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

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ClinicalTrials.gov Identifier: NCT02223273
Recruitment Status : Completed
First Posted : August 22, 2014
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital do Coracao

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.


Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Behavioral: Multifaceted Strategy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1624 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Cluster Randomized Trial to Evaluate the Increase in Usage of Evidence-based Practices for Stroke Treatment Using a Multifaceted Strategy
Actual Study Start Date : September 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multifaceted Strategy

Multifaceted Intervention

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

No Intervention: Usual Care
Hospital Standard Treatment



Primary Outcome Measures :
  1. Frequency of Evidence Based Strategies [ Time Frame: Discharge or 7 days after admission ]
    For phase 1: Proportion of prescription of evidence-based strategies. in the first 48 hours and prior to discharge

  2. Composite Adherence Score [ Time Frame: Discharge or 7 days after admission ]
    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 :
  1. "All or None" Quality Measures [ Time Frame: Discharge or 7 days after admission ]
    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

  2. Additional Strategies [ Time Frame: Discharge or 7 days after admission ]
    Proportion of usage of the additional strategies: use of recombinant Plasminogen Activator (Rt-PA), anti-hypertensive agents, and door to needle time< 45 min)

  3. Total Mortality [ Time Frame: Discharge or 7 days after admission and 90 days ]
    In hospital and 90 days mortality

  4. Disability [ Time Frame: 90 days ]
    Degree of disability (measured by the Modified Rankin Scale) at discharge and in 90 days.

  5. Stroke Recurrence [ Time Frame: 90 days ]
    Number of patients presenting a new stroke in 90 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223273


Locations
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Brazil
Brazil
São Paulo, Brazil, 04004-050
Sponsors and Collaborators
Hospital do Coracao
Investigators
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Study Chair: Otavio Berwanger, MD, PhD Hospital do Coração
Principal Investigator: M. Julia Machline Carrion, MD, MHS, PhD Hospital do Coração

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT02223273     History of Changes
Other Study ID Numbers: BRIDGE-Stroke
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018
Keywords provided by Hospital do Coracao:
stroke,
quality improvement
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases