EMERGENCY MEDICINENCT03943810
Analysis and Improvising Working Practices in the ER
An observational study of EMERGENCY MEDICINE, run by Sheba Medical Center.
Trial summary
Analysis of electronic files of patients presenting to the emergency department to improve current practice Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EMERGENCY MEDICINE
- How many people
- 500,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2013to 31 Dec 2017
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All the patients admitted to the adult primary SMC ED ED between August 2014 and December 2017. . The data here did not include other EDs located elsewhere in SMC, (e.g., pediatric ED, gynecology ED, ophthalmology ED and psychiatric ED).
Who may be able to join
- all the patients that visited the SMC - ED between August 2014 and December 2017
Who cannot join
- patients in which the electronic file is absent
About this study
Official title: Characterizing ER Activities for Failure Prevention
Analysis of electronic files of patients presenting to the emergency department to improve current practice
Read the detailed description
Overcrowding in the emergency department (ED) is a pressing healthcare issue globally and has been shown to negatively affect the quality of treatment, clinical outcomes and patient satisfaction.
In recent years, an increasing number of studies have tried to implement changes in the ED to increase efficiency and thereby reduce the length of stay (LOS). Examples to these efforts include physician triage, expanding the nursing scope of practice and patient-flow design (e.g., creating fast track units) in the ED. Importantly, not all intuitive changes in the ED resulted in the reduction of LOS Therefore, implementing changes in the ED must be done with caution and preceded with a cost-benefit analysis of the effects of the intervention using available retrospective data.
This research was conducted in the ED of Sheba Medical Center (SMC), a tertiary government-owned hospital in Israel with 1400 beds. This study is a retrospective medical record review of patients admitted to the adult primary SMC ED. The study sample comprises all the walk-in patients that visited the ED between January 2013 and December 2017. The data here does not include other EDs located elsewhere in SMC, (e.g., pediatric ED, gynecology ED, ophthalmology ED, and psychiatric ED). All admissions files in SMC ED are recorded in a computerized system with negligible exceptions (such as power outage and connection or server maintenance). The time and date of every change in the electronic files are also recorded in the system. Therefore, it is possible to track the waiting times as well as the full content of the admission file.
The aim of this study is to identify and analyze potential modifications in current ED practice which may improve outcomes such as LOS, missed diagnosis, leaving without being seen, patient satisfaction, etc.
- Conditions
- EMERGENCY MEDICINE
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
The time between admitting the patient to the ED and the time of decision to release or admit to hospital
Measured: Starting from January1st 2014 until January 30th 2018
left without being seen
amount of patients who leave the ED without being seen by a physician
Measured: Starting from January1st 2014 until January 30th 2018
missed diagnosis
Change of preliminary diagnosis made by ED physician compared to diagnosis after admission to hospital, or after readmission to ED
Measured: Starting from January1st 2014 until January 30th 2018
physician mistakes
Errors made by ED physician in the management of patients in the ED
Measured: Starting from January1st 2014 until January 30th 2018
Admission to hospital
The rate of hospitalization compred to the rate of discharge from ED
Measured: Starting from January1st 2014 until January 30th 2018
return to ED after discharge
patients returning to hospital within 30 days of discharge from ED
Measured: Starting from January1st 2014 until January 30th 2018
Time till being seen by a physician
We measure the time it took for the patient to be seen by an ED physician
Measured: Starting from January1st 2014 until January 30th 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start1 Aug 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EMERGENCY MEDICINEStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Retrospective
- Enrolment
- 500,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Dr. Yahel Giat, Pr. Merav Lidar, Dr. Michael Dreyfuss, Dr. Avinoah Irony, Dr. Gabrieal Breuer
- Responsible party
- Principal investigator, Dr. Eitan Giat, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943810
- Sponsor's protocol ID
- 5132-18-SMC
- Status last verified
- May 2019
- First submitted
- 5 May 2019
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: all data is encrypted and unidentified
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing ER Activities for Failure Prevention
- ClinicalTrials.gov ID
- NCT03943810
- Acronym / sponsor ID
- 5132-18-SMC
- Conditions
- EMERGENCY MEDICINE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500,000 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Dr. Yahel Giat, Pr. Merav Lidar, Dr. Michael Dreyfuss, Dr. Avinoah Irony, Dr. Gabrieal Breuer
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 9 May 2019 (actual)
- 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.
