Development and Validation of a Tool to Measure Hand-off Quality

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01059942
Recruitment Status : Completed
First Posted : February 1, 2010
Last Update Posted : September 5, 2013
Yale University
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment
Communication Patient Care Quality of Health Care Other: mock handoff exposure Other: Introduction of CEX tool in Actual Hand-offs

Detailed Description:

Transitions of patient care among inpatient providers occur frequently and require providers to transmit critical clinical information. If information is omitted or misunderstood during a hand-off, serious clinical consequences may result for patient care. In fact, studies have shown that hand-offs are often variable and represent a major gap in safe patient care. For patients cared for by resident physicians, dangers posed by poor communication may be amplified since the implementation of resident duty hour restrictions in July 2003 has increased transfer frequency.In addition, few trainees receive formal training on hand-offs. The Joint Commission currently requires hospitals to implement a standardized, interactive approach to hand-off communications. Unfortunately, due to a lack of valid, standardized tools to evaluate hand-off quality, hospitals and educators cannot assess whether their hand-offs meet these criteria. More recently, the Institute of Medicine has recommended that all residents receive formal education on hand-off strategies.

Education about best practices during hand-offs and assessment of hand-off quality is needed for several reasons: to improve clinical practice through evaluation and feedback, to illuminate areas of deficiency in current practices and to maximize patient safety in this era of duty hour restrictions. At the University of Chicago and Yale, investigators have extensive experience in describing hand-off quality, designing and implementing novel curricula to improve hand-off education amongst varying levels of trainees and have elucidated the relationship between patient care outcomes and poor hand-off quality. Therefore, drawing from our preliminary work in this area, and relevant practices in other industries, we aim to develop and test a generalizable tool to evaluate hand-offs in clinical settings.

Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Development and Validation of a Tool to Evaluate Hand-off Quality
Study Start Date : January 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : December 2012

Group/Cohort Intervention/treatment
Hospitalist physicians/house-staff
Consented Academic Hospitalist and Internal Medicine Residency staff
Other: mock handoff exposure
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.
Other: Introduction of CEX tool in Actual Hand-offs
We will teach hospitalist physicians and house-staff how to utilize the Hand-off CEX in conducting their own hand-offs.

Primary Outcome Measures :
  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. [ Time Frame: January 2010-January 2015 ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: January 2010-January 2015 ]
  2. 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. [ Time Frame: January 2010-January 2015 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Academic Hosptialists and Internal Medicine Residents of the University of Chicago Medical Center.

Inclusion Criteria:

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

Exclusion Criteria:

  • We have no exclusion criteria. All internal medicine residents and hospitalist physicians at the University of Chicago will be invited to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01059942

United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Yale University
Principal Investigator: Vineet M Arora, MD, MA University of Chicago

Responsible Party: University of Chicago Identifier: NCT01059942     History of Changes
Other Study ID Numbers: 09-258-A
1R03H5018278-01 ( Other Grant/Funding Number: The Agency for Healthcare Research and Quality )
First Posted: February 1, 2010    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

Keywords provided by University of Chicago:
communication barriers
clinical competence
medical education
internship and residency
Quality Assurance, Healthcare
Patient Care
Internal Medicine