Sepsis, Cancer, Heart Attack, Heart Failure, Abdominal Surgery, Trauma, Diabetes, Lung Disease, Gynaecology, Fertility, Cardiac Surgery,NCT02044718
Medical Record Study on Adverse Events Requiring a Higher Level of Care in Flemish Hospitals
An observational study of Sepsis, Cancer, Heart Attack, Heart Failure, Abdominal Surgery, Trauma, Diabetes, Lung Disease, Gynaecology, Fertility, Cardiac Surgery,, run by Hasselt University at 1 site in Belgium.
Trial summary
An adverse event (AE) is defined as unintended injury or complication, which results in disability, death or prolongation of hospital stay, and is caused by healthcare management (including omissions) rather than the patient's disease. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sepsis, Cancer, Heart Attack, Heart Failure, Abdominal Surgery, Trauma, Diabetes, Lung Disease, Gynaecology, Fertility, Cardiac Surgery,
- How many people
- 878 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2011to Jun 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- All patients being transferred to a higher level of care during the study period (November 2011 - May 2012)
- In practice, the higher level of care means
- (1) (re)admission to the Intensive Care Unit from other care units in the hospital providing lower intensity care,
- (2) to an intervention by a Medical Emergency Team due to an unanticipated change in the patient's clinical status
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
An adverse event (AE) is defined as unintended injury or complication, which results in disability, death or prolongation of hospital stay, and is caused by healthcare management (including omissions) rather than the patient's disease. Retrospective record reviews in several countries have shown that 2,9% to 16,6% of patients in acute hospitals experience one or more AEs. A patient with an AE may require a higher level of care. Although all AEs are important, preventable AEs that result in an upgraded level of patient care are of particular concern. In this study it's defined as an unplanned admission to intensive care unit (ICU) or a Mobile Emergency Team (MET) intervention. The objectives of this study are to determine the incidence of (preventable) adverse events requiring ICU admission or MET intervention and to assess the level of harm of each AE.
- Keywords
- adverse events, unplanned admission intensive care, chart review
- Medical subject headings
- Sepsis, Neoplasms, Myocardial Infarction, Heart Failure, Wounds and Injuries, Diabetes Mellitus, Lung Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events requiring a higher level of care
An adverse event is an unintended injury or complication, which results in disability at discharge, death or prolongation of hospital stay, and is caused by healthcare management (including omissions) rather than the patient's disease. (Wilson, 1995)
Measured: 6 months
The number of participants with preventable adverse events
Assess the preventability of these adverse events using six point scale with a range of not preventable until totally preventable
Measured: 6 months
Secondary outcomes (3)
Type adverse events
Divide the adverse events into categories, like diagnosis, therapy, medication, surgery, non-surgery, etc.
Measured: 6 months
Clinical impact of adverse events in terms of outcome
Assess the impact of the adverse events in terms of disability, mortality, readmission.
Measured: 6 months
Quality of the chart review
The patient chart will be judge on the completeness and adequacy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startNov 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis, Cancer, Heart Attack, Heart Failure, Abdominal Surgery, Trauma, Diabetes, Lung Disease, Gynaecology, Fertility, Cardiac Surgery,Studies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 878 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital, Algemeen Ziekenhuis Vesalius, Sint-Franciscus Ziekenhuis, Regionaal Ziekenhuis Sint-Trudo, Ziekenhuis Maas en Kempen, Ziekenhuis Oost-Limburg
- Responsible party
- Principal investigator, prof. dr. Neree Claes, Hasselt University
- Investigators
- Kristel Marquet, drs, Principal investigator, Hasselt UniversityArthur Vleugels, prof. dr., Study chair, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044718
- Sponsor's protocol ID
- 11.50/intens11.01
- Status last verified
- Jan 2014
- First submitted
- 19 Dec 2013
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Record Study on Adverse Events Requiring a Higher Level of Care in Flemish Hospitals
- ClinicalTrials.gov ID
- NCT02044718
- Acronym / sponsor ID
- 11.50/intens11.01
- Keywords
- adverse events, unplanned admission intensive care, chart review
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 878 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital, Algemeen Ziekenhuis Vesalius, Sint-Franciscus Ziekenhuis, Regionaal Ziekenhuis Sint-Trudo, Ziekenhuis Maas en Kempen, Ziekenhuis Oost-Limburg
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Jan 2014 (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.
An adverse event (AE) is defined as unintended injury or complication, which results in disability, death or prolongation of hospital stay, and is caused by healthcare management (including omissions) rather than the patient's disease. Retrospective record reviews in several countries have shown that 2,9% to 16,6% of patients in acute hospitals experience one or more AEs. A patient with an AE may require a higher level of care. Although all AEs are important, preventable AEs that result in an upgraded level of patient care are of particular concern. In this study it's defined as an unplanned admission to intensive care unit (ICU) or a Mobile Emergency Team (MET) intervention. The objectives of this study are to determine the incidence of (preventable) adverse events requiring ICU admission or MET intervention and to assess the level of harm of each AE.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (4 listed)
- All patients being transferred to a higher level of care during the study period (November 2011 - May 2012)
- In practice, the higher level of care means
- (1) (re)admission to the Intensive Care Unit from other care units in the hospital providing lower intensity care,
- (2) to an intervention by a Medical Emergency Team due to an unanticipated change in the patient's clinical status
Key exclusion criteria (1 listed)
- -
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
Incidence of adverse events requiring a higher level of care
Time frame: 6 months
An adverse event is an unintended injury or complication, which results in disability at discharge, death or prolongation of hospital stay, and is caused by healthcare management (including omissions) rather than the patient's disease. (Wilson, 1995)
The number of participants with preventable adverse events
Time frame: 6 months
Assess the preventability of these adverse events using six point scale with a range of not preventable until totally preventable
3 secondary outcomes
Type adverse events
Time frame: 6 months
Clinical impact of adverse events in terms of outcome
Time frame: 6 months
Quality of the chart review
Time frame: 6 months
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 24 Jan 2014.
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.
Kristel Marquet, drs principal investigator
Hasselt University
Arthur Vleugels, prof. dr. study chair
KU 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 Sepsis, Cancer, Heart Attack, Heart Failure, Abdominal Surgery, Trauma, Diabetes, Lung Disease, Gynaecology, Fertility, Cardiac Surgery,, run by Hasselt University 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 4 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: finished, as of the sponsor's last update on 24 Jan 2014. 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?
Incidence of adverse events requiring a higher level of care (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2014.