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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifaceted Strategy | Experimental | Multifaceted Intervention
|
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| Usual Care | No Intervention | Hospital Standard Treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multifaceted Strategy | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| "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 |
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Patient Eligibility Criteria
Inclusion Criteria:
Exclusion Criteria:
Cluster Eligibility Criteria
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Otavio Berwanger, MD, PhD | Hospital do Coração | Study Chair |
| M. Julia Machline Carrion, MD, MHS, PhD | Hospital do Coração | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brazil | São Paulo | 04004-050 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31058947 | Derived | 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. | |
| 30415083 |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Discharge or 7 days after admission |
| 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) | Discharge or 7 days after admission |
| Total Mortality | In hospital and 90 days mortality | Discharge or 7 days after admission and 90 days |
| Disability | Degree of disability (measured by the Modified Rankin Scale) at discharge and in 90 days. | 90 days |
| Stroke Recurrence | Number of patients presenting a new stroke in 90 days | 90 days |
| 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |