NCT05218135

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,610

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

3.8 years

First QC Date

January 18, 2022

Last Update Submit

February 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    through study completion, an average of 3 months

Secondary Outcomes (2)

  • Mortality rate

    Through study completion on average of 3 months

  • modified Rankin Scale

    Through study completion on average of 3 months

Study Arms (1)

Intervention

Breakthrough improvement collaborative

Other: Intervention

Interventions

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute ischemic stroke

You may qualify if:

  • Minimum age of 18 years
  • Admitted to the emergency department and diagnosed with an ischemic stroke

You may not qualify if:

  • Diagnosed with cerebral venous thrombosis
  • Diagnosed with hemorrhage
  • Thrombectomy performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Methods

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2022

First Posted

February 1, 2022

Study Start

March 1, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations