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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01116323
Recruitment Status : Unknown
Verified September 2011 by Verelst Sandra, Katholieke Universiteit Leuven.
Recruitment status was:  Recruiting
First Posted : May 4, 2010
Last Update Posted : September 21, 2011
Information provided by (Responsible Party):
Verelst Sandra, Katholieke Universiteit Leuven

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.

Condition or disease
Adverse Effects

Detailed Description:

Since "ED crowding" is an unplanned condition, a randomized controlled trial is not possible to assess its impact on adverse patients' outcome. Therefore, a large prospective cohort study, with careful matching and correcting for risk factors is the second best design.

The ED occupancy rate, defined as the ratio of the total number of ED patients to the number of licensed treatment bays per hour, will be used as a measure of ED crowding. The numerator includes all patients in the ED at any point during each study hour, regardless of ED location (including in the waiting room, boarding, hallway location). The denominator, constant per study hour, includes the total number of licensed treatment bays as defined according to the ED's original blueprint but excludes hallway locations. For each hour of the day, the ED occupancy rate will be derived from the ED information system. 104 weeks are divided into 13-week seasonal blocks and nursing shifts starting 23:00, 07:00 and 15:00. The mean ED occupancy rate is calculated for each shift as the sum of the occupancy rates within that shift divided by 8. The top quartile of all mean ED occupancy rates during the cohort period is considered as crowded. In order to match both 'crowded 'and 'not crowded' cohorts, the following data elements are extracted from the hospital information system for each registered patient: demographic data (age, sex, co-morbidities); referral source, surgical or medical admission; time of arrival (including season, month of year, day of week, time of day); triage category; ED and total hospital length of stay; and final admission diagnosis.

Medical records of patients who presented to the ED will be reviewed for the occurrence of six adverse events and mortality up to ten days of their ED stay. The six adverse events are searched through explicit clinical criteria. The reviewer first rates on a scale of 1 to 6 the confidence that medical management caused an adverse event. If the rating is 5 or 6, indicating that the injury is probably or definitely caused by management, the event is considered an adverse event. The same rating score is used to assess the degree of preventability. Hospital mortality will be searched for all patients who presented to the ED at some point in time and died during that hospital stay.

In order to identify an adverse event occurrence hazard ratio of 1.2 with a power of 0.9 during ED crowding, a cohort of 104,000 patients is needed. Therefore, data will be retrieved during a 2 year period during which the reviewer is blinded to the degree of ED crowding in relation to the findings on adverse events. The occurrence of adverse events and mortality will be compared to not crowded shifts, corrected for baseline risk factors. A carefully standardized admission form for registration of relevant information as well as a computerized search tool for screening for adverse events will allow finalizing this study within the foreseen time frame.

Study Type : Observational
Estimated Enrollment : 104000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Emergency Department Crowding in Relation to In-hospital Adverse Medical Events
Study Start Date : June 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Occurrence of six adverse events [ Time Frame: 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 ]
    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.

Secondary Outcome Measures :
  1. Mortality [ Time Frame: During the 2 year period of prospective study, mortality will be searched from the time to ED admission until hospital discharge of the patient ]
    Hospital mortality

  2. ED length of stay [ Time Frame: Whole ED stay ]
    Time from ED admission until discharge home or to hospital ward

  3. Hospital length of stay [ Time Frame: Whole hospital stay ]
    Time from hospital admission until hospital discharge

  4. Time to antibiotics administration in case of pneumonia [ Time Frame: Whole ED stay ]
    Time (in hours and minutes) to administration of antibiotics in case a diagnosis of pneumonia is made in the ED

Biospecimen Retention:   None Retained
None Retained - no samples retained

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult (18 years or older) patients presenting to the ED

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01116323

Contact: Sandra JJ Verelst, MD 32-16-340-695
Contact: Greet Van den Berghe, MD, Ph D 32-16-344-017

Emergency Department, Catholic University Leuven Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Sandra JJ Verelst, MD    32-16-340-695   
Contact: Greet Van den Berghe, MD, Ph D    32-16-344-+017   
Principal Investigator: Sandra JJ Verelst, MD         
Principal Investigator: Greet Van den Berghe, MD, Ph D         
Sub-Investigator: Jean-Bernard Gillet, MD, Ph D         
Sponsors and Collaborators
Katholieke Universiteit Leuven
Principal Investigator: Greet Van den Berghe, MD, Ph D Catholic University Leuven

Responsible Party: Verelst Sandra, MD, Katholieke Universiteit Leuven Identifier: NCT01116323     History of Changes
Other Study ID Numbers: AE1.7.005.11.N.00
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: September 21, 2011
Last Verified: September 2011

Keywords provided by Verelst Sandra, Katholieke Universiteit Leuven:
Adverse events
Adverse effects
Emergency Service, Hospital
Emergency department

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes