Medical Errors Related to Emergency Department Sign OutSAID-EDNCT01859286
Improving Signout Accuracy and Information Delivery in the Emergency Department
An observational study of Medical Errors Related to Emergency Department Sign Out, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The investigators sought to determine if implementing a standardized sign out process would reduce the amount of medical errors related to patient sign out. The standardized process included the following interventions: implementation of a data resident to review patients lab values, vital signs, radiologist results… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medical Errors Related to Emergency Department Sign Out
- What is being tested?
- standardized sign out process
- How many people
- 321 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to May 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: ED Physicians. We looked at the amount of errors due to signout that ED Physicians commit with standard signout procedure and then with a revised signed out process
Who may be able to join
- ED transfers of care occurring at 0700 or 1900.
Who cannot join
- Attending only handovers (1500, 2300)
- Handovers including midlevel providers (Thursday 0700, 1300).
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, 77030
About this study
Official title: Improving Transfer of Care Accuracy and Information Delivery in the Emergency Department
The investigators sought to determine if implementing a standardized sign out process would reduce the amount of medical errors related to patient sign out. The standardized process included the following interventions: implementation of a data resident to review patients lab values, vital signs, radiologist results, and orders in real time, conducting sign out in a standardized location and using the attending physician as an "interruption manager." The investigators defined medical errors related to sign out as any piece of information was incorrectly reported or omitted during sign out that caused a change in treatment or disposition discussed during sign out. The investigators hypothesis was that implementing a standardized sign out process would lead to a decrease in the amount of sign out related errors.
- Being tested
- standardized sign out process
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized sign out processOther
The intervention phase included was the introduction of a standardized TOC (transfer of care) process, which occurred during April and May of 2012. TOC was done at a predefined location in each section of the emergency department (Medicine and Trauma). All participating residents were given a diagram detailing the central location and seating arrangement. The outgoing attending was designated to handle all distractions or disturbances that occurred during sign out. The most senior resident coming on to shift was designated the data resident. The data resident's role was to operate a centralized computer with the ED tracking board and EMR and review pending orders, vital signs and resulted labs and radiology reports after each patient was signed out. A brief pause was implemented to allow the oncoming team to ask any questions regarding that patient's care or course. The post TOC data form and protocol were identical to that of the control phase.
| Study group | Role | What they receive |
|---|---|---|
| regular sign out process | Not described Receives: Other: standardized sign out process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sign out related errors
Measured: 4 months
Secondary outcomes (1)
perception of sign out
Measured: 1 year after implementation of revised sign out process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startFeb 2012
- Primary completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Errors Related to Emergency Department Sign OutStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Prospective
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Mazzillo, The University of Texas Health Science Center, Houston
- Investigators
- Nnaemeka G Okafor, MD, Principal investigator, UT Houston Health Sciences Center at Houston Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859286
- Sponsor's protocol ID
- HSC-MS-11-0655
- Acronym
- SAID-ED
- Status last verified
- May 2013
- First submitted
- 27 Apr 2013
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Transfer of Care Accuracy and Information Delivery in the Emergency Department
- ClinicalTrials.gov ID
- NCT01859286
- Acronym / sponsor ID
- SAID-ED / HSC-MS-11-0655
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2012 (actual)
- First posted
- 21 May 2013 (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 investigators sought to determine if implementing a standardized sign out process would reduce the amount of medical errors related to patient sign out. The standardized process included the following interventions: implementation of a data resident to review patients lab values, vital signs, radiologist results, and orders in real time, conducting sign out in a standardized location and using the attending physician as an "interruption manager." The investigators defined medical errors related to sign out as any piece of information was incorrectly reported or omitted during sign out that caused a change in treatment or disposition discussed during sign out. The investigators hypothesis was that implementing a standardized sign out process would lead to a decrease in the amount of sign out related errors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| regular sign out process | – | Other: standardized sign out process |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ED Physicians. We looked at the amount of errors due to signout that ED Physicians commit with standard signout procedure and then with a revised signed out process
Key inclusion criteria (1 listed)
- ED transfers of care occurring at 0700 or 1900.
Key exclusion criteria (2 listed)
- Attending only handovers (1500, 2300)
- Handovers including midlevel providers (Thursday 0700, 1300).
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 |
|---|---|---|
| standardized sign out processThe intervention phase included was the introduction of a standardized TOC (transfer of care) process, which occurred during April and May of 2012. TOC was done at a predefined location in each section of the emergency department (Medicine and Trauma). All participating residents were given a diagram detailing the central location and seating arrangement. The outgoing attending was designated to handle all distractions or disturbances that occurred during sign out. The most senior resident coming on to shift was designated the data resident. The data resident's role was to operate a centralized computer with the ED tracking board and EMR and review pending orders, vital signs and resulted labs and radiology reports after each patient was signed out. A brief pause was implemented to allow the oncoming team to ask any questions regarding that patient's care or course. The post TOC data form and protocol were identical to that of the control phase. | Other | regular sign out process |
Primary outcome
Sign out related errors
Time frame: 4 months
1 secondary outcome
perception of sign out
Time frame: 1 year after implementation of revised sign out process
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 21 May 2013.
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.
Nnaemeka G Okafor, MD principal investigator
UT Houston Health Sciences Center at Houston Department of Emergency Medicine
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 Medical Errors Related to Emergency Department Sign Out, run by The University of Texas Health Science Center, Houston 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 2 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 21 May 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?
Sign out related errors (time frame: 4 months). 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 21 May 2013.