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

NCT ID: NCT02223273

Last Updated: 2018-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1624 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Multifaceted Strategy

Multifaceted Intervention

1. Simulation Based Team Training
2. Case Manager
3. Check lists
4. Reminders
5. Educational Materials

Group Type EXPERIMENTAL

Multifaceted Strategy

Intervention Type BEHAVIORAL

1. Simulation Based Team Training
2. Case Manager: a trained person who works in the hospital and is responsible for ensuring the usage of all interventions
3. Reminders -
4. Check lists - decision support algorithm
5. Distribution of educational materials: guidelines and recommendations for best practices

Usual Care

Hospital Standard Treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multifaceted Strategy

1. Simulation Based Team Training
2. Case Manager: a trained person who works in the hospital and is responsible for ensuring the usage of all interventions
3. Reminders -
4. Check lists - decision support algorithm
5. Distribution of educational materials: guidelines and recommendations for best practices

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years old, diagnosed with ischemic stroke (including transient ischemic attack) with symptoms lasting up to 24 hours.


* Hospitals with a emergency department, with available tomography, neurologist and alteplase

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


* Hospitals that don't provide Institutional Authorization Form
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital do Coracao

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Otavio Berwanger, MD, PhD

Role: STUDY_CHAIR

Hospital do Coração

M. Julia Machline Carrion, MD, MHS, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital do Coração

Locations

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Brazil

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 31058947 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30415083 (View on PubMed)

Other Identifiers

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BRIDGE-Stroke

Identifier Type: -

Identifier Source: org_study_id

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