BIC: Evaluation of the Current Care Processes for Stroke Care in Flemish Hospitals

Sponsor
KU Leuven (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05218135
Collaborator
(none)
2,610
1
46
56.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
2610 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Evaluation of the Current Care Processes for Stroke Care in Flemish Hospitals Via a Breakthrough Improvement Collaborative
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Intervention

Breakthrough improvement collaborative

Other: Intervention
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

Outcome Measures

Primary Outcome Measures

  1. Variation within and between hospitals [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

Secondary Outcome Measures

  1. Mortality rate [Through study completion on average of 3 months]

    Mortality rate

  2. modified Rankin Scale [Through study completion on average of 3 months]

    modified Rankin Scale going from 0 (no symptoms) until 6 (death)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Minimum age of 18 years

  • Admitted to the emergency department and diagnosed with an ischemic stroke

Exclusion Criteria:
  • Diagnosed with cerebral venous thrombosis

  • Diagnosed with hemorrhage

  • Thrombectomy performed

Contacts and Locations

Locations

Site City State Country Postal Code
1 KU Leuven Leuven Vlaams-Brabant Belgium 3000

Sponsors and Collaborators

  • KU Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kris Vanhaecht, Professor, KU Leuven
ClinicalTrials.gov Identifier:
NCT05218135
Other Study ID Numbers:
  • BIC4Stroke
First Posted:
Feb 1, 2022
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2022