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

NCT02223273 | Completed

• 1 other identifier: BRIDGE-Stroke
• Study Type: interventional
• Target: 1,624
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

stroke,; quality improvement

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• "All or None" Quality Measures

  Discharge or 7 days after admission

• Additional Strategies

  Discharge or 7 days after admission

• Total Mortality

  Discharge or 7 days after admission and 90 days

• Disability

  90 days

• Stroke Recurrence

  90 days

Study Arms (2)

Multifaceted Strategy

EXPERIMENTAL

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

Behavioral: Multifaceted Strategy

Usual Care

NO INTERVENTION

Hospital Standard Treatment

Interventions

Multifaceted Strategy 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

Multifaceted Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 with a emergency department, with available tomography, neurologist and alteplase
• Hospitals that don't provide Institutional Authorization Form

Sponsors & Collaborators

• Hospital do Coracao: lead

Study Sites (1)

Brazil

São Paulo, 04004-050, Brazil

Location

Related Publications (2)

• 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.

  PMID: 31058947 DERIVED

• 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.

  PMID: 30415083 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Otavio Berwanger, MD, PhD

  Hospital do Coração

  STUDY CHAIR

• M. Julia Machline Carrion, MD, MHS, PhD

  Hospital do Coração

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 22, 2014
• Study Start: September 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-10

Locations

BR (1)