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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Other: Intervention

• Study Type: Observational
• Enrollment (Anticipated): 2610

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute ischemic stroke

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	Mortality rate	Through study completion on average of 3 months
modified Rankin Scale	modified Rankin Scale going from 0 (no symptoms) until 6 (death)	Through study completion on average of 3 months

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (ACTUAL): February 1, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: BIC4Stroke

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No