- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01059942
Development and Validation of a Tool to Measure Hand-off Quality
Development and Validation of a Tool to Evaluate Hand-off Quality
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- The University of Chicago Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Hospitalist physicians/house-staff
Consented Academic Hospitalist and Internal Medicine Residency staff
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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.
We will teach hospitalist physicians and house-staff how to utilize the Hand-off CEX in conducting their own hand-offs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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January 2010-January 2015
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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January 2010-January 2015
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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
|
January 2010-January 2015
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vineet M Arora, MD, MA, University of Chicago
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 09-258-A
- 1R03H5018278-01 (Other Grant/Funding Number: The Agency for Healthcare Research and Quality)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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