Adverse EffectsNCT01116323
Emergency Department Crowding in Relation to In-hospital Adverse Medical Events
An observational study of Adverse Effects, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Effects
- How many people
- 104,000 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2010to Dec 2013
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All adult (18 years or older) patients presenting to the ED
Who may be able to join
- 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
Who cannot join
- All patients who died on arrival in the ED
- Patients transferred from another acute care facility
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Emergency Department, Catholic University Leuven
Leuven, Vlaams Brabant, 3000
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Adverse Effects
- Keywords
- Adverse events, Adverse effects, Emergency Service, Hospital, Emergency department, Crowding
- Medical subject headings
- Emergencies, Crowding
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Hospital mortality
Measured: 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
Time from ED admission until discharge home or to hospital ward
Measured: Whole ED stay
Hospital length of stay
Time from hospital admission until hospital discharge
Measured: Whole hospital stay
Time to antibiotics administration in case of pneumonia
Time (in hours and minutes) to administration of antibiotics in case a diagnosis of pneumonia is made in the ED
Measured: Whole ED stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse EffectsStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Prospective
- Enrolment
- 104,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Verelst Sandra, KU Leuven
- Investigators
- Greet Van den Berghe, MD, Ph D, Principal investigator, Catholic University Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116323
- Sponsor's protocol ID
- AE1.7.005.11.N.00
- Status last verified
- Aug 2021
- First submitted
- 3 May 2010
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16515430
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Crowding in Relation to In-hospital Adverse Medical Events
- ClinicalTrials.gov ID
- NCT01116323
- Acronym / sponsor ID
- AE1.7.005.11.N.00
- Conditions
- Adverse Effects
- Keywords
- Adverse events, Adverse effects, Emergency Service, Hospital, Emergency department, Crowding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104,000 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jun 2010 (actual)
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 May 2010 (estimated)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult (18 years or older) patients presenting to the ED
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- All patients who died on arrival in the ED
- Patients transferred from another acute care facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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
ED length of stay
Time frame: Whole ED stay
Hospital length of stay
Time frame: Whole hospital stay
Time to antibiotics administration in case of pneumonia
Time frame: Whole ED stay
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 6 Aug 2021.
- Background: PubMed 16515430Richardson 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.
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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.
Greet Van den Berghe, MD, Ph D principal investigator
Catholic University Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Effects, run by KU Leuven at 1 site in Belgium.
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 2 inclusion and 2 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 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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). 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 NCT01116323, which also lists 1 linked publication.
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 6 Aug 2021.