Stroke, IschemicNCT05218135
BIC: Evaluation of the Current Care Processes for Stroke Care in Flemish Hospitals
An observational study of Stroke, Ischemic, run by KU Leuven at 1 site in Belgium.
Trial summary
Different studies showed large variation between care processes in multiple diseases, which lead to large variation in outcomes. Better adherence to evidence-based guidelines for these diseases can reduce this variation and can improve the health outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Intervention
- How many people
- 2,610 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2021to 31 Dec 2024
- 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: Patients with acute ischemic stroke
Who may be able to join
- Minimum age of 18 years
- Admitted to the emergency department and diagnosed with an ischemic stroke
Who cannot join
- Diagnosed with cerebral venous thrombosis
- Diagnosed with hemorrhage
- Thrombectomy performed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Current Care Processes for Stroke Care in Flemish Hospitals Via a Breakthrough Improvement Collaborative
Different studies showed large variation between care processes in multiple diseases, which lead to large variation in outcomes. Better adherence to evidence-based guidelines for these diseases can reduce this variation and can improve the health outcomes. Since international studies have demonstrated wide variations in care processes for acute stroke, it would be interesting to repeat these investigations in the population of stroke patients. Worldwide, stroke is a leading cause of disability and death. Every two seconds, someone across the world experiences a symptomatic stroke. 50% of stroke survivors has moderate to severe neurologic deficits, 25% of them depend on others. In Belgium, stroke is one of the most important causes of invalidity. Every year approximately 18 000 people in Belgium experiences a stroke, which results in almost one person every two hours, with a mortality rate of 30%. The world health organization has the ambition to significantly reduce the mortality and risk factors for non-communicable diseases by 2025. The mortality and disability in stroke patients can be reduced by organized stroke care, which includes effective strategies in stroke management, treatment and prevention. Also, other health domains, like functional recovery, healthcare costs and patient satisfaction, were positively related to adherence on stroke guidelines. This evidence had been converted in several clinical guidelines for stroke care. However, the adherence to these guidelines is variable. As already mentioned before, international studies have demonstrated wide variations in care processes for acute stroke. However, a positive relationship has been shown between the implementation of evidence-based clinical guidelines and the quality of stroke care. Therefore, it is important to both implement these guidelines and to improve the adherence to them.
The aim of this study is to map the variation in stroke care in Flemish hospitals and to get an overview about the variation within and between these hospitals. During this study, electronic patient records will be analyzed to check which interventions are performed in a specific patient and of which no information could be found in de patient record.
- Conditions
- Stroke, Ischemic
- Being tested
- Intervention
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Learning session 1: explain key interventions, explain BIC methodology, retrospective patient record analysis Learning session 2: feedback report, share best practices, discussion, set priorities, teaching and improvement, retrospective patient record analysis Learning session 3: feedback report, share best practices, discussion, set priorities, teaching and improvement, retrospective patient record analysis Learning session 4: feedback report
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Breakthrough improvement collaborative Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation within and between hospitals
Variation of Brain imaging + timing, Glycemia (venous blood sample or finger prick) + timing, Clinical neurologic examination + timing, Time of onset, Administration of IV tPA + timing, Administration of aspirin + timing Blood pressure, time of first measurement and measurement frequency during first 72h, Oxygen saturation, time of first measurement and measurement frequency during first 72h, Temperature, time of first measurement and measurement frequency during first 72h, Glycemia and measurement frequency during first 72h, First dysphagia screening and timing, Advice from speech therapist if screening failed and timing, Cardiac monitoring, Screening for depression, ADL screening, The use of a bladder catheter is not recommended, Prophylactic treatment with antibiotics is not recommended, Deep venous thrombosis prevention
Measured: through study completion, an average of 3 months
Secondary outcomes (2)
Mortality rate
Mortality rate
Measured: Through study completion on average of 3 months
modified Rankin Scale
modified Rankin Scale going from 0 (no symptoms) until 6 (death)
Measured: Through study completion on average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Mar 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kris Vanhaecht, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218135
- Sponsor's protocol ID
- BIC4Stroke
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Current Care Processes for Stroke Care in Flemish Hospitals Via a Breakthrough Improvement Collaborative
- ClinicalTrials.gov ID
- NCT05218135
- Acronym / sponsor ID
- BIC4Stroke
- Conditions
- Stroke, Ischemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,610 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Feb 2022 (actual)
- 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.
Different studies showed large variation between care processes in multiple diseases, which lead to large variation in outcomes. Better adherence to evidence-based guidelines for these diseases can reduce this variation and can improve the health outcomes. Since international studies have demonstrated wide variations in care processes for acute stroke, it would be interesting to repeat these investigations in the population of stroke patients. Worldwide, stroke is a leading cause of disability and death. Every two seconds, someone across the world experiences a symptomatic stroke. 50% of stroke survivors has moderate to severe neurologic deficits, 25% of them depend on others. In Belgium, stroke is one of the most important causes of invalidity. Every year approximately 18 000 people in Belgium experiences a stroke, which results in almost one person every two hours, with a mortality rate of 30%. The world health organization has the ambition to significantly reduce the mortality and risk factors for non-communicable diseases by 2025. The mortality and disability in stroke patients can be reduced by organized stroke care, which includes effective strategies in stroke management, treatment and prevention. Also, other health domains, like functional recovery, healthcare costs and patient satisfaction, were positively related to adherence on stroke guidelines. This evidence had been converted in several clinical guidelines for stroke care. However, the adherence to these guidelines is variable. As already mentioned before, international studies have demonstrated wide variations in care processes for acute stroke. However, a positive relationship has been shown between the implementation of evidence-based clinical guidelines and the quality of stroke care. Therefore, it is important to both implement these guidelines and to improve the adherence to them.
The aim of this study is to map the variation in stroke care in Flemish hospitals and to get an overview about the variation within and between these hospitals. During this study, electronic patient records will be analyzed to check which interventions are performed in a specific patient and of which no information could be found in de patient record.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: InterventionBreakthrough improvement collaborative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke
Key inclusion criteria (2 listed)
- Minimum age of 18 years
- Admitted to the emergency department and diagnosed with an ischemic stroke
Key exclusion criteria (3 listed)
- Diagnosed with cerebral venous thrombosis
- Diagnosed with hemorrhage
- Thrombectomy performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionLearning session 1: explain key interventions, explain BIC methodology, retrospective patient record analysis Learning session 2: feedback report, share best practices, discussion, set priorities, teaching and improvement, retrospective patient record analysis Learning session 3: feedback report, share best practices, discussion, set priorities, teaching and improvement, retrospective patient record analysis Learning session 4: feedback report | Other | Intervention |
Primary outcome
Variation within and between hospitals
Time frame: through study completion, an average of 3 months
Variation of Brain imaging + timing, Glycemia (venous blood sample or finger prick) + timing, Clinical neurologic examination + timing, Time of onset, Administration of IV tPA + timing, Administration of aspirin + timing Blood pressure, time of first measurement and measurement frequency during first 72h, Oxygen saturation, time of first measurement and measurement frequency during first 72h, Temperature, time of first measurement and measurement frequency during first 72h, Glycemia and measurement frequency during first 72h, First dysphagia screening and timing, Advice from speech therapist if screening failed and timing, Cardiac monitoring, Screening for depression, ADL screening, The use of a bladder catheter is not recommended, Prophylactic treatment with antibiotics is not recommended, Deep venous thrombosis prevention
2 secondary outcomes
Mortality rate
Time frame: Through study completion on average of 3 months
modified Rankin Scale
Time frame: Through study completion on average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stroke, Ischemic, 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 3 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: status not confirmed, as of the sponsor's last update on 9 Feb 2023. 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?
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?
Variation within and between hospitals (time frame: through study completion, an average of 3 months). 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 9 Feb 2023.