A Study of the Efficacy of the Code Stroke in Spain

Study Overview
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Brief Summary
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Code Stroke is a system for the rapid identification, pre-notification and transport of acute ischemic stroke patients. The objective of this study was to define quality indicators and to compare treatment outcomes in hospitals where Code Stroke has been implemented and hospitals without the use of Code Stroke (control patients).

Detailed Description
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In a first step qualitative technique has been conducted to define treatment quality indicators of acute ischemic stroke patients. In a second step a prospective study is conducted to collect data of 240 inpatients from two groups of hospitals. Two hospitals applying Code Stroke (N= 120) and four hospitals non-applying Code Stroke procedure (N=120). A consecutive sampling method will be conducted. Inclusion criteria: acute ischemic stroke patients treated in the hospitals during the field study. The referral to the hospital could be from primary care, Emergency Unit of other hospital. Patients will enroll after inform consent. A Singer-blind- research method will applied. Quality indicators defined in the first phase will be applied and comparisons will be realized using ANOVA.

Official Title
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Indicators for Quality Assessment of Hospitalized Ischemic Stroke Patients. A Study of the Efficacy of the Code Stroke in Spain

Conditions
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Stroke, Acute

Intervention / Treatment
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* Procedure: Code Stroke


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute ischemic stroke in-patients Exclusion Criteria: Patients who refuse participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Hospital using Code Stroke | Procedure: Code Stroke<br>* Apply a protocol called Code Stroke that involves the entire care chain from emergency teams outpatient specialists of Neurology, Internal Medicine, Radiology or Intensitivos Care, among other hospital areas.<br>|
| No Intervention: Group B<br>Hospital not using Code Stroke | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery rate of the Intravenous trombolysis treatment | Number of patients showing an adequate recovery after Intravenous trombolysis treatment as assessed by the criteria of the Quality Indicator Board of the German Stroke Registers Study Group and the National Sentinel Audit of Stroke. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Patient Satisfaction Scale | 1 month | 
| Patient engage | Health literacy Scale | 1 month | 
| response capacity | Response time for the initial evaluation and treatment | 1 day | 
| Treatment adequacy: Intravenous trombolysis treatment | Intravenous trombolysis treatment applied in eligible ischemic stroke patients | 1 month | 
| Patient safety. Complications in the recombinant tissue plasminogen activator treatment after tromobysis | Recombinant tissue plasminogen activator complication rates | 1 month | 
| Mortality rates of the Intravenous trombolysis treatment | Mortality rates of the Intravenous trombolysis treatment when applied in eligible ischemic stroke patients | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ischemic stroke, quality