Emergency Department Crowding in Relation to In-hospital Adverse Medical Events

NCT01116323 | Completed

• 1 other identifier: AE1.7.005.11.N.00
• Study Type: observational
• Target: 104,000
• Locations: 1 country
• Sites: 1

Brief Summary

Since the report "To Err is Human" by the Institute of Medicine (IOM) in 1999, attention was brought to the general public that adverse events in medicine are common and are one of the leading causes of morbidity and mortality within the United States. The report estimates that 44,000 - 98,000 patients hospitalized in the United States die each year as a result of medical errors. In spite of the growing patient safety movement worldwide, health care has not become measurably safer. Health care is one of the few risk-prone areas in which public demand limits the use of common-sense safety-enhancing solutions, such as limiting the flow and choosing the type of incoming patients. The latter is especially true for emergency departments (EDs) since they deliver an important public service by providing emergency care 24 hours a day, 365 days per year, without discrimination by social or economic status. One of the key expectations of EDs is the ability to provide immediate access and stabilization for those patients who have an emergency medical condition. However, emergency department (ED) crowding is recognized to be a major, international problem that affects patients and providers. A recent report from the IOM noted that the increasing strain caused by crowding is creating a deficit in quality of emergency care. Crowding has been associated with reduced access to emergency medical services, delays in care for cardiac patients, increased patient mortality, inadequate pain management, increased costs of patient care, and delays in administration of antibiotic therapy. Several issues remain concerning ED crowding and it's relation to adverse events. First, the existing evidence on adverse event occurrence during ED crowding is largely anecdotal and inconclusive. Secondly, although a few studies showed a relationship between ED crowding and mortality, neither of these examined the causes of excess mortality. Finally, although a significant increase in the average length of hospital stay was shown during ED crowding the reasons for this are open to speculation. The purpose of this study therefore is to identify six explicit adverse events and mortality for patients who were admitted through ED and to compare these results in relation to ED crowding. This will provide us novel insight into the reasons for the hypothesized increased mortality during ED crowding.

Conditions

Adverse Effects

Keywords

Adverse events; Adverse effects; Emergency Service, Hospital; Emergency department; Crowding

Outcome Measures

Primary Outcomes (1)

• Occurrence of six adverse events

  Search for either hospital acquired pneumonia, deep venous thrombosis/pulmonary embolism, sepsis, acute renal failure, shock/cardiac arrest, or gastrointestinal hemorrhage/gastric ulcer through explicit clinical criteria.

  During the 2 year period of prospective study, the occurrence of 6 adverse events will be searched from the time to ED admission up to 10 days after discharge from ED

Secondary Outcomes (4)

• Mortality

  During the 2 year period of prospective study, mortality will be searched from the time to ED admission until hospital discharge of the patient

• ED length of stay

  Whole ED stay

• Hospital length of stay

  Whole hospital stay

• Time to antibiotics administration in case of pneumonia

  Whole ED stay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult (18 years or older) patients presenting to the ED

You may qualify if:

• All adult (18 years or older) patients presenting to the ED
• All adult (18 years or older) patients transferred from the ward to ED for upgrading of care

You may not qualify if:

• All patients who died on arrival in the ED
• Patients transferred from another acute care facility

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Emergency Department, Catholic University Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (1)

• Richardson DB. Increase in patient mortality at 10 days associated with emergency department overcrowding. Med J Aust. 2006 Mar 6;184(5):213-6. doi: 10.5694/j.1326-5377.2006.tb00204.x.

  PMID: 16515430 BACKGROUND

Biospecimen

Retention: NONE RETAINED

None Retained - no samples retained

MeSH Terms

Conditions

Emergencies; Crowding

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Spatial Behavior; Behavior

Study Officials

• Greet Van den Berghe, MD, Ph D

  Catholic University Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 4, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2013
• Last Updated: August 6, 2021

Record last verified: 2021-08

Locations

BE (1)