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

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Multifaceted Strategy
Sponsored by
Hospital do Coracao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Ischemic Stroke focused on measuring stroke,, quality improvement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brazil

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multifaceted Strategy

Usual Care

Arm Description

Multifaceted Intervention Simulation Based Team Training Case Manager Check lists Reminders Educational Materials

Hospital Standard Treatment

Outcomes

Primary Outcome Measures

Frequency of Evidence Based Strategies
For phase 1: Proportion of prescription of evidence-based strategies. in the first 48 hours and prior to discharge
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

Secondary Outcome Measures

"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
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)
Total Mortality
In hospital and 90 days mortality
Disability
Degree of disability (measured by the Modified Rankin Scale) at discharge and in 90 days.
Stroke Recurrence
Number of patients presenting a new stroke in 90 days

Full Information

First Posted
August 19, 2014
Last Updated
October 1, 2018
Sponsor
Hospital do Coracao
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1. Study Identification

Unique Protocol Identification Number
NCT02223273
Brief Title
Brazilian Intervention to Increase Evidence Usage in Practice - Stroke (BRIDGE-Stroke)
Acronym
BRIDGEStroke
Official Title
A Cluster Randomized Trial to Evaluate the Increase in Usage of Evidence-based Practices for Stroke Treatment Using a Multifaceted Strategy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital do Coracao

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
stroke,, quality improvement

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1624 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multifaceted Strategy
Arm Type
Experimental
Arm Description
Multifaceted Intervention Simulation Based Team Training Case Manager Check lists Reminders Educational Materials
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Hospital Standard Treatment
Intervention Type
Behavioral
Intervention Name(s)
Multifaceted Strategy
Intervention Description
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
Primary Outcome Measure Information:
Title
Frequency of Evidence Based Strategies
Description
For phase 1: Proportion of prescription of evidence-based strategies. in the first 48 hours and prior to discharge
Time Frame
Discharge or 7 days after admission
Title
Composite Adherence Score
Description
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
Time Frame
Discharge or 7 days after admission
Secondary Outcome Measure Information:
Title
"All or None" Quality Measures
Description
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
Time Frame
Discharge or 7 days after admission
Title
Additional Strategies
Description
Proportion of usage of the additional strategies: use of recombinant Plasminogen Activator (Rt-PA), anti-hypertensive agents, and door to needle time< 45 min)
Time Frame
Discharge or 7 days after admission
Title
Total Mortality
Description
In hospital and 90 days mortality
Time Frame
Discharge or 7 days after admission and 90 days
Title
Disability
Description
Degree of disability (measured by the Modified Rankin Scale) at discharge and in 90 days.
Time Frame
90 days
Title
Stroke Recurrence
Description
Number of patients presenting a new stroke in 90 days
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Otavio Berwanger, MD, PhD
Organizational Affiliation
Hospital do Coração
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
M. Julia Machline Carrion, MD, MHS, PhD
Organizational Affiliation
Hospital do Coração
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brazil
City
São Paulo
ZIP/Postal Code
04004-050
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
31058947
Citation
Machline-Carrion MJ, Santucci EV, Damiani LP, Bahit MC, Malaga G, Pontes-Neto OM, Martins SCO, Zetola VF, Normilio-Silva K, Rodrigues de Freitas G, Gorgulho A, De Salles A, Pacheco da Silva BG, Santos JY, de Andrade Jesuino I, Bueno PRT, Cavalcanti AB, Guimaraes HP, Xian Y, Bettger JP, Lopes RD, Peterson ED, Berwanger O; BRIDGE-Stroke Investigators. Effect of a Quality Improvement Intervention on Adherence to Therapies for Patients With Acute Ischemic Stroke and Transient Ischemic Attack: A Cluster Randomized Clinical Trial. JAMA Neurol. 2019 Aug 1;76(8):932-941. doi: 10.1001/jamaneurol.2019.1012.
Results Reference
derived
PubMed Identifier
30415083
Citation
Machline-Carrion MJ, Santucci EV, Damiani LP, Bahit C, Malaga G, Pontes-Neto OM, Martins SCO, Zetola VF, Normilio-Silva K, de Freitas GR, Gorgulho A, De Salles A, da Silva BGP, Santos JY, de Andrade Jesuino I, Bueno PRT, Cavalcanti AB, Guimaraes HP, Xian Y, Bettger JP, Lopes RD, Peterson ED, Berwanger O. An international cluster-randomized quality improvement trial to increase the adherence to evidence-based therapies for acute ischemic stroke and transient ischemic attack patients: Rationale and design of the BRIDGE STROKE Trial. Am Heart J. 2019 Jan;207:49-57. doi: 10.1016/j.ahj.2018.09.009. Epub 2018 Sep 30.
Results Reference
derived

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

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