CommunicationNCT01059942
Development and Validation of a Tool to Measure Hand-off Quality
An observational study of Communication and Patient Care, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Communication, Patient Care, Quality of Health Care
- What is being tested?
- mock handoff exposure and Introduction of CEX tool in Actual Hand-offs
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Academic Hosptialists and Internal Medicine Residents of the University of Chicago Medical Center.
Who may be able to join
- All academic hospitalist and internal medicine house-staff are eligible to participate.
Who cannot join
- We have no exclusion criteria. All internal medicine residents and hospitalist physicians at the University of Chicago will be invited to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: 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.
Read the 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.
- Conditions
- Communication, Patient Care, Quality of Health Care
- Being tested
- mock handoff exposure, Introduction of CEX tool in Actual Hand-offs
- Keywords
- communication barriers, clinical competence, medical education, internship and residency, hospitalist, Quality Assurance, Healthcare, Patient Care, Internal Medicine
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mock handoff exposureOther
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.
Introduction of CEX tool in Actual Hand-offsOther
We will teach hospitalist physicians and house-staff how to utilize the Hand-off CEX in conducting their own hand-offs.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalist physicians/house-staff | Consented Academic Hospitalist and Internal Medicine Residency staff Receives: Other: mock handoff exposure; Other: Introduction of CEX tool in Actual Hand-offs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: January 2010-January 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Vineet M Arora, MD, MA, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059942
- Sponsor's protocol ID
- 09-258-A
- Other IDs
- 1R03H5018278-01
- Status last verified
- Sep 2013
- First submitted
- 27 Jan 2010
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Tool to Evaluate Hand-off Quality
- ClinicalTrials.gov ID
- NCT01059942
- Acronym / sponsor ID
- 09-258-A
- Conditions
- Communication, Patient Care, Quality of Health Care
- Keywords
- communication barriers, clinical competence, medical education, internship and residency, hospitalist, Quality Assurance, Healthcare, Patient Care, Internal Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- Jan 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalist physicians/house-staff | – | Other: mock handoff exposure, Other: Introduction of CEX tool in Actual Hand-offsConsented Academic Hospitalist and Internal Medicine Residency staff |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Academic Hosptialists and Internal Medicine Residents of the University of Chicago Medical Center.
Key inclusion criteria (1 listed)
- All academic hospitalist and internal medicine house-staff are eligible to participate.
Key exclusion criteria (1 listed)
- We have no exclusion criteria. All internal medicine residents and hospitalist physicians at the University of Chicago will be invited to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mock handoff exposureAttending 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 | Hospitalist physicians/house-staff |
| Introduction of CEX tool in Actual Hand-offsWe will teach hospitalist physicians and house-staff how to utilize the Hand-off CEX in conducting their own hand-offs. | Other | Hospitalist physicians/house-staff |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vineet M Arora, MD, MA principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Communication and Patient Care, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013.