Clinical trial NCT02223273: Brazilian Intervention to Increase Evidence Usage in Practice - Stroke (BRIDGE-Stroke)
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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: stroke,
quality improvement
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
First posted: 2014-08-22
Enrollment: 1624
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Frequency of Evidence Based Strategies
timeFrame: Discharge or 7 days after admission
measure: Composite Adherence Score
timeFrame: Discharge or 7 days after admission
Secondary outcomes:
measure: "All or None" Quality Measures
timeFrame: Discharge or 7 days after admission
measure: Additional Strategies
timeFrame: Discharge or 7 days after admission
measure: Total Mortality
timeFrame: Discharge or 7 days after admission and 90 days
measure: Disability
timeFrame: 90 days
measure: Stroke Recurrence
timeFrame: 90 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Brazil
Study officials:
affiliation: Hospital do Coração
name: Otavio Berwanger, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital do Coração
name: M. Julia Machline Carrion, MD, MHS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.