Analysis of electronic files of patients presenting to the emergency department to improve current practice
Detailed description
Overcrowding in the emergency department (ED) is a pressing healthcare issue globally and has been shown to negatively affect the quality of treatment, clinical outcomes and patient satisfaction.
In recent years, an increasing number of studies have tried to implement changes in the ED to increase efficiency and thereby reduce the length of stay (LOS). Examples to these efforts include physician triage, expanding the nursing scope of practice and patient-flow design (e.g., creating fast track units) in the ED. Importantly, not all intuitive changes in the ED resulted in the reduction of LOS Therefore, implementing changes in the ED must be done with caution and preceded with a cost-benefit analysis of the effects of the intervention using available retrospective data.
This research was conducted in the ED of Sheba Medical Center (SMC), a tertiary government-owned hospital in Israel with 1400 beds. This study is a retrospective medical record review of patients admitted to the adult primary SMC ED. The study sample comprises all the walk-in patients that visited the ED between January 2013 and December 2017. The data here does not include other EDs located elsewhere in SMC, (e.g., pediatric ED, gynecology ED, ophthalmology ED, and psychiatric ED). All admissions files in SMC ED are recorded in a computerized system with negligible exceptions (such as power outage and connection or server maintenance). The time and date of every change in the electronic files are also recorded in the system. Therefore, it is possible to track the waiting times as well as the full content of the admission file.
The aim of this study is to identify and analyze potential modifications in current ED practice which may improve outcomes such as LOS, missed diagnosis, leaving without being seen, patient satisfaction, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All the patients admitted to the adult primary SMC ED ED between August 2014 and December 2017. . The data here did not include other EDs located elsewhere in SMC, (e.g., pediatric ED, gynecology ED, ophthalmology ED and psychiatric ED).
Key inclusion criteria (1 listed)
- all the patients that visited the SMC - ED between August 2014 and December 2017
Key exclusion criteria (1 listed)
- patients in which the electronic file is absent
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 |
|---|---|---|
| No interventionThere is no intervention | Other | – |
Primary outcome
Length of stay
Time frame: Starting from January1st 2014 until January 30th 2018
The time between admitting the patient to the ED and the time of decision to release or admit to hospital
left without being seen
Time frame: Starting from January1st 2014 until January 30th 2018
amount of patients who leave the ED without being seen by a physician
missed diagnosis
Time frame: Starting from January1st 2014 until January 30th 2018
Change of preliminary diagnosis made by ED physician compared to diagnosis after admission to hospital, or after readmission to ED
physician mistakes
Time frame: Starting from January1st 2014 until January 30th 2018
Errors made by ED physician in the management of patients in the ED
Admission to hospital
Time frame: Starting from January1st 2014 until January 30th 2018
The rate of hospitalization compred to the rate of discharge from ED
return to ED after discharge
Time frame: Starting from January1st 2014 until January 30th 2018
patients returning to hospital within 30 days of discharge from ED
Time till being seen by a physician
Time frame: Starting from January1st 2014 until January 30th 2018
We measure the time it took for the patient to be seen by an ED physician
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 9 May 2019.
- Individual participant dataSharing planned: No. all data is encrypted and unidentified
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of EMERGENCY MEDICINE, run by Sheba Medical Center.
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 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Length of stay (time frame: Starting from January1st 2014 until January 30th 2018). The study lists 7 primary outcomes in all. 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 9 May 2019.