off CEX(Clinical Evaluation Exercise) will be used by academic hospitalists and house-staff physicians to assess feasibility. We, the investigators, will also assess the construct validity and inter-rater reliability of the tool through the use of standardized, videotaped hand-off scenarios depicting various levels of performance of a hand-off scenario. We hypothesize that the Hand-off CEX will arm educators with an innovative, necessary, valid and feasible method for training health professionals to conduct safe and effective hand-offs. Finally, the Hand-off CEX will be a useful tool to assist hospitals in improving patient safety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

1.6 years

First QC Date

January 27, 2010

Last Update Submit

September 4, 2013

Conditions

Keywords

communication barriersclinical competencemedical educationinternship and residencyhospitalistQuality Assurance, HealthcarePatient CareInternal Medicine

Outcome Measures

Primary Outcomes (1)

  • Residents and Hospitalists will use the Hand-off CEX to conduct evaluations of their sign-out process. In addition, each hand-off will be evaluated simultaneously by a trained observer.

    January 2010-January 2015

Secondary Outcomes (2)

  • Upon completion of the Hand-Off evaluation, participants and observers will be asked about their overall satisfaction with the evaluation. This will be a marker of the feasibility of the Hand-Off CEX.

    January 2010-January 2015

  • For the validity part of the study, attending and house-staff physicians will analyze six video scenarios using the Hand-off CEX, rating each of the dimensions of hand-off competence for both the senders and receivers of the handoff.

    January 2010-January 2015

Study Arms (1)

Hospitalist physicians/house-staff

Consented Academic Hospitalist and Internal Medicine Residency staff

Other: mock handoff exposureOther: Introduction of CEX tool in Actual Hand-offs

Interventions

Attending and house-staff physicians will analyze six video scenarios using the Hand-off CEX, rating each of the dimensions of hand-off competence for both the senders and receivers of the mock hand-off.

Hospitalist physicians/house-staff

We will teach hospitalist physicians and house-staff how to utilize the Hand-off CEX in conducting their own hand-offs.

Hospitalist physicians/house-staff

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Academic Hosptialists and Internal Medicine Residents of the University of Chicago Medical Center.

You may qualify if:

  • All academic hospitalist and internal medicine house-staff are eligible to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Vineet M Arora, MD, MA

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2010

First Posted

February 1, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2011

Study Completion

December 1, 2012

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations