A Cluster Randomized Trial to Evaluate the Increase in Usage of Evidence-based Practices for Stroke Treatment Using a Multifaceted Strategy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospital do Coracao
- Enrollment
- 1,624
- Locations
- 2
- Primary Endpoint
- Frequency of Evidence Based Strategies
Study Overview
Brief Summary
Phase 1: An observational study ( registry) will be conducted with the objective of documenting the practice of stroke treatment in brazilian and latin american hospitals.
Phase 2: A cluster randomized trial aiming to evaluate the effect of a multifaceted strategy to increase evidence based treatments usage for stroke patients. The hospitals will be randomized into two groups: the multifaceted strategy group and the usual care group.
Detailed Description
Study Objective: The purpose of this study is to evaluate a multifaceted strategy to increase evidence based therapies for patients with acute ischemic stroke.
Study Population; Patients with suspected stroke or transient ischemic attack (TIA) with symptoms lasting up to 24h hours.
Quality Improvement Multifaceted Intervention: The strategy includes a simulation based team training, case manager, check lists, reminders and educational material.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients over 18 years old, diagnosed with ischemic stroke (including transient ischemic attack) with symptoms lasting up to 24 hours.
Exclusion Criteria
- •Patients with signs of hemorrhagic stroke, expansive lesions, central nervous system infections, and those coming from institutions that did not provide institutional approval form signed by the patients' guardians.
- •Cluster Eligibility Criteria
- •Inclusion Criteria:
- •Hospitals with a emergency department, with available tomography, neurologist and alteplase
- •Exclusion Criteria:
- •Hospitals that don't provide Institutional Authorization Form
Arms & Interventions
Multifaceted Strategy
Multifaceted Intervention
- Simulation Based Team Training
- Case Manager
- Check lists
- Reminders
- Educational Materials
Intervention: Multifaceted Strategy (Behavioral)
Usual Care
Hospital Standard Treatment
Outcomes
Primary Outcomes
Frequency of Evidence Based Strategies
Time Frame: Discharge or 7 days after admission
For phase 1: Proportion of prescription of evidence-based strategies. in the first 48 hours and prior to discharge
Composite Adherence Score
Time Frame: Discharge or 7 days after admission
Composite Adherence Score: defined as the sum of usage of evidence based therapies in the first 48 hours and at discharge among the patients' total eligible opportunities. For this purpose, patients with contraindications (which are specific for each endpoint) were excluded from the denominators. Evidence based therapies in the first 48 hours include: antithrombotics within 48 hours of admission, use of recombinant Plasminogen Activator (Rt-PA)in patients who arrive at the hospital within 3.5 hours of symptom onset and who are treated within 4.5 hours of symptom onset, dysphagia screening, pre-deep venous thrombosis prophylaxis, door to needle time \< 60 minutes, dysphagia screening). Discharge Therapies include: antithrombotics, lipid lowering agents in patients with LDL 100 or not documented, anticoagulants for atrial fibrilation or flutter, assessment for rehabilitation and smoke cessation education
Secondary Outcomes
- Stroke Recurrence(90 days)
- "All or None" Quality Measures(Discharge or 7 days after admission)
- Disability(90 days)
- Additional Strategies(Discharge or 7 days after admission)
- Total Mortality(Discharge or 7 days after admission and 90 days)