- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02754245
ED Overcrowding Validation Study (EDOVS)
A Validation Study of Emergency Department Crowding Estimation
Study Overview
Status
Conditions
Detailed Description
In recent years, emergency department (ED) overcrowding has become more and more common in regional and tertiary referral hospitals. ED overcrowding status significantly affects ED operational efficiency, resulting in ambulance diversion, increased ED 72h return visits, patient satisfaction, and left without being seen (LWBS) rates.
Several estimation tools were derived to determine ED overcrowding status using various operational parameters such as, but not limited to, total number of ED patients, total ED admission holds, nursing staff, and patient injury severity. However, these tools cannot precisely evaluate ED overcrowding status, nor show strong correlations with ED operational inefficiency. The National Emergency Department Overcrowding Study (NEDOCS) is a widely used estimation tool to determine ED overcrowding status with relatively high consistency rates. However, the study was not able to evaluate interrater reliability since no standard definition of overcrowding existed.
An ED overcrowding estimation tool, SONET, was developed and internally validated at JPS and showed more consistency and accuracy when compared to estimation rates utilizing NEDOCS. All things considered, it is worthwhile to perform a survey study to determine the interrater variability between different evaluators for an ED overcrowding evaluation tool, one utilizing all possible collectible operational variables. In order to minimize the bias and further determine the accuracy of evaluating ED overcrowding status, a multi-center external validation study is warranted. This study will extend to six sites for the purpose of externally validating JPS' novel ED overcrowding estimation tool, SONET, by comparing its overcrowding estimation rates with those derived utilizing NEDOCS.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- all adult patients visiting the emergency department or urgent care clinic at any one of the six participating sites during the allocated one month time period
Exclusion Criteria:
- those who do not meet inclusion criteria
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
JPS
study sample at JPS included for analysis
|
BUMC Dallas
study sample at Baylor University Medical Center Dallas included for analysis
|
BUMC at Gardin
study sample at Baylor University Medical Center Gardin included for analysis
|
BUMC Waxahachie
study sample at Baylor University Medical Center Waxahachie included for analysis
|
BUMC Carrolton
study sample at Baylor University Medical Center Carrolton included for analysis
|
BUMC McKinney
study sample at Baylor University Medical Center McKinney included for analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hospital mortality
Time Frame: 30 days
|
30 days
|
|
left without being seen disposition chart review
Time Frame: 30 days
|
LWBS refers to patients who have been called at least three times, using 20 minute intervals, to occupy an ED exam bed, however, do not respond.
If after the third attempt the patient responds, the investigators will consider this a new patient registration/encounter.
These data will be collected for each patient during the study period during initial ED registration and upon ED disposition.
|
30 days
|
emergency department 72 hour return chart review
Time Frame: 30 days
|
ED 72h return will be defined to patients who re-register to the same ED as a new patient (unplanned) within 72h of a previous departure, regardless of the complaint.
Planned ED revisits within 72h will be excluded.
These data will be collected during initial ED registration during study period and will follow up each patient at least 72h post-discharge.
|
30 days
|
emergency department mortality
Time Frame: 30 days
|
30 days
|
|
emergency department length of stay
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patient satisfaction survey
Time Frame: 30 days
|
Patient satisfaction will be measured using Qualitick (Clearwater, FL), a real-time patient satisfaction program reporting tool using a Likert scale format.
Patient will complete their Qualitick survey upon departure from ED regardless of their ED dispositions (e.g.
transfer to inpatient service, discharge to home, transfer to another facility, etc.).
Patients, or patient designees, will use a tablet to answer a series of questions.
Patients, or their designees, have the option of omitting their name to ensure their information is kept anonymous.
|
30 days
|
physician empathy scale
Time Frame: 30 days
|
Jefferson Physician Empathy Scale, available online, will be conducted by ED staff and compared with 1) staff working different shifts with different levels of crowding; 2) the norms; 3) staff working a more balanced schedule (roughly equal numbers of day, evening, and night shifts); and 4) attending physicians versus nursing staff versus residents.
