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Emergency Department OvercrowdingEDOVSNCT02754245

ED Overcrowding Validation Study

An observational study of Emergency Department Overcrowding, run by Baylor Research Institute.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim of this study is to externally validate a new emergency department overcrowding estimation tool (SONET) developed at John Peter Smith Health Network (JPS). Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Emergency Department Overcrowding
How many people
7,000 participants
Where
No sites listed yet
Study dates
14 Nov 2016to Mar 2019
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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: all adult patients visiting any one of the six participating sites (one JPS ED or urgent care clinic or one of five Baylor emergency departments or urgent care clinics) during the allocated one month time period

Who may be able to join

  • 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

Who cannot join

  • those who do not meet inclusion criteria

About this study

Official title: A Validation Study of Emergency Department Crowding Estimation

The aim of this study is to externally validate a new emergency department overcrowding estimation tool (SONET) developed at John Peter Smith Health Network (JPS).

Read the 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.

Keywords
multicenter study, emergency department, overcrowding status, estimation tool, validation
Medical subject headings
Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02754245
Study groupRoleWhat they receive
JPSstudy sample at JPS included for analysis
BUMC Dallasstudy sample at Baylor University Medical Center Dallas included for analysis
BUMC at Gardinstudy sample at Baylor University Medical Center Gardin included for analysis
BUMC Waxahachiestudy sample at Baylor University Medical Center Waxahachie included for analysis
BUMC Carroltonstudy sample at Baylor University Medical Center Carrolton included for analysis
BUMC McKinneystudy sample at Baylor University Medical Center McKinney included for analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. left without being seen disposition chart review

    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.

    Measured: 30 days

  2. emergency department 72 hour return chart review

    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.

    Measured: 30 days

  3. emergency department mortality

    Measured: 30 days

  4. hospital mortality

    Measured: 30 days

  5. emergency department length of stay

    Measured: 30 days

Secondary outcomes (2)
  1. patient satisfaction survey

    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.

    Measured: 30 days

  2. physician empathy scale

    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).

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2016 (estimated)
  2. Study start14 Nov 2016
  3. Primary completion31 Jan 2017
  4. Study completionMar 2019

Why it stopped: Failure to submit the required continuing review report prior to expiration.

Resources

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
7,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02754245
Sponsor's protocol ID
014-013
Acronym
EDOVS
Status last verified
Nov 2025
First submitted
20 Apr 2016
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 12957975
  • 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.

    PubMed 14709427
  • 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.

    PubMed 16581932
  • 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.

    PubMed 17980458
  • 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.

    PubMed 16902050
  • 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.

    PubMed 26167302

Questions about this trial

What is this clinical trial studying?

An observational study of Emergency Department Overcrowding, run by Baylor Research Institute.

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: stopped early, as of the sponsor's last update on 18 Feb 2026. 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 was stopped early (reason given: Failure to submit the required continuing review report prior to expiration.). Results are not available in the source record.

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?

left without being seen disposition chart review (time frame: 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02754245, which also lists 6 linked publications.

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 18 Feb 2026.

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