Brazilian Intervention to Increase Evidence Usage in Practice - Stroke (BRIDGE-Stroke)

Acute Ischemic Stroke Clinical Trial

— BRIDGEStroke  

Official title:

A Cluster Randomized Trial to Evaluate the Increase in Usage of Evidence-based Practices for Stroke Treatment Using a Multifaceted Strategy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223273
• Other study ID #: BRIDGE-Stroke
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 2018

Study information

• Verified date: October 2018
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1624
• Est. completion date: June 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient Eligibility Criteria

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Stroke

Intervention

Behavioral:
• Multifaceted Strategy
Simulation Based Team Training Case Manager: a trained person who works in the hospital and is responsible for ensuring the usage of all interventions Reminders - Check lists - decision support algorithm Distribution of educational materials: guidelines and recommendations for best practices

Locations

Country	Name	City	State
Brazil	Brazil	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Evidence Based Strategies	For phase 1: Proportion of prescription of evidence-based strategies. in the first 48 hours and prior to discharge	Discharge or 7 days after admission
Primary	Composite Adherence Score	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	Discharge or 7 days after admission
Secondary	"All or None" Quality Measures	Proportion of prescription of evidence-based strategies in the first 48 hours and at discharge "All or none" measures including the evidence based therapies in the first 48h: antithrombotics, 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	Discharge or 7 days after admission
Secondary	Additional Strategies	Proportion of usage of the additional strategies: use of recombinant Plasminogen Activator (Rt-PA), anti-hypertensive agents, and door to needle time< 45 min)	Discharge or 7 days after admission
Secondary	Total Mortality	In hospital and 90 days mortality	Discharge or 7 days after admission and 90 days
Secondary	Disability	Degree of disability (measured by the Modified Rankin Scale) at discharge and in 90 days.	90 days
Secondary	Stroke Recurrence	Number of patients presenting a new stroke in 90 days	90 days