Average scores will be used to determine any differences among groups.
The measurement tool will be repeated 6-9 months later to determine whether dynamic changes have occurred and whether an association exists with respect to changes in operation efficiency as a function of relative ED crowding at the individual physician level during the study period.
The investigators recognize that the inclusion of the psychometric tests will be, to some extent, exploratory and the most important assessment will be the simple descriptive display of the mean scores (and standard deviations).
|
30 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bernstein SL, Verghese V, Leung W, Lunney AT, Perez I. Development and validation of a new index to measure emergency department crowding. Acad Emerg Med. 2003 Sep;10(9):938-42. doi: 10.1111/j.1553-2712.2003.tb00647.x.
- Weiss SJ, Derlet R, Arndahl J, Ernst AA, Richards J, Fernandez-Frackelton M, Schwab R, Stair TO, Vicellio P, Levy D, Brautigan M, Johnson A, Nick TG. Estimating the degree of emergency department overcrowding in academic medical centers: results of the National ED Overcrowding Study (NEDOCS). Acad Emerg Med. 2004 Jan;11(1):38-50. doi: 10.1197/j.aem.2003.07.017. Erratum In: Acad Emerg Med. 2004 Apr;11(4):408. Fernandez-Frankelton M [corrected to Fernandez-Frackelton M].
- Epstein SK, Tian L. Development of an emergency department work score to predict ambulance diversion. Acad Emerg Med. 2006 Apr;13(4):421-6. doi: 10.1197/j.aem.2005.11.081.
- McCarthy ML, Aronsky D, Jones ID, Miner JR, Band RA, Baren JM, Desmond JS, Baumlin KM, Ding R, Shesser R. The emergency department occupancy rate: a simple measure of emergency department crowding? Ann Emerg Med. 2008 Jan;51(1):15-24, 24.e1-2. doi: 10.1016/j.annemergmed.2007.09.003. Epub 2007 Nov 5.
- Jones SS, Allen TL, Flottemesch TJ, Welch SJ. An independent evaluation of four quantitative emergency department crowding scales. Acad Emerg Med. 2006 Nov;13(11):1204-11. doi: 10.1197/j.aem.2006.05.021. Epub 2006 Aug 10.
- Wang H, Robinson RD, Garrett JS, Bunch K, Huggins CA, Watson K, Daniels J, Banks B, D'Etienne JP, Zenarosa NR. Use of the SONET Score to Evaluate High Volume Emergency Department Overcrowding: A Prospective Derivation and Validation Study. Emerg Med Int. 2015;2015:401757. doi: 10.1155/2015/401757. Epub 2015 Jun 8.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 014-013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Emergency Department Overcrowding
-
healthEworks LLCNational Institutes of Health (NIH)UnknownCompliance | Emergency Department Aftercare | Emergency Department UtilizationUnited States
-
University of Southern CaliforniaUniversity of California, Los Angeles; National Institute on Aging (NIA); University... and other collaboratorsWithdrawnEmergency DepartmentUnited States
-
Centre Hospitalier de Saint-DenisRecruiting
-
University of Wisconsin, MadisonActive, not recruitingEmergency Department VisitUnited States
-
The Hospital for Sick ChildrenCompletedEmergency Department VisitCanada
-
Assistance Publique - Hôpitaux de ParisRecruitingHospitalization | Emergency DepartmentFrance
-
Brigham and Women's HospitalRecruiting
-
Hospital Pharmacy of North Norway TrustUniversity Hospital of North Norway; University of Tromso; Nordlandssykehuset HF and other collaboratorsActive, not recruitingEmergency Department | Clinical PharmacistNorway
-
The Behavioural Insights TeamUnknownAvoidable Emergency Department Attendances
-
Wesley Medical CenterCardinal HealthTerminatedEmergency Department | Medication ReconciliationUnited States