A Study of the Efficacy of the Code Stroke in Spain

Not Applicable

Completed

• Conditions: Stroke, Acute
• Interventions: Procedure: Code Stroke

• Registration Number: NCT02647957
• Lead Sponsor: Universidad Miguel Hernandez de Elche

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-12-26
• Study Start: 2016-01
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-06
• Primary Completion: 2016-03
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• acute ischemic stroke in-patients

Exclusion Criteria

• Patients who refuse participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Code Stroke	Hospital using Code Stroke

Primary Outcome Measures

Name	Time	Method
Recovery rate of the Intravenous trombolysis treatment	1 month	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.

Secondary Outcome Measures